National Institutes of Health Privacy Impact Assessments
06.3 HHS PIA Summary for Posting (Form) / NIH CC 3M Automated Medical Record Processing System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Automated Medical Record Processing and Tracking Applications
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: Automated medical record processing and tracking applications containing demographic and tracking information is maintained on registered Clinical Center patients in order to route documents for creation, recording, retention, signature and location.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): None
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information is collected to identify and route clinical documentation electronically for user review and confirmation. Patient and clinician demographic information, along with clinical documentation identifiers and location information. The information is voluntarily provided at the time of dictation or authorship and each patient is informed of CC information practices before admission as a patient at the Clinical Center.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The automated medical record processing and tracking applications are a part of the medical record system which is an approved Privacy Act System. As such, each individual is informed of all information practices and any major system changes are published under a revised SORN.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: All information is protected by applying user ID, hierarchal passwords and administrative controls including supervisor limiting employee access on a need-to-know and minimum amount basis.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Activity Based Cost System (ABC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-01-02-3099-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): None
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): NIH CC Activity Based Costing System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: The ABC System contains information about resource allocation across research protocols conducted in the Intramural Resesarch Program of the NIH, including specific protocol identification data, as well as other information related to medical care, supplies and services related to those protocols.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): NIH employees for budget review and development.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The only IIF involved in the ABC System are the names of the investigators related to each research protocol, all of whom are NIH employees. It is mandatory that each protocol have a related principal investigator. All remaining information relates to budgetary requirements, including specific clinical services, IC budgets and resource allocation.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Employees provide names at the time they apply for protocol approval from their IRB, which is required for protocol review and administrative approval. If any information other than employee names are collected, then notification will be sent out from OFRM to each indiviudal. However, there are no current plans to collect additional IIF in the future.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Only authorized person may have access to the ABC System and the system is protected through door locks and other physical controls, as well as technical controls including user identification and password protection.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240: smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Admissions and Travel Voucher Application (ATV)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Admissions and Travel Voucher (ATV) Application
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: This is an ancillary application part of the CRIS system that allows research teams to register and procure travel requistions and payments.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Shares information with travel agents so that travel arrangements can be made. Sharing is done per SOR 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Legislation authority is the Public Health Service Act. (42 U.S.C. 241, 242, 248, 281, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.) The information collected is name, date of birth, social security number, mailing address, medical record number. This information is used to register individuals as participitants in clinical trials and to assist in providing travel arrangements for those individuals. Information is disclosed to travel agents to assist in making the necessary travel arangements. Information submission is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Notification of all information practices are provide to every patient particpating in research upon initial registration and upon every re-registration, including any changes to collection and types of information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: IIF is secured using username/passwords, secure sockets, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained,
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin, CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Automated Medication Dispensing (Omnicell)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): In process
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): CC Automated Medication Dispensing (Omnicell)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: The system automates the Pharmacy Dept's ability to manage and dispense medications at the point of use, increasing patient safety with the use of medication profiles, improving workflow efficiency and enhancing medication security.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not Applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system captures and maintains information on registered CC patients including patient name, Date of Birth, MRN, gender, allergies, medication order number and administration instructions. The system captures and maintains information on CC caregivers including staff name, user role and fingerprint biometric identifier. The information is shared with Omnicell administrators in Pharmacy, CC Nurse Managers responsible for the investigation of dispensing cabinet diversion reports. The collection of PII is voluntary since admission to the CC and specific research protocol(s) is completely voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Admission to the Clinical Center (CC) is completely voluntary and requires consent of each patient. Additionally, each patient is provided a full written accounting of established information practices at the CC, including the capture and use of PII, and has the opportunity to ask questions. Each patient must acknowledge receipt of same through manual signature on the Information Practices Form.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: PII will reside on a server in the CC DataCenter protected by restricted access and video monitoring. The server will be behind the NIH and CC clinical firewall. The Omnicell SecureVault PC and stand alone PC in the Pharmacy Dept are protected by restricted access and video monitoring. The Omnicell automated medication dispensing cabinets are on the medical VLAN and located in the Nursing Units behind locked doors with access restricted by Staff ID badge or key or cipher lock. Access to the dispensing cabinets is granted by user type and is set by the Pharmacy Dept Omnicell Administrator in accordance with Pharmacy policies. Access to the dispensing cabinets will require password or fingerprint identification and inclusion in specific user types based on the user role.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, 301-496-4240
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Automated Nurse Staff Office Schedule (ANSOS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 9, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-3008-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): CC ANSOS: Automated Nurse Staff Office Schedule
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Barbara Quinn
10. Provide an overview of the system: The ANSOS System is used to arrange schedules and project staffing needs for nurses caring for patients at the Clinical Center and is authorized by Section 301 of the Public Health Service Act.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): As per SOR 09-90-0019. This information is further addressed in the HHS Privacy Act Systems of Record Notice 09-90-0018, published in the Federal Register, Volume 59, November 9, 1994.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Includes basic identification data including name, date of birth, address, phone numbers and related information (CC training attendance records) necessary to develop schedules for nurses. Submission is mandatory if the individual wishes to be employed as a nurse at the Clinical Center. In addition, inpatient census data by patient care unit and outpatient census data by outpatient clinic and day hospital is collected to project utilization and staffing needs across the Clinical Center.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Each individual is informed of information practices at the time of job application and subsequently when individual schedules are developed. In addition, the CC Nursing Department is responsible for notifying each nurse of major system changes related to IIF, which may be done electronically or in written form.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Only authorized person may have access to the ANSOS System and the system is protected through door locks and other physical controls, as well as technical controls including user identification and password protection.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Biomedical Translational Research Information System (BTRIS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 9, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 00-00-00
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH Biomedical Translational Research Information System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Elaine Ayres
10. Provide an overview of the system: BTRIS will contain longitudinal data, text and images from NIH intramural clinical care and research systems to facilitate data analysis, hypothesis generation and patient recruitment in support of the NIH intramural research mission. Principal investigators and designees (e.g. associate investigators) will be allowed to access identified data only as permitted by their active protocol(s). Other users with appropriate IRB or OHSR clearances will be able to access and query only data in a de-identified manner.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): PII data in BTRIS will only be shared with authorized principal investigators for patients enrolled in their active protocols or others authorized by the appropriate IRB or OHSR e.g. associate investigators. All others will only be granted access to de-identified data. Data will be used for statistical analysis, hypothesis development & testing, clinical comparison and subject recruitment.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Clinical and research data including diagnostic, therapeutic, imaging, and research testing results will be stored in BTRIS. PII will be collected and will include names, medical record numbers and diagnosis. PII data in BTRIS will only be shared with authorized principal investigators for patients enrolled in their active protocols or others authorized by the appropriate IRB or OHSR e.g. associate investigators. All others will only be granted access to de-identified data. Data will be used for statistical analysis, hypothesis development & testing, clinical comparison and subject recruitment. The collection of all data is voluntary. Every patient must voluntarily execute a protocol consent and admission consent prior to entry onto an intramural research protocol and treatment at the Clinical Center. In addition, each patient is provided a formal notificaion of Information Practices at the Clinical Center must certify that they have be so advised.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Every patient must voluntarily execute a protocol consent and admission consent prior to entry onto an intramural research protocol and treatment at the Clinical Center. In addition, each patient is provided a formal notificaion of Information Practices at the Clinical Center must certify that they have be so advised. BTRIS will contain longitudinal data, text and images from NIH intramural clinical care and research systems to facilitate data analysis, hypothesis generation and patient recruitment in support of the NIH intramural research mission. Principal investigators and designees (e.g. associate investigators) will be allowed to access identified data only as permitted by their active protocol(s). Other users with appropriate IRB or OHSR clearances will be able to access and query only data in a de-identified manner. If a major change occurs, a revised Information Practices From will be developed and presented to each patient.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The BTRIS system and all data contained therein are protected using administrative, technical and physical security and privacy control. The system is behind locked doors, monitored by closed circuit TV and security cipher locks. In addition, only principal investigators or others authorized by an appropriate IRB or OHSR have access PII, while all others only have access to de-identified data. Access is also restricted based on user roles and password authentication.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jerry P. King, CC Privacy Officer, (301) 451-4954, jking@nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Blood Bank Collection System (BBCS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 29, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-3007-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0011
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Blood Bank Collection System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Boyd Conley
10. Provide an overview of the system: The systems contains data regarding donors at the Department of Transfusion Medicine used to conduct clinical care and research at the Clinical Center as authorized by Section 301 of the Public Health Service Act.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): None
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information, including past donations, blood types, phenotypes, lab results, serologic reactions and related information, is collected from donors of blood and blood components to be used for clinical care and research at the Clinical Center. Submission is mandatory since donations must be directly attributable to each individual donor.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Each individual donor is informed of required information collection and uses before donation. Major systems changes would be sent directly to each donor and new consents obtained upon new donations.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Only authorized person may have access and the system is protected through door locks and other physical controls, as well as technical controls including user identification and password protection.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Clinical Research Information System (CRIS Core)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 27, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-06-01-3006-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: NO
6. Other Identifying Number(s): CC-1
7. System Name (Align with system Item name): Clinical Research Information System (CRIS Core)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dr. Jon McKeeby
10. Provide an overview of the system: Core system and component applications to document clinical care and research for registered patients at the Clinical Research Center: NIH. This activity is authorized by Section 301 of the Public Health and Safety Act
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The Mayo Clinic for contracted lab tests not performed by the Department Of Laboratory Medicine at the CC.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information collected includes individual pateint demographics, clinical research data and those related to diagnosis and treatment at the Clinical Center. These may include results of laboratory tests, imaging studies, blood product utilization,social work encounters, medical & ethical consults, surgery and other related clinical interactions while a patient at the Clinical Center. Patient information collected by the NIH as described in the NIH System of Records 09-25-0099 is utilized as the official clinical research record for each research participant. The information contains IIF and the submission is voluntary based on an individual's consent to become a registered patient at NIH.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Information is obtained from patient interviews, referring physicians, a multi-disciplinary care team, and diagnostic, therapeutic, and research results. Admission and protocol consent forms are signed by each patient and an information practices notification form is provided to each patient a the time of initial admission. Each patient would be advised at the time of admission about major system changes and the CC Information Practices notice would be revised and provided to each patient.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The system and all contained data are protected using administrative, technical, and physical security and privacy controls. System is behind locked doors, monitored by CC TV and cipher locks. In addition, only authorized users have access which is restricted based on user roles and hierarchal passwords.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin, CC Privacy Officer, (301) 496-4240
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Clinical Research Volunteer Program (CRVP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 6, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3099-00-110-031
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0012
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Clinical Research: Candidate Potential Volunteer and Research Subject Records
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: System is used to contain information about potential candidates for participation as volunteers or research subjects participating in clinical research protocols at the Clinical Center.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This information is addressed in the NIH Privacy Act Systems of Record Notice 09-25-0012, published in the Federal Register, Volume 67, No. 187, September 26, 2002.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Demographics and health information are collected from program applications, health questionnaires and records of prior participation to provide appropriate persons as volunteers or research subjects in approved research protocols conducted at the Clinical Center. Submission is voluntary if person does not want to be referred as a potential research subject but mandatory for those who do wish to be referred. Information is also used to process requests for compensation and authorization of payments to research volunteers. Checks are issued by the Treasury Department.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Each person is verbally informed of information uses and verabl consent is obtained from each person who wishes to be evaluated as a potential research subject. Each indiviudal is informed of information collection and uses prior to acceptance as a volunteer or patient. Each applicant would be notified directly by phone of any major system changes and new consent would be obtained.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: As per standard CIT procedures for the collection, maintenance and destruction of computer files, as well as as specified in the PA Systems Notice.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240 - smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Data Center (CCDC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 13, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3007-00-110-031
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): NO
5. OMB Information Collection Approval Number: NO
6. Other Identifying Number(s): NO
7. System Name (Align with system Item name): Clinical Center Data Center
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system:
The CC Data Center (CCDC) supports approximately 4,500 users within the NIH Clinical Center, and is located in Bldg 10 on the NIH campus in Bethesda, Maryland. The CCDC hosts a myriad of servers, components, workstations and infrastructure devices used to manage NIH information. The Department of Clinical Research Informatics (DCRI) is responsible for the management of the CCDC
The CCDC comprises a variety of servers including network servers, application servers, and Web and Internet servers. CCDC has been identified as a Data Center.
While many applications reside within the servers in the CCDC, the CCDC itself does not processes or store any data that could be considered IIF.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No IIF collected, stored, or processed. Private shares on CCDC file servers are used by CC personnel for storage of working documents to facilitate performance of their assigned duties. The information in working documents is not IIF per NIH and CC policies.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No IIF collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A--No IIF collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin, CC Privacy Officer, 301-496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC DTM SQL System Applications
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0011
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): CC DTM Applications Non-COTS (DANC)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: The DTM Applications Non-Cots (DANC) provides the Department of Transfusion Medicine (DTM) with administrative reporting functionality for donors and research management. The system provides DTM staff with tools to make decisions about the collection, use and distribution of donated blood.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not Applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The DANC system will collect demographic information, medical notes, travel history and laboratory results on donors and NIH research participants. The information is used by DTM staff to perform routine tasks required by the American Association of Blood Banks and the FDA and support CC research protocols. The system will collect PII on donors and NIH research participants. The submission is mandatory since donations must be directly attributable to each individual donor.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Each individual donor is informed of required information collection and uses before donation. Major systems changes would be sent directly to each donor and new consents obtained upon new donations.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Only authorized persons with assigned roles may have access to the system. The DANC system is protected in the CC Data Center through door locks and other physical controls. Access to DANC is secured by technical controls; including user identification and password protection.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, 301-496-4240
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Executive Information System (EIS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 24, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-02-3099-00-403-131
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): YES, 09-25-0099 with revision to routine uses pending
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): CC Executive Information System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: The Executive Information System (EIS) is an application designed to provide real time reporting of key hospital performance indicators. The EIS provides query and reporting capabilities for executive decision makers, and allows staff to view daily, monthly, annual patient census information and key hospital performance metrics. Census data can be reported by hospital unit and protocol, IC, branch, and Principal Investigator.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Yes
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: EIS reports (does not collect) census statistics. Metrics include admissions, inpatient days, outpatient visits, average length of stay, discharges, and patient counts. The information is used by nursing and clinical departments to manage operations and is used by executive leadership to track trends in hospital census activity. Principle investigator name associated with protocol activity is reported.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Priniciple investigators provide name at the time they apply for protocol approval from their IRB, which is required for protocol review and administrative approval. If any information other than principle investigator names are collected, then notification will be sent out from OFRM to each individual. CC social workers provide name when they confirm the outpatient appointment in the scheduling.com application. If any information other than CC social workers name are collected, then notification will be sent out from OFRM to each individual.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: IIF is secured using user names/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access and background investigations.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin, CC Privacy Officer, 301-496-4240
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Lawson
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 29, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3099-00-110-031
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Lawson
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: John Franco
10. Provide an overview of the system: Lawson is an Inventory Management System. Everything that is bought, received, stored, transferred, issued, or disposed of is recorded and controlled. The program is a live inventory instantaneously recording any supply activity that is entered in the system. It makes daily recommendations for both replenishing the Central Hospital Supply shelves from the Storage & Distribution Warehouse; as well as provide reorder for supplies that have fallen below their "par levels". It is the database that is linked to the Visual Supply Catalogue to provide the users the best "picture" and information on medical supplies. Finally, in the absence of a true financial link to inventory.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Lawson is a supply/inventory software that stores customer (patient care units, Clinics, ancillaries, not real people names) and product information. The information stored is a history of purchases, receipts, issues, transfers etc. of supplies purchased and equipment purchased by the Materials Management Department and consumed by the CC.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) This is an inventory management system - No IIF is collected or maintained
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: This is an inventory management system - no IIF is collected or maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: jfranco@nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Medical Staff Credentialing Processes (SACRED)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-3099-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0169
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Medical Staff Credentials Files
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: Information is collected from individual members of the Clinical Center Medical Staff and is used to document their credentialing and privileging under authority of Section 301 of the Public Health Service Act.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Private medical facilities, state medical boards and accrediting bodies as part of the credentialing process.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Names, addresses, phone numbers, medical licenses, college information and related data as part of the individual's application for membership on the Clinical Center Medical Staff. Submission is voluntary since application for membership is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Information is obtained directly from each applicant and each is informed about information collection procedures and rules when each applicant signs the consent authorizing the collection. Major systems changes would be sent electronically to each member of the medical staff and new consents obtained at the time of reappointment to the staff.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: As per standard CIT procedures for the maintenance, archiving and destruction of computer files and as published in the PA SORN.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Medicolegal Request Tracking System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 24, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3099-00-110-031
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Medicolegal Request Tracking System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: The Medicolegal Request Tracking System is used to receive requests for and track copies of medical record documentation sent out by the Medical Record Department to Clinical Center patients and the third parties they authorize to receive such information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This information is addressed in the NIH Privacy Act Systems of Record Notice 09-25-0099, published in the Federal Register, Volume 67, No. 187, September 26, 2002.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system collects patient names, addresses, type of documentation requested for release, as well as the name and addresses of the person/organization to which the documentation is to be sent and the dates of receipt and release. Information is voluntary since release requests are also voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Each individual patient is informed of CC information practices before they are accepted as patients. In addition, each patient must provide a written release before information if sent out for any other purpose. The Medical Record Department would be responsible for revising release request authorization and information practices forms if any major system changes take place.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The system is maintained under controlled physical access and user identification as well as passwords are in effect for all users.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Picker: Clinical Center Survey Results
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 13, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Required
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0156
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): NRC Picker/NIH: Clinical Center Survey Results
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: Information resulting from various surveys and questionnaires conducted by the Clinical Center from patients and staff regarding quality of care and hospital operations. The categories of evaluative information varies according to the service being surveyed and may include data related to the research experience, the clinical services received, the respondent's level of satisfaction, time of delivery and future plans.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No identified data is shared. Only de-identified aggregate data is shared with CC Administration. Once individual responses are aggregated, indiviudals are no longer able to be retrieved by name.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Data is abstracted from various survey and questionnaires, including demographics and is primarily related to the quality and performance of various selected hospital services. The only IIF collected is name. The information is used to target areas for improvement to satisfy patient and staff expectations. Participation is entirely voluntary and CC Administration is provided with de-identified aggregate data only. Submission is completely voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Consent is not obtained because participation is entirely voluntary and because the data derived from the surveys and questionnaire is only provided in a de-identified aggregate manner. Any indiviudal can opt not to participate. Each particpant is provided a written introduction and explanation of the survey. There has never been any major changes to the system and none are anticipated at this time. If such changes do occur, each participant will be notified directly. There are no other notification procedures in place.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The information is kept in a physically secure location utilizing guards, identification badges and key cards. Data is secured behind adequate firewalls and is protected by use of passwords and role-based access.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin, CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC Protocol Tracking (PROTRACK)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Apr 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-3099-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): Systems Notice Submitted for Approval
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): CC Patient & Research Services: Protocol Tracking
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: The Protocol Tracking System is used to collect, maintain and report administrative data about intramural research protocols under authority of Section 301 of the Public Health Service Act.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): NIH Employees for protocol approval, control and reporting.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The only IIF involved in the Protocol Tracking System are the names of the investigators related to each protocol, including NIH employees, contractors and other collaborators.. The submission of all names are mandatory when the protocol is submitted to the IRB for approval.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Employees provide names at the time as a part of the protocol approval process and the names of Government employees are a matter of public record. There are no plans to add additional IIF information at the current time, but the Office of Protocol Services would provide notification to each investigator if additions were made in the future.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Only authorized person may have access to the Protocol Tracking System and the system is protected through door locks and other physical controls, as well as technical controls including user identification and password protection.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin: CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CC ProVation
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 15, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): CC Provation
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sue Martin
10. Provide an overview of the system: CC Provation is a Major Application whose mission is to digitally report findings from gastroenterological endoscopic exams of the upper and lower gastrointestinal tract, including the ability to record digital pictures. It is part of modern clinical practice in gastroenterology and considered a part of routine clinical care. Procedures are recorded as they are done and the information for each procedure is collected from a particular patient for a particular procedure.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Printed reports of endoscopic procedures are printed from the system and stored in the patient's medical record.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: CC Provation is a Major Application whose mission is to digitally report findings from gastroenterological endoscopic exams of the upper and lower gastrointestinal tract, including the ability to record digital pictures. It is part of modern clinical practice in gastroenterology and considered a part of routine clinical care. Procedures are recorded as they are done and the information for each procedure is collected from a particular patient for a particular procedure.
The submission of the personal information is voluntary. SSNs are not entered into the CC Provation database here at NIH although there is a field that could be used. Instead, we identify and track patients by their medical record #, name and procedure dates. We have no plans to use SSNs
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Protocol consent forms are signed by each patient and an information practices notification form is provided to each patient at the time of initial admission. Data is retained on servers maintained by DCRI in the CC Data Center and a hard copy is printed which is inserted into the patient’s medical chart. This is kept in medical records.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Technical, Physical and administrative controls are in place to ensure the security of the information. These include an up to date System Security Plan, Contingency Plan, regular offsite backup of the data, and yearly security awareness training for all personnel. The system is certified and accredited.
The information is secured through multiple levels of security and access controls have been established to authenticate the user and to determine if the user has the authorization to perform actions requested. The access controls are supplemented with a secure network at both NIH and the CC.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Sue Martin, CC Privacy Officer, (301) 496-4240, smartin@cc.nih.gov
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Administrative Database (ADB)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-01-01-3104-00-402-129
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH Administrative Database System (ADB)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Carol A. Perrone
10. Provide an overview of the system: The Administrative Data Base (ADB) is a legacy system project that is over twenty years old. The new NIH Business System (NBS) is projected to replace the ADB by FY06. The system provides support for a broad range of NIH business (financial and administrative) functions including the purchase, receipt, and payment of goods and services (internal and external); the tracking and supplying of inventories; services and supply fund activities; and property management. Development of the ADB began in 1978 to automate the processes related to the procurement of goods and services and to translate the procurement actions into accounting transactons that are processed by the Central Accounting System (CAS). Since then the CAS has been modified to interface with the ADB. Several other systems have been added and modifications/enhancements continue to be made to the ADB to reflect changing policies, requirements and the need for increased functionality. NIH heavily relies on this system for much of its business transactions and management information. The legislation authorizing this activity is found in the Privacy Act System of Record (SOR) Notice #09-90-0018. It is 5 U.S.C. 1302, 2951, 4118, 4308, 4506, 7501, 7511, 7521 and Executive Order 10561.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The information is shared with the IRS and the Department of the Treasury. SOR 09-90-0018.
The agency collects data pertaining to the procurement of goods and services for the NIH as well as data pertaining to stipend payment to NIH Fellows. Some of the data collected such as the EIN or SSN and ACH Banking information is required in order to effect payments and prepare 1099s and 1042s. Submission of this data is mandatory.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency collects data pertaining to the procurement of goods and services for the NIH as well as data pertaining to stipend payment to NIH Fellows. Some of the data collected is IIF such as the EIN or SSN and ACH Banking information and is required in order to effect payments and prepare 1099s and 1042s. Submission of this data is mandatory. The data is maintained on a Vendor file in the Administrative Database (ADB) System.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Notification or consent is not done via the Operations and Maintenance Support group; the system is merely collecting and storing data entered by the users. Any notification will have to be done by the Business Owners and ICs.
Changes to the ADB system software does not affect the data collected and maintained in the ADB Vendor file. However, if changes in uses occur, notification to the individuals are done by the Institute or Center (IC) where the original request was initiated or by the Office of Financial Management (OFM) and follows the processes in place for those organizations.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The system is run under a secure server and access is restricted through RACF as well as security within the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele Mulholland France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT ALTIRIS
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 5, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Altiris Client Management Suite
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Connie Latzko NIH/CIT/DCS
10. Provide an overview of the system: Altiris Client Management Suite is an agent based systems management solution used to provide hardware and software inventory, patch management, and software delivery for CIT commodity desktops.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected includes Machine Hardware, Software, IP address, User ID, User Location (Imported from the GAL) and status of Tasks run or to be run on the machine. This data is collected to improve the efficiency of managing and the security of CIT desktops and clients supported by CIT desktop support. The purpose is to manage the client system. i.e.: Provide missing patches, deliver software packages, to provide assistance for determining hardware/software upgrades required (such as minimum hardware requirements to run a new OS or Application). No IIF is collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is collected.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF is collected
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele Mulholland France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Business Intelligence System (formerly nVision)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-01-3105-00-404-142
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018 and 09-90-0024
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH Business Intelligence System (NBIS) (nVision)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Michael Foecking
10. Provide an overview of the system: The NIH Business Intelligence System (NBIS) is an enhanced data warehouse that is a consolidation of the legacy data warehouse, and the next generation data warehouse, nVision. It is designed to improve reporting capabilities of the NIH business source systems. This consolidation integrates the query and reporting capabilities of NIH business systems into one system. The legal authority is referenced in HHS Privacy Act Systems of Record 09-90-0018 and 09-90-0024.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Only authorized personnel have access to this data. Data may be obtained through FOIA requests. SOR 09-90-0018 and 09-90-0024
HHS, Congress and via FOIA requests.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency collects both administrative and financial data. This data is collected from NIH source systems and includes name, DOB, SSN, education records, employee status, business mailing address, e-mail address and phone numbers, and is used for business reporting purposes. NIH BIS only collects the following PII when users are registered for NIH BIS : Username, Full Name, Phone Number, Office, Email, and Institute. This data is used for support, reporting, auditing purposes. This data is mandatory for any users of the NIH BIS system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Agreements have been obtained from the NIH source systems in collaboration with the business community requirement groups to provide the data needed to support the mission of NIH. The warehouse and source systems teams are in constant communication with regard to the data and changes in that data or access permissions granted to users. Users sign the NIH BIS registration form, consenting to the use of PII for NIH BIS registration purposes. When a major change occurs to the NIH BIS system, users are notified by email. A privacy statement is posted on the NIH BIS website.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: NBIS administrative controls include C&A, a System Security Plan, a Contingency Plan, system backups, and documented procedures. Technical controls include a User ID and strong password to access the system and access is only granted when there is a documented request by an authorized official. Other technical controls include Firewalls and VPN. Physical controls to the server room include guards, ID Badges, Key Cards and locks.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Central Accounting System (CAS) (FISMA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: May 5, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-01-01-3101-00-402-124
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0024
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH Central Accounting System (CAS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Carol A. Perrone
10. Provide an overview of the system: The NIH CIT Central Accounting System is a legacy system that processes all accounting and financial transactions for the NIH from systems: ADB, Central Payroll, PMS and IMPAC II.
The CAS will be replaced by the new NIH Business System (NBS). Please refer to project # 009-25-01-4601. The CAS project resides in the Division of Enterprise and Custom Applications, Center for Information Technology, NIH. The CAS is a legacy system project that is over twenty years old, and processes accounting and financial transactions for the NIH. It processes data from several sources including: the Administrative Data Base (ADB); Central Payroll; Payment Management System (PMS); and Information for Management, Planning, Analysis and Coordination (IMPAC). The CAS provides data exchange to the ADB, PMS and IMPAC. Data is extracted from the CAS nightly and made available to the NIH through the NIH Data Warehouse. The CAS produces a wide range of reports that detail spending within the Agency. Financial reports are generated for the Department of Health and Human Services, the Treasury Department, the Office of Management and Budget, and the Public Health Service. The legal authority for SOR #09-90-0024 is found in the Budget and Accounting Act of 1950 (P.L. 81-784) and Debt Collection Act of 1982 (P.L. 97-365).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Department of Treasury for payments and IRS for 1099 reporting. SOR 09-90-0024
Financial reports are generated for the Department of Health and Human Services, the Treasury Department, the Office of Management and Budget, and the Public Health Service.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency collects data pertaining to the procurement of goods and services for the NIH as well as data pertaining to stipend payment to NIH Fellows. Some of the data collected is IIF such as the EIN or SSN and ACH Banking information and is required in order to effect payments and prepare 1099s and 1042s. Submission of this data is mandatory. The data is maintained on a Vendor file in the Administrative Database (ADB) System and is only passed through the CAS.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place other than those specified through the ADB, Central Payroll, IMPAC and PMS systems.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The CAS is a mainframe legacy system that operates in a batch environment. The CAS is not accessible to users other than the individuals who maintain it. Those individuals must have proper RACF security in order to access the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele Mulholland France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Computer Installation Management System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: N/A
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Computer Installation Management System (CIMS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: John Burke
10. Provide an overview of the system: CIMS is a COTS product. CIMS is an automated, non-intrusive system used to collect for resources consumed by CIT users, computer charges are collected from various CIT system administrators and does not affect the performance or operation of the computer center. This data is used to create invoices and summary reporting files for the central accounting system. CIMS supports fee for service and flat fee standard rates. CMIS collects no sensitive information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected are account usage and costs associated with use. This data is used to create invoices and summary reporting files for the central accounting system. CIMS supports fee for service and flat fee standard rates. CMIS collects no sensitive information.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Connect
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): This system contains no PII.
5. OMB Information Collection Approval Number: This system contains no PII.
6. Other Identifying Number(s): None.
7. System Name (Align with system Item name): Adobe Connect
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Teresa Church
10. Provide an overview of the system: Adobe Connect allows individuals to hold online meetings using PowerPoint, screen sharing, teleconferencing, Voice over IP, video, and other features. Users can also upload on demand content.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This system does not share IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency collects names, email addresses, and phone numbers for users of the system. Names and email addresses are required to identify users and to contact them. Phone numbers are not required.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Users must contact us to create an account. We do not put information on individuals into our system without their knowledge.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Only users who have accounts can access the system. Once a user has an account, the only information they can access is another’s email address, name, and phone number, similar to a Global Active Listing (GAL) in Outlook.
If a user stores any other information in the system, it can be protected using Access Control Lists (ACLs).
The machines are located in the NIH Data Center, and are protected by the physical controls provided by the Data Center.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Data Center
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00-109-026
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH Data Center
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Adriane Burton
10. Provide an overview of the system: NIH Data Center Facility is a general support system hosting information technology equipment for information processing services.
The computers located in the Data Center are general support systems that may host sensitive data and applications. Data and applications are the sole responsibility of the application owners. CIT provides the environment and utilities that enable customers to effectively manage the security of their applications and data.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This system does not share or disclose IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The only information collected from individuals is their names and work-related information such as office locations, phone numbers, etc., solely for the purpose of establishing user accounts on the Data Center host systems. No personally-identifying information is collected, maintained, or dissemenated as part of customer support for Data Center services. This information is collected from government employees and contractors only.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT DCB Systems
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-3103-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): DCB Systems
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anthony Fletcher NIH/CIT/DCB
10. Provide an overview of the system: This system (“DCB Systems”) is used to provide CIT support for the Institutes and Centers (IC) at NIH. DCB collaborates with the NIH intramural research program to provide expertise and develop software on computational research problems of significance to the ICs. DCB Systems host this software which includes development and pre-production versions. The application areas include molecular modeling, protein structure prediction, biomedical imaging, mathematical modeling, and biomedical informatics.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): SOR 09-25-0200 This information is addressed in the NIH Privacy Act Systems of Record Notice 09-25-0200, published in the Federal Register, Volume 67, No. 187, September 26, 2002.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: CIT/DCB does not collect any of the data it uses in its research and collaborations with the Institutes. DCB develops tools for principal investigators to use in collecting data. DCB merely keeps a copy of the data, which depends on the protocol but may include IIF such as name, date of birth, phone number, medical records, medical notes, and gender. The principal investigators with whom DCB collaborates determine which data will be collected. All data are provided voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Any IIF data in the system are obtained from the ICs with which DCB collaborates, particularly NINDS. The processes by which the IIF data are collected are determined by the principal investigators in charge of the protocols. The clinical staff at NINDS handle all consent forms and notifications. DCB has no processes in place in addition to those processes provided by NINDS.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Restricted physical and logical access; no project personnel will be allowed to see project data.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Democracy II Server Room
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): There is no PII - this is for a server room
5. OMB Information Collection Approval Number: There is no OMB ICA Number - this is for a server room
6. Other Identifying Number(s): There are no unique identifying numbers
7. System Name (Align with system Item name): Democracy II Server Room
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Deborah Bucci
10. Provide an overview of the system: This is a development and test environment used by CIT's Division of Enterprise and Custom Applications.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: There is no PII - this is for a server room
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no PII - this is for a server room
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: There is no PII - this is for a server room
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT ePolicy Orchestrator (ePO)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): There is no SOR for this application.
5. OMB Information Collection Approval Number: There is no PII in this application.
6. Other Identifying Number(s): There are no other identifying numbers.
7. System Name (Align with system Item name): ePolicy Orchestrator
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Connie Latzko
10. Provide an overview of the system: This is a COTS product used for antivirus protection, tracking, removal and reporting for CIT systems.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The system does not contain any IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system does not contain any IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The system does not contain any IIF.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The system does not contain any IIF.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT IFORGOTMYPASSWORD
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): not applicable.
5. OMB Information Collection Approval Number: not applicable.
6. Other Identifying Number(s): not applicable.
7. System Name (Align with system Item name): IForgotMyPassword
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Adrienne Yang
10. Provide an overview of the system: IFogotMyPassword allows users to reset their forgotten passwords on their own. The users’ identities are verified through a simple set of personalized questions via quiz-based authentication. Users self-register for this service.
When registering, users choose three questions from a list of 21 choices and provide the answers. One question is used by the NIH Help Desk to identify users when they call for assistance. The NIH Help Desk employees cannot see any of the answers; they ask the user the question, and type in the response. The IForgotMyPassword application then confirms if the answer is correct.
The choices of questions are:
What is the last name of your favorite school teacher?
What is the name of your favorite sports team?
What is the name of your favorite singer or band?
What is the name of your favorite television series?
What is the name of your favorite restaurant?
What is the name of your favorite movie?
What is the name of your favorite song?
What is the furtherest place to which you have traveled?
What is the name of your favorite actor or actress?
Who is your personal hero?
What is your favorite hobby?
Your mother's first name?
The city name or town name of your birth?
A four digit PIN (personal identification number)?
What is your least favorite sports team?
What is your mother's occupation?
What was your SAT score?
What is your favorite brand of candy?
What is your least favorite food?
What is your least favorite beverage?
What was your first pet's name?
None of this information is in the official list of IIF categories.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Does not share or disclose IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The IForgotMyPassword database only contains the activity logs. The answers are stored in the user's AD record in encrypted format.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) no
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Infrastructure Graphical Database (IGDB)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: There is no unique identifier for this system
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): There is no SOR needed - no IIF exists in this system
5. OMB Information Collection Approval Number: This does not apply - there is no IIF in this system
6. Other Identifying Number(s): There are no other identifying numbers
7. System Name (Align with system Item name): Infrastructure Graphical Database (CIT Archibus)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Tony Trang, NIH/CIT/DNST
10. Provide an overview of the system: This is the National Institutes of Health (NIH) infrastructure assets management system used to track cabling and telecommunications infrastructure information.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): There is no IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: There is no IIF. This system collects infrastructure, telecommunications and cabling pair information.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no IIF.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: There is no IIF.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Integrated Service Center (ISC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00-109-026
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): There are no additional numbers.
7. System Name (Align with system Item name): NIH Integrated Services Center (incldues NIH Login)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Debbie Bucci
10. Provide an overview of the system: The Integrated Services Center includes NIH Login and TIBCO. NIH Login provides a single authentication mechanism for NIH enterprise systems and IC specific applications.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF is shared or disclosed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: There is no data collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no data collected.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: There is no IIF.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT KNOVA
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: none
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): Not applicable.
5. OMB Information Collection Approval Number: Not applicable.
6. Other Identifying Number(s): Not applicable.
7. System Name (Align with system Item name): KNOVA
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Geoff Marsh
10. Provide an overview of the system: This is a Commercial-Off-The-Shelf (COTS) product that provides help desk knowledge base services. It allows agents to type in the customer issue and then be presented with a variety of options depending on their search, including tailored search results, Q&A dialogs, and fields to fill in. It can exchange problem and incident management data with the Customer Relationship Management (CRM) system however no IIF data from the CRM system will be available to Knova. All customer information and IIF is collected in the CRM system, only technical problem related information is entered into Knova. Any integration between the two will strictly pass non-uniquely-identifiable problem information from the CRM to Knova, and then pass resolution information back from Knova to the CRM. No IIF will enter Knova.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): There is no IIF contained within this system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system is a help desk knowledge management tool and as such, non-uniquely-identifiable information about technical problems and how to solve them will be housed in the system. These solutions are technical in nature (how-to's etc) and do not contain IIF. These solutions will be available to the NIH Help Desk and, in the future, support staff and the NIH user community. The information will be used to assist the NIH community with technical issues. There is no IIF in the system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no IIF contained within this system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: There is no IIF contained within this system
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele Mulholland France NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT National Database for Autism Research (NDAR)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3110-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200; 09-25-0156
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): National Database for Autism Research
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Matthew McAuliffe
10. Provide an overview of the system: NDAR, the National Database for Autism Research, is a collaborative biomedical informatics system being created by the National Institutes of Health to provide a national resource to support and accelerate research in autism. *
NDAR will make it easier and faster for researchers to gather, evaluate, and share autism research data from a variety of sources. By giving researchers access to more data than they can collect on their own and making their own data collection more efficient, the time to discovery can be reduced.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): IIF information is not shared on research participants. However the PI’s granted access to data will give permission to post their name on the NDAR Web site with the research aims. The purpose of this is facilitate transparency in how NDAR data is being used. PIs who submit information to NDAR will not have their information posted on the Web site.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system will collect a wide variety of clinical information including images of the brain, genetics information, and data from diagnostic criteria specific to clinicians in the autism field. None of this information will be IIF. Recent changes to NDAR make sure that all IIF on research subjects (used to generate encrypted hashes that allow cross checking studies for the same individuals) is kept at the researcher’s institution.
NIH will collect IIF on PIs who submit information about research participants to NDAR. This information will be used by NIH to document, track, monitor and evaluate NIH clinical, basic, and population-based research activities.
NIH will also collect IIF on PIs who wish to gain access to the information. This information will be used to document, track, monitor, and evaluate the use of NDAR datasets and to notify recipients of updates, corrections or other changes to NDAR.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) As part of the research protocol, all subjects will be required to fill out consents that describe how their information will be used even though NDAR will contain no IIF on research participants. If these change or expire, all participants will be contacted.
PIs submitting information to NDAR and accessing information from NDAR will sign relevant agreements for submission and access, both of which include a Privacy Act notification.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: 1) Management policies require that all new users be part of an approved site, with the request coming through a system administrator.
2) Technical Controls require that each user log in to the NDAR application with a unique user name and password. Additionally, the password is set to expire after 75 days, must be at least 8 characters long, with at least 2 of the following character types: Control Character, Number, Capital Letter.
3) Physical Controls require badged access to all server rooms, with badge lockdown policies in line with existing NIH procedures.
Physical rack will be key-locked.
Physical rack will be located in data center behind both biometric and keycard access with 100% identification badge check by 24/7 security guard. The Data Center is behind 3 independent 24/7 security guards that will perform identification badge checks.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT NIH Application Manager (NappMan)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: This system does not require a UPI.
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH Application Manager (NAppMan)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Doug Meyer
10. Provide an overview of the system: The intention of NAppMan is to alert a responsible individual when an application is not available or is suffering a problem of some sort. It summarizes information received from underlying monitors that more directly monitor the application and maintains statistics.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The NAppMan system does not collect IIF and therefore cannot disclose or share IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: NAppMan stores application up-time information including the date and time of occurrence, the name of the application component, and the status of the component, its relationship to other components, and business rules to represent the status properly at higher levels. No personal information, or IIF is gathered.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is being collected.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF is available in the NAppMan system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT NIH Consolidated Co-Location Site (NCCS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): This is not applicable; there is no IIF.
5. OMB Information Collection Approval Number: This is not applicable; there is no IIF.
6. Other Identifying Number(s): There are no additional identifying numbers.
7. System Name (Align with system Item name): NIH Consolidated Co-Location Site
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Adriane Burton
10. Provide an overview of the system: The NIH Consolidated Co-Location Site (NCSS) is an off-campus site used to house IC servers, including CIT servers. The NCCS is a secure, environmentally controlled facility located approximately 30 miles from the NIH campus in Northern Virginia. Multiple telecommunications links between NIH and the NCCS provide extremely high bandwidth. These links are part of NIHnet which is managed and operated by the CIT Division of Network Systems and Telecommunications (DNST).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This system does not share or disclose IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: This C&A is for a facility only; this does not include any data.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) This C&A is for a facility only; this does not include any data.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: This C&A is for a facility only; this does not include any data.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT NIH Listserv
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): There is no PII, and therefore no SORN needed.
5. OMB Information Collection Approval Number: There is no OMB information collection approval needed.
6. Other Identifying Number(s): There are no other identifying numbers.
7. System Name (Align with system Item name): NIH Listserv
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Adriane Burton, NIH/CIT/DCSS
10. Provide an overview of the system: The NIH LISTSERV facility is an e-mail-based server that allows users to create, manage, and control electronic "mailing lists" on a network. LISTSERV manages list subscriptions, maintains archives of posted messages, optimizes mass mail delivery, and so forth. LISTSERV allows any networked user to subscribe to lists, receive list postings, query LISTSERV, set up a new list, access list archives, etc. These functions are available either via e-mail or via a secure web server.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Listserv is an email list service for HHS. To perform this function a user must supply an email address. A user has the option to supply their name, but it is not required information. Listserv does not contain IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no PII.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT NIH Portal
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: None
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH Portal
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Renee Edwards
10. Provide an overview of the system: The NIH Portal is a web-based application that gives NIH staff a single point of access to the data, documents, applications and services available at the National Institutes of Health.
The NIH portal enables employees to bring together in one site the links to NIH data and documents used to support the mission of the NIH.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NIH Portal maintains links to NIH data and documents that NIH staff use to support the mission of the NIH.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A - There is no IIF.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT NIHnet
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00-109-026
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIHnet
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Renita Anderson
10. Provide an overview of the system: NIHnet provides centralized network intercommunication/transport services and network security services between NIH Institutes and Centers and external resources such as the Internet and HHSnet.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: NIHnet provides data transport services for NIH Institutes and Centers. Per NIST SP 800-60 NIHnet maintains Information and Technology Management information (e.g., IT infrastructure maintenance, IT security, system development, etc.). NIHnet does not collect, maintain or disseminate IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Remedy
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-02-00-01-3109-00-109-026
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0216
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Help Desk Ticket Tracking System (CIT Remedy)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Chris Ohlandt
10. Provide an overview of the system: The system is used by the IT Support Community at NIH to track customer technical issues from the time of first contact to the point of problem resolution. Authorized users from NIH and certain sister agencies can log in, enter tickets, track their own tickets, and view tickets for other users within their own area.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Information is disclosed only to other support organizations within NIH or with DHHS organizations outside of NIH with whom we share an SLA. SOR 09-25-0216
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Name, business contact information, business computer information, and IT support issue information is collected. Submission is voluntary. Information is shared in order to provide technical support, training, and other support services to the customer.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Consent is voluntary and is provided by users of NIH services in order to obtain IT support. Any changes to data collected will be addressed at the next contact with the customer. No disclosure is made outside the scope of this statement therefore no additional consent is needed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical hardware is located in a secured machine room environment and accessible only via cardkey and/or biometric retinal scanning.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Scientific Coding System (SCS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-04-00-02-3106-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Scientific Coding System (SCS) OnDemand
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Aileen Kelly
10. Provide an overview of the system: SCS is a scientific coding and reporting IMPAC II extension system application. The data included in the system is required for NIH to fulfill its scientific reporting obligation to the Public, Congress, and the White House, for national health policy and goals.
SCS uses the IMPAC II Reporting Database (IRDB) as the primary data source. SCS users also have the ability to add projects (e.g. contracts) to the system that are not included in the IRDB.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The system does not disclose IIF. SOR is 09-25-0036
09-25-0038
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: 1) PI Name (mandatory and extracted from IMPAC II) – used as a business point of contact on grants and contracts
2) PI Birth Year (mandatory and extracted from bio-sketch info from the abstract/summary statement, or other internet data sources, and then entered into SCS by the Scientific Coder) – used for analysis of the NIH scientific program
3) PI Gender (mandatory and extracted from bio-sketch info from the abstract/summary statement, or other internet data sources, and then entered into SCS by the Scientific Coder) – used for analysis of the NIH scientific program.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Will use Privacy Act Notification Statement as defined by IMPAC II. Wil use the same format as that of IMPAC II to notify users.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The SCS is hosted by the NIH Data Center which provides the administrative, technical and physical controls. Technical controls will include the use of user ids, passwords, and a firewall. Physical access controls will include the use of identification badges and key cards. Administrative controls will include a security and contingency plan. Additionally, files will be backed up using the schedule defined by the NIH Data Center. User manuals will also be provided.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT SharePoint
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No SORN is required.
5. OMB Information Collection Approval Number: There is no OMB collection approval necessary.
6. Other Identifying Number(s): There are no other identifying numbers.
7. System Name (Align with system Item name): SharePoint
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Adriane Burton
10. Provide an overview of the system: CIT Sharepoint is a collection of services designed to connect people and information by offering basic web portal and intranet functionality, including version-controlled document storage and basic search functionality. Sharepoint allows employees to collaborate around documents, web pages and databases therefore increasing the efficiency of operations and improving team productivity.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This system does not share or disclose IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system is a web repository for customer’s document storage. No personally-identifying information is collected, maintained, or disseminated.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) This system does not share or disclose IIF.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: This system does not share or disclose IIF.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CIT Status of Funds Internet Edition
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jun 8, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): There is no PII.
5. OMB Information Collection Approval Number: There is no PII.
6. Other Identifying Number(s): There are no additional identifying numbers.
7. System Name (Align with system Item name): Status of Funds Internet Explorer (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robin Lyons
10. Provide an overview of the system: SOFie is a Web based application employing Microsoft’s IIS and SQL server software. The SOFie application supports the efforts of several offices and branches within CIY, allowing budget offices to track expenditures of direct, reimbursable, and non-appropriated funds in a fiscal year. Additionally, SOFie is used to reflect budget allocations and projected expenditures at the operating level. The program also contains a tracking mechanism to track prior year funds. The application downloads this information from the NIH Data Warehouse weekly. SOFie is not a source database for other information systems.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): There is no PII.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: SOFie is a commercial-off-the-shelf web-based application tool for providing advanced financial reporting and analysis. The application supports an Excel interface that allows for the development of spreadsheets using custom functions that extract real-time expenditure, budget, and planning data from the SOFiE database.
The CIT/FMO uses SOFie to track expenditures of direct, reimbursable, and non-appropriated funds in the fiscal year. Additionally, SOFie is used to reflect budget allocations and projected expenditures at the operating level. The program also contains a tracking mechanism to track prior year funds. The data used by SOFie is downloaded from the NIH Data Warehouse weekly. SOFie is not a source database for other information systems. SOFie does not contain PII.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no PII.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: There is no PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Michele France, NIH/CIT/PECO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Asynchronous Electronic Discussion (AED)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3222-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Asynchronous Electronic Discussion (AED)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: A strategic objective of the Center for Scientific Review is to enrich methods for review of grant applications. This new method, based upon the use of a threaded message board with features tailored to NIH review, permits the asynchronous discussion and private scoring of grant applications without the need for concurrent assembly or teleconference. As an alternative review format, it complements and extends the ways that CSR conducts peer-review at NIH.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The system shares or discloses email address, name and IMPAC II identifiers (Commons ID name, and NIH login name) with reviewers, NIH program officers, and CSR SRO's for the purposes of peer review.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information type: Grant related information is used during the discussion of grant applications in an online collaborative space in lieu of a physcial meeting. The reviewers score applications on a scientific merit basis.
The submission is mandatory and does contain IIF (Information Identifiable Form which is name and email using SSL.).
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The system does not gather any information from the public and it is not a publicly accessible system. The system only uses downloaded data in read format from IMPAC II.
The information stored in the system is not disclosed to anyone outside of HHS/NIH in a manner that identifies the individual except for the applicants themselves and except as permitted by the Privacy Act.
AED does not change any information and does not have any consent procedures for this. There might be minor changes in IMPACII of some information such as grant application identifiers. Applicants can also access their personal information through NIH Commons with their personal passwords and logon names. Significant changes to grant application information that AED downloads from IMPACII are achieved by voluntary resubmission of grant application by applicants and there are no consent procedures in place for CSR staff. Applicants are informed of major changes in internal use of their data via publication in the NIH Guidelines published on the CSR Internet.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The PII is secured through Technical controls: User ID and passwords have to be used for network authentication. SSL is used to secure downloaded data. Administrative controls: AED training is available for CSR users and reviewers. Training materials are updated and AED system is backed up on a regular basis.
Physical controls: Security guards, identification badges, and key cards are used to gain access to Building 12, where the system is located.
The required password strength for CSR and NIH users is implemented by NIH through logical access controls that provide protection from unauthorized access, alteration, loss, disclosure, and availability of information in accordance with HHS' Information Security Program. The required password strength for external users is enforced through account lockout controls with limiting number of consecutive failed log-on attempts; sign-on warning banner at AED access point; automatically timed out session; deletion of external user information with automatic deletion of whole AED web site 2 hrs after the meeting is completed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Automated Referral Workflow System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-3223-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): HHS/NIH/CSR/ARWS
7. System Name (Align with system Item name): NIH/CSR ARWS
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: The National Institutes of Health (NIH), Center for Scientific Review (CSR) is responsible for managing the receipt, referral and review of grant applications submitted to NIH. The grant applications referral process from initial receipt of an application until the time at which a peer review of the application is completed has been automated by NIH.
CSR’s mission is to receive, refer and review rapidly increasing flow of grant applications, now reaching several thousand applications per year. CSR goal is to speed up the grant application review process by reducing the amount of time from receipt to referral. CSR believes that complete automation of the referral workflow is necessary to achieve CSR’s goals based on NIH, HHS, and the President Management Agenda (PMA) strategic goals and objectives.
The CSR Automated Referral Workflow System (ARWS) achieves CSR’s strategic goals and objectives by (1) shortening the review process and (2) increasing the transparency, accountability, and uniformity of NIH peer review.
The primary goal of the Automated Referral Workflow System (ARWS) project is to reduce the amount of time required for referral of grant applications by CSR through the development and use of software tools to automate and assist with the assignment of grant applications to the Integrated Review Groups (IRGs) and Scientific Review Groups (SRGs). Secondary goals include providing Institutes/Centers (ICs), IRGs and SRGs with more information about how referral assignments are made and information about possible alternative referral assignments.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Information is disclosed only to Scientific Review Officers, Administrative Assistants and Program Officers from NIH.
Disclosure may be made to the National Technical Information Service (NTIS), Department of Commerce, for dissemination of scientific and fiscal information on funded awards (abstract of research projects and relevant administrative and financial data).
Disclosure may be made to the cognizant audit agency for auditing.
Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
Disclosure may be made to qualified experts outside NIH as a part of the application review process.
Disclosure may be made to a Federal agency, in response to its request, in connection with the issuance of a license, grant or other benefit by the requesting agency, to the extent that the record is relevant and necessary to the requesting agency's decision in the matter.
Disclosure of past performance information pertaining to contractors may be made to a Federal agency upon request. In addition, routine access to past performance information on contractors will be provided to Federal agencies that subscribe to the NIH Contractor Performance System.
A record may be disclosed for a research purpose, when the Department: (A) has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained; (B) has determined that the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identifiable form, and (2) justifies the risk to the privacy of the individual that additional exposure of the record might bring; (C) has required the recipient to (1) establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record, (2) remove or destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining that information, and (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of any individual, (b) for use in another research project, under these same conditions, and with written authorization of the Department, (c) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law; and (D) has secured a written statement attesting to the recipient's understanding of, and willingness to abide by these provisions.
Disclosure may be made to a private contractor or Federal agency for the purpose of collating, analyzing, aggregating or otherwise refining records in this system. The contractor or Federal agency will be required to maintain Privacy Act safeguards with respect to these records.
Disclosure may be made to a grantee or contract institution in connection with performance or administration under the conditions of the particular award or contract.
Disclosure may be made to the Department of Justice, or to a court or other adjudicative body, from this system of records when (a) HHS, or any component thereof; or (b) any HHS officer or employee in his or her official capacity; or (c) any HHS officer or employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the officer or employee; or (d) the United States or any agency thereof where HHS determines that the proceeding is likely to affect HHS or any of its components, is a party to procee
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) System contains first, middle, last name, suffix and email addresses of Scientific Review Officers (SROs) and IRG Chiefs employed by NIH. This identifying information can be used to link an SRO and IRG Chief to NIH IMPAC II records. Users log on ARW system with NIH login name. ARWS has unique identifier for system user. (2) There is also NIH IMPACII identifying information for applicant-Principal Investigator (PI): first, middle, last name and suffix of applicant. The grant application information is mandatory and is IIF. It has a voluntary cover letter from Principal Investigators with their names and work addresses. The letter is disclosed only to intended personnel within CSR maintaining ARWS system. (3) Yes. (4) Voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All data contained within this system is pulled from IMPAC II, at which point notification and consent is obtained, used, or shared.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: ARWS requirements for security must comply with the Privacy Act System of Records Number 09-25-0036, “Extramural Awards and Chartered Advisory Committees: IMPAC (Grant/Contract/Cooperative Agreement Information/Chartered Advisory Committee Information),” HHS/NIH/OER and HHS/NIH/CMO. Included in the system design is the definition of users, roles assigned to users, and system privileges that are linked to user roles. Both the roles and privileges are flexibly defined within ARWS to allow for specification of privileges required to perform specific system functions or view specific data items appropriate for each role. The system permits only authorized and authenticated user access. Additionally, there are Federal (NIST, FIPS, OMB, GAO, agency-level HHS/NIH guidelines and directives compliant) and industry-best practices security measures in place to ensure the system utilizes and ensures the effective use of security controls and authentication tools to protect privacy to the extent feasible. Access to the ARWS system user's records is restricted to authorized users behind the NIH firewall. Risk of unauthorized access is, therefore, considered low. The ARWS system is maintained in strict compliance with the Privacy Act of 1974.
Authorized user access to information is limited to authorized personnel for performance of their duties. Authorized personnel include system managers and their staff, computer personnel, and NIH contractors and subcontractors. Physical safeguards are in place at CSR. Procedural and Technical Safeguards: A password is required to access the terminal and data set name controls the release of data to only authorized users. All users of personal information in connection with the performance of their jobs protect information from public view and from unauthorized personnel entering an unsupervised office. Files with data on a local area network are accessed
by keyword known only to authorized personnel.
Codes by which automated files may be accessed are changed periodically. This procedure also includes deletion of access codes when employees or contractors leave organization. New employees and contractors have obligatory training and NIH/CSR security department is notified of all staff members and contractors authorized to be in secured areas during working and nonworking hours. The list is revised at NIH and requires the completion of a computer-based training (CBT) course entitled ‘Computer Security and Awareness’ for NIH staff and contractors. This CBT provides an overview of basic IT security practices and the awareness that knowing or willful disclosure of the sensitive information processed in the system can result in criminal penalties associated with the Privacy Act, Computer Security Act, and other federal laws that apply.
All data transmitted between the server currently resides in CIT's facility behind the firewall and workstations at CSR are encrypted.
The NIH ISSO and Incident Response Team (IRT) (along with the Security Team Network Operations Team, Web Development Teams, and Administrator Teams) help assure the security of NIH systems, data, and information while maintaining connectivity and interoperability throughout NIH. The IRT responds to computer security incidents, characterizes the nature and severity of incidents, and when appropriate, provides immediate diagnostic and corrective actions. Audit logs are reviewed by appropriate staff.
These practices are in compliance with the standards of Chapter 45-13 of the HHS General Administration Manual, "Safeguarding Records Contained in Systems of Records," supplementary Chapter PHS 45-13, and the Department's Automated Information System Security Handbook.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Committee Management Application
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Committee Management Application
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: The Committee Management Application is a sub-application of the existing employee database (NIH Enterprise Directory via the CSR Intranet) which stores employee committee involvement data. The system also has a reporting capability for management and committee members.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The Committee Management Application allows senior management access to query and report functions. Other access will be granted on a need-to-know basis as determined by senior management. Application administrators will have access to add, edit, and delete all committees and memberships. Employees will have read-only access to their current list of committee memberships through a link in the employee information update screen located on the CSR Intranet. This application is only accessible to NIH employees and NIH/CIT employees as needed since the application resides on a CIT server.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) Application includes information on NIH/CSR Committee name, membership of committee, and member contact information (NIH email and phone number). (2) NIH/CSR uses this application to remove the manual touchpoints, i.e. paper, and streamline the flow of data to users and management. (3) Yes, PII data in the form of the employee name, NIH email address, and NIH phone number. (4) Per CSR policy, amm committee membership rosters are included.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) (1) N/A - no major changes anticipated. (2) On the CSR Intranet (the parent system to this application) a message is displayed to the employees explaining the purpose and protections in place to safeguard information. (3) Users have read-only access to view committee memberships; administrators have add, edit, and delete capability for all committee memberships; developers/contractors have access to maintain and operate the application.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative Controls: role-based access; appropriate system security plan, contingency plan, file back-up, training of users, and retention and destruction policies are in place.
Technical: User ID, passwords, firewall, VPN, encryption and IDS are in place on all CSR systems.
Physical: guards, ID badges and key cards are utilized at the server location and the CSR offices.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Grant Redundant Application Search Program (GRASP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Grant Redundant Application Search Program (GRASP)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: The proposed system should have the following operational requirements:
- Compare new grant application submissions to a database of previous applicatioin submissions (and potentially other sources).
(1) use of original material from others
(2) submission of multiple applications
(3) renamed applications
(4) already completed work
- Displays output summarizing findings
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not Applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) Data provided will be text parseable documents, specifically grant applications in one or more 'pdf' files and other files that communicate other grant application information as extracted from the IMPAC II system (eCommons name, PI name, etc).
.) Only text will be uploaded to GRASP system; that text will be readily parseable, and not image format requiring optical character recognition.
(2) CSR shall use the information provided in order to minimize the resources and time used in identifying inequality amongst grant applicants. These inequalities include the duplicative and overlapping use of original material from others, the submission of multiple applications, renamed applications, and requesting funding for already completed work.
(3) Yes, this system does contain PII.
(4) Voluntary. The PII information is collected from the existing IMPACII system where applicants submit grant applications for review.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) As GRASP will utilize historical data from IMPACII , no processes are in place to obtain consent from individuals whom submitted applications. IMPAC II Systems of Record Notice is in place.
The GRASP system shall collect historical application data to be part of the comparison effort and transferred to the data warehouse (dbGRASP) in the GRASP system. This data will be parsed, formatted and indexed for use by the GRASP system. The source for all comparison work will be historical information from IMPAC II. Periodically, a data extract representing new entries to IMPAC will be created and transferred to the GRASP data warehouse.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative Controls: role-based access; appropriate system security plan, contingency plan, file back-up, training of users, and retention and destruction policies are in place.
Technical: User ID, passwords, firewall, VPN, encryption and IDS are in place on all CSR systems.
Physical: guards, ID badges and key cards are utilized at the server location and the CSR offices.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Internet Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-27-02-3204-00-305-109
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): CSR-3
7. System Name (Align with system Item name): CSR Internet
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Bhattacharyya, Dipak
10. Provide an overview of the system: Provide resources for applicants, news and reports, information about CSR and peer review meetings to the general public. Authorized by Section 301 of the PHS Act.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): General public, applicants and reviewers can get access to CSR staff directory and study sections rosters. CSR Internet application has been created for the purpose of providing information to NIH and scientific community on the world wide web.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: CSR Internet website is designed to provide information about CSR's mission, its resources, peer review meetings and important news to the general public. We do not collect PII information from the public. CSR maintains its own staff directory.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Data in staff directory and rosters do not change without users' consent, and approval. Users submit their information for posting to CSR web developers mostly in electronic form.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Covered by CSR Security Plan
Authorized by Section 301 of the PHS Act.
CSR Web site is designed as a public service to provide information to general audience. Every page on CSR web site is accessible to general public including people with disabilities.
Technical controls are provided by NIH. The application data are backed up daily.
CSR Web site is updated regularly.
hysical controls: Security guards, identification badges, and key cards are used to gain access to building 12, where the system is located.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Intranet Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-27-02-3204-00-305-109
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0216
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): CSR-2
7. System Name (Align with system Item name): CSR Intranet
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: Provides information on all aspects of CSR work to CSR and NIH staff. Authorized by Section 301 of the PHS Act.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Provides information on all aspects of CSR work to CSR and NIH staff. The system provides contact information to CSR supervisors for crisis notification. SORN #09-25-0106 CSR staff directory contains working addresses for all CSR employees.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Provides information on CSR work (forms, publications, policies) to CSR and NIH staff. The system shares contact information (home phone #, email address, cell phone #) with CSR supervisors for use for crisis notificiation. The mandatory information will be cell phone, home address, home phone, and personal email address. Voluntary information will be out of area contact information, i.e.: contact name, address, phone, and email address.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) A message is displayed to the employees explaining the purpose and protections in place to safeguard information. There is no consent process since this information is mandatory and critical to continue the CSR mission in case of emergency.
Also, CSR users make changes to their personal information by themselves thus eliminating errors and misrepresentation of their personal information such as phone and email address in CSR staff directory.
NIH maintains NED directory with CSR users PII information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Photos of staff are limited to the NIHnet users. IIF in the form of home phone numbers will be restricted to a SSL enabled website and require user authentication with NIH login and password.
Administrative
To log on the Intranet requires an active directory account, which is created and maintained by the central NIH account authority. The initial employee record is entered by the supervisor as part of a desktop support request. Once the employee is settled, he/she enters additional emergency contact information, i.e. home address, cell phone or home phone number. This information is mandatory in case of emergency, so that CSR can contact employees. Prior to the employee departure/separation date, the employee is required to complete form on CSR Intranet and return NIH badge and CSR property items. The automated record is removed from the system in 30 calendar days after the departure date. All database backups no longer have the information about former employee after 60 calendar days.
Technical
The employee entry form is located on the CSR Intranet. The server where CSR database resides is hosted and maintained by the CIT hosting branch. It is physically located in Building 12. The building has the technical infrastructure to ensure protection of the server from physical and online attacks via ADP room access controls and WAN and LAN intrusion protection. The software program allows the following access to employee records:
Role: Director, CSR, Emergency Coordinator, Division Directors (6) - Records Access: All
Role: Branch and IRG Chiefs - Records Access: Employees Supervisor
Role: All Employees - Records Access: Supervisor
This access is maintained through NIH active directory. The system administrator's password is changed every year. Due to operational necessities, an exception to policy was granted for a year long password. The CIT hosting branch provides the operating and database systems patch in accordance with policy set by CERT and the manufacturer.
Physical
Building 12 has access controls procedures in place to prevent unauthorized access to CSR Severs. In addition, CSR employees are not authorized without escort to enter the ADP room or access servers. All supervisors have the ability to save and/or print a hardcopy of the employee directory. The supervisor is required to keep this information in a locked file cabinet at all times. In addition, the list is stored on the local drive of the supervisor. All hard drives are encrypted.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Member Application Notifcation (MAN)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Member Application Notification (MAN)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: The MAN system provides daily notifications of initial application assignment to a given Integrated Review Group (IRG) Chief (or their designee) if at least one application has received its initial review assignment to their IRG (or directly to a SRG or SEP within their IRG) or their SRC99 (in the case of ICs) and meets the specified business rules.
- Identify only applications with mechanism types limited to R01, R21, and R34 submitted by only appointed chartered study section members (not temporary or ad hoc) to as recorded in IMPAC II.
- Exclude applications for which appointed members have a role other than PD/PI, including appointed members serving as sponsors for fellowship applications or mentros for career award applications.
- Applications with multiple PI/PDs should be identified if one or more are eligible based on their status as a study section member (It's not necessary for all of the PI/PD's of a given application to be members)
- Identify and include eligible funding opportunity announcements such as PA, PAR, and PAS per CSR R&R guidance
- Send notifications to individual Outlook group addresses for each of the IRGs (Chiefs and their designees) and each of the ICs (Review Chief and their designees)
- The application accession number, appid, application title, application assignment information, and the list of PI/PDs should be included in the notification to the IRGs or ICs.
- Application title in the IRG Chief's report
- Allow IRG Chiefs to indicate whether or not applications are continuous submissions and capture designation in the database
- Allow IRG Chiefs to look at applications from all other IRGs received within the last two months and indicate which they can review by entering status into database.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The MAN system provides daily notifications of initial application assignment to a given Integrated Review Group (IRG) Chief (or their designee) if at least one application has received its initial review assignment to their IRG (or directly to a SRG or SEP within their IRG) or their SRC99 (in the case of ICs) and meets the specified business rules.
- Identify only applications with mechanism types limited to R01, R21, and R34 submitted by only appointed chartered study section members (not temporary or ad hoc) to as recorded in IMPAC II.
- Exclude applications for which appointed members have a role other than PD/PI, including appointed members serving as sponsors for fellowship applications or mentros for career award applications.
- Applications with multiple PI/PDs should be identified if one or more are eligible based on their status as a study section member (It's not necessary for all of the PI/PD's of a given application to be members)
- Identify and include eligible funding opportunity announcements such as PA, PAR, and PAS per CSR R&R guidance
- Send notifications to individual Outlook group addresses for each of the IRGs (Chiefs and their designees) and each of the ICs (Review Chief and their designees)
- The application accession number, appid, application title, application assignment information, and the list of PI/PDs should be included in the notification to the IRGs or ICs.
- Application title in the IRG Chief's report
- Allow IRG Chiefs to indicate whether or not applications are continuous submissions and capture designation in the database
- Allow IRG Chiefs to look at applications from all other IRGs received within the last two months and indicate which they can review by entering status into database.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) The combined monthly report and the email generated have the fields specified:
a. IC
b. MEMBER IRG
c. CMTE
d. MEM PI NAME
e. MEMBER START DATE
f. MEMBER END DATE
g. GRANT NUM
h. ACCESSION NUM
i. APPL CLUSTER IRG
j. STUDY SECTION FULL
k. RFA PA NUMBER
l. COUNCIL DATE
m. APPLICATION RECEIVED DATE
IMPAC II is the source of all application data.
(2) The MAN System ensures that Integrated Review Groups (IRGs) Chiefs and IC Review Chiefs/contacts are aware of the assignment of applications submitted by chartered members of the standing study sections to Integrated Review Groups (IRGs) and Study Sections.
(3) Yes
(4) Voluntary. All information is provided via the IMAC II system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All data contained within this system is pulled from IMPAC II, at which point notification and consent is obtained, used, or shared.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative Controls: role-based access; appropriate system security plan, contingency plan, file back-up, training of users, and retention and destruction policies are in place.
Technical: User ID, passwords, firewall, VPN, encryption and IDS are in place on all CSR systems.
Physical: guards, ID badges and key cards are utilized at the server location and the CSR offices.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR National Registry of Volunteer Reviewers
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): CSR National Registry of Volunteer Reviewers
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Nair Prema, Diane Stassi, Weijia Ni
10. Provide an overview of the system: The CSR National Registry of Volunteer Reviewers is an Access-based database that contains information provided by volunteer scientists who are interested in serving on CSR grant review panels. Information provided includes: Name, Degree, Title, Institution, Department, Email, Web Address(es), Area of Expertise/Keywords, Study Section or IRG, Recent funding sources, Referring Society, QVR Person ID, NIH review and grant history, Geographical Region, Date Registered, SRO Contact Records (check boxes for “Contacted” and “Served” as well as date and SRO name), and an SRO Reviewer Evaluation field (check boxes 1-5 – for scientific expertise and review performance). The database is available to everyone in CSR who has access to the CSR share drive. The database is searchable by Keyword, IRG, and Region.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Information is disclosed to anyone in CSR with access to the Share Drive, including, Scientific Review Officers, IRG Chiefs, Division Directors, personnel in the Director’s Office. The information will be used to 1) identify highly qualified reviewers who are willing to serve on study sections and 2) report back to the referring societies on how many of their recommended reviewers have served on panels.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected for the CSR National Registry of Volunteer Reviewers contains IIF. The following information is voluntarily provided by scientists who are interested in serving on CSR grant review panels: Name, Degree, Title, Institution, Department, Email, Web Address(es), Area of Expertise/Keywords, Study Section or IRG, Recent funding sources, and Referring Society. In addition to this information, the developers of the database add the volunteer’s QVR Person ID and NIH Review history (if they are in the system), Geographical Region, Date Registered, and Reviewer Evaluation (check boxes 1-5 – for scientific expertise and review performance). Individuals using the database (primarily Scientific Review Officers) may add Contact Records (check boxes for “Contacted” and “Served”, date and SRO name) as well as reviewer evaluation. The information will be used to identify highly qualified reviewers to serve on study section panels and to provide feedback to societies on whether their members are serving on panels.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No major changes are expected to occur to the database. If any changes are made, we will notify all individuals via email. We will be collecting the following IIF: Name, Mailing Address, Phone Numbers, Device Identifiers, Web Uniform Resource Locator(s) (URL), Email Address, and QVR Identifier. Individuals will be notified via email describing the IIF obtained and that we will use this information to identify highly qualified reviewers who are willing to serve on study sections. This information is stored in a database that is available to CSR employees, and specifically created for Scientific Review Officer use. The email notification will also give the individual the option of rescinding their information, at which point the system developers will destroy (permanently delete) the IIF provided.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative controls. To run the database, SROs download it to their C-Drives from Share drive. Access to the CSR Share drive is limited. Personnel with access to the database have been trained and are aware of their responsibilities for protecting IIF.
Physical controls. Rockledge 2 is secured by guards, employee identification badges and keycards.
Technical controls: All CSR laptop computers are encrypted. User identification, passwords, firewall, VPN are currently in place. Security patches for servers and laptops are always kept current.
The NIH incident response team will notify the CSR ISSO of any security incidents detected. Users will notify the CSR ISSO and NIH Helpdesk of any security incidents.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR Performance Management Appraisal Program (PMAP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Performance Management Appraisal Program (PMAP)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dipak Bhattacharyya
10. Provide an overview of the system: The PMAP review system is intended to provide an automated process for specific members of Office of the Director (OD) and Managers to review the written performance summaries of two categories of CSR staff. This new process streamlines the existing manual process and provides for more effective time management and evaluation techniques. The scope of the PMAP review system is to automate the existing process for performance reviews for ease of use. This goal will be achieved through the following product features:
• PMAPs grouped by Division, IRG and/or Branch – in a table-like structure
• Display the names of all CSR staff within selected group/IRG/branch
• Ability to individually select performance summary, out of staff listing
• Allow display of performance summary and assigned score, for the PMAP being reviewed
• Ability to change the assigned score, if desired
• Ability to update changes to the PMAP and create a permanent record
• Store the performance summaries
• Display the current number out of total for specified group (3 out of 10)
• Ability to move to next performance summary within same group
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not Applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) The PMAP system will maintain information including employee name, work phone, work email, performance rating, and salary. (2) PMAP is a required HHS annual process to rate the performance of employees. This system streamlines the process electronically. (3) Yes. (4) Mandatory.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) (1) No major changes anticipated. (2) The PMAP process is a required HHS process of which employees are notified when they are hired. (3) Information will be used by supervisors and the administrators to rate the performance of employees.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative
To log on the Intranet requires an active directory account, which is created and maintained by the central NIH account authority. This system is hosted by the CSR intranet and will have role-based access for supervisors, administrators and the technical team.
Technical
The employee entry form is located on the CSR Intranet. The server where CSR database resides is hosted and maintained by the CIT hosting branch. It is physically located in Building 12. The building has the technical infrastructure to ensure protection of the server from physical and online attacks via ADP room access controls and WAN and LAN intrusion protection.
This access is maintained through NIH active directory. The system administrator's password is changed 60 days. The CIT hosting branch provides the operating and database systems patch in accordance with policy set by CERT.
Physical
Building 12 has access controls procedures in place to prevent unauthorized access to CSR Severs. In addition, CSR employees are not authorized without escort to enter the ADP room or access servers. All hard drives are encrypted.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR SOFie ( Status of Funds)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Status of Funds Internet Edition (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Nair Prema, Kevin Laser
10. Provide an overview of the system: The SOFie application supports the efforts of several offices and branches within the IC, allowing budget offices to track expenditures in appropriate funds in a fiscal year. The program contains a tracking mechanism to track prior year funds as well. The application downloads this information from the NIH Data Warehouse weekly. Information entered into the SOFie database is not uploaded into the NIH Data Warehouse database. SOFie is not a source database for other information systems.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Accounting data and related document information is downloaded from CAS/Central Accounting System mainframe and is specific to CSR for its fiscal year operations. The information is general acounting info by category (ex. wages), with totals by category, and nothing specific to individual employees. The system contains no IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Authorized user access to information is limited to authorized personnel for performance of their duties. Authorized personnel include NIH employees, system managers and computer personnel. Physical safeguards are in place at CSR. and the contractor facilities. Access codes are deleted when employees leave CSR. New employees have obligatory training and NIH/CSR security department is notified of all staff members and contractors authorized to be in secured areas during working and nonworking hours. The list is revised at NIH and requires the completion of a computer-based training (CBT) course entitled ‘Computer Security and Awareness’ for NIH staff and contractors. This CBT provides an overview of basic IT security practices and the awareness that knowing or willful disclosure of the sensitive information processed in the system can result in criminal penalties associated with the Privacy Act, Computer Security Act, and other federal laws that apply.
All data transmitted between the server (currently at contractor location) and workstations at CSR are encrypted.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH CSR SREA Financial Tracking System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0024
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): CSR SREA Financial Tracking System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Renee Harris, Dipak Bhattacharyya, and Prema Nair
10. Provide an overview of the system: The SREA Office’s main functions is to support the CSR Peer Review by the 1) procurement of hotel meeting rooms, sleeping rooms, reviewer airfare, AV and 2) Payment to Non-Federal Reviewers who provide expertise in reviewing grants applications.
We expect that by having a SREA Financial Tracking system we will be better equipped to serve NIH/CSR as a whole. Specifically, it is proposed a web-based system will enable SREA to better monitor and track Peer Review expenditures in an electronic format which can be queried to do historical data analyses on a regular basis. We will also be able to allow secured access to SREA Data at multiple levels: administrative, user, and read-only. In addition, we will be in compliance with the NIH COOP and NIH Vital Records initiatives by electronically housing procurement documents attached to a corresponding ticket.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not Applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The SREA Financial Tracking Database utitlizes PII - in the form of the Scientific Review Officer (SRO) name - from IMPAC-II. This information is used to create a dropdown menu with the SRO names listed in the SREA database. SRO names are used to identify review meetings. In the event a reviewer declines payment of honorarium, their name is manually entered into the SREA database by users to document payment refusals. SRO name is mandatory. Reviewer name is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) We do not anticipate any major changes to the system. In the event of a major change involving PII, a process will be put in place. Individuals are notified via email regarding the PII in the system and how it is used.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Access controls are in place for servers along with FDCC guidelines.
NIST and FISMA rules and regulations are applied to servers.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Kerry Murphy, CSR Privacy Coordinator
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH FIC CareerTrac
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jul 31, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-1903-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0156
5. OMB Information Collection Approval Number: 0925-0568
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): CareerTrac
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Linda Kupfer
10. Provide an overview of the system: CareerTrac is a global trainee tracking and evaluation system for the Fogarty International Center (FIC), National Institutes of Health. The goal of this system is to create a complete trainee roster for all FIC research training programs and to monitor outputs, outcomes and impacts of FIC international trainees.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): FIC takes every reasonable precaution to protect information. CareerTrac system is securely hosted under NIH firewall and the password is encrypted. FIC maintains appropriate physical, electronic and procedural safeguards to ensure the security, integrity and privacy of trainee’s personal information. Unless legally mandated, FIC will not disclose any of the following information: employment history, phone, fax, year of birth, biographical data, gender (except in aggregate), minority status (except in aggregate), current training status, return home (except in aggregate), and career accomplishments (only in aggregate – except where in the public domain).
FIC understands the delicate balance between protecting the data and permitting access to those who need to use the data for authorized purposes. Access to CareerTrac data will be granted only to those organizations/individuals, which must, in the course of exercising their responsibilities, use the specific information. The requests for access to CareerTrac data will be carefully reviewed and the following information may be disclosed for routine uses: trainee’s name, area of training, country of origin, work email, degrees earned through FIC funded programs, accomplishments that are public products, and career highlights of the trainee information. The audience for this information may include, but not restricted to:
The FIC, NIH, HHS and Congress for reporting and evaluation purposes;
The Principal Investigator (PI) and Collaborators for the purpose of monitoring the program, submitting progress reports and grant applications and writing journal articles describing the programs;
FIC co-funding partners and Co-sponsors of FIC programs for the purpose of reporting progress and conducting evaluations of the programs
Interested public, for example, for the purpose of convening a scientific meeting in a particular country to which former trainees will be invited
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system will collect, track, and report on information about international trainees - such as trainee name, contact information, biographical information, and training information. The system also supports tracking of trainee accomplishments - such as fellowships, awards, employment, other education, product or policy developments, publications, funding received, presentations, posters at scientific conferences, and students taught.
The purpose of the system is to enable effectiveness evaluations of health research training programs, funded by NIH/FIC, for international trainees.
The information may be used by or disclosure may be made to (1) the FIC, NIH, HHS and Congress for reporting and evaluation purposes; (2) the academic community (including PIs and Collaborators) for the purpose of monitoring the program submitting progress reports and grant applications and writing journal articles describing the programs; (3) FIC co-funding partners and co-sponsors of FIC programs for the purpose of reporting progress and conducting evaluations of the programs; (4) interested public, for example for the purpose of convening a scientific meeting in a particular country to which former trainees will be invited.
The personal information is submitted on a voluntary basis.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) We will provide the trainees with a written document that will notify the trainees about the purpose of data and how it will be used and shared. The trainees will have to read Privacy Act Disclosure and sign 'Certificate and Acceptance' form (which is part of the document) before PIs can enter their personal information into the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: A variety of safeguards are implemented in order to protect the information collected through CareerTrac system. Regular access to information in CareerTrac is limited to PHS or to contractor employees who are conducting, reviewing or contributing to the system. Other access is granted only on a case-by-case basis, consistent with the restrictions, as authorized by the system manager or designated responsible official.
Administrative Control: CareerTrac has a system security plan and backup plan. The files are backedup regularly and they are stored in secure offsite locations.
Technical Control: CareerTrac system is securely hosted under NIH firewall and the password is encrypted and changed routinely. PIs can only view the trainees from their grant. FIC maintains appropriate physical, electronic and procedural safeguards to ensure the security, integrity and privacy of trainee's information.
Physical access controls are in place for CareerTrac. Records are stored in closed or locked containers, in areas which are not accessible to unauthorized users, and in facilities which are locked when not in use. Sensitive records are not left exposed to unauthorized persons at any time. The following are some of the physical controls in place to safeguard system and data collected: closed circuit TV, identification badges and guards.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Marcia Smith
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Applications Database
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 18, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-003
7. System Name (Align with system Item name): Application Database
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Linda Rich
10. Provide an overview of the system: The system holds grant application information that is retrieved from the IMPAC II database with additional tracking information added for the purpose of application grant approval. The system tracks grant applications under authority 42 USC 287c-21.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): For internal purposes only; it will not be shared. SOR #09-25-0036
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected is from the NIH IMPAC II system and is used to communicate with the applicants and to disseminate information to staff involved in the applications process. The information collected does contain Names, Mailing Addresses, and Email Addresses of applicants. IIF is obtained from the IMPAC II system and all notifications and consent procedures with subjects are handled at that level. Personal information is required to complete an application however, submissions are voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All IIF information is obtained from the NIH IMPAC II system. Any major changes to the system should be handled at the NIH level. Notifications and consent procedures with subjects are also handled at the NIH level. NCCAM does not have a notification process in place as the applications database does not collect the initial IIF. It is only a recipient of IIF collected by another database that is maintained at the NIH level thus we do not have our own notification process to obtain IIF from individuals. This system does not have any notification procedures in place in addition to those in place for the IMPACII system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The information is physically secured by a required key card and employee badge, and electronically secured by a password login procedure to the NIH computer system, a restricted folder location, and a requirement of a password when accessing the database. Information is also secured by least privilege, separation of duties, an intrusion detection system, firewalls, locks and background investigations. A comprehensive IRT is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Employee Database, Internet Edition (EDie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-02-3196-00-403-131
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-014
7. System Name (Align with system Item name): NIH NCCAM Employee Database, Internet Edition (EDie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Lori Thompson
10. Provide an overview of the system: EDie is a web-based application that allows institutes to accurately maintain individual employee, contractor, and volunteer information, as well as plan for, monitor, and report on workforce staffing levels.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Information is intended for internal senior administrative use only and will not be shared by other entities. Refer to SORN 09-90-0018.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected is all information pertinent to a personnel file. There are many uses for this information: (a) tracking a time-limited appointment to ensure renewals are done in a timely manner thereby avoiding any break in service; (b) ensuring that allocated FTE ceilings are maintained; (c) ensuring salary equality for various hiring mechanisms; (d) the ability to provide reports requested by the NIH Director; (e) maintaining lists of non FTEs, special volunteers, contractors, etc. Information is mandatory at time of hire.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Information is collected from documents provided by employees (CV, resumes, etc) at the time of appointment. It is provided in personnel packages submitted through channels in order to affect a hire. This information is put into Capital HR and Fellowship Payment System (FPS) and subsequently downloaded into EDie. Individuals are notified of the collection and use of data as a part of the hiring process. Changes to the system, or use of the information, is relayed to employees via official notices from HR and the system owner.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Access to sensitive data fields is limited on need to know basis. Each user signs a security statement and received a password. Any violations results in loss of access to system. Information is also secured by separation of duties, and intrusion detection system, firewalls, locks and background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Grantee Bibliographic Database
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 18, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM -007
7. System Name (Align with system Item name): NCCAM Grantee Bibliographic Database
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Linda Rich
10. Provide an overview of the system: The database was developed for internal use to collect information about research articles that have resulted from the work funded by NCCAM grants.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The information is used only by NCCAM staff for internal purposes to assess the scientific results of funded research projects. SOR#09-25-0036
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The legislation authorizing this activity is 42 USC 287c-21. The purpose is to collect research results to be internally used to assess the scientific results of funded grants. Personal/IIF information (including the grantee's name and grant number) is required/collected to complete an application, however, submissions are voluntary. The information is gathered from reports submitted by the investigator, disseminated to NCCAM staff involved in the grants process, and maintained in the grantee file.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All IIF information is obtained from the NIH IMPAC II system. Any major changes to the system should be handled at the NIH level. Notifications and consent procedures with subjects are also handled at the NIH level. Consent is given by the investigator when she/he submits the application or progress report. NCCAM does not have a notification process in place as the grantee bibliographic database does not collect the initial IIF because it is only a recipient of IIF collected by another database that is maintained at the NIH level. This system does not have any notification procedures in place in addition to those in place for the IMPACII system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: SOR: 09-25-0036
Information is secured by a required key card and employee badge, and electronically secured by a password login procedure to the NIH computer system, and a requirement of a password when accessing the database. Information is also secured through least privilege, separation of duties, an intrusion detection system, firewalls, locks, and background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Internet Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: OMB # 0925-0486-2501-05
6. Other Identifying Number(s): NCCAM-001
7. System Name (Align with system Item name): NCCAM Internet Web Site
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Irene Liu
10. Provide an overview of the system: The NCCAM Web site (www.nccam.nih.gov) is used to disseminate scientifically accurate information about complementary and alternative medicine to the public and to health officials via the World Wide Web.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No - SOR#09-25-0106
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NCCAM Web site (www.nccam.nih.gov) is used to disseminate scientifically accurate information about complementary and alternative medicine to the public and to health officials via the World Wide Web. NCCAM is not collecting personal information through the NCCAM Web site. Note: NCCAM has submitted a separate PIA for the NCCAM Online Continuing Education Series (please reference that PIA for more information).
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Not Applicable
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Intranet Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-002
7. System Name (Align with system Item name): NCCAM Intranet Web Site
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Irene Liu
10. Provide an overview of the system: The NCCAM Intranet Web site (www.nccamintranet.nih.gov) is used to disseminate relevant information and useful dynamic applications to employees of the National Center for Complementary and Alternative Medicine (NCCAM). The key legislation authorizing this Web site is 42 USC 287c-21.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No - SOR#09-25-0106
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NCCAM Intranet Web site (www.nccamintranet.nih.gov) is used to disseminate relevant information and useful dynamic applications to employees of the National Center for Complementary and Alternative Medicine (NCCAM). We are not collecting personal information through the NCCAM intranet Web site.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Not Applicable
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Local Network
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): Not Applicable
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): NCCAM-015
7. System Name (Align with system Item name): NCCAM Local Network
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Lori Thompson
10. Provide an overview of the system: The system is a General Support System (GSS) and does not directly collect or store information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Not Applicable
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system is a General Support System (GSS) and does not directly collect or store information. The applications/systems residing on the GSS collect and store information. Therefore, individual PIAs have been prepared and submitted for the applications/systems residing on this GSS,
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Not Applicable
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Not Applicable
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Online Continuing Education Series
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-010
7. System Name (Align with system Item name): NCCAM Online Continuing Education Series
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Irene Liu
10. Provide an overview of the system: This program is for health care providers, and the public, to view lectures on CAM and receive continuing education credit.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No - SOR#09-25-0106
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Users may VOLUNTARILY provide the following information:
Name, Mailing address, Email, Degree or Credentials, Phone number, Fax number, Specialty, Hospital affiliation.
The purpose is to provide continuing education credits. The information is only to be used by Cine-med Inc, an accrediting entity.
Collection of this data is authorized under authority 42 USC 287c-21
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) NCCAM does not expect to have major changes to the system.
A privacy policy is posted to inform users of the purpose of data collection and explain that data will only be used to confirm registrant participation in the continuing education program ( in case they request a copy of their certificate).
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Personnel using the system have been trained and made aware of their responsibilities for protecting the information being collected. Technical controls are in place to minimize the possibility of unauthorized access, use, or dissemination of the data.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Records Management Database
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: Not Applicable
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-008
7. System Name (Align with system Item name): NCCAM Records Management Database
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robin Klevins
10. Provide an overview of the system: The purpose of this system is to track the disposition of records sent to the Federal Records Center or the National Archives. Authorizing legislation: 42 USC 287c-21.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected includes file names and disposition dates in an effort to effectively manage records. Only necessary information is collected. No IIF is collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM SharePoint
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 18, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-013
7. System Name (Align with system Item name): NCCAM SharePoint
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Linda Rich
10. Provide an overview of the system: The system holds grant application information that is retrieved from the IMPAC II database with additional tracking information added for the purpose of application grant approval. The system tracks grant applications under authority 42 USC 287c-21.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): For internal purposes only; IIF will not be shared OR disclosed. SOR #09-25-0036
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: A grant application is submitted voluntary by the Investigator through the electronic application submission process in Grants.gov. That information subsequently is stored in the centralized NIH eRA/IMPAC II database - all notifications and consent procedures with subjects are handled at that level. For the purpose of preparation and tracking of selected grants for funding at the IC/NCCAM level, selected data are downloaded from the eRA database into SharePoint. The selected IIF data are restricted to: Investigator Name and Degrees, Institution, Project Title, e-mail address. In SharePoint that data is used only by NCCAM staff members who have been selected and approved by senior level staff for the purpose of grant preparation and tracking. The data is not shared with nor disclosed to any party, and is deleted on a routine basis (each fiscal year) when it is no longer needed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All IIF information is obtained from the NIH IMPAC II system. Any major changes to the system should be handled at the NIH level. Notifications and consent procedures with subjects are also handled at the NIH level. NCCAM does not have a notification process in place as the applications database does not collect the initial IIF. It is only a recipient of IIF collected by another database that is maintained at the NIH level thus we do not have our own notification process to obtain IIF from individuals. This system does not have any notification procedures in place in addition to those in place for the IMPAC II system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The SharePoint system is electronically behind the NIH firewall and can only be accessed from behind the firewall. The information is physically secured by a required key card and employee badge, and electronically secured by a password login procedure to the NIH computer system, and a requirement of a password when accessing the database. A comprehensive IRT is also maintained. Information is also secured by least privilege, separation of duties, an intrusion detection system, locks and background investigations.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Smart Study Version 4.1
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCCAM-012
7. System Name (Align with system Item name): NCCAM Smart Study Version 4.1
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Laura Lee Johnson
10. Provide an overview of the system: Internet data entry system. Purpose is to provide database and data management system for the conduct of clinical investigation at the Division of Intramural Research / NCCAM. Authorizing legislation: 42 USC 287c-21.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The data is restricted to NCCAM data management, monitoring, and analysis personnel, collaborating study investigators, and KAI Research Inc. staff. No outside access is permitted. For internal purposes only; it will not be shared. SOR #09-25-0200
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Patient information without identifiers (i.e. date of birth and biometric identifiers) is collected for the purpose of the conduct of clinical investigations in Complementary and Alternative Medicine (CAM). Clinical data collected in accordance with NCCAM protocols of clinical investigations enable study investigators to advance knowledge about CAM according to study outcomes set forth in clinical study protocols, and to advance the knowledge about the safety and efficacy of CAM for the treatment of human diseases. This system does collect IIF (date of birth and biometric identifiers) and the submission of this personal information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) If major changes occur to the system then the principle or associate investigator would have to obtain new consent forms from study subjects. Study information will be collected only from study subjects, and their medical records, according to written consent forms read, explained to, and signed by study subjects prior to study entry.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: All access to the Smart Study™ system is restricted to those with appropriate user names and passwords. Passwords expire at regular intervals and inactive users have their access removed. The system makes use of thin client architecture and all data transmitted is encrypted (128 bit encryption). The data base servers are maintained at KAI research offices which are locked 24/7. Access is permitted using magnetic pass cards. Doors make use of dead bolt and magnetic locks. The database servers are kept in a temperature controlled room behind a double locked metal door. Access to the server room is restricted to the network support staff, two lead programmers and the IT director. SETEC monitors entry to KAI facilities during the off hours.
There is no wireless access to the KAI network and KAI network is protected by a Cisco ASA firewall.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCCAM Status of Funds Internet Edition (SOFie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: no
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): no
5. OMB Information Collection Approval Number: no
6. Other Identifying Number(s): NCCAM-011
7. System Name (Align with system Item name): NIH NCCAM Status of Funds Internet Edition (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Celena Shirley
10. Provide an overview of the system: SOFie is a financial tracking tool that allows users to access financial data and download data into spreadsheets in order to perform analysis.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Status of Funds internet edition (SOFie) is required by the Administrative and Budget offices of NCCAM for tracking and monitoring the Center’s budget. Utilizing client-server technology, SOFie gives users flexible views and summaries of their accounting structure. The Accounting data and related document information is downloaded from CAS and is relevant to/specific to NCCAM for its fiscal year operations. It is necessary to have access to this data in order to comply with appropriation laws and regulations. The system contains no IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A - No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using user name and password, least privilege, separation of duties and intrusion detection system, firewalls, locks, badge access, background investigations.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Robin Klevins (301) 451-6574
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI AARP Phase I Pilot Study (APS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: 0925-0594
6. Other Identifying Number(s): Z01 CP010196
7. System Name (Align with system Item name): NIH NCI AARP Phase I Pilot Study (APS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Yikyung Park
10. Provide an overview of the system: The APS is a web-based system that manages the data collection activities related to the completion of four web-based instruments that capture dietary, physical activity and health information. The APS allows for a respondent to consent and complete a self-enrollment process. Enrollment includes the collection of contact information. Upon successful enrollment, respondents are assigned instruments to complete and a schedule by which to complete. Access to the instruments is granted to respondent based on assigned schedule. Email, text messaging, and automated phone calls are generated to remind respondents of upcoming and overdue events.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): IIF will not be shared nor disclosed. This collection is covered under System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Respondents will be asked for their name, email address and phone numbers as part of the study conduct to send reminders of upcoming events via outgoing automated outgoing phone calls, cell phone text messaging and email. Respondents can opt-out of cell phone text message and automated phone call reminders.
Phone numbers are also collected for use of providing support to study respondents.
Date of birth is collected to verify enrollment criteria (>50 yrs of age) as well to characterize respondent when determining aggregate response rates.
Race, ethnicity, and state are also collected to characterize respondent.
Social security number is collected for a subset of the respondents in order to determine the response rates and the likelihood in any main study of being able to link to cancer and other health registries for endpoint analyses.
The following fields are required:
Gender, OMB race category(ies), ethnicity, first and last names, mailing address, email, and social security number for a subset of respondents.
Participation is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The scope of the feasibility study is limited and there are no plans to make any major changes to the system. In the event of any changes that impact IIF, respondents will be notified via email of a change and be directed to log into their APS account for details or contact the APS helpdesk.
The consent text included in the system specifies what IIF is being collected and how it will be used or shared. Additionally, the systems includes frequently asked questions (FAQS) that further explain how IIQ information is stored and will be used.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The following classes of controls are in place to protect the APS and respondent IIF: access such as user account management, access enforcement, password strength, least privilege concept, session termination; security awareness and training; audit and accountability; configuration management; contingency planning; identification and authentication for users, devices; incident response including training, testing, monitoring; timely and controlled maintenance; media protection; physical and environment controls such as id badges, physical access authorization using access cards, key locks and cipher locks for building and room entry, monitoring, visitor control, emergency power, and shutoff, disaster protection and recovery; system security plan; personnel security; rules of behavior; risk assessment planning, monitoring, update; technical and communication protection including denial of service protection; boundary protection, programmable firewalls, transmission integrity; security certificates, encryption, regular virus detection and monitoring; policies and procedures are in place for each family control class
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI AdEERS Filing System (AdEERS FS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: To be obtained
6. Other Identifying Number(s): NA
7. System Name (Align with system Item name): NIH NCI AdEERS Filing System (AdEERS FS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Jan Casadei
10. Provide an overview of the system: The purpose of the CTEP AdEERS Filing System is to collect, store, manage and report expedited adverse events related data. The data collected is stored in hardcopy format in secure filing systems as well as secure Electronic Filing Systems operated by NCI CTEP contractors managing this process. Expedited adverse event information is reported to FDA as required in accordance with FDA regulations and guidelines.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): AdEERS FS shares and discloses adverse events related information on NCI sponsored clinical trials with FDA, NCI Investigators and Pharmaceutical sponsors in accordance with federal regulations and guidelines. Most of the information that AdEERS FS collects and shares in publicly available elsewhere.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Legislation authority is the Public Health Service Act (42 U.S.C. 241, 242, 248, 282, 284, 285a-j, 285l-q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.).
The types of data collected are scientific and health data about cancer clinical trials, including clinical and pre-clinical data with associated regulatory and administrative supporting information.
AdEERS FS collects clinical trials data including study information, submitter/reporter information, principal investigator information, treatment assignment, relationship of events to treatments, time of resolution of events, narrative description, events that occurred and their grading and attribution, primary source documents that provide clinical information on the patient’s evaluations and course of treatments and hospitalization, etc.
The information is used to assure patient safety, for scientific decision making, drug distribution, regulatory oversight (i.e., investigator registration, trial audits, etc.), and to facilitate administrative operations.
NCI Investigators who participate in NCI sponsored clinical trials submit their information to CTEP in a signed Investigator Registration (IR) packet. This investigator registration packet, along with additional cover letter, explains to the investigators intended purpose and usage of their information.
Patient participation in CTEP clinical trials is voluntary and participants in CTEP clinical trials sign an informed consent.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All patients sign informed consent forms prior to enrollment on study. Informed consent forms are obtained in compliance with OHRP/IRB and ORI regulations.
AdEERS FS shares and discloses adverse events related information on NCI sponsored clinical trials with FDA, NCI Investigators and Pharmaceutical sponsors in accordance with federal regulations and guidelines. Most of the information that AdEERS FS collects and shares in publicly available elsewhere.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Data in AdEERS Filing System is protected via Administrative, Technical and Physical controls. Hard copy documents are filed in the secure filing cabinets behind locked door in a secure environment with restricted access to the facilities. Only select authorized staffs are allowed to access the hard copies. Access logs to hard copy documents are maintained. Access to data stored in the Electronic Filing System is through password protection account. The Server on which the Electronic Filing System is hosted is maintained in secure facilities.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Advanced Biomedical Computing Center (ABCC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-15
7. System Name (Align with system Item name): NCI Advanced Biomedical Computing Center ABCC
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robert Lebherz
10. Provide an overview of the system: The mission of the Advanced Biomedical Computing Center (ABCC) is to provide high performance computing for the National Cancer Institute, both for its intramural and extramural scientists.
Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1, Sec. 285, Sec. 285a
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information collected consists of name, work phone number, work address, and work e-mail of government employees. This is collected when people sign up to take a class on how to use the ABCC. None of the data collected is information subject to the Privacy Act
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF in this system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF collected. System uses firewalls, passwords, locks, id badges, background investigations, network monitoring and an Incidence Response team.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Agricultural Health Study- Iowa (AHSI)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: 0925-0406
6. Other Identifying Number(s): AHSI
7. System Name (Align with system Item name): NIH NCI Agricultural Health Study - Iowa (AHSI)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Michael Alavanja/Charles Lynch
10. Provide an overview of the system: The Agricultural Health Study is a collaborative effort involving the National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), and the U.S. Environmental Protection Agency (EPA). The study has four major components:
1. The main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data
System (USRDS)
b. ongoing data collection (i.e., telephone interview, food frequency
questionnaire and cheek cell collection
2. Cross-sectional studies - including questionnaire data, functional
measures, biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
The cohort includes 58,564 private pesticide applicators, spouses of private applicators, and commercial pesticide applicators recruited within Iowa. Phase I, initial cohort recruitment, began in 1993 and concluded in 1997. Phase II follow-up began in 1999 and concluded in 2003. The phase III follow-up began in 2005. Phase I observation involved administration of a questionnaire to obtain information on pesticide use, other agricultural exposures, work practices that modify exposures, and other activities that may affect either exposure or disease risks (e.g. diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations, and smoking history). Phase II had three data collection components: a computer assisted telephone interview (CATI), buccal cell collection, and a mailed dietary questionnaire. Phase II interviews are designed to record updated information on pesticide use since enrollment, current farming and work practices, and changes in health status. In addition, the Dietary Health Questionnaire in phase II makes a detailed evaluation of subjects' cooking practices and dietary intake. The buccal cell collection of phase II was implemented to assess the impact of genetic risk factors on epidemiologic outcomes. Phase III interviews are designed to record updated information on pesticide use since Phase II, current farming and work practices, and changes in health status. In addition to phase II and phase III data collection activities that include the whole cohort, a series of sub-studies involving a small number of study participants will directly measure applicator and family member exposures to selected pesticides and/or focus in greater detail on subgroups with specific diseases or exposures.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Agricultural Health Study Coordinating Center for data analysis and annual linkages to the National Death Index and the Internal Revenue Service. Designated sub-contractors within the AHS for the purpose of completing sub studies. The State Health Registry of Iowa for the purpose of completing linkages for Iowa Cancer outcomes and Iowa mortality. The system is also covered under the Privacy Act System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: We share IIF with sub-studies or other designated sub-contractors with the Ag Health Study to allow them to complete their contract within the study. In all cases we contact the participant to inform them of the release and allow them to refuse. We share IIF with the State Health Registry of Iowa to complete linkages to determine cancer outcomes and deaths within our cohort. We share IIF with the Ag Health Study Coordinating Center to complete linkages with the National Death Index for additional deaths that didn't occur in Iowa and the Internal Revenue Service for updated addresses of participants who have moved out of state.
Phase I involved questionnaire to obtain information on pesticide use, other agricultural exposures, work practices that modify exposures, and other activities that may affect either exposure or disease risks. Phase II had three data collection components: a computer-assisted telephone interview (CATI), buccal cell collection, and a mailed dietary questionnaire. Phase II and Phase III include data collection activities that include the whole cohort. There are also a series of sub-studies involving a small number of study participants that will directly measure applicator and family member exposures to selected pesticides and/or focus in greater detail on subgroups with specific diseases or exposures.
Participation is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There have been no major changes in the system and none are contemplated. Our IRB would review any major changes prior to implementation and provide us with guidance on any needed notification and consent requirements.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Several layers of passwords exist to ensure unauthorized access to the electronically stored data is not permitted. Long term backups on tape or external hard disk are stored in a locked fireproof safe in a locked room at the Iowa Field Station. Transient backups are written to encrypted hard drive until they can be written to long term media. Hard copies of contact sheets, questionnaire identifier pages, and consent forms are stored in locked file cabinets in locked rooms at the Iowa Field Station. User ID, passwords, firewalls and encryption is used. All personnel involved with the project have signed confidentiality agreements.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Agricultural Health Study- North Carolina (AHSNC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: 0925-0406
6. Other Identifying Number(s): AHSNC
7. System Name (Align with system Item name): NIH NCI Agricultural Health Study - North Carolina
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Michael Alavanja / Charles Knott
10. Provide an overview of the system: The Agricultural Health Study is a collaborative effort involving the National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), and the U.S. Environmental Protection Agency (EPA). The study has four major components:
1. The main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data System (USRDS)
b. ongoing data collection (i.e., telephone interview, food frequency questionnaire and cheek cell collection
2. Cross-sectional studies - including questionnaire data, functional measures, biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
The cohort includes 89,658 private pesticide applicators, spouses of private applicators, and commercial pesticide applicators recruited within Iowa and North Carolina. Phase I, initial cohort recruitment, began in 1993 and concluded in 1997. Phase II follow-up began in 1999 and concluded in 2003. The phase III follow up began in 2005. Phase I observation involved admininstration of a questionnaire to obtain information on pesticide use, other agricultural exposures, work practices that modify exposures, and other activities that may affect either exposure or disease risks (e.g., diet exercise, alcohol consumption, medical conditions, family history of cancer, other occupations, and smoking history.) Phase II had three data collection components: a computer-assisted telephone interview (CATI), buccal cell collection, and a mailed dietary questionnaire. Phase II interviews were designed to record updated information on pesticide use since enrollment, current farming and work practices, and changes in health status. In addition, the Dietary Health Questionnaire in phase II makes a detailed evaluation of subjects' cooking practices and dietary intake. The buccal cell collection of Phase II was implemented to assess the impact of genetic risk factors on epidemiologic outcomes. Phase III activities are in the planning stage. In addition to phase II and phase III data collection activities that include the whole cohort, a series of sub-studies involving a small number of study participants will directly measure applicator and family member exposures to selected pesticides and/or focus in greater detail on subgroups with specific diseases or exposures.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): North Carolina Field Station (Battelle CPRHE, Durham, NC - separately contracted by NCI - handles all direct interactions with NC participants.) National Death Index (NDI) - Annual match with NDI Plus files; initiated by the Coordinating Center but processed by Battelle. Internal Revenue Service - to obtain updated address information which is stored at field stations; initiated by the Coordinating Center but processed by Battelle North Carolina Central Cancer Registry (NCCCR) - Battelle CPHRE, Durham, NC - separately contracted by NCI - annual match with NCCCR incidence files. North Carolina Decedent Database (NCDD) - Battelle CPHRE, Durham, NC - Annual matches with NCDD files. The system is also covered by under the Privacy Act System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Battelle's North Carolina Field Station maintains all identifiers in a separate and secure database from other AHS data. This information is critical for active and passive follow-up of the cohort. This is a requirement and adheres to AHS' Certificate of Confidentiality.
There are four major components:
1. Main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data System (USRDS)
b. ongoing data collection (i.e., telephone interviews, food frequency questionnaire and cheek cell collection)
2. Cross-sectional studies - including questionnaire data, functional measures, biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
Phase I involved questionnaire to obtain information on pesticide use, other agricultural exposures, work practices that modify exposures, and other activities that may affect either exposure or disease risks. Phase II had three data collection components: a computer-assisted telephone interview (CATI), buccal cell collection, and a mailed dietary questionnaire. Phase II and Phase III include data collection activities that include the whole cohort. There are also a series of sub-studies involving a small number of study participants that will directly measure applicator and family member exposures to selected pesticides and/or focus in greater detail on subgroups with specific diseases or exposures.
Participation is voluntary
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There have been no major changes in the system and none are contemplated. Battelle's CPHRE IRB reviews any major changes prior to implementation and provides us with guidance on any needed notification and consent requirements.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Extensive safeguards are in place to ensure the confidentiality of each subject is protected. Each subject is assigned a six-digit number; these IDs are used for any references to subjects on an individual basis. Names and other identifying information are kept in separate databases maintained by Battelle. These data files are joined only for performing necessary active and passive follow-up activities. Contact of subjects occurs only through the Field stations. Several layers of passwords exist to ensure unauthorized access to the electronically stored data is not permitted. Hard copies of consents and questionnaires that contain any personal information are stored in locked rooms at Battelle.
User IDs, passwords, firewalls, VPN, encryption, intrusion detection system, and smart cards in use.
All personnel involved with the project have signed confidentiality agreements and adhere to the project's Certificate of Confidentiality. Access to physical and electronic records are limited to authorized AHS Field Station staff and appropriate physical, administrative, and technical controls are in place.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Agricultural Health Study --Westat (AHSW)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: 0925-0406
6. Other Identifying Number(s): AHSW
7. System Name (Align with system Item name): NIH NCI Agricultural Health Study - Westat (AHSW)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Michael Alavanja / Stanley Legum
10. Provide an overview of the system: The Agricultural Health Study is a collaborative effort involving the National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), and the U.S. Environmental Protection Agency (EPA). The study has four major components:
1. The main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data
System (USRDS)
b. ongoing data collection (i.e., telephone interview, food frequency
questionnaire and cheek cell collection
2. Cross-sectional studies - including questionnaire data, functional measures,
biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
The cohort includes 89,658 private pesticide applicators, spouses of private applicators, and commercial pesticide applicators recruited within Iowa and North Carolina. Phase I, initial cohort recruitment, began in 1993 and concluded in 1997. Phase II follow-up began in 1999 and concluded in 2003. The Phase III follow-up began in 2005. Phase I observation involved administration of a questionnaire to obtain information on pesticide use, other agricultural exposures, work practices that modify exposures, and other activities that may affect either exposure or disease risks (e.g. diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations, and smoking history). Phase II had three data collection components: a computer-assisted telephone interview (CATI), buccal cell collection, and a mailed dietary questionnaire. Phase II interviews are designed to record updated information on pesticide use since enrollment, current farming and work practices, and changes in health status. In addition, the Dietary Health Questionnaire in Phase II makes a detailed evaluation of subjects' cooking practices and dietary intake. The buccal cell collection of Phase II was implemented to assess the impact of genetic risk factors on epidemiologic outcomes. In addition to Phase II and Phase III data collection activities that include the whole cohort, a series of sub-studies involving a small number of study participants will directly measure applicator and family member exposures to selected pesticides and/or focus in greater detail on subgroups with specific diseases or exposures.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Iowa Field Station (University of Iowa - separately contracted by NCI - handles all direct interactions with Iowa participants) North Carolina Field Station (Battelle CPRHE, Durham, NC - separately contracted by NCI - handles all direct interactions with NC participants) Information Management Services (IMS - separately contracted by NCI - performs data analyses for NCI) National Death Index (NDI) - Annual match with NDI Plus files. Internal Revenue Service - to obtain updated address information which is stored at the field stations. This system is also covered under the Privacy Act System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The data do not contain direct identifiers such as name, address, or SSNs except for the periods when we are performing matches to NDI and IRS files.
The AHS has four major components:
1. Main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data
System (USRDS)
b. ongoing data collection (i.e., telephone interview, food frequeny
questionnaire and cheek cell collection
2. Cross-sectional studies - including quesitonnaire data, functional measures,
biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
Phase I involved questionnaire to obtain information on pesticide use, other agricultural exposures, work practices that modify exposures, and other activities that may affect either exposure or disease risks. Phase II had three data collection components: a computer-assisted telephone interview (CATI), buccal cell collection, and a mailed dietary questionnaire. Phase II and Phase III include data collection activities that include the whole cohort. Three are also a series of sub-studies involving a small number of study participants that will directly measure applicator and family member exposures to selected pesticides and/or focus in greater detail on subgroups with specific diseases or exposures.
Participation is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There have been no major changes in the system and none are contemplated. Our IRB would review any major changes prior to implementation and provide us with guidance on any needed notification and consent requirements.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Extensive safeguards are in place to ensure the confidentiality of each subject is protected. Each subject is assigned a six-digit number; these IDs are used for any references to subjects on an individual basis. Names and other identifying information are kept in separate databases maintained by the Field Stations. These data files are joined only for performing linkages to the mortality and cancer incidences databases. Contact of subjects occurs only through the Field Stations. Several layers of passwords exist to ensure unauthorized access to electronically stored data is not permitted. Hard copies of questionnaires that contain any personal information (primarily the female/family health questionnaires and selected follow-up questionnaires) are stored in locked rooms at the Coordinating Center. All personnel involved with the project have signed confidentiality agreements.
For a few weeks each year, Westat also has names, social security numbers, and other identifying information when we consolidate files from the field stations for submission to NDI Plus for matching to death records and to IRS to obtain current address data. Once the matched records are returned from these sources they are sent to the originating field station and the files are deleted from Westat servers. While at Westat, these files are stored in a directory accessible only to the project's lead systems manager and one programmer. They are also encrypted when not in use and the encryption key is known only by the same two staff members. The files are never left in unencrypted form over night so that automatic backups contain only encrypted versions. After the field stations confirm receipt of readable files, the copies at Westat are deleted.
The system is protected by firewalls, intrusion detection systems, and passwords. There are comprehensive system security and contingency plans in place. An Incident Response capability is maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Automated Self-Administered 24-Hour Recall (ASA24)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH NCI Automated Self-Administered 24-hour Recall (ASA24)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dr. Nancy Potischman
10. Provide an overview of the system: Self-reported dietary assessment methods are commonly used to measure food intakes for dietary surveillance, nutritional epidemiology, clinical and intervention research. We developed a 24-hour dietary recall that could be unannounced, automated, and self-administered to make feasible the administration of multiple days of recalls in large-scale epidemiological studies, surveillance sites, behavioral trials and clinical research. The format and design were modeled on the interviewer-administered Automated Multiple Pass Method (AMPM) developed by the US Department of Agriculture (USDA). The website collects information about subjects' diet for the previous day for extramural researchers doing epidemiologic or clinical research. There is no personally identifiable information collected on this site. The respondents are given a username and password by the NCI in order to gain access to the website. Participation in these studies are voluntary and nonparticipation has no impact on the subjects' care or involvement in other aspects of the studies.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The diet information collected provides a service for outside researchers and will not be used by the agency. The system does not contain PII and the information is provided by subjects on a voluntary basis.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No PII in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII in the system
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Automated Self-Administered 24-Hour Recall (ASA24) Researcher Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH NCI Automated Self-Administered 24-Hour Recall (ASA24) Researcher Website
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Nancy Potischman
10. Provide an overview of the system: Researchers visit this website to gain access to the subjects' website (ASA24) for their research studies. The researcher will visit the site to provide lists of subjects' IDs with their dates for visiting the subjects' website and later will monitor their study and obtain the final data files of nutrients and foods consumed by each subject. Subject IDs are not linked to personal information at NCI. The Study ID is linked at the NCI to a username and password for each subject to gain access to the ASA24. The researcher provides their name, institution and email contact information as well as similar information for other staff with permission to visit the site on thier behalf. The researcher provides only institutional information not personal email and other contact information. Participation is voluntary.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information the researcher provides is institutional email and contact information. None of this information relates to personal information and is not shared with anyone outside of the ASA24 team. The Study ID, username and password information on respondents is not linked to any personal information. The username is linked to dietary information stored from the respondent 's reports while visiting the ASA24 website. Participation by the researcher is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No PII in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII in the system
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI California Health Interview Survey (CHIS) Information Technology System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jul 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: 0925-0598
6. Other Identifying Number(s): N02-PC-54400
7. System Name (Align with system Item name): California Health Interview Survey (CHIS) Information Technology System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Nancy Breen - NCI /Neil Sehgal - UCLA
10. Provide an overview of the system: The California Health Interview Survey (CHIS) is a population-based random-digit dial telephone survey of California's population conducted every other year since 2001 by the UCLA Center for Health Policy Research (UCLA-CHPR). UCLA-CHPR has the lead responsibility of managing the survey, preparing, maintaining, and disseminating the CHIS data files, reporting the survey findings, and disseminating the survey results. All CHIS confidential data files are maintained at the Data Access Center (DAC). No PII is contained with the CHIS confidential data files. The Data Access Center is designed to provide access to CHIS confidential files in a secured, controlled environment that protects the confidentiality of respondents.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII in the system.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: All data received by UCLA-CHPR is in the de-identified form with all personal identiers removed. All research participants provide verbal consent to participate in CHIS. The verbal consent script for each CHIS survey is approved by the UCLA Institutional Review Board and the California Health & Human Services Committee for the Protection of Human Services. The consent script informs respondents about the voluntary and confidential nature of the survey and assures them that their individual answers would not be linked to their identity or disclosed. There is no PII in the system. All data is given voluntarily by respondents.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No PII in the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII in the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jun 24, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: 0925-0598
6. Other Identifying Number(s): N02-PC-54400
7. System Name (Align with system Item name): NIH NCI California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Nancy Breen
10. Provide an overview of the system: IMS is contracted by NCI to maintain CHIS microdata in a secure environment. There is no identifying information in the data. CHIS data include a range of cancer control variables for respondents including use of cancer screening, and a wide range of socio-demographic variables including health insurance status, usual source of health care. NCI analysts examine statistical patterns and trends in cancer control outcomes in California using CHIS. IMS staff develop programs to conduct statistical analyses as specified by NCI researchers.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: 1) IMS is under contract with NCI to maintain CHIS microdata files as needed for analysis by NCI. IMS programers and statisticians work under contract with NCI staff to help with programming and statistical analysis as specified by NCI staff. 2) NCI uses CHIS data to conduct statistical analysis of cancer control outcomes. These include use of cancer screening services, patterns and trends in tobacco use, physical activity and other cancer-control related behaviors. 3) No PII in the system. 4) No PII in the system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No PII in the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII in the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI cancer Biomedical Informatics Grid (caBIG, caGRID)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 25, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: None
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Cancer Biomedical Informatics Grid (caBIG) caGRID
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Krishnakant Shanbhag
10. Provide an overview of the system: caGrid is the underlying service-oriented infrastructure that supports caBIG. Driven primarily by scientific use cases from the cancer research community, it provides the core infrastructure to compose the Grid of caBIG. caGrid provides the technology that enables collaborating institutions to share information and analytical resources efficiently and securely, while also allowing investigators to easily contribute to and leverage the resources of a national-scale, multi-institutional environment.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: caGRID does not collect, maintain or disseminate any data.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) caGRID is an infrastructure and does not contain PII.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Central Clinical Patient Registry (C3PR)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): NIH NCI Cancer Central Clinical Patient Registry (C3PR)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Christo Andonyadis, System Owner
10. Provide an overview of the system: C3PR is a central participant registry and underlying database that will allow the management of patient clinical trials registration information and protocol information across studies, sites, systems and organizations.
C3PR operates on its own data tables with a close interface with Oracle Clinical. The implementation of the system will preserve the fundamental independence of the storage of the patient and registration information from the scientific and research data. System identifiers will be used to relate patient demographics and identifying information to eligibility, medical or treatment data.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The System shares PII with users of the Cancer Central Clinical Database (C3D) who are health care professionals who input patient data into the C3D System.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The Agency will collect from patients their name, date of birth, address, gender, race, and ethnicity, from patients for registry purposes for the Cancer Central Clinical Database (C3D) application. Submission of all personal information is voluntary. A medical records number will be assigned to them. This information is Personally Identifiable Information (PII) and submission of this personal information is voluntary subject to a Consent Form.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Patients voluntarily sign a consent form to voluntarily provide names, dates of birth, gender as PII and that it will be used for the registry, as well as for cancer research. The consent form obtains consent from the patient and notifies the patient of his/her rights. The patient will be notified if any major changes occur to the system. The PII will be destroyed when the system is decommissioned.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative controls include annual risk assessments and the SDLC. Operational controls include personnel controls and strict account granting. Technical controls include firewalls, IDS, logon banner warnings, identification and authentication, database roles, file permissions and anti-virus/malware scanning.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Data Standards Repository-Standards Reporting-Common Data Elements (caDSR-SBR-CDE)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4921-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-31
7. System Name (Align with system Item name): NIH NCI Standards Based Report (caDSR)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dave Hau
10. Provide an overview of the system: One of the problems confronting the biomedical data management community is the panoply of ways that similar or identical concepts are described. Such inconsistency in data descriptors (metadata) makes it nearly impossible to aggregate and manage even modest-sized data sets in order to be able to ask basic questions. The NCI, together with partners in the research community, develops common data elements (CDEs) that are used as metadata descriptors for NCI-sponsored research. The caDSR is a database and tool set that the NCI and its partners use to create, edit and deploy the CDEs.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NCI, together with partners in the research community, develops common data elements (CDEs) that are used as metadata descriptors for NCI-sponsored research. The system does not collect IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Diagnosis Program (CDP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): Not Appliciable
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): NCI-7
7. System Name (Align with system Item name): NIH NCI DCTD Cancer Diagnosis Program (CDP)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Magdalena Thurin, Ph.D.
10. Provide an overview of the system: A contractor independently receives de-identified data or minimal datasets with data use agreement from cooperative agreement funded participants in NCI supported human specimen resources and makes subsets of that data available to researchers using the specimens. A contractor manages password-secure websites that provide logistics support for the research projects.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Does not share IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No IIF is collected. De-identified information is being provided from the records of cooperative agreement funded institutions participating in NCI funded human specimen resources. The purposes and procedures of these activities have been reviewed by institutional review boards and deemed appropriate.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is collected. Only de-identifiad or a limited dataset with data use agreements under the DHHS the Privacy Rule is involved.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF in the system, however username/passwords, least privilege, seperation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained,
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Genome Anatomy Project (CGAP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-25
7. System Name (Align with system Item name): NCI Cancer Genome Anatomy Project (CGAP)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Carl Schaefer
10. Provide an overview of the system: The goal of the NCI's Cancer Genome Anatomy Project is to determine the gene expression profiles of normal, precancer, and cancer cells, leading eventually to improved detection, diagnosis, and treatment for the patient. By collaborating with scientists worldwide, such as the Ludwig Institute for Cancer Research and Lund University, CGAP seeks to increase its scientific expertise and expand its databases for the benefit of all cancer researchers. Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1, Sec. 285, Sec. 285a and 44 U.S.C. 3101
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The Cancer Genome Anatomy Project determines the gene expression profiles of normal, precancer, and cancer cells, with the goal of improved detection, diagnosis, and treatment for the patient. Gene expressions are not identified with any individual.
No IIF is collected. Data is downloaded by NIH NCI NCICB authorized users, in this case, cancer researchers.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF collected. System uses firewalls, passwords, locks, id badges, background investigations, network monitoring and an Incidence Response team.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Imaging Camp (CIC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: This is a minor app and does need a UPI
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): NCI-79
7. System Name (Align with system Item name): NIH NCI Cancer Imaging Camp
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: This application supports a workshop and allows potential participants of the to workshop to submit information to the workshop organizers.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The collected information is shared with the workshop 's reviewers and organizers.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: 5 U.S.C. 301; 44 U.S.C. 3101. Workshop participatns post a limited ammount of work-related information and a presentation(s) to a website. IIF includes name, e-mail address, telephone number, CV, insititution, and their experiences. The information is used to identify the participants and collect their submission information. Information is submitted voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There are no procedures in place for notifying individuals when major changes occur to the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, and background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Blaise Czekalski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Imaging Program Website (CIP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): Not Applicable
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): NCI-74
7. System Name (Align with system Item name): Cancer Imaging Program http://imaging.cancer.gov
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Barbara Y Croft / Anne Menkens
10. Provide an overview of the system: This is the public website for the NCI Cancer Imaging Program. It is used to provide information concerning the program to the public and research community.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The Cancer Imaging Program uses this website to disseminate information concerning the Program to the public. It is for information purposes. There is no IIF contained in the system. There is a webpage form used to generate an e-mail to CIP staff which allows individuals to ask questions. The information on the webpage is not kept and is the equivilant of an individual sending an e-mail to the program
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF in the system, however the site is protected by NCICB infrastructure security measures including firewalls, server password protection mechanisms and is monitored by the IRT for intrusion detection.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Integrator (caIntegrator)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-76
7. System Name (Align with system Item name): NIH NCI Cancer Integrator (caIntegrator)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anand Basu
10. Provide an overview of the system: The caIntegrator knowledge framework provides cancer researchers with the ability to perform ad hoc querying and reporting across multiple domains of cancer data. This application framework comprises an n-tier service oriented architecture that allows pluggable web-based graphical user interfaces, a business object layer, server components that process the queries and result sets, a data access layer and a robust data warehouse. At the heart of caIntegrator is the Clinical Genomics Object Model (CGOM) that provides standardized programmatic access to the integrated biomedical data collected in the caIntegrator data system. Design of the CGOM is driven by usecases from two critical NCI-sponsored studies, a brain tumor trail called GMDI (Glioma Molecular Diagnostic Initiative) and a breast cancer study called I-SPY TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular analysis). The model represents data from clinical trials, microarray-based gene expression, SNP genotyping and copy number experiments, and Immunohistochemistry-based protein assays. Clinical domain objects in CGOM allow access to Clinical trial protocol, treatment arms, patient information, sample histology, clinical observations and assessments. Genomic domain objects allow access to biospecimen information, raw experimental data, in-silico transformation and analyses performed on the raw experimental datasets and biomarker findings. The clinical and genomic findings domain objects have relationships to the FindingsOntology object, as the findings can be complex concepts which, in turn, can be generically represented as items occurring in an ontology (for example, WHO histopathological classification for brain tumor histology findings). caIntegrator supports the mission of the National Cancer Institute, NIH Center for Bioinformatics as a web application for cancer research.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency collects from authorized researchers, maintains, and disseminates via a strictly controlled process to authorized researchers de-identified medical data consisting of de-identified imaging and molecular analysis cancer data, including DNA snippets. This information is submitted on a voluntary basis. No personal information is collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is collected.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Therapy Evaluation Program (CTEP FISMA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4902-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: NA
6. Other Identifying Number(s): NCI-14
7. System Name (Align with system Item name): NIH NCI Cancer Therapy Evaluation Program Enterprise System (CTEP-ESYS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Steve Friedman (George Redmond is alternate POC)
10. Provide an overview of the system: The purpose of the system is to assure patient safety and meet the NCI CTEP scientific, regulatory, administrative and operational program mission. Specifically, it is used to document, track, monitor and evaluate NCI clinical research activities. The Cancer Therapy Evaluation Program Enterprise System (CTEP-ESYS) project is the primary data collection mechanism for NCI's vast clinical trials program. CTEP-ESYS collects safety and clinical results data on ongoing cancer clinical trials (trials not yet completed). Data reporting and analysis in real time is critical to ensuring adequate monitoring of the ongoing clinical research. Timely data reporting and analysis also assures effective planning for the required successor studies, thus accelerating the evaluation of promising new agents and regimens for patients with cancer.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): CTEP-ESYS shares NCI Investigator and NCI Associates data with the Clinical Trials Support Unit (CTSU), a CTEP/NCI sponsored project to increase participation in NCI sponsored cancer related clinical trials. The CTSU system provides additional information about the clinical trials that are ongoing at various cooperative groups. With increased awareness and access to the trials information, CTEP intends to increase physician and patient participation in the NCI sponsored trials.
CTEP-ESYS also shares IIF with NCI Center for Biomedical Informatics and Information Technology’s Clinical Data System (CBIIT-CDS) to facilitate clinical trials related data collection functions that CBIIT-CDS application performs for CTEP-ESYS applications.
Some of the information that CTEP-ESYS shares with CTSU and CBIIT-CDS is also publicly available elsewhere.
This system falls under the guidelines of Privacy Act System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Legislation authority is the Public Health Service Act (42 U.S.C. 241, 242, 248, 282, 284, 285a-j, 285l-q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.).
The types of data used are scientific and health data about cancer clinical trials, including clinical and pre-clinical data with associated regulatory and administrative supporting information. Patient participation in CTEP clinical trials is voluntary and participants in CTEP clinical trials sign an informed consent. Types of information available in the enterprise include protocols and protocol attributes, drug inventory and site distribution records, adverse event report, site audit reports, IND submission records, Investigator registration details, and Non-IIF patient accrual details. The information is used to assure patient safety, for scientific decision making, drug distribution, regulatory oversight (i.e., investigator registration, trial audits, etc.), and to facilitate administrative operations.
CTEP Staff routinely generate standard reports and request ad-hoc reports that display CTEP-ESYS data. The reports are used by CTEP Staff to analyze clinical trial operations and are also used to communicate with external collaborators. In addition to CTEP initiated reports, occasionally ad-hoc reports are created from CTEP-ESYS to support a response to a FOIA request.
In addition, CTEP has coordinated a procedure where commercial pharmaceutical companies can request reports that provide data related to adverse events and accrual of on-going cancer related clinical trials. This procedure requires review and approval by the CTEP Regulatory Affairs Branch (RAB) prior to the generation of reports.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) CTEP-ESYS collects Information in Identifiable Format (IIF) related to NCI Investigators and Associates who are aware of the intended purpose and usage of the information. NCI Investigators furnish their information to CTEP in a written application. NCI Associates furnish their information to CTEP via an online registration process. CTEP-ESYS users are required to acknowledge the NIH Privacy Policy posted on the Warning Banners prior to accessing the CTEP-ESYS.
Changes to CTEP-ESYS are managed and controlled via CMMI Level 3 compliant change management processes. All changes are discussed at and approved by Enterprise Change Management Committee (ECMC). ECMC memberships include, but not limited to, CTEP-ESYS Project Officers, CTEP Branch Chiefs, CTEP-ESYS contractors and CTEP-ESYS stakeholders.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: CTEP-ESYS data is maintained in a secure database. The following are in place as Management Controls:
· Logon Banners
· Rules of Behavior
· System Security Plan
· Configuration Management, Change Management Plans and Processes
· Disaster Recovery Plan (tested)
· Interconnection Security Agreement
The following are in place as Technical controls for CTEP-ESYS:
· User ID and Passwords are required to login to CTEP-ESYS applications
· The CTEP-ESYS application is hosted within NIH Network boundaries and is protected by NIH CIT provided Perimeter Firewall and Intrusion Detection Systems
· SSL Encryption is enabled for access to web based interfaces of CTEP-ESYS modules, where necessary
· Proactive Systems Monitoring and Alerts Management
· Anti-virus, security updates and patching procedures
· Periodic SARA Scans for CTEP-ESYS systems
· Incidence Response Procedures
· System and Database Audit Trails and Logs
The following are in place as Operational controls for CTEP-ESYS:
· Personnel Security
· Security Clearance Process for all contractor personnel working on CTEP-ESYS
· CTIS Hiring and Termination Process
· NIH Non-Disclosure Agreement for all CTIS employees working on CTEP-ESYS
· Annual requirement by employee to take NIH CIT Security Awareness Training
· Physical and Environmental Protection
· Visitor Log Procedures
· Backup Procedures
· Offsite Storage for Tapes
· Video Surveillance of Data Center
· AC Maintenance Process
· Contingency /Disaster Recovery Plan
· Incidence Response Procedures
· Alerts and Scans
· Identification and Authentication
· User Account Management Process
· Role based user access to systems
· Password Change Policies
· Procedures for handling lost/compromised passwords
· Audit Trails
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Cancer Trials Support Unit (CTSU
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: Requested
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH NCI Cancer Trials Support Unit (CTSU)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mike Montello
10. Provide an overview of the system: The Cancer Trials Support Unit (CTSU) is a service offered by the National Cancer Institute to enhance and facilitate access to cancer clinical trials for clinical investigators in the United States and Canada. The CTSU maintains a broad menu of trials developed by the adult cancer Cooperative Groups and other research consortia and works with these organizations to offer patient enrollment, data collection, data quality management, and enrollment reimbursement services to clinical sites entering patients in these trials. In addition, the CTSU offers a regulatory support service to all adult cancer clinical trials by collection of regulatory documents and maintenance of a national database of investigators and sites. The CTSU also provides education and training for clinical site staff and clinical trials promotion services to help increase enrollment in cancer trials. A large and complex information technology infrastructure has been developed to support CTSU operations and exchange data with other data centers involved in cancer research. Westat is the prime contractor on the project, having two subcontractors, and working with numerous other organizations.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): CTSU shares NCI Investigator and NCI Associates data with CTEP-ESYS – a NCI sponsored project and other Cooperative Groups, to increase participation in NCI sponsored cancer related clinical trials.
With increased awareness and access to the trials information, CTEP intends to increase physician and patient participation in the NCI sponsored trials.
CTSU shares this information, which may contain IIF, with lead research organizations for the purpose of assuring patient safety, for scientific decision making, drug distribution, regulatory oversight (i.e., investigator registration; trial audits) and to facilitate administrative operations.
CTSU also shares this information with the Cooperative Groups and with NCI Center for Biomedical Informatics and Information Technology’s Clinical Data System (CBIIT-CDS). Some of this information is available to staff at Cooperative Group member sites on a limited basis.
Some of the information that CTSU shares with CTEP and CBIIT-CDS is also publicly available elsewhere.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Legislation authority is the Public Health Service Act (42 U.S.C. 241, 242, 248, 282, 284, 285a-j, 285l-q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.).
The types of data used are scientific and health data about cancer clinical trials, including clinical and pre-clinical data with associated regulatory and administrative supporting information. Patient participation in CTEP clinical trials is voluntary and participants in CTEP clinical trials sign an informed consent. Types of information available in the CTSU Enterprise include protocols and protocol attributes, Investigator registration details, and non-IIF patient accrual details. The information is used to assure patient safety, for scientific decision making, drug distribution, regulatory oversight (i.e., investigator registration; trial audits) and to facilitate administrative operations.
The CTSU collects and maintains various types of data.
Investigator and treatment site staff information is obtained from the CTEP-ESYS and maintained in the CTSU. Cooperative Group staff use this data to maintain their membership rosters. This data is used as part of the credentialing requirements for patient enrollments.
Protocol and regulatory information related to the member sites is collected and maintained in the CTSU Enterprise.
This data is disseminated to Cooperative Groups to support patient enrollment and data collection processes.
The CTSU also performs patient enrollments and will begin to collect demographic, eligibility criteria data, and other enrollment required data as part of this process. This data is collected on behalf of and shared with the organization that is leading a study.
For some studies, the CTSU performs the complete data management and collects/maintains the clinical data collected for a study and disseminates it to the organization leading the study.
Patient participation in CTEP clinical trials is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Users that access the systems must reregister on an annual basis and any changes would be communicated through that process.
NCI Investigators furnish their information to CTEP in a written application. IIF related to the Regulatory Support System (RSS)/Financial Management System (FMS) [JM1] are supplied to the CTSU at the time of account request via a standard application.
Participating research organizations require trial participants to sign an authorization to use or disclose identifiable health information for research. A subject cannot enroll in a study without providing one of these release forms. They can withdraw the authorization at a later time, but then must leave the study. The link to the form is https://members.ctsu.org/readfile.asp?sectionid=1&fname=HIPAA/NSABP_HIPAA_Permission_030503.pdf&ftype=PDF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: CTSU data is maintained in a secure database.
The following are in place as Management Controls:
· Rules of Behavior
· System Security Plan
· Configuration Management, Change Management Plans and Processes
· Disaster Recovery Plan
· Interconnection Security Agreement
The following are in place as Technical controls for CTSU:
· User ID and Passwords are required to login to CTSU applications
· The CTSU application is hosted within Westat Network boundaries and is protected by Westat provided Perimeter Firewall and Intrusion Detection Systems
· SSL Encryption is enabled to access web based interfaces of CTSU modules, where necessary
· Proactive Systems Monitoring and Alerts Management
· Anti-virus, security updates and patching procedures
· Periodic vulnerability scans for CTSU systems – both internal and external
· Incidence Response Procedures
· System and Database Audit Trails and Logs
The following are in place as Operational controls for CTSU:
· Personnel Security
· Security Training/Clearance Process for all personnel working on CTSU
· Westat Hiring and Termination Process
· Non Disclosure Agreements for all employees working on CTSU
· All employees take/review NIH CIT Security Awareness Training on an annual basis
· Physical and Environmental Protection
· Visitor Log Procedures
· Backup Procedures
· Offsite Storage for Tapes
· Video Surveillance of Data Center
· AC Maintenance Process
· Contingency /Disaster Recovery Plan – tested regularly (last test on 11/2/08)
· Incidence Response Procedures
· Alerts and Scans
· Identification and Authentication
· User Account Management Process
· Role based user access to systems
· Password Change Policies (in sync with CTEP-ESYS)
· Procedures for handling lost/compromised passwords
· Audit Trails
The system falls under the Privacy Act System of Records Notice 09-25-0200
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI CB CaArray
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 25, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-28
7. System Name (Align with system Item name): CaArray (Director's Challenge Toward a Molecular Classification of Cancer)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Juli Klemm
10. Provide an overview of the system: caArray is an open-source, web and programmatically accessible array data management system. caArray guides the annotation and exchange of array data using a federated model of local installations whose results are shareable across the cancer Biomedical Informatics Grid (caBIG™). caArray furthers translational cancer research through acquisition, dissemination and aggregation of semantically interoperable array data to support subsequent analysis by tools and services on and off the Grid. As array technology advances and matures, caArray will extend its logical library of assay management.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Clinical investigators/submitters are asked to provide their professional contact information in order to further scientific collaboration and provide a point of contact for their area of interest/research. Personal email addresses, mailing addresses and phone numbers may be unintentionally provided by the investigator/submitter in lieu of professional information. Personally identifiable information in the form of contact information for the clinical investigator/submitter can be obtained from caArray on the Contacts tab once a particular experiment is selected/accessed. This information (which is provided voluntarily by the investigator/submitter) is shared to encourage scientific collaboration and the aggregation of semantically interoperable array data which will allow for easier subsequent analysis.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) Clinical investigators/submitters are asked to provide their business contact information, including name, mailing address, phone number, and e-mail address.
(2) Professional contact information is collected in order to identify the researcher and associate the researcher with a particular experiment or other collected research information.
(3) This information does ask for PII, but investigators may unintentionally provide personal contact information.
(4) The submission of this information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) NCI will post notices on the caArray website to inform clinical investigators/submitters of:
(1) major changes that occur to the caArray system that may affect the use/disclosure of PII in the system;
(2) changes in the type of PII to be collected from them;
(3) any changes to how PII is used or shared.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: System uses firewalls, passwords, locks, id badges, background investigations, network monitoring and an Incident Response team.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI CB Clinical Trials - Bioinformatics (C3D)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4917-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-27
7. System Name (Align with system Item name): NCI CB Clinical Trials - Bioinformatics
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Christo Andonyadis
10. Provide an overview of the system: The Cancer Centralized Clinical Data System (C3DS) is leading the National Cancer Institute's (NCI) effort to create and distribute information technology infrastructure to support the conduct all aspects of NCI's supported clinical trials. Public Health Act, Title 42, Chapter 6A, Subchapter III, Part C, Subpart 1, Sec. 285, Sec. 285A And 44 U.S.C. 3101
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): IIF data is limited to the doctors and nurses specifically linked to that study.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: DOB, Medical Notes and Medical Record Numbers. The C3D will collect clinical trial data for efficacy analysis and safety monitoring. Clinical Centers collect the data that is stored in C3D voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Notification and consent for individuals is covered under the Privacy Policy provided on the site. Alll NCICB websites contain a Privacy Preference statement which enables NCICB to express its privacy practices in a standard format that can be retrieved automatically and interpreted easily by user agents to automate decision-making based on these practices when appropriate
Notices of consent is provided via an electronic notice. (in both machine- and human-readable formats)
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: System uses firewalls, passwords, locks, id badges, background investigations, network monitoring and an Incidence Response team.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI CB Mouse Models (CaMOD)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4919-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-30
7. System Name (Align with system Item name): NIH NCI CB Mouse Models
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Juli Klemm
10. Provide an overview of the system: The NCI Mouse Models of Human Cancers Consortium (MMHCC) is a collaborative program designed to derive and characterize mouse models, and to generate resources, information, and innovative approaches to the application of mouse models in cancer research. In addition to the MMHCC initiative, the NCI sponsors numerous other projects to develop, analyze, and apply mouse cancer models. This NCI Mouse Model project provides the cancer research community with information about mouse models and mouse research generated by the MMHCC and other NCI-supported projects. Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1, Sec. 285, Sec. 285a and 44 U.S.C. 3101
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Clinical investigators/submitters are asked to provide their professional contact information in order to further scientific collaboration and provide a point of contact for their area of interest/research. Personal email addresses may be unintentionally provided by the investigator/submitter in lieu of professional information. Personally identifiable information in the form of contact information for the clinical investigator/submitter can be obtained from caMOD on the Model Characteristics page once a particular experiment is selected/accessed. This information (which is provided voluntarily by the investigator/submitter) is shared to encourage scientific collaboration and allows users to query the Cancer Models database for models submitted by researchers, and retrieve information about the making of models, their genetic description, histopathology, derived cell lines, associated images, carcinogenic agents, and therapeutic trials.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) Clinical investigators/submitters are asked to provide their business contact information, including name and e-mail address.
(2) Professional contact information is collected in order to identify the researcher and associate the researcher with a particular experiment or other collected research information.
(3) This information does contain PII.
(4) The submission of this information is voluntary.
This system falls under the Privacy Act System of Records Notice 09-25-0200.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) NCI will post notices on the caArray website to inform clinical investigators/submitters of:
(1) major changes that occur to the caArray system that may affect the use/disclosure of PII in the system;
(2) changes in the type of PII to be collected from them;
(3) any changes to how PII is used or shared.
This system falls under the Privacy Act System of Records Notice 09-25-0200.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: System uses firewalls, passwords, locks, id badges, background investigations, network monitoring and an Incident Response team.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Central European Renal Cell Cancer Follow-Up Study (CERCC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): NA
5. OMB Information Collection Approval Number: 0925-New
6. Other Identifying Number(s): CAS 10420
7. System Name (Align with system Item name): NIH NCI Central European Renal Cell Cancer Follow-Up Study (CERCC)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Lee E Moore
10. Provide an overview of the system: In addition to publications of benefit to the scientific community, data collected will be used to assess the 5-year survival status of kidney cancer patients that had participated in a case-control study to assess the prevalence of recurrent disease and progression, and to investigate patient, tumor and genetic determinants of survival in cases. This information will be used to identify prognostic indicators of survival that will be used to identify determinants of high-risk patients in effort to reduce disease mortality. The information will be collected in the study centers by PIs and questionnaires and abstraction forms will be immediately coded with a personal identification number before questionnaires are sent to the International Agency for Research on Cancer in Lyon France. Here they will be made into an electrnoic format and forwarded to the NCI. All disks will be mailed and require a password that will be given by phone in order to open the coded files. Information that will be collected will include patient related factors (age, sex, tobacco usage), tumor related factors (anatomic site, histology, disease staging, tumor size, extension) and treatment related factors (surgery, radiotherapy, chemotherapy, resection margins). Biologic prognostic characteristics of kidney cancer subsets will be measured and correlated with mortality to identify predictive indicators of disease outcome. The four outcomes we intend to evaluate specifically include; 1) Renal Cell Carcinoma (RCC) death, 2) Alive at 5-years with disease recurrence (same clinical stage or disease independent of primary tumor), 3) Alive at 5-years with disease progression (disease presents at higher clinical stage than primary diagnosis), and 4) Censored (alive at 5-years, lost to follow-up, or died of other causes). As in the case-control study, physicians and experienced medical staff will be employed to abstract hospital records, pathology reports, and treatment information on coded forms that do not contain personal idenfying inforamtion. After we distinguish the types of follow-up protocols used and procedures followed in each country, we will develop a definition of those cases confirmed to be disease-free (using high-confidence methods, i.e. CT, PET, laboratory methods other), and patients for whom follow-up was not confirmed, incomplete, or undetermined (“low confidence confirmation”) so that we can stratify by this variable and conduct restricted analyses. We plan to collect information on methods used to evaluate disease status. Treatment variables will be grouped into broad categories and will be used as adjustment variables. Lastly, we will initiate follow-up at date of diagnosis and collect survival at 5-years, controlling for treatment and perhaps with time dependent co-variables for treatment duration as needed. We will not discount any time during cancer treatment towards survival as this could make more advanced cases with longer treatment duration incorrectly appear to have a longer disease-free survival.
.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): NA
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency will collect information as variables that is coded with a personal subject ID code that will inform us of the survival status of individuals who had previously participated in a case-control study of kidney cancer conducted in central Europe. This information includes date of death, cause of death, and date of last follow-up in a hospital by a physician. We will also receive information regarding the stage and grade of the cases tumor if they recurred or progressed. We will also receive in a coded manner information on the type of surgical and medical treatment procedures used to treat primary disease.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) This work will be conducted in the study centers in Central europe and we will not be involved nor have access to any material with names of cases. Briefly, once individuals have agreed to participate at each center, cases and next-of-kin to cases will be given a paper consent form to sign by the study center Principal Investigator. This form informs them of the procedures involved in the study, tells them about the questionnaire and how this follow-up study related to the original study, states that there will be no compensation or payment for completion of the questionniare, described the potential discomfort, risks, and benefits. It also assures the patient or next-of-kin of confidentiality of the information collected at each study center, of their rights as a participant, and certifies that they have read the form, and whether they agree (yes/no) to participate in the interview, and whether they agree for us to access their hospital records.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: PII will never be on the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Central Institutional Review Board (CIRB)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): SORN 09-25-0200
5. OMB Information Collection Approval Number: Requested
6. Other Identifying Number(s): NCI Control No. N02CM-2008-00010
7. System Name (Align with system Item name): NIH NCI Central Institutional Review Board (CIRB)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mike Montello
10. Provide an overview of the system: The overall purpose of the NCI CIRB data systems is to provide comprehensive informatics support for a centralized process of facilitating Institutional Review Board (IRB) activities for National Cancer Institute (NCI) Cooperative Group clinical trials. The NCI CIRB data systems is comprised of 3 modules and fulfills multiple functions: 1) to enroll local sites with their contacts and track their local IRBs, 2) to manage study-related documents and other information, 3) to convey study and board review information to sites and collect from sites facilitated review acceptance forms via the web, 4) to track and report on CIRB help desk issues, and 5) to track and report on board membership attendance and management of board member reimbursement.
The three modules are comprised of the Membership Attendance and Tracking (MAT) internal database, and CIRB HelpDesk Application internal database (CHAD) maintained by EMMES; the CIRB Enrollment System (CES), CIRB Website hosted by CTIS; and, IRBManager web-based application hosted by BEC.
Information is sent from IRBManager to the CIRB oracle database which serves as the backend of the CIRB website. The MAT and CHAD databases are internal systems used for operations and do not exchange information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): IRB Manager and CIRB Web Site, both of which are modules of the CIRB system, exchange study information and related documents. The CIRB web site includes both password-protected and publicly available sections. Some of the information exchanged is also publicly available elsewhere. This system falls under the guidelines of Privacy Act System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Legislation authority is the Public Health Service Act (42 U.S.C. 241, 242, 248, 282, 284, 285a-j, 285l-q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.), CFR Title 45 Part 46 (Protection of Human Subjects), and CFR Title 21 Part 50 (Protection of Human Subjects) and Part 56 (Institutional Review Boards).
The types of data used are both scientific and administrative and used to inform board members concerning the studies under review, manage the operations and communications of Adult and Pediatric Central Institutional Review Boards, and convey information to sites concerning studies reviewed by the CIRB and decisions made by the CIRB.
The CIRB Operations Office staff routinely generates standard and ad-hoc reports, including quality control metrics that display CIRB information concerning studies, Boards, local sites, local site IRBs, and Operations Office activities.
Personal information provided by Board members is provided as part of their voluntary service to the CIRB and the NCI. Names and contact information provided by contacts at the local sites and IRBs is provided by site representatives on a voluntary basis but required for effective participation of their site in the CIRB Initiative.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The CIRB collects IIF from Board members and local sites using forms that may be completed as hard or electronic copies and mailed or emailed to the Operations Office for data entry. Board members and site representatives are aware of the purposes for which their contact information will be used. Privacy statement is available electronically and additional privacy statement information is shared during enrollment application process.
Changes to CIRB processes, including development, utilization, or revision of CIRB information systems and using or sharing of data, are subject to review and approval by an NCI Project Officer. IT Change Management processes are in place at the respective contractor or subcontractor.
Users that access the systems must reregister on an annual basis and any changes would be communicated through that process.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: CIRB data is maintained in secure databases.
The following are in place as Management Controls:
· Login Banners
· Rules of Behavior
· System Security Plan
· Configuration Management, Change Management Plans and Processes
· Disaster Recovery Plan
The following are in place as Technical controls for CIRB:
· Network security via User ID and Password login
· User ID and Passwords required to login to CIRB applications
· The CIRB applications are hosted within Network boundaries and protected by Perimeter Firewall and Intrusion Detection
· SSL Encryption is enabled for access to web based interfaces of CIRB modules, where necessary
· Proactive Systems Monitoring and Alerts Management
· Anti-virus, security updates and patching procedures
· Periodic scans for CIRB systems – both internal and external
· Incidence Response Procedures
· System and Database Audit Trails and Logs
The following are in place as Operational controls for CIRB:
· Personnel Security
· Security Clearance Process for designated contractor and subcontractor personnel working on CIRB
· Contractor and Subcontractor Hiring and Termination Process (NIH suitability investigations for key personnel)
· NIH Non-Disclosure Agreement for all contractor and subcontractor employees working on CIRB
· Annual requirement for all employees to take/review NIH CIT Security Awareness Training
· Physical and Environmental Protection (including individualized door entry cards and photo ID)
· Visitor Log Procedures
· Backup Procedures
· Offsite Storage for Tapes
· Video Surveillance of Data Center
· AC Maintenance Process
· Contingency / Disaster Recovery Plan
· Incidence Response Procedures
· Alerts and Scans
· Identification and Authentication
· User Account Management Process
· Role based user access to systems
· Password Change Policies (for systems per NIH requirements)
· Procedures for handling lost/compromised passwords
· Audit Trails
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Clinical Research Information Exchange Federal Investigator Registry (CRIX FIREBIRD)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable (this is a minor application)
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): NCI-75
7. System Name (Align with system Item name): Clinical Research Exchange Federal Investigator Registry CRIX FIREBIRD
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: John Speakman Project Manager Federal Investigsation Registry
10. Provide an overview of the system: The Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD) is a software application that supports electronic submission of clinical trial investigator information to trial sponsors and regulatory bodies. It is the first module realized from the vision of the Interagency Oncology Task Force (IOTF), a partnership of the National Cancer Institute (NCI) and the Food and Drug Administration (FDA), to create an electronic infrastructure for the submission of regulatory data. Through a single web-based platform, investigators will be able to maintain a secure profile of the most common information required when participating in drug trials.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The IIF may be shared with Pharmaceutical companies and the Food and Drug Administration via an Oracle link. The IIF is under SOR 09-25-0200, Clinical, Basic and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency collects voluntarily given data on researcher’s name, birth date, mailing address, phone numbers, e-mail address, Medical license number and the State in which it was issued, and the researcher’s Unique Physical ID number (UPIN) in order to identify the researcher to authorized viewers and provide contact information and credential information to authorized users. The National Cancer Institute authorizes all users.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Researchers give only their own personal information and do so voluntarily. The Firebird web site will disclose any changes to how IIF is used or shared on the website itself.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The IIF will be secured by management, operational, and technical controls. Some of these controls include user identification and authentication, public key encryption (PKI) certificates, the concept of least privilege, and firewalls. The PKI certificates will be validated by NCI. Infrastructure product, username and password, annual risk assessments, background checks on administrative employees, and key locks, cipher locks and keycards necessary to enter server rooms.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Clinical Trials Reporting Program (CTRP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jul 20, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: 0925-0600
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): NIH NCI Clinical Trials Reporting Program (CTRP)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Christo Andonyadis
10. Provide an overview of the system: The Clinical Trials Reporting Program (CTRP) is a web-based program to submit data about cancer-related clinical trials and to search for data concerning cancer-related clinical trials. The CTRP system is an electronic resource that is intended to serve as a single, definitive source of information about all NCI-supported clinical research. Deployment of this resource will allow the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information will be submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: (1) Clinical investigators are requested to provide their professional contact information, including
name, business mailing address, business phone numbers, and business e-mail address.
(2) Professional contact information is collected in order to identify the researcher to authorized viewers and associate the researcher with a protocol. The information will be made available to designated, appropriate NCI employee and contractor staff for purposes of portfolio management and compliance with regulatory and administrative reporting obligations. Access will be limited to those with a direct need to access the data. Access will be granted to non-Federal staff under a non-disclosure agreement and staff will be given mandatory privacy and security training.
(3) The information does not contain PII.
(4) N/A
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No PII in the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII in the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Consortia Data Transfer Website (CDT)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NCI Consortia Data Transfer Website (CDT)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anne Ryan (Troy Budd is alternate POC)
10. Provide an overview of the system: The DCP Consortia Clinical Data Transfer (CDT) Website is an Internet web portal that provides DCP and Consortia clinical data management staff with access to study-specific SAS datasets and reports of clinical data entered in DCP OC-RDC. It also provides a platform to publish any network announcements and/or updates regarding DCP Consortia clinical data management.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF is present in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Type of data available in CDT include adverse events, agent information, discrepancies reports and Non-IIF participant level data. The CDT Website is designed for the users from seven different clinical sites as well as DCP and Westat. Each site has an individual user content area from which the approved users can access and download the study-specific datasets and reports and view user profiles.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is present in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF is present in the system
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI DCEG Intramural (DCEG)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4926-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-17
7. System Name (Align with system Item name): NCI DCEG Information System (Intramural)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico / Dennis Leggett
10. Provide an overview of the system: This system allows the users in the Division of Cancer Epidemiology and Genetics (DCEG) to analyze costs of scientific studies and provide more efficient and accurate reporting to both NIH and NCI. Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1, Sec. 285, Sec. 285a and 44 U.S.C. 3101
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Work-related information is used from other systems. This includes name, work address, e-mail address, and phone number for government employees. A limited amount is entered by staff. This includes such things as research title, research description, lead investigator, collaborators, risk factors, study type, cancer sites, research category, common scientific outlne coding, keywords, and study population accrual. Information is then available for dissemination about the research within NCI and to the NIH.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF collected
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF collected. System uses firewalls, passwords, locks, id badges, background investigations, network monitoring and an Incidence Response team.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI DCP Collaboration Repository (DCPCR)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NCI DCP Collaboration Repository (DCPCR)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anne Ryan (Troy Budd is alternate POC)
10. Provide an overview of the system: The DCPCR provides the means for DCP and its contractors to centralize the management of project collateral. It serves as a single point of access from which DCP and its contractors can obtain and share timely and accurate DCP enterprise information in an organized environment. Documents are posted to topic-specific content areas to which user access is authorized by DCP based on user role/function within DCP or a DCP contractor organization.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): DCPCR information is shared with the Food and Drug Administration (FDA) to fulfill regulatory requirements. However the FDA does not interface directly with DCPCR. The IIF is under SOR 09-25-0200 Clinical, Basic, and Population-based Research Studies of the National Institutes of Health (NIH), HHS
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: DCP collects researcher's name, date of birth, mailing address, phone numbers, financial information, education records and military status in order to identify, review and approve individuals to conduct NCI DCP clinical trials.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) IIF information is provided to fulfill regulatory requirements. The data is for internal DCP use only. However, we do share some information that is contained with the DCPCR with FDA - for example Form 1572 and CVs are sent to FDA as hard copies. No other information are shared with FDA.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative controls includes SOPs, policies and guidelines. Technical controls includes user identifiction and authentication, an Intrusion Detection System, logon warning banners, the concepts of least privilege and firewalls. Physical controls include server room, proximity card entry, an automatic fire suppression system and surveillance video. This system falls under System of Records Notice 09-25-0200.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI DCP Enterprise System Knowledgebase (DESK)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-45
7. System Name (Align with system Item name): NIH NCI DCP Enterprise System Knowledgebase (DESK)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anne Tompkins / Troy Budd
10. Provide an overview of the system: DESK is an enterprise database with a suite of applications that support the scientific and administrative work of the NCI Division of Cancer Prevention (DCP) and its mission. Specifically, the DESK is used to document, track, monitor and evaluate DCP clinical research activities. DESK enables DCP to collect, analyze and report adequate clinical trials data to fulfill NCI, NIH and DHHS requirements.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF is present in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Type of data available in DESK include protocol attributes, site and investigator contact information, agent information, IND records, adverse events, site audit reports, and non-IIF patient level data. The information is critical to track the receipt, abstraction, review, approval and implementation of clinical trials; it is also used to facilitate administrative operations (including reporting), support scientific decision making, regulatory oversight, and future planning of clinical trials.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is present in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF in the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Bruce Woodcock
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI DCTD Developmental Therapeutics Program (DCTD DTP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-27-02-AD;4999-00-202-072
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-22
7. System Name (Align with system Item name): NIH NCI DCTD Developmental Therapeutics Program (DCTD DTP)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Daniel Zaharevitz
10. Provide an overview of the system: This is the NCI DCTD DTP Program website.
The main function of the DTP web site is to provide the research community with access to DTP data, policies and procedures. The data include over 250,000 chemical structures, growth inhibition data in human tumor cell lines for over 40,000 compounds, gene expression data measured in human tumor cell lines, results in mouse tumor models for over 100,000 compounds and much other data. Almost all of this data is freely available to all and no registration is required and no personal information is collected. The exception is for people who wish to submit compounds for testing. They must register and personal information necessary to contact them is collected (name, address, phone, email).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, PART C, subpart 1, Sec.285, Sec. 285a, and 44 U.S.C. 3101. General Program and support information for grantees and clinical trial personnel. Workplace contact information is collected for users that wish to submit compounds for screening. No IIF is collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF, however investigating partners are emailed notification of use of information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF collected. We have business contact information with business partners.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI e-Grants/web-Grants (e-Grants)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-04-00-02-4930-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-38
7. System Name (Align with system Item name): NCI e-Grants/web-Grants
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Terry Dunne
10. Provide an overview of the system: The eGrants/web-Grants provides online access over the web to the official grant files including the ability to search for particular grants or documents.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The name and contact information is shared with the NIH IMPACII system. Other information is not shared. Sharing is done in accordance with SOR 09-25-0036.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Authority for collection of this information is 5. U.S.C. 301; 42 U.S.C. 217a, 241, 282(b)(6), 284a, and 288. 48 CFR Subpart 15.3 and Subpart 42.15. IIF contained in this system consists of the following information about grantees: name, social security number, mailing address, telephone number, financial information, e-mail address, education records, and a notice of grant award. This is information is maintained as part of the grants management system. The majority of this information is not shared outside of NCI. The name and contact information is shared with the NIH IMPAC II system. Information is submitted voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no process in place to notify individuals in the event of major changes to system.
The grantees submit their information voluntarily and are made aware that it will be used in the grant funding process.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Electronic Early Concurrence System (EEC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: Not Applicable
6. Other Identifying Number(s): NCI-41
7. System Name (Align with system Item name): NCI DEA Electronic Early Concurrence System (EEC)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Greg Fischetti
10. Provide an overview of the system: Records National Cancer Advisory Board concurrence and Program staff approval for early funding of highly scored grant applications. Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1, Sec. 285, Sec. 285a and 44 U.S.C. 3101 The system downloads basic grant data from IMPACII and allows a limited number of the NCAB Members, who are special government employees, to indicate whether they concur with the initial peer review. The system also allows NCI Program Directors to indicate whether there are any reasons the grants would not be currently eligible for payment
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No Data is shared.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: System records approvals by NCAB and program staff. The only information about the Principal Investigators that is downloaded from IMPAC II is the Principal Investigator Name. The system maintains Name and email address for the 4 NCAB members. The system also maintains a list of NCI Program Directors which has their name, email, and phone number. This information is available to the public via the NIH Web Site.
The PI names are used along with Grant Number and Title to assist staff in identifying the grant application, the NCAB Member and Staff email addresses are used to send email reminders. No information from the system is published, it is just used by NCI Grants Management staff in helping to determine whether to send early concurrence letters to applicants.
Submission of information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All data is collected and maintained by the NIH Grants Management System (IMPAC II), so notifications would be handled by that system. Changes to the NIH Grants Management System are announced in the NIH Guide.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained..
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Enterprise Vocabulary System (EVS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: New Public Access
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4920-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-29
7. System Name (Align with system Item name): NIH NCI Enterprise Vocabulary System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Gilberto Fragoso
10. Provide an overview of the system: NCI Enterprise Vocabulary Services (EVS) provides resources and services to meet NCI needs for controlled terminology, and to facilitate the standardization of terminology and information systems across the Institute and the larger biomedical community.
Two key terminology resources are produced and published by EVS:
NCI Thesaurus is a reference terminology used in a growing number of NCI and other systems. It provides rich textual and ontologic descriptions of some 50,000 key biomedical concepts.
NCI Metathesaurus is a comprehensive biomedical terminology database, connecting 2,500,000 terms from more than 50 terminologies, including some propriety vocabularies with restrictions on their use.
EVS is a partnership between the NCI Office of Communications and the NCI Center for Bioinformatics. It is a key component of the cancer Common Ontologic Resource Environment (caCORE) and the cancer Biomedical Informatics Grid (caBIG), and is used in the NCI Web Portal and Physician Data Query (PDQ) cancer information services.
A new wiki-based component of the EVS system is being constructed to facilitate collaborative vocabulary development with NCI partners.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The new wiki-based application allows end-users to create web pages to share with other end-used of the system. The end-users might do this to add additional contact information that they wish to share with other end-users, as the purpose of the wiki-based application is to foster collaborative development of vocabularies to be served by the EVS. The professional/business information is not observable by non-registered users of the application.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: 1. The system collects the end-user's email address.
2. The information is collected so that password information can be automatically sent on request by the end-user.
3. No other PII other than the email address is required for a person to register.
4. Entering this information is mandatory for end-users of the system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) 1. Notifications will be posted on the wiki-based applications home page, as well as advertised on a listserv. 2. The nature of the information collected from end-users will be posted in a privacy notice on the web site, as well as 3. the use which the EVS will make of this information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Access to raw data will be controlled through file permissions, database roles and user groups. Files will be backed up regularly and stored off site. User access with write permissions will be credentialed (username/password), and internet access will be protected by a firewall, and encryption used where necessary (login through https). The production servers are physically secured, in facilities operated by NCI/CBIIT.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Environmental and Genetic Lung Etiology (EAGLE)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: None
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): NCI-80
7. System Name (Align with system Item name): NIH NCI Environmental and Genetic Lung Etiology (EAGLE)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anand Basu
10. Provide an overview of the system: Environmental and Genetic Lung Etiology (EAGLE) is an interdisciplinary multi-center case-control study of lung cancer conducted in Milan, Italy, designed to explore the genetic determinants both of lung cancer and smoking. The objectives of the EAGLE study, as identified by DCEG, are as follows:
· Perform genetic profiling of study participants by 15STR markers
· Conduct analysis of gene expression in adenocarcinoma lung cancer tissue of smokers and non-smokers
· Identify histologic characteristics of lung cancer in relation to genotype, gene expression, somatic mutations, and smoking
· Monitor therapy efficacy and survival of lung cancer patients
· Identify lung cancer-affected siblings of cases and the unaffected siblings in the same sibs hips
· Perform integrative analyses of the above-mentioned datasets in the context of the epidemiological data from the study.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The agency voluntarily collects from authorized Researchers, maintains, and disseminates via a strictly controlled process to authorized researchers de-identified medical data consisting of de-identified molecular analysis cancer data, including DNA snippets. No personal information is collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is collected
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Fiscal Linked Analysis Research Emphasis (FLARE)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-4920-00-202-069
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-18
7. System Name (Align with system Item name): NIH NCI Fiscal Linked Analysis Research Emphasis (FLARE)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Elaine Taylor/Greg Fischetti
10. Provide an overview of the system: Supports Science Area Coding of grants and contracts for categorization of research dollars
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The system does not share IIF. The disclosures permitted by SOR 09-25-0036.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Grants and contracts are coded by NCI staff to allow categorization of research dollars. The information about Principal Investigators is their person ID, name, and degree. No IIF is collected.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is collected
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI IMPAC II Extensions (IMPAC II)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-04-00-02-4904-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-1
7. System Name (Align with system Item name): NIH NCI IMPAC II Extensions (IMPAC II)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: This system extends the NIH IMPACII extramural information to include the specifics of the NCI extramural business process of grant portfolio management. This includes the transition from a paper business process to an electronic process across the life cycle of an NCI sponsored grant. Comprehensive Minority Biomedical Branch (CMBB) has been rolled into IMPAC II Extensions. CMBB provides metrics to assess the success rate of the NCI CMBB program and to provide grantees information about other training opportunities.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No information is shared. Disclosures permitted in SOR 09-25-0036 are not utilized.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Authority for collection of this information is 5. U.S.C. 301; 42 U.S.C. 217a, 241, 282(b)(6), 284a, and 288. 48 CFR Subpart 15.3 and Subpart 42.15. The IIF that the system captures on the public concerns only grantees and is obtained from the NIH IMPACII system and the NIH Data Warehouse. The IIF that the system directly collects is about individuals employed by NCI and involved in the grants business process. IIF includes, name, work address, work phone number, and financial account information. Information is given voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) We have a agreement with IMPAC II that describes what data we will receive and limits how it will be used. If we need to change how it will be used, the agreement will be renegotiated and notification and consent issues will be part of any new agreement.
Individuals are notified and consent to the use of their information in this type of system is given when they receive grants or are hired by the government.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, database roles, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Internet Website (cancer.gov)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-5
7. System Name (Align with system Item name): NIH NCI Internet Website - www.cancer.gov
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Jonathan Cho
10. Provide an overview of the system: This is the NCI's internet Web site. It disseminates cancer-related information, including information on prevention, screening, diagnosis, treatment, and survivorship. Individuals may enter their e-mail address in order to receive the NCI Cancer Bulletin.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Does not share or disclose IIF. If this changes, disclosure will be done per SOR 09-25-0106
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: SEC.407 (b) (4) of the National Cancer Act authorizes NCI to: “collect, analyze, and disseminate all data useful in the prevention, diagnosis, and treatment of cancer, including the establishment of an international cancer research data bank to collect, catalog, store, and disseminate insofar as feasible the results of cancer research undertaken in any country for the use of any person involved in cancer research in any country.” The only information collected is e-mail addresses. It is used to disseminate the e-newsletter, theNCI Cancer Bulletin. Submission of this information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Individuals enter their e-mail address in order to receive the NCI Cancer Bulletin. They are told this on the web site when they subscribe. This is voluntary. E-mail notifications can be sent if a major change to the system is made.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Investigator Registration Filing Process
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: Requested
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH NCI Cancer Therapy Evaluation Program (CTEP) Investigator Registration Filing Process
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Charles. L. Hall, Jr.
10. Provide an overview of the system: The purpose of the CTEP Investigator Registration Filing Process is to manually collect, store, and manage data about registered investigators who are eligible to receive NCI supplied investigational agents from the Pharmaceutical Management Branch (PMB) of CTEP. The data collected is stored in hardcopy format in secure filing systems as well as secure Electronic Filing Systems operated by NCI.
CTEP contractors managing the Investigator Registration Process.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Information is shared with the FDA and pharmaceutical companies for the purposes of exchanging clinical trials data.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information collected as part of the Investigator Registration Filing Process is that contained in the following documents collectively termed the IR packet. The information collected in the IR packet is used for the purposes of conducting clinical research. Some of the information provided in the IR packet is mandatory while some of it is voluntary.
1) DHHS FDA 1572 Form which collects FDA required attributes such as Investigator name, education and training experience, name and address of medical school, hospital or research facility where clinical investigation will be conducted, name and address of clinical laboratory facilities to be used in the study, name and address of Institutional Review Board responsible for review and approval, and Investigator Signature.
2) Supplemental Investigator Data Form which collects information such as Investigator name, Degrees, NCI Investigator Number, Month and Year of Birth, Provider number, Primary Specialties, Investigator related Training Information, Office Address for official correspondence with the Investigator, Address for Agent shipments, Shipping and Ordering Designee information and Investigator Signature.
3) Financial Disclosure Form which collects FDA required financial disclosure information based on four generic questions related to the Investigator’s relationship to any pharmaceutical company or sponsor to the extent that the investigator has received any compensation from pharmaceutical companies, or the investigator may have any proprietary interest in any of the studies not limited to patent, trademark or licensing, or if the investigator has any equity interest in any pharmaceutical company or if the investigator or his/her institution has received any large payments in the form of funds, grants or equipment from pharmaceutical companies exclusive of the costs of supporting conducting clinical studies.
4) The Investigators are also required to submit an updated copy of their resume / CV.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) NCI Investigators who wish to participate in NCI sponsored clinical trials submit their information to CTEP Investigator Registration Process in a signed Investigator Registration (IR) packet. This investigator registration packet, along with additional cover letter, informs the investigators about intended purpose and usage of their information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Policies and procedures exist to securing and providing access to IR packet information. For the hard copies of the Investigator Registration (IR) packet that are filed in the secure filing systems, the filing cabinets are secured behind double locked doors with restricted access to the facilities. Only select authorized staffs are allowed to access the hard copies. Access logs to hard copy documents are maintained. Access to data stored in the Electronic Filing System is through password protection account. The Server on which the Electronic Filing System is hosted is maintained in secure Key control based facilities. Audit Trails are kept regarding the Electronic Filing System to track data access.
Since the same hard copy documents are scanned and filed into the Electronic Filing System, no backups are maintained for the hard copy documentation. Contingency plans exist for the Electronic Filing System. Backups of tapes are not stored offsite.
The system falls under the Privacy Act System of Records Notice 09-25-0200
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Labmatrix (Labmatrix)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: none
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: none
6. Other Identifying Number(s): NCI-84
7. System Name (Align with system Item name): NIH NCI Labmatrix
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Jason Levine
10. Provide an overview of the system: Labmatrix is a system which allows for the tracking of tissue and fluid specimens obtained as part of clinical and translational research, and the tracking and collation of the results of experiments performed on those specimens. The system uses a Microsoft SQL database for its back-end data store; data entry and reporting is performed using either a web-based application or via custom-written applications which access the system via a standardized API. Labmatrix incorporates a user-based system of security and data partitioning, providing for the ability to restrict access to the system as a whole and to restrict users to the ability to view and manipulate only the data to which they have appropriate rights. Likewise, the security system incorporates a system-wide awareness of the idea of protected health information (PHI), and enforces strict access to this information on a granular basis to only those system users with both a need and the rights to know.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): IIF is shared among clinical and translational investigators who have been approved by the NIH Institutional Review Board to collaborate on any given clinical trial, such that these individuals can maintain accurate records of the specimens and results generated on their clinical trials. As stated in the SORN 09-25-0200 under Routine Uses of Records Maintained in the system, including categories of users and purposes of such uses: Disclosure may be made to agency contractors, grantees, experts, consultants, collaborating researchers, or volunteers who have been engaged by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The information which will be collected within Labmatrix will be that for which collection has been approved by the NIH Institutional Review Board for any given clinical research trial. This generally includes both IIF and non-IIF, such as: a subject’s name, date of birth, medical record numbers, contact information, notes about the subject’s clinical care, records of all biological specimens obtained from the subject during the course of participation in the clinical research trial, and results of clinical and research tests performed on specimens obtained from the subject. Submission of this information on the part of the subjects is voluntary, and permission is provided by trial participants via the standard clinical trial consent process.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) If and when major changes occur to the Labmatrix system such that data is either disclosed or the use of the data changes, our standard practice would be to inform the clinical and translational research investigators who have primary contact with the participants in their trials, and ask them to notify the subjects and obtain any further consents which are needed. Likewise, we rely on these investigators to obtain the initial consent from any subjects whose IIF will be stored in Labmatrix, and expect that the IRB-approved clinical trial consent documents will contain all relevant information about how this information is both used and shared.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative: Labmatrix incorporates its own list of permitted users, and restricts administrative control of the system to only those users who are specifically granted this right within Labmatrix. Similarly, the back-end database maintains its own list of approved administrative users, and grants administrative access and control only to these approved users.
Technical: Labmatrix incorporates encryption of all communication that travels over any network interface entering or leaving the system; this includes secure HTTP for all communication with the web application, and SSL encryption of all communication using the APIs for the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Local Network
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): NA
5. OMB Information Collection Approval Number: NA
6. Other Identifying Number(s): NA
7. System Name (Align with system Item name): NCI Local Network
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Eric Williams
10. Provide an overview of the system: The system is a General Support System (GSS) and does not directly collect or store information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system is a General Support System (GSS) and does not directly collect or store information. The applications/systems residing on the GSS collect and store information. Therefore, individual PIAs have been prepared and submitted for the applications/systems residing on this GSS.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) NA
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No Pii
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Local Network- Frederick
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): NA
5. OMB Information Collection Approval Number: NA
6. Other Identifying Number(s): NA
7. System Name (Align with system Item name): NCI Local Network Frederick
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dianna Conrad
10. Provide an overview of the system: The system is a General Support System (GSS) and does not directly collect or store information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system is a General Support System (GSS) and does not directly collect or store information. The applications/systems residing on the GSS collect and store information. Therefore, individual PIAs have been prepared and submitted for the applications/systems residing on this GSS.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) NA
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Network and Directory (eDir)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-4
7. System Name (Align with system Item name): NIH NCI Network & Directory
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Doug Hosier
10. Provide an overview of the system: This system provides network and directory services to the NCI. It is used to control access to NCI computer resources. To accomplish this, it contains username/password information, contact information, and information about access rights.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Collects work related /assigned information necessary for network operations. The system contains username, password, work phone, work address, and name for NCI employees, contractors, fellows, and others who have a business relationship with NCI.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Office of Acquisitions (OA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): no
5. OMB Information Collection Approval Number: no
6. Other Identifying Number(s): NCI-2
7. System Name (Align with system Item name): NIH NCI Office of Acquistion System (OA)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Tish Best
10. Provide an overview of the system: This system collects and maintains pre- and post-award contract data for reporting to Department and Federal Contract Information Systems (DCIS & FPDS-ng). The types of information include the socio-economic classification of the contractor (small, disadvantaged, etc.) as well as information about the type of project.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The primary data collected by the system is of a financial/budgetary nature. Additional NIH reporting requirements relating to each project i.e., socioeconomic classification of the contractor (e.g. small disadvantaged business); information about the type of project, i.e. clinical trial; human subject research; animal research; epidemiological study; is also collected. No personal information (IIF) on any individual is collected in this system. The project information collected is required by the HHS Department Contract Information System (DCIS) which transmits the information to the Federal Procurement Data System-Next Generation (FPDS-NG) which provides this budget and project information to Congress.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF collected.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF collected.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Office of Liaison Activities Database (OLA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4915-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-64
7. System Name (Align with system Item name): NIH NCI Office of Liaison Activities Database (OLA)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: The Office of Liaison Activities Database (OLA) maintains contact information for advocacy organizations and professional societies. The system also maintains information about individual advocates that serve the NCI through the Director’s Consumer Liaison Group (DCLG) and the Consumer Advocates in Research and Related Activities (CARRA) program.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Does not share outside the agency. Disclosures permitted in SOR 09-25-0106 are not made.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Legislative authority is 42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the Public Health Service Act. Information is maintained for advocates that are members of the CARRA program include membership status (active or non-active), race/ethnicity/age/gender of member, occupation, highest educational degree earned, area of educational degree, primary/personal/constituency cancer type, location/race/ethnicity of constituency, activity preferences, computer skills, ability to travel, and skills/accomplishments/activities. Information is used only within the agency. Submission of information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Notification and consent in both cases is done via e-mail.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Oracle Clinical- Remote Data Capture (OC-RDC)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NCI DCP Oracle Clinical-Remote Data Capture (OC-RDC)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anne Ryan (Troy Budd is alternate POC)
10. Provide an overview of the system: OC-RDC serves as the primary database and data management tool for the Division of Cancer Prevention (DCP) phase I and II clinical trial portfolio. Westat the prime contractor on this project; works with the DCP Chemoprevention Consortia Lead Orgs to develop clinical trial menus which each consortium can enter participant enrollment data and adverse events. OC-RDC also provides DCP and Consortia Lead Orgs with data quality management, including data discrepancies reports, audit trail, etc… OC-RDC is DCP effort to manage and support the data collection of clinical trials conducted under our phase I and II Chemoprevention Consortia Program.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF is present in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Type of data available in OC-RDC include protocol attributes, site information, agent information information, adverse events, data discrepancies information, and Non-IIF participant level data. The information is critical to for data management of DCP chemoprevention consortia clinical trials.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF is present in the system
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF is present in the system
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Orientation Registration (OrienReg)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4915-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-35
7. System Name (Align with system Item name): NIH NCI Orientation Registration (OrienReg)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: A website used to register new employees for the NCI Orientation Program.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): IIF not collected
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Employee names are entered into a database in order to register them for employee orientation. No IIF is collected. Submission of this information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Individuals are notified when they are hired about how the information will be used. No procedures are in place to notify individuals if major changes to the system are made.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI OWD Leadership Study Intent to Enroll
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0156
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): NIH NCI OWD Leadership Study Intent to Enroll
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: The Intent to Enroll form is an electronic data collection form used to simplify the recruitment of volunteer participants in a leadership study that NCI's Office of Workforce Development (OWD) is conducting. The form allows volunteers to indicate their interest in participating in the study. The information gathered will be used to contact participants and will be used to create male-female matched pairs for the purposes of the study.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The form will be shared with a limited number of OWD staff (Teresa Estrada and perhaps one or two others to assist) and a contractor from Doyen Consulting (Mary Burness) who works full-time on-site in OWD. This information will be used to create male-female study pairs. The information will also be shared with two staff at Denison Consulting until such time as subject numbers can be generated.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: • The form will collect name, work contact information, demographic information, education and work history, CV, and availability to participate in the study.
• The information will be use to create matched study pairs (male-female) and to contact study volunteers.
• The information does contain PII.
• Participation in the study is voluntary. Submission of PII is required in order to participate in the study.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Participation is voluntary. Submitters voluntarily submit their information and CVs per the website. Participants submittal of the information constitutes consent and participants must checkmark a field indicating their interest in the Leadership Study in order for the data to be uploaded. The main purpose of the information is to create matched study pairs (male-female) and to contact study volunteers. If a major change occurs to the system that affects how PII is disclosed or used, the System Owner will inform the submitters via e-mail.
No PII is shared at all outside of the National Institutes of Health.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI PLCO Research Database (PLCO)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-59
7. System Name (Align with system Item name): NIH NCI PLCO Research Database (PLCO)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dorothy Sullivan
10. Provide an overview of the system: The system is used for monitoring, quality control, and analysis of the PLCO trial.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF in the system
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: This sytem is used to store and monitor data from the participants in the PLCO and NLST prevention trials. Such data consists of results of screening tests such as chest x-rays, serum PSA and CA-125, sigmoisoscopy, etc. Medical history and other questionaire information is also stored. To protect confidentially, the data in this system is referenced by a randomly assigned participant ID code only. The actual identity of the participant is known only to the screening center at which these tests were conducted. Since these participants are treated as clinical patients at these centers, their true identity is considered confidential, as with any patient, and is protected in accordance with HIPPA regulations to which all of these screening centers must adhere.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Portfolio Management Application (PMA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: NA
6. Other Identifying Number(s): NCI-32
7. System Name (Align with system Item name): NIH NCI DCCPS Portfolio Management Application (PMA)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Everett Carpenter
10. Provide an overview of the system: This application is used by NCI Extramural Division staff to manage their Research Portfolio (Grants, Contracts, Interagency Agreements) Responding to Congressional Requests (Coding, Searching, Reporting); mass mailing, Dynamic Dissemination of Research Portfolio on Public Web site etc
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Shared with NREP to identify and collect programs for the RTIPS application. Shared with Input Solutions Inc. to convert Program Products for RTIPS application. Share RTIPS contact Information with ASPEN Systems for the purpose of order fulfillment. Dissemination of Principle Investigator name on DCCPS Public web site. Share CCPlanet contact information. Information sharing is done in accordance with SOR 09-25-0036.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Public Health Act, TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1, Sec. 285, Sec. 285a and 44 U.S.C. 3101. The information is collected and reviewed by the Federal Program and DCCPS Management Staff to provide timely information for analysis, processing and/or dissemination. IIF collected is name, mailing address, e-mail address, and phone number. Information is submitted voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Change in Data Use/Shared – Individuals will be notified via telephone or email to obtain consent.
Via the CCPlanet order form, individuals are told how the information will be used/not used and consent is obtained by the user entering their information and executing the submit order button.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations, scheduled scan of servers and application code. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Research Resources
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): None
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): NCI Research Resources
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Star A. Kline
10. Provide an overview of the system: NCI Research Resources is a directory of research tools and services that the National Cancer Institute (NCI) makes freely available to cancer researchers on the Web at http://resresources.nci.nih.gov/. This centralized listing of scientific tools, reagents and services developed by the NCI is provided as part of our ongoing commitment to cancer investigators to enable and expedite their research. It includes descriptions of each resource and is organized by research category and by NCI organization. The categories include animal, specimen, genomic, epidemiological, and scientific computing resources; drugs, chemicals, and biologicals; clinical trials; and statistics.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The system does not share or disclose PII
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: This public Web site will not collect any information from public users - it is simply a catalogue of services. The application will collect information from NCI staff, but it will not collect any PII. The information that will be collected from NCI staff, maintained by the application, and disseminated via the public Web site is the name of the research resource, a description of that resource, the research category to which it belongs; the NCI organization that provides the resource; and general contact information for the NCI organization.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Because the system does not collect any PII, there are no processes in place to manage PII.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Because the system does not collect, maintain, or disseminate any PII, there are no controls in place to secure PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Starcatcher-StarGazer (Starcatcher)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4915-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-12
7. System Name (Align with system Item name): NIH NCI Starcatcher/Stargazer (Starcatcher)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mary Velthuis
10. Provide an overview of the system: StarCatcher/Star Gazer is a web application in which the public can enter and submit resumes for referral within the NCI.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Shared within NCI with NCI hiring managers per SOR 09-90-0018. This information is further addressed in the HHS Privacy Act Systems of Record Notice 09-90-0018, published in the Federal Register, Volume 59, November 9, 1994.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Authority to collect this information is National Cancer Act of 1971, SEC.407 (b) (4). A limited amount of information collected via StarCatcher is used by authorized NCI staff via StarGazer to identify candidates interested in working at the NCI. Submission of information is voluntary. The information specifically collected is the person's name, phone number, mailing address and e-mail address. There may or may not be other IIF on the resumes that individuals submit.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Candidates input information into StarCatcher and upon entry into the site, it is stated that: NCI maintains a resume databank of interested applicants for professional, administrative and internship positions that may have future openings. If you would like to post your resume, please choose a job category/specialty that we list.
On the website it is noted that: “The NCI StarCatcher Website accepts resumes from interested applicants for positions that may have future openings, it is not intended to solicit or accept applications for official vacancy announcements. Your contact information and resume will be kept on file in the StarCatcher Website for one year from the date you post your resume.
There are no procedures in place to notify individuals when major changes occur to the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Status of Funds Internet Edition (SOFie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): NCI-73
7. System Name (Align with system Item name): NIH NCI Status of Funds Internet Edition (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Bob Barber
10. Provide an overview of the system: SOFie is a financial tracking tool that allows users to access financial data and download the data into spreadsheets in order to perform analysis.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: All accounting transactions are available for viewing in SOFie. The information is used to track and plan fiscal budgets. It is necessary to have access to this data in order to comply with appropriations laws and regulations.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: May 20, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0156
5. OMB Information Collection Approval Number: 0925-0595
6. Other Identifying Number(s): NA
7. System Name (Align with system Item name): Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) Study Management System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Paul Han
10. Provide an overview of the system: SPARCCS is a mail survey of a national sample of practicing physicians. Physician offices are called to confirm the specialty of the physician and the mailing address. Eligible physicians are then mailed a paper survey to complete and return to Westat. After 3 mailings, physicians that have not returned a questionnaire are called and asked to participate in the study by returning a paper survey. The Study Management System tracks the physicians’ contact and eligibility information. Once questionnaires are returned, they are scanned to capture responses. Individual identifying information is stripped from the response data prior to delivery to NCI.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Identifying information is provided to authorized study staff in order to make contact with respondents and to track information. The identifying information is not shared with anyone outside of Westat. This systems falls under the guidelines of Privacy Act System of Records Notice 09-25-0156.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: 1. Authorization: The Public Health Service Act, Section 412 (42 USC 285a-1) and Section 413 (42 USC 285a-2)
2. Information collected: SPARCCS collects information about the beliefs, knowledge, attitudes, and practices of primary care physicians and cancer specialists regarding the care of cancer survivors.
3. Purpose of collection: NCI’s primary objective for supporting SPARCS is to identify whether physicians are meeting the components described by the Institute of Medicine’s 2005 report that described the essential components of cancer survivorship care within a health care delivery system. These data will inform the process of standardization of survivorship care practices; augment the data collected in other cancer survivorship studies such as the Cancer Care Outcomes Research and Surveillance Consortium and the Cancer Research Network; and monitor the progress made toward achieving NCI strategic goals of improving the quality of cancer care across the cancer control continuum.
4. Routine disclosure: There are no routine uses for which IIF would be disclosed to those not authorized to use the system (e.g., Westat employees assigned to the project).
5. Voluntary or mandatory? Information is provided on a voluntary basis only.
6. If mandatory, effects of not providing information: Not mandatory – there are no effects if the information is not provided.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Information about the study and data disclosure is provided to respondents in written form along with the survey instrument. Completion and return of the survey is considered to be consent to participate. No changes in disclosure or data use will be permitted without explicit consent from each survey respondent.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: IIF is secured using password protected networks, system firewalls, and key cards/identification badges for all physical locations. Data is maintained in a secure database. Information will be secured on the system through access controls, personnel security awareness and training, regular auditing of information and information management processes, careful monitoring of the information system, control of changes to the system, appropriate handling and testing of contingencies and contingency planning, ensuring that all users are properly identified and authorized for access, and that they are aware of the rules and acknowledge that fact, by ensuring that any incident is handled expeditiously, properly maintaining the system and regulating the environment the system operates in, controlling media, evaluating risks and planning for information management and information system operations, by ensuring that the system and any exchange of information is protected, by maintaining the integrity of the system and the information stored in it, and by adhering to the requirements established in the contract and statement of work.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI The Cancer Genome Atlas (TCGA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-4918-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): None
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): NCI-83
7. System Name (Align with system Item name): NIH NCI The Cancer Genome Atlas (TCGA)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Carl Schaefer
10. Provide an overview of the system: The Cancer Genome Atlas (TCGA) is a three-year pilot cancer genome characterization and sequencing project to determine the feasibility of large-scale effort to identify most of the genomic changes in three separate tumor types. The Data Coordinating Center (DCC), establishes and executes standard operating procedures, designs and implements data analysis procedures that perform quality checks on incoming data and report anomalies to the data source sites, and implements a data management pipeline to process data and prepare it for public distribution in formats and systems compatible with the caBIG program.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system collects medical gene data that is de-identified. The system does not collect any IIF. There are multiple de-identifying steps, so that no names, social security numbers, or none of the eighteen (18) HIPAA identifiers is collected. The system does collect de-identified gene data for research.
Patients voluntarily sign a consent form to allow their data to be used for research.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI This Fine System (TFS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4915-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: NA
6. Other Identifying Number(s): NCI-3
7. System Name (Align with system Item name): NCI TFS
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: Collects and maintains personnel management information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Does not share IIF. The disclosures permitted by SOR 09-90-0018 are not made.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Regulatory authority: 42 U.S.C. 241(a)(2), 42 U.S.C. 282(b)(10), and 42 U.S.C. 284(b)(1)(k). Information is used for routine personnel management. The information contains IIFincluding name, date of birth, social security number, and employment status. Submission of information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) TFS only imports data from other HHS/NIH personnel systems that are specifically used for personnel related reports. Consent is obtained from employees by the offices that run the systems that are the source of the data. There is no process in place to notify individuals of major changes in the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCI Translational Science Meeting (TSMS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 1, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: None
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): NIH NCI Translational Science Meeting
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Anita LoMonico
10. Provide an overview of the system: NIH NCI Translational Science Meeting participants register for a workshop and submit abstracts that the participants will potentially present at the meeting. There is no data on the system and no PII on the system and no data will be collected, maintained, or stored until July 2010. The information collection mechanism is disabled until July 2010.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: 5 U.S.C. 301; 44 U.S.C. 3101. Meeting participants will register for the workshop and will post a limited amount of work-related information (abstracts) to a website when a conference is forthcoming. The information is used to identify the participants and collect their submission information. There is no data on the system and no PII on the system and no data will be collected, maintained, or stored until July 2010. The information collection mechanism is disabled until July 2010. Information will be submitted voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained. There is no PII on the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Clinical & Translational Science Awards (CTSA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Clinical and Translational Science Awards (CTSA)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sean Hagan
10. Provide an overview of the system: CTSA is a collaborative web site facilitating robust communications among clinical and translational science communities, which enables multi-way discussions about the important new national effort to develop clinical and translational research. The CTSA system consists of the CTSA public website, the CTSA Management System for managing data, and the CTSA-Wiki (for information sharing among grantees funded under the CTSA program).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Control and Oversight -Program Monitoring Information; Public Affairs – Customer Services; Public Affairs – Product Outreach; and, Public Affairs – Public Relations. The system does not collect or maintain IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Construction Grants Management System (CGMS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR Construction Grants Management System (CGMS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sean Hagan
10. Provide an overview of the system: The system is used to track C06 Construction grants.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: CGMS only contains Grant data, not financial data and not Privacy Act data: Grants Financial Management – Reporting and Information; Grants Planning and Resource Allocation - Budget Formulation Information; Program Monitoring Control and Oversight. No IIF is collected or maintained in the system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Electronic Funds Management System (eFMS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR Electronic Funds Management System (eFMS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sean Hagan
10. Provide an overview of the system: The eFMS is a web-enabled fiscal planning tool of the current fiscal year for the Office of Financial Management (OFM) and NCRR managers. Both dynamic data from IMPAC II and local non-enterprise data are available. Grant data are displayed in a variety of formats, including web pages, web summary tables, Excel spreadsheets and formal reports. This system provides the Budget Officer with a means to ensure appropriate fiscal control, monitor obligations to verify compliance, and provide accurate, current information to NCRR management for the NCRR extramural portfolio.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: eFMS only contains Grant data, not financial data and not Privacy Act data: Grants Financial Management – Reporting and Information; Grants Planning and Resource Allocation - Budget Formulation Information; Program Monitoring Control and Oversight. No IIF is collected or maintained in the system.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR General Support System
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR General Support System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sean Hagan
10. Provide an overview of the system: The system is a General Support System (GSS) and does not directly collect or store information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system is a General Support System (GSS) and does not directly collect or store information. The applications/systems residing on the GSS collect and store information. Therefore, individual PIAs have been prepared and submitted for the applications/systems residing on this GSS.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Grants Workflow Information System (GWIS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Grants Workflow Information System (GWIS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Gregory Farber, Ph.D.
10. Provide an overview of the system: GWIS provides web-based and Microsoft Outlook integration to help authorized NCRR personnel automate and improve the grant management processes/workflows.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: GWIS is an internal grants workflow solution. Information is obtained from the IMPAC II and eFMS (NCRR Electronic Funds Management System). This information is for internal use only, and only the minimal necessary data is collected to support the NCRR internal grants workflow process. GWIS is integrated with Microsoft Outlook for authorized NCRR users. Workflows have been identified and are being developed to process Unsolicited Administrative Supplements, Carry-Over Requests, Funding Opportunity Announcements (FOAs)/ Program Announcements, Annual Progress Report Approvals, National Advisory Research Resources Council (NARRC) Processes, New and Competing Continuation Awards, and Competitive Administrative Supplements.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Internet
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4803-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR Internet Website
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sean Hagan
10. Provide an overview of the system: NCRR Public Website used to disseminate information about NCRR resources and grant programs to biomedical researchers with NIH or other peer-reviewed funding via the world wide web.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NCRR website will disseminate information on NCRR initiatives and activities of relevence to the research community. Shares employee office contact information: name, title, position description, office location and phone numbers to expedite communication with the public. This information is not considered IIF because it is publically available and in the context of how it is presented cannot cause harm to the individual.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF. NCRR employees are notified that their office contact information is made publically available in the course of their duties.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Intranet
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4803-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR Intranet
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Sean Hagan
10. Provide an overview of the system: To disseminate relevant information and useful dynamic applications to Center employees.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NCRR Intranet is used internally to disseminate useful information to authorized NCRR employees and contractors. Shares employee information: name, title, position description, office location and phone numbers (internally only) to increase organizational communication and efficiency. This information is not considered IIF because it is publically available and in the context of how it is presented cannot cause harm to the individual. This information is "opt out" for each employee.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Science Information System (SIS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4802-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR Science Information System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: R. Jean Babb
10. Provide an overview of the system: A database system used by NCRR staff to review annual progress report data, code the research activites, and prepare reports highlighting scientific accomplishments. This information is invaluable in supporting GPRA, PART, and other materials used to inform the Administration, Congress, interested parties and the general public. NCRR is working to integrate and strengthen clinical informatics.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): NCRR and NIH budget officials for reporting to Congress. Shares information internally for generating funding reports for NIH OD and congress. Ref: 09-25-0036
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information is obtained from the IMPAC II system and populates this database for internal use only. Information collected is the minimal necessary to code and report on research projects for funding the grantees and investigators. Mandatory for eRA submission. In addition, SIS now collects the name, email address, phone number (and Fax) for external users needed for the Federated Login process of registering users in the external active directory.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The process in place is governed by IMPAC II, an NIH Enterprise System maintained by eRA. SIS has no additional processes in place.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Policy and procedures are in place for administrative management of the system. Technical control is: username and password login, firewalls, IDS, antivirus, and audit logs. Physical access to the server room is protected by double set of locked doors and must be accessed using a key fob and pass code (cipher lock).
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Status of Funds Internet Edition (SOFie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR SOFIE
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Bonnie Richards
10. Provide an overview of the system: Manage expenditures and obligations. The purpose of the system is to monitor expenditures. Program helps project the budget; allows users to know how much money is left in the FY to spend.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: All accounting transactions are available for viewing in VSOF. The information is used to track and plan fiscal budgets. It is necessary to have access to this data in order to comply with appropriations laws and regulations. Data elements stored are: arbitrary Document #, Object Class Code, Vendor, Description of Expenses, and Purchase Amount.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No IIF
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NCRR Visual Employee Database System (VEDS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-02-3196-00-403-131
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NCRR Visual Employee Database System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Bonnie Richards
10. Provide an overview of the system: VEDS is a windows based application primarily used to track personnel information.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The data is shared internally for administrative use only and will not be shared with other entities. Ref: 09-90-0018
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NETCOMM application collects personal information from the NIH Human Resource Database (HRDB) through bi-weekly downloads. Social security numbers, names, grades, salaries, addresses, telephone numbers, and job titles are included in the data collected. The data collected is used to manage the organization's personnel information. Under authority 42 USC 287c-21
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) IIF in the system is gathered from the HRDB and NED systems. Changes to the system or changes in the way the information is used is relayed to employees via official notices from NCRR or the System Owners. Individuals are notified of the collection and use of data as part of the hiring process and is mandatory if the potential job applicant wishes to seek employment at NIH.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Access to sensitive data fields is limited to those that need to know. Each user signs a security statement, and any violations results in loss of access to system. Policy and procedures are in place for administrative management of the system. Technical control is: username and password login, firewalls, IDS, antivirus, and audit logs. Physical access to the server room is protected by double set of locked doors and must be accessed using a key fob and pass code (cipher lock).
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Jim Blagaich
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Clinical Studies Update System (CSUS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: N/A
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Clinical Studies Update System
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Kym Collins-Lee
10. Provide an overview of the system: The CSUS is used to update the content of the NEI’s web-based clinical studies database. The database is intended to provide public information on clinical vision research results and assist in recruiting patients into appropriate studies. This information is made available to the public, but is maintained by NEI staff and grantees who conduct clinical research studies.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): (1) Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
(2) Disclosure may be made from this system of records by the Department of Health and Human Services (HHS) to the Department of Justice, or to a court or other tribunal, when (a) HHS, or any component thereof; or (b) any HHS employee in his or her official capacity; or (c) any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or (d) the United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components, is a party to litigation or has any interest in such litigation, and HHS determines that the use of such records by the Department of Justice, court or other tribunal is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Names and e-mail addresses are used by the NEI staff and grantees to access the system to update the information and add new study descriptions. Names and e-mail address are required for the user to access the CSUS. The only PII disseminated is already publicly available.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) A statement is included on the web site indicating the only usage is for the subscribers to share information. The only information collected is that supplied by the subscriber. If any change of information usage is made the subscribers will be contacted via email.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The server containing the VISION Network Members Only section is maintained by an NEI contractor who follows guidance from NSA, NIST, SANS, and CERT to maintain the security and integrity of the system.
Information contained in the lists is maintained by NEI staff and by specific request of the subscriber.
The system is monitored daily for intrusion by Big Brother, system logs, disk usage, and other indications of intrusion. McAfee Outbreak Manager is used to control any possible virus outbreaks.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Eye Bank (NEIBank)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-8710-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): 2004 UPI=009-25-01-26-02-8710-00-202-069, Older UPI=009-25-01-26-02-8710-00
7. System Name (Align with system Item name): NIH NEI Eye Bank (NEIBank)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Terry Williams
10. Provide an overview of the system: NEIBank is a web-based resource for the ocular genomics community.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The data presented includes annotated, public domain expressed sequence tag (partial cDNA sequences) collections for multiple eye tissues from human and several other species; public domain eye-related human SAGE data; a database of known human eye disease genes from the published literature; and visualization tools for the genomic loci of as yet unmapped eye diseases. These resources provide an overview of the known transcriptional repertoire of the eye with visualization of specific clones, splice variants, human SAGE tag counts and candidate disease regions.
There is no IIF or personal information.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There are no processes in place. The system does not collect, maintain or store IIF or any user solicited material.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI EyeGene v2
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NEI EyeGene
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Terry Williams
10. Provide an overview of the system: A national collaborative network for ophthalmic research and diagnostic genotyping.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): 09-25-0099 Physicians enter patient contact and medical information. The NEI coordinator is the only user outside the physician's office that has access to contact information. Medical information is tracked by either a generated number or by sex and date-of-birth.
CLIA labs have access to biometrics and medical notes.
Researchers have access to anonymized medical notes and biometrics.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Data is maintained for several purposes. Physicians enter and review symptomatic and contact information for their patients. CLIA labs will provide test results on minimally identified physician submitted patient sample. Results are available for physicians and their own patients.
Besides the physician, the project central administrator has access to participant contact information. The software developer/maintainer
assists users who are authorized to have access to data.
Anonymized aggregate results are available to cooperating researchers.
Participation is voluntary and requires consent forms. Information includes contact information, disease history and symptoms, possibly including photographic images, and medical information relative to the symptoms.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) A written, signed consent form is required for patients to participate. For each participating clinical organization collecting data, the phone number of the organization and the email of at least one staff member of the organization will be kept as a contact information should some intrusion into eyeGENE that could compromise privacy be detected.
There is no process to contact individuals when major changes occur to the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: CIT maintains physical, technical and administrative security on the shared sever hosting this application.
The database application internally maintains valid access controls for the user.
All CIT controls for physical, technical, and administrative are applicable for the IIF. Access to the system requires a userid and password. CIT sites are protected by the NIH perimeter firewall. Physical access to NIH requires admission by guards that assures the individual has an NIH badge or whose identity is registered upon entering the campus. Entry to the CIT host site requires review by a guard. CIT institutes other required administrative, technical, and physical controls as mandated by HHS Secure One security program and NIST 800-53 standards.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Grants Management
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-04-00-02-8712-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): 2004 UPI=009-25-04-00-02-8712-00-205-080, Older UPI= 009-25-01-03-02-8703-00
7. System Name (Align with system Item name): NIH NEI Grants Management
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Terry Williams
10. Provide an overview of the system: Support managment of NEI's grants.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): This system shares IIF with NIH IMPACT II. Information is shared to allow grants management administration data to be synchronized with IMPACT II.
09-25-0036
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: This system shares IIF with NIH IMPACT II. Information is shared to allow grants management administration data to be synchronized with IMPACT II.
IMPACT II states that Information is given to IMPACT II voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All information is extracted from IMPAC II - all consent and notification is handled by IMPAC II.
The system does not have any notification and consent processes in place in addition to the IMPAC II procedures.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical access to the NIH campus requires an identification badge or as a registered visitor. Physical access to all server rooms is restricted, brass key required.
Data is stored on the system in folders with permissions appropriate to the data. Active directory enforces access. Folder owners are responsible to authorizing access for individuals and adding to existing permission groups.
Access to the files and databases is through userid and password as enforced by NIH active directory. An additional userid/password challenge is presented when logging in to the database.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Internet Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: Not Applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): Old:
2004 UPI 009-25-01-27-02-8711-00-305-109, Old UPI: 009-25-02-01-02-3036-00
7. System Name (Align with system Item name): NIH NEI Internet Web site
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Terry Williams
10. Provide an overview of the system: To share information with the public about vision research and eye diseases and disorders.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Mailing list and contact information for those requesting information from NEI's Office of Communications. 09-25-0106
A separate email list is maintained by the subscribers. It contains only the email address of the subscriber.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Contact information is voluntarily collected. Information collected is only the information necessary to mail pamphlets or other printed information. Email address is voluntarily entered if the user joins an email list.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Information is submitted voluntarily, consent is assumed when contact information is submitted. Individuals may request corrections to or be removed from the email list.
There are no processes in place to notify users when major changes occur to the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Requests for information, name and address, are only available to NEI staff.
Email addresses on the email list are maintained by NEI staff and by specific request of the subscriber.
The system is monitored daily for intrusion by Big Brother, system logs, disk usage, and other indications of intrusion. MacAfee Outbreak Manager is used to control any possible virus outbreaks.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Personnel Actions Tracking System (PATS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Mar 20, 2007
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Personnel Actions Tracking System (PATS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Trevor Peterson
10. Provide an overview of the system: PATS (Personnel Actions Tracking System) is a NEI automated system that allows for the tracking of HR actions from beginning to end. It is an Institute-wide, mandatory, automated system that provides Program and Administrative staff with up-to-date status and history of individual HR actions and provides supervisors with standardized reports to manage and measure HR, Program support, and administrative workloads. PATS facilitates streamlined tracking of processes which replaced a manual process supported by numerous stand-alone logs.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Disclosures are made in accordance with SOR # 09-90-0018
Names and e-mail addresses of induviduals are collected and may be shared within the Institute or division in order to carry out the business process.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: This system is used to track personnel actions through the administrative process. Other than names and e-mail addresses of employees affiliated with such actions, and the names and e-mail addresses of the administrative officers involved in the work flow, it tracks no other personally identifiable information. The workflow process involved allows the position and disposition of a task or activity (with whom, when) to be identified in the organization. Information is obtained voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The IIF contained in the system is that of employees of the Institute. This information was obtained voluntarily from the employees and is used to manage administrative tasks within the department. There is no process in place to notify individuals of how their IIF will be used or if major changes occur.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The system is on the intranet and is password protected. It does not have outward facing web access.
User access is strictly controlled. Permissions are granted on need-to-know. The campus has full time security and key lock access controls. The server room where the application resides is a controlled access site with a limited roster.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Apr 12, 2007
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Recognizing Extraordinary Work and Rewarding Distinguished Service (REWARDS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jun 17, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): N/A
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): none
7. System Name (Align with system Item name): NEI Recognizing Extraordinary Work And Rewarding Distinguished Service (REWARDS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Trevor Peterson
10. Provide an overview of the system: database and web interface to submit, route, and approve incidental award nominations
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: staff names, work contact info, and award justification and approval information, to automate workflow of the award nomination and approval process; there is no PII
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Status of Funds Internet Edition (SOFie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-06-02-3199-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0217 "NIH Business System (NBS), HHS/NIH"
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NEI Status of Funds Internet Edition (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Don Smith
10. Provide an overview of the system: SOFie is a Web-based financial reporting/tracking tool that enables NIH ICs to manipulate and report on financial transactions downloaded from the Budget & Finance database in the NIH Data Warehouse. (The NIH DW Budget & Finance database comprises data downloaded from the NIH Business System.) Appointment and authority is given to the National Institutes of Health under 5 U.S.C. 301 and 302, 44 U.S.C. 3101 and 3102, Executive Order 9397.
The SOFie application supports the efforts of several offices and branches within NEI, allowing budget offices to track expenditures of direct, reimbursable, and non-appropriated funds in a fiscal year. Additionally, SOFie is used to reflect budget allocations and projected expenditures at the operating level.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the Privacy Act systems notice 09-25-0217 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Grantee and contractor (NIH grant recipient and contractor) personal information maintained comprises: name and financial account information. User (NIH employee) personal information maintained comprises: name, phone numbers, email addresses. NEI accounting transactions are downloaded from the Budget & Finance database in the NIH Data Warehouse. (The NIH DW Budget & Finance database comprises data downloaded from the NIH Business System.) The data is used to plan, track, and report on NEI fiscal budgets.
The SOFIE system collects IIF in the form of First Names, Last Names, Phone Numbers, Fax Numbers, and Email Addresses of its users voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
When applying for grants or contracts, applicants are informed that personal information is collected for accurate identification, referral and review by program managers. Refer to the system of record 09-25-0217 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for a summary of the notice of uses of information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: Guards, Identification badges, key cards and closed circuit TV
Technical controls: User ID, passwords, firewall, Virtual Private Network (VPN)
Administrative controls: Weekly backups, weekly log file checks, warning banners, database management
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI Telework
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: no
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0216
5. OMB Information Collection Approval Number: no
6. Other Identifying Number(s): no
7. System Name (Align with system Item name): NEI Telework Application
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Trevor Peterson
10. Provide an overview of the system: NEI Telework Application is a NEI Automated System that allows for the submission, routing, and approval of telework requests. It is an institute-wide, mandatory, automated system that replaces a manual process.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Disclosures are made in accordance with SOR # 09-25-0216
Names contact information of individuals are collected and may be shared within the Institute or division in order to carry out the business process.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: This system is used to request approval for telework and store agreement (schedule, work arrangement, justifications) and necessary contact information (name, work org, address, phone, fax, e-mail, home address, phone, fax). Other than names and contact information of applicant employees, and the names and e-mail addresses of the approving officials, it tracks no other personally identifiable information. The workflow process involved allows the position and disposition of a task or activity (with whom, when) to be identified in the organization. Information is obtained voluntarily.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The IIF contained in the system is that of employees and contractors of the Institute. This information was obtained voluntarily from the employees and is used to manage administrative tasks within the department. There is no process in place to notify individuals of how their IIF will be used or if major changes occur.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical access to the NIH campus requires an identification badge or as a registered visitor. Physical access to all server rooms is restricted; combination or brass key is required.
Data is stored on the system in directories with permissions appropriate to the data and reviewed by the system administrator. The operating system enforces access based on the userid.
Access to the files and databases is through userid and password as enforced by the operating system. An additional userid/password challenge is presented when logging in to a database.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NEI VISION Network Members Only
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 10, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: N/A
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): VISION Network Members Only
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Kym Collins-Lee
10. Provide an overview of the system: The purpose of the VISION Public Information Network is to communicate vision research results to the public through its grantee institutions. Public Information Officers from NEI grantee institutions work with the NEI to develop ongoing programs to educate the public about the benefits of vision research. The Members Only section allows members to access special media materials and to post news release, projects and events; and advertise job opportunities.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): (1) Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
(2) Disclosure may be made from this system of records by the Department of Health and Human Services (HHS) to the Department of Justice, or to a court or other tribunal, when (a) HHS, or any component thereof; or (b) any HHS employee in his or her official capacity; or (c) any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or (d) the United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components, is a party to litigation or has any interest in such litigation, and HHS determines that the use of such records by the Department of Justice, court or other tribunal is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Names and e-mail addresses are used by the NEI staff and grantees to access the system to update the information and add new study descriptions. Names and e-mail address are required for the user to access the VISION Network Members Only section. Contact information of list members is available only to each other.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) A statement is included on the web site indicating the only usage is for the subscribers to communicate with each other. The only information collected is that supplied by the subscriber. If any change of information usage is made the subscribers will be contacted via email.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The server containing the VISION Network Members Only section is maintained by an NEI contractor who follows guidance from NSA, NIST, SANS, and CERT to maintain the security and integrity of the system.
Information contained in the lists is maintained by NEI staff and by specific request of the subscriber.
The system is monitored daily for intrusion by Big Brother, system logs, disk usage, and other indications of intrusion. MacAfee Outbreak Manager is used to control any possible virus outbreaks.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Trevor Peterson
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Attention Deficit Hyperactivity Disorder Database (ADHD)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-9199-00-404-138
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: not applicable
6. Other Identifying Number(s): not applicable
7. System Name (Align with system Item name): NHGRI Attention Deficit Hyperactivity Disorder Database (ADHD)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Maria Acosta, MD
10. Provide an overview of the system: Database of demographic and clinical research data on ADHD (Attention Deficit Hyperactivity Disorder).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Data is shared among members of the ADHD research team. This information is further addressed in the NIH Privacy Act Systems of Record Notice 09-25-0200, published in the Federal Register, Volume 67, No. 187, September 26, 2002.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Name, date of birth, mailing address, phone numbers, medical notes, email address, family and blood sample accession numbers, questionnaires completed by study subjects. Information is given voluntarily.
This research study on the genetics of Attention Deficit/Hyperactivity Disorder is collecting information from families with affected children in order to better understand the impact of genetics on the transmission of the disorder, and its manifestations.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Patients and/or parents sign an IRB (Internal Review Board) informed consent form mailed to them and mailed back to the research study coordinator. Patients and/or parents are informed that protocol related information will be used for research purposes and restricted to study team members only. Families that agree to participate are contacted by the study coordinator. No changes in the system or modifications in the database have been done from the original design. No modifications are expected. Currently no reason to re-contact families that have finished the data collection part of the study.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Access is limited to research team members only; files backed up regularly and back up files stored offsite; user ID and password required; firewall present; accounts locked after five minutes of inactivity, computers in locked offices
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler, 301-594-1061
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Community of Genetic Educators (CoGE)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Jul 7, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0156
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Community of Genetic Educators (CoGE) NIH
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Jeff Witherly
10. Provide an overview of the system: The "Community of Genetic Educators" web site was created to help connect genetic educators online. It is a forum for information sharing. With so many resources available, it is sometimes difficult for educators to know what will work in the classroom. This web site may be used to find resources, to recommend resources, learn from other members in similar situations, act as a mentor to other members, submit helpful lessons learned and resources, and work with the education team at the NIH Genome Institute (NHGRI) in reviewing and refining learning tools.
Each site visitor is asked to register on the first visit. Registration includes setting up an account with password, name, email address, state/country, language, time zone, current education position, type of school info, teaching experience and instructional focus. Voluntary information that further defines the visitor includes affiliations, a text box for a biography and the option to add a photograph.
After registration the visitor is given immediate access to the site which includes many resources and a messaging forum.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: To register for site access, the following information is mandatory: First and last name, email address, country, state, language, time zone , current education position, other positions, type of school, minority serving institution, location, school level, teaching experience, and instructional focus. Of the information required, name and email address are considered to be information in identifiable form (IIF).
The following information is voluntary: affiliations, biography, photo. A photo is considered to be information in identifiable form (IIF).
The "Community of Genetic Educators" web site was created to help connect genetic educators online. It is a forum for information sharing. With so many resources available, it is sometimes difficult for educators to know what will work in the classroom. This web site may be used to find resources, to recommend resources, learn from other members in similar situations, act as a mentor to other members, submit helpful lessons learned and resources, and work with the education team at the NIH Genome Institute (NHGRI) in reviewing and refining learning tools.
Each site visitor is asked to register on the first visit. Registration includes setting up an account with password and includes the mandatory information listed above. Voluntary information that further defines the visitor and will better introduce this person to others visiting the site.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is an extensive Privacy statement displayed on the registration page. Additional information is made available through a link called “Privacy” displayed on each web page, which includes the following:
Personally Provided Information
Information Required For Membership:
We require each member to enter a limited amount of personal information as part of the registration process of the CoGE web site. This information is typically required as part of our NHGRI educational course registrations, and will be used at the CoGE for contacting CoGE members about events, opportunities, and new educational products of value.
We have made every attempt to make the required information as minimal as possible for members. This information includes: your name, your email address, country, state, and current educational position (teacher, administrator, other). We will also ask you to choose a member name and a member password.
Your real name, and your email address are not shared online in the CoGE. Only CoGE administrators have access to this personal information. Members will only know your member name and your CoGE email address.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: The amount of IIF collected is minimal, only that which is absolutely needed to meet the needs of the system's purpose.
Registration information is not available to the users of this site unless they chose to share with one another. This voluntary sharing of information is not being managed by the system.
From an administrative point of view, only a limited number of staff have access to the IIF. Support personnel will have access for maintenance purposes. The system owners and administrators will have access for the creation of aggregate reports. A well constructed set of rules of behavior are in place for all who have access to the IIF.
The technical and physical aspects are properly cared for by placing the system on a secured server, in a secured location. A separate C&A was completed for the server that houses this application by the IT staff.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler, 301-594-1061
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI LabMatrix
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: no/a
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: not applicable
6. Other Identifying Number(s): not applicable
7. System Name (Align with system Item name): Labmatrix
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dr Gretchen Gibney
10. Provide an overview of the system: Research and clinical database which contains information related to clinical and research laboratory data collection and findings from Institutional Review Board study protocols. NHGRI professional medical staff (MD, RN, Genetic Counselor) and scientific laboratory personnel (PhDs, technicians, data managers) access for research purposes only.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Restricted to research. This information is further addressed in the NIH Privacy Act Systems of Record Notice 09-25-0200, published in the Federal Register, Volume 67, No. 187, September 26, 2002.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Research and clinical database of patient information including demographics, protocol data, medical records, medical record number, photographic identifier, email address, employment data. IIF contained. Information submission is voluntary. Information is used for research purposes only per individual research protocol.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) IRB (Institutional Review Board) approved informed consent form. In the event of sharing of information or major changes to database, individuals would be re-consented per IRB guidance.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Access is password/ID restricted to authorized users and controls for each user are specified individually. All data transmissions are encrypted, all transactions are monitored, and application and database server are housed in a locked, secure setting.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler 301-594-1061
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Planning Pages
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 0
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 0
5. OMB Information Collection Approval Number: 0
6. Other Identifying Number(s): 0
7. System Name (Align with system Item name): NHGRI Planning Pages
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: David Smith
10. Provide an overview of the system: This is a public web based system that requires a person's name, email, institute and comments on the public document. This information is moderated similar to a blog site, and once approved, the comments will be pushed back out for public display.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The system shares IIF with everybody inside, and, with the exception of email, outside NHGRI.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: NHGRI will collect, maintain, and disseminate internally information containing a person's name, email, institute/organization, and comments. The information being collected is to provide feedback that can be used for the NHGRI planning process. This information is not mandatory. Once approved, only the comments are published to the general public .
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The use of PII is indicated on the web page informing individuals about how the information will be used.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Key Cards
PIA Approval
PIA Reviewer Approval: -
PIA Reviewer Name: Gloria Butler, NHGRI Privacy Liaison
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Status of Funds Internet Edition (SOFie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-02-3199-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): no
5. OMB Information Collection Approval Number: no
6. Other Identifying Number(s): no
7. System Name (Align with system Item name): NHGRI Status of Funds Internet Edition (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Eddie Rivera
10. Provide an overview of the system: An organizational reporting tool that allows an organization to manipulate and report on financial transactions downloaded from the NIH Central Accounting System. The information is general accounting info by category, with totals by category, and has no info specific to employees.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): no
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Accounting data and related document information is downloaded from CAS/Central Accounting System mainframe and is specific to NHGRI/OD Office for its fiscal year operations. The information is general accounting info by category (ex. wages), with totals by category, and nothing specific to individual employees. The system contains no IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler, 301-594-1061
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Telework Application
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: no
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0216
5. OMB Information Collection Approval Number: no
6. Other Identifying Number(s): no
7. System Name (Align with system Item name): Telework Application
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Gloria Butler
10. Provide an overview of the system: This system automates the Telework application and approval process. Each applicant logs into the Telework program, enters an application to telework, which is then electronically routed to those who will review/approve the application.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The questions asked are all mandatory, needed to determine where and under what circumstances the applicant will be teleworking. Data items: name, work phone numbers, home address and phone are IIF.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Before a telework application is submitted, each applicant discusses requirements and forms that must be completed with his/her supervisor. All IIF information is then submitted by the applicant through the automated telework program. At log on to the system, on the main login screen, each applicant sees a Privacy statement that describes how the data will be used. The following statement is viewed by each person who enters the system: "Purposes and Uses - The information entered into this data system will become a part of the NHGRI Telework Application & Approval System which managed the electronic evaluation of telework applications. The primary use of the information is to evaluate an employee's request to telework. The information will only be used as part of the application process and will not be disclosed to anyone other than the NHGRI Telework Coordinator, Managing Supervisor, NHGRI Executive Officer and appropriate contracting staff. "
If/when changes are made, each applicant or person renewing an application will have access to the new procedures through the log on screen "Purposes and Uses" section, which will be modified to accommodate any access or policy changes made to the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Key Cards
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Trainee Tracking Database
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: not applicable
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: not applicable
6. Other Identifying Number(s): not applicable
7. System Name (Align with system Item name): Trainee Tracking Database
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Dave Kanney and/or Michelle Hamlet
10. Provide an overview of the system: The system supports the overall training mission of the intramural program through the monitoring and tracking of trainees at all levels. The database enables the ITO (Intramural Training Office) to create and manage records for all trainees. A record of each trainee contains name, degree, gender,race, department and mentor and is maintained to capture aggregate demographic information, to track the progress of individual trainees, and to manage follow-up surveys, annual reviews, and exit interviews critical for the evaluation of the training program. The information in the database aggregated across the data set, presents a snapshot of the size and demographics of the trainees each year.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Annual review dates, branch, position title, EOD (Enter on Duty) date, merit award data, mentor’s name, name, gender, race/ethnicity for diversity and evaluation purposes. The system contains IIF and submission of gender, race/ethnicity is voluntary.
The information is used to track the progress of individual trainees, and to manage follow-up surveys, annual reviews, and exit interviews.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Any changes in the system would not change the data, therefore, there is no need to notify and obtain consent.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Database secured behind locked doors, login/password/ ID protected with very limited 'need-to-know' users.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler, 301-594-1061
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHGRI Visual Employee Database System (VEDS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 30, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-02-3196-00-403-131
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-90-0018
5. OMB Information Collection Approval Number: no
6. Other Identifying Number(s): no
7. System Name (Align with system Item name): NHGRI Visual Employee Database System (VEDS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Patricia Hylla
10. Provide an overview of the system: VEDS is a windows-based application primarily used to manage and track personnel information. Authority for maintenance of the system: 5 U.S. C 1302, 2951, 4118, 4308, 4506,7501,7511, 7521, and Executive Order 10561.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): For internal administrative use only and not shared with other entities. SOR 09-90-0018
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Information is for internal administrative use only and will not be shared with other entities. Information downloaded from the NIH Human Resources Database. Mandatory.
Name, date of birth, SS#, mailing address, phone numbers, email address, employment status/records, VISA status, salary information, personnel action information.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) It is an electronic system with very limited "need-to-know" users, and is password protected. Individuals are not consented or notified individually. IIF is not collected from individuals, only through downloading of data from NIH Human Resources Database.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: user ID, passwords, firewall, VPN, encryption
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Gloria Butler, 301-594-1061
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI Clinical Data System (CDS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 22, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-7213-00-202-069
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NHLBI Clinical Data System (CDS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Zeyad Mobassaleh
10. Provide an overview of the system: The NHLBI-CDS collects and manages data emanating from clinical studies and allows for monitoring recruitment and tracking patients. It is a multi-tiered, Web-based system where research-related data are entered to facilitate the generation of regulatory reports and data sets for analyses.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): The NHLBI-CDS produces Medical Record reports that are filed in the Clinical Center Medical Records Department and are also used to send to the patient’s referring physician. SOR number is 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The NHLBI-CDS collects and manages data emanating from clinical studies and allows for monitoring recruitment and tracking patients and analyzing results. Collection of this information is authorized under sections 301, 319F-1, 402, and 405 of the PHS Act which authorize the HHS Secretary to conduct and support research.
The primary use of this information is to track clinical research results for studies conducted at the National Institutes of Health. Information such as patient name, address, medical history, test and procedure results, and other research related information is collected and maintained. NHLBI-DIR uses this information to analyze and report the results of clinical research being conducted within the division. The information collected includes IIF and all patients enrolled on clinical studies sign an informed consent related to their participation in clinical research. Some of the information is used for Medical Record reporting and for providing the patient’s referring physicians with the test results and assessments related to the patient’s visit. Information is provided on a voluntary basis as participation in clinical trial research is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All patients sign an informed consent (paper) related to their participation in clinical research and how their data will be used. There is no process for obtaining consent from individuals whose IIF is in the system when major system changes occur, however this system is an internal system (only available within NIH) and data are de-identified for the purpose of summarizing and publishing research results.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Data is maintained in a secure database. Routine access is restricted to authorized employees and contractors only according to the principal of least privilege by the use of user name and password access controls. Additional technical and administrative controls are also employed, including badge access, intrusion detection system, firewalls, virtual private networks, encryption, etc. The NHLBI-CDS staff monitors system access for intrusion detection and reviews audit logs to identify inappropriate browsing or inappropriate database access. Computer security incidents are referred to the NIH Incident Response Team (NIH IRT). Contractors are required to have employment suitability determinations, National Agency Checks, credit checks, and/or background investigations, commensurate with the position. Contractors are also required to sign an NIH non-disclosure agreement prior to being given access to the NHLBI-CDS. Contractors must take the NIH security awareness training.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Zeyad Mobassaleh
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI Data Center
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: NO
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): NO
5. OMB Information Collection Approval Number: NO
6. Other Identifying Number(s): NO
7. System Name (Align with system Item name): NHLBI Data Center
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Cindy Walczak
10. Provide an overview of the system: The NHLBI Data Center supports approximately 1,500 users at the NHLBI. The NHLBI Data Center is located in the Customer Service Area (CSA) 2 in the NIH Data Center in Building 12 on the NIH main campus in Bethesda, MD and at the NIH Consolidated Co-Location Site (NCCS) at the Qwest data center in Sterling, VA.
The NHLBI Data Center comprises servers and SANs constituting a General Support System.
Although many applications reside on servers in the NHLBI Data Center, the Data Center itself does not process or store any IIF. (Individual application PIAs will address any and all IIF.)
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF shared or disclosed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No IIF collected, contained, maintained, or disseminated.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No IIF in the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A--No IIF in the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Cindy Walczak, NHLBI ISSO
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI Extramural Program Development (EP)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-7204-00-202-069
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NHLBI Extramural Program
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Zeyad Mobassaleh
10. Provide an overview of the system: Manage NHLBI Extramural Research Programs.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Grant data is available to reviewers during submission/evaluation of potential grants. See SOR 09-25-0036
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Collection of this information is authorized under 5 U.S.C 301. Information collected by the system includes: funding applications, awards, trainee appointments and advisory committee records. The primary use of this information is for government personnel to conduct grant application reviews, approvals, and to create reports related to grant applications. Submission of this information is mandatory for grant applications to be processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) There is no process to notify or obtain consent when there is a major change to the system that affects disclosure and/or data uses since the notice at the time of the original collection.
Applicants are notified data is collected when they enter it into the system, or fill in the paper application.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: This system has been subject to a Certification and Accreditation (C&A) process, during which, all technical, administrative and physical controls were evaluated. These controls are defined in NIST publication 800-53 Recommended Security Controls for Federal Information Systems.
The system is housed in a secure server room, which is located in a building protected by security personnel 24/7 (door locks, key badge, etc…). Technical controls ensure that no unauthorized access is permitted (passwords, certificates, encryption, firewalls, etc…). Strict administrative controls are in place to ensure the system is operated in a safe, consistent manner (least privilege, separation of duties, background investigations, etc…).
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Zeyad Mobassaleh
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 11, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI Internet Website
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 15, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-27-02-7299-00-305-109
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0106, 09-90-0024
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NHLBI Web Site
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Matt Raschka
10. Provide an overview of the system: Disseminates health information and information and policies related to NHLBI Extramural and Intramural Programs.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Credit Card information is transferred to Verisign for cost recovery.
Information from Techfinder may be shared the NIH Office of Technology Transfer, which is responsible for licensing NIH technology. SOR is 09-25-0106 and 09-90-0024.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Voluntary; contains IIF:
o names and mailing addresses, email addresses, phone and FAX numbers for delivery of purchased items, purchase confirmation, verification, and updating information,
o credit card numbers for: purchase of items (cost recovery),
o Login credentials needed to update staff profiles
Voluntary; does not contain IIF
o Names of organizations and description, general job titles, organizational unit, research interests, contact information, information about an activity (including dates), expected audience, and setting (e.g., healthcare, work site, community, media, etc.) for posting on the Web, publicizing local activities, or developing interest in NHLBI activities, also for staff recruitment of new postdocs and principal investigators.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) The individuals are contacted by either email or US Post, depending on the information in that particular system
Notification of intent to use information is available on the Web application or Web sites.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: Yes
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Information is secured using username/passwords, least privilege, separation of duties, an intrusion detection system, firewalls, locks, badge access, background investigations. A comprehensive IRT capability is also maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Matt Raschka
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI Intramural Research Application Development (IR)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-26-02-7203-00-202-069
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0099
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NHLBI Intramural Program
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Zeyad Mobassaleh
10. Provide an overview of the system: Manage NHLBI Intramural Research Programs.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): Clinical test results are available to authorized researchers and caregivers. See SOR 09-25-0099
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Collection of this information is authorized under 42 U.S.C. 241, 248. The system collects medical treatment record data. This information is used to provide evaluations and treatments to patients, and for subsequent medical research. The researchers and caregivers will have access to this information. Submission of this information is mandatory for all medical research patients.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All patients sign an informed consent (paper) related to their participation in clinical research and how their data will be used. There is no process for obtaining consent from individuals whose IIF is in the system when major system changes occur, however this system is an internal system (only available within NIH) and data are de-identified for the purpose of summarizing and publishing research results.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: This system has been subject to a Certification and Accreditation (C&A) process, during which, all technical, administrative and physical controls were evaluated. These controls are defined in NIST publication 800-53 Recommended Security Controls for Federal Information Systems.
The system is housed in a secure server room, which is located in a building protected by security personnel 24/7 (door locks, key badge, etc…). Technical controls ensure that no unauthorized access is permitted (passwords, certificates, encryption, firewalls, etc…). Strict administrative controls are in place to ensure the system is operated in a safe, consistent manner (least privilege, separation of duties, background investigations, etc…).
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Zeyad Mobassaleh
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI LAN GSS
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Jun 23, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: NO
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): NO
5. OMB Information Collection Approval Number: NO
6. Other Identifying Number(s): NO
7. System Name (Align with system Item name): NHLBI LAN GSS
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Cindy Walczak
10. Provide an overview of the system: The NHLBI-managed LANs general support system (GSS) is owned and maintained by the Information Technology Resources Branch (ITRB) of the NHLBI Center for Biomedical Informatics (CBI). NHLBI LANs assets are located in buildings 10, 14, and 31 on the NIH main campus in Bethesda, MD as well as in the off-campus Rockledge One and Two buildings in Bethesda, MD and the 5RC building in Rockville, MD. The NHLBI LANs GSS provides network connectivity for NHLBI information systems, applications, and users.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF shared or disclosed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No IIF collected, contained, maintained, or disseminated.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No IIF in the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A--No IIF in the system.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Cindy Walczak
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NHLBI Survey of NHLBI Constituents’ Health Information Needs and Preferred Formats
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: Initial PIA Migration to ProSight
1. Date of this Submission: Jul 31, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): SORN 09-25-0156
5. OMB Information Collection Approval Number: N/A
6. Other Identifying Number(s): N/A
7. System Name (Align with system Item name): Survey of NHLBI Constituents’ Health Information Needs and Preferred Formats
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Ann Taubenheim
10. Provide an overview of the system: A Web-based survey tool, WebSurveyor, will be used to contact and collect data from NHLBI constituents who have contacted the NHLBI Health Information Center website within the past 3 years. These previous customers will be invited by e-mail to participate in a short online survey. Survey questions ask about respondents’ health information and education needs and format preferences. No personally identifiable information (PII) will be collected from survey respondents. Constituents who choose to complete the survey are identified by e-mail address. Upon completion of the survey, all data tying the assigned identifier to an e-mail address will be destroyed; namely, the contents of the e-mail fields will be erased.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Survey questions ask about respondents’ health information and education needs and format preferences. No personally identifiable information (PII) will be collected from survey respondents.
The survey data will be used to support the NHLBI Office of Communications and Legislative Activities’ efforts in developing a strategic plan. All survey responses are voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) All e-mails to potential respondents, as well as each page of the survey will contain the message: “Your answers will be kept completely confidential and not linked to personal or identifying data of any kind. Moreover, your information will not be shared with any other party.”
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Administrative Security: Only contractor personnel whose duties require the use of the information in the system have access. This includes the system administrator only.
Technical Security: The multiserver architecture is isolated on a dedicated internal subnet separated from both the internal AIR network and the public Internet by an enterprise-grade firewall managed by the AIR Web Hosting Services team. In addition to the firewall, Web Hosting Services has deployed an intrusion prevention system appliance that can employ granular security policies commensurate with the level of risk on a per-host basis. For security purposes, only the Web server itself is accessible from the Internet, and even then, solely over ports 80 and 443 for HTTP and SSL-encrypted HTTP, respectively. The databases are not Internet-accessible, and furthermore, are accessible strictly from within the internal AIR network only to those users whose roles require that they be expressly granted access to these systems. Internal access to the servers may take the form of SFTP to the Web server, Terminal services to any servers, directly via the local console, or via an installed eEnterprise client. Authorized internal users are able to access only those servers to which they need access and only via the methods that are applicable to their specific roles.
The WebSurveyor tool will assign a unique identifier to each potential respondent in the study tied to his/her e-mail address to ensure one response per respondent. That identifier will not be accessible to anyone but the AIR system administrator for the WebSurveyor tool. Upon completion of the survey, all data tying the assigned identifier to an e-mail address will be destroyed; namely, the contents of the e-mail fields will be erased.
Physical Safeguards: The system administrator’s role is to ensure a stable and secure operating environment within which the WebSurveyor tool can function. This includes establishing and executing a long-term vision that guards the security and reliable operation of the system. This includes managing backups of system files and data; installation of patches to ensure system security and stability; monitoring system log files for suspicious activity; assigning server-level access rights to users as needed; and coordinating with vendors to replace and enhance system hardware as needed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Cindy Walczak
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Aging Data Administration Management System (ADAMS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-04-00-02-4302-00-101-001
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036 Extramural Awards and Charted Advisory Committees
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Aging Data Administration Management System (ADAMS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robert Feaga
10. Provide an overview of the system: The Aging Data Administration Management System (ADAMS) is a tracking and recording system for grants. It allows the user to code competing applications before council meetings, scientifically code grants based on their study, perform ad hoc queries, and generate reports. Legislation to authorize this activity is under 5. U.S.C.301;42U.S.C.217a.241,282(b)(6),248a, and 288.48 CFR Subpart
15.3 and Subpart 42.15. More specific functions include: allocation and adjusting funding estimates for grants based on their budgets, summarizing grant funding by specific categories for reporting to Congress, and reporting committed, pending, and obligated records with future year commitments.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0036 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system stores informaiton on grant applications and current and historical information on grant applications and contracts awarded by the NIH, including performance evaluations. The information is used to support centralized grant programs and contract management. IIF in the system includes name, mailing address, email address, telephone number, financial account information, and grant and/or contract number.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
When applying for grants, applicants are informed that personal information is collected for accurate identification, referral and review by grants program managers. Refer to the system of record 09-25-0036 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm, for a summary of the notice of uses of information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: Guards, Identification badges, key cards and closed circuit TV.
Technical controls: User ID, passwords, firewall, Virtual Private Network (VPN) .
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Baltimore Longitudinal Study of Aging (BLSA)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4303-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200 Clinical, Basic and Population-based Research Studies
5. OMB Information Collection Approval Number: None
6. Other Identifying Number(s): None
7. System Name (Align with system Item name): Baltimore Longitudinal Study of Aging (BLSA)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Luigi Ferrucci
10. Provide an overview of the system: The Baltimore Longitudinal Study of Aging collects information on study participants for clinical research. The system is located on the 5th floor of the Harbor Hospital Center and the 2nd floor of the Gerontology Research Center in Baltimore, MD. Appointment and authority is given to the National Institutes of Health under Public Service Act, 42 U.S.C. 241, 242, 248, 281, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Information regarding potential disclosure practices is further addressed in the NIH Privacy Act Systems of Record Notice 09-25-0200, published in the Federal Register, Volume 67, No. 187, September 26, 2002.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The personal information collected includes: name, mother’s maiden name, date of birth, (voluntary) SSN, mailing address, phone number, medical record numbers, notes and email address. Information is used in examining the clinical questions addressed by the study, and to contact the consenting participants with the results of testing and to collect clinical follow-up information. The information collected is the minimum required to accomplish the stated mission.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Noprocesses are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
All participants sign an informed consent form acknowledging their voluntary participation in the study and their rights under HIPAA. (Refer to the Privacy Act systems notice 09-25-0200 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for a summary of the notice of uses of information.)
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: Guards, Identification badges, key cards and closed circuit TV
Technical controls: User ID, passwords, firewall, Virtual Private Network (VPN)
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Clinical Research System (CRS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4303-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200 Clinical, Basic and Population-based Research Studies
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Clinical Research System (CRS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Linda Jo Byrd
10. Provide an overview of the system: The Clinical Research System is a product of the Clinical Research Branch of the NIA Intramural Research Program. It collects personal information on the participants of the Baltimore Longitudinal Study on Aging as well as clinical research studies. The system is physically located on the 5th floor of the Harbor Hospital Center in Baltimore, Maryland.
Appointment and authority is given to the National Institute on Aging under Public Service Act, Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0200 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The personal information collected during the initial and subsequent visits to the clinical research branch. This information includes: name, mother’s maiden name, date of birth, social security number, mailing address, phone number, medical record numbers, notes and email address. Information is used to contact the consenting participants with the results of testing, to collect follow-up information, and as part of the clinical research. The information collected is the minimum required to accomplish the stated mission
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
All participants sign an RRB-approved informed consent form acknowledging their voluntary participation in the study and their rights under HIPAA. (Refer to the system of record 09-25-0200 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm, for a summary of the notice of uses of information.)
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: Guards, Identification badges, key cards and closed circuit TV
Technical controls: User ID, passwords, firewall, Virtual Private Network (VPN)
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA ERP Data Centers
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA ERP Data Centers
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mike Valdez
10. Provide an overview of the system: NIA Extramural Research Program (ERP) Data Centers in Bethesda, MD. These data centers support NIA ERP administrative activities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Server configuration and event log data is collected and maintained to support data center operations. Data is collected and maintained as needed to administer servers, SAN, and tape backup system. No PII collected, stored, or processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No PII collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA ERP LANs
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-03-00-02-4399-00-304-104
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): ERP Local Area Networks (LANs)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mike Valdez
10. Provide an overview of the system: NIA Extramural Research Program (ERP) Local Area Networks (LANs) in Bethesda, MD. These networks support NIA ERP clinical research and administrative activities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No IIF collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No IIF collected, stored, or processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No IIF collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No IIF collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA ERP Web
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-03-00-02-4399-00-304-104
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA ERP Web
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mike Valdez
10. Provide an overview of the system: The NIA Extramural Research Program (ERP) Web comprises the NIA public and intranet Websites. The NIA public Website http://www.nia.nih.gov/ provides Web-based worldwide access to NIA public information. The public portion of the NIA website has no identification/authentication of visitors or encryption of traffic between the Web server and user browsers. The NIA intranet Website http://intranet.nia.nih.gov/ provides Web-based local (NIHnet) access to NIA private information and applications. (ADAMS Web-based applications are located on the intranet Website. See the ADAMS PIA.) Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No PII collected, stored, or processed. No Submission of personal information.
Information on the ERP Web website http://www.nia.nih.gov/ comprises NIA health information publications, clinical trials descriptions, public service ads, links to related sites, links to health and aging organizations, extramural research program descriptions, intramural research descriptions, materials from NIA conferences, workshops, and meetings, information on NIH's inclusion policies, and descriptions of scientific resources.
Information on the ERP Web website http://intranet.nia.nih.gov/ comprises links to login pages of NIA applications accessible only from NIA LANs. A few public links that are provided for internal users such as the NIH home page.
No PII on ERP Web site.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No PII collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Extramural Financial Management Branch application (FINeX)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-04-02-8610-00-404-136
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036 Extramural Awards and Charted Advisory Committees
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA Extramural Financial Management Branch Application (FINeX)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robert Feaga
10. Provide an overview of the system: The FINeX application facilitates maintenance of NIH extramural grant budgets. The NIA FINeX application accesses NIA financial grant information from the eRA IMPAC II and NIH Data Warehouse databases.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0036 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Financial grant information. The FINeX application facilitates maintenance of NIH extramural grant budgets. The NIA FINeX application accesses NIA financial grant information from from the IMPAC II and NIH Data Warehouse databases. IIF in the system includes name, financial account information, and grant and/or contract number. Submission of personal information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the e-Government Act of 2002, occur to the system. IIF is submitted by grant applicants during the grant application process. Information used by the NIA FINeX application originates in the eRA grant application and NIH Data Warehouse. Notification and consent from the individual is assumed when the grant application is submitted.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: guards, identification badges, key cards and closed circuit TV.
Technical controls: user IDs, passwords, firewall, VPN, IDS.
Administrative controls: system security plan, contingency plan, files are backed up regularly, backups are stored offsite, user manual, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Healthy Aging in Neighborhoods of Diversity across the Life Span System (HANDLS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4303-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200 Clinical, Basic and Population-based Research Studies
5. OMB Information Collection Approval Number: CE-04-06-01
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Alan Zonderman
10. Provide an overview of the system: The HANDLS system is a product of the Research Resources Branch of NIA Intramural Research Program. It collects personal information on the participants in the HANDLS study. The system is physically located in the Gerontology Research Center in Baltimore, Maryland. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0200 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The personal information collected includes: name, date of birth, social security number, mailing address, phone number, medical record numbers, notes and email address. Information is used in examining the clinical questions addressed by the study, and to contact the consenting participants with the results of testing and to collect clinical follow-up information. The information collected is the minimum required to accomplish the stated mission.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
All participants sign an RRB-approved informed consent form acknowledging their voluntary participation in the study and their rights under HIPAA. (Refer to the system of record 09-25-0200 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm, for a summary of the notice of uses of information.)
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: Gards, Identification badges, key cards and closed circuit TV.
Technical controls: User ID, passwords, firewall, VPN, IDS.
Administrative controls: system security plan, contingency plan, files are backed up regularly, backups are stored offsite, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Pla
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA IRP Data Centers
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA IRP Data Centers
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Alan Zonderman
10. Provide an overview of the system: NIA Intramural Research Program (IRP) Data Centers in Baltimore, MD. These data centers support NIA IRP clinical research and administrative activities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Server configuration and event log data is collected and maintained to support data center operations. Data is collected and maintained as needed to administer servers, SAN, and tape backup system. No PII collected, stored, or processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No PII collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A--No PII collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA IRP LANs
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4399-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): IRP Local Area Networks (LANs)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Alan Zonderman
10. Provide an overview of the system: NIA Intramural Research Program (IRP) Local Area Networks (LANs) in Baltimore, MD. These networks support NIA IRP clinical research and administrative activities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): N/A--No PII collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No PII collected, stored, or processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No PII collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A--No PII collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA IRP RAS
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4399-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): IRP Remote Access Service (RAS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Alan Zonderman
10. Provide an overview of the system: The NIA Intramural Research Program (IRP) Remote Access Service (RAS) enables modem access to NIA LANs in Baltimore, MD via the public switched telephone network (PSTN). The IRP RAS supports NIA IRP clinical research and administrative activities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII collected, stored, or processed.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: No PII collected, stored, or processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No PII collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): No
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: N/A--No PII collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA IRP SSH Gateway
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): No
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA IRP SSH Gateway
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Alan Zonderman
10. Provide an overview of the system: The IRP SSH Gateway system provides access to sensitive NIA IRP information on private shares for collaboration between NIA IRP and non-NIH investigators. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): No
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): No
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No PII collected, stored, or processed
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: De-identified clinical research data, non-human research data, statistical reports, and study reports. No PII collected, stored, or processed.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) N/A--No PII collected, stored, or processed.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: No PII collected, stored, or processed.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA IRP Web
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-05-02-4303-00-110-219
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0200 Clinical, Basic and Population-based Research Studies
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): IRP Web
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Alan Zonderman
10. Provide an overview of the system: NIA Intramural Research Program (IRP) Web is a suite of Web-enabled applications in Baltimore, MD, that supports NIA IRP clinical research and administrative activities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures. While this system does not intend to share or disclose any PII, the system of record 09-25-0200 indicates some potential disclosure of information practices.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The personal information is collected from a Website. This information includes: name, street address, telephone number, email address, date of birth, gender, height, weight, ethnic background, medications currently taken, and comments. The information is used to screen the potential participants in clinical research. The information collected is the minimum required to accomplish the stated mission
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) Participants supply basic personal identifying information during the intake process to the Clinical Research Branch. All participants sign a consent form acknowledging their anonymity and rights under HIPAA. Refer to system of record 09-25-0200 for a detailed summary. No process for notifying individuals when major changes occur to the system.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: guards, identification badges, key cards, and closed circuit TV.
Technical controls: user IDs, passwords, firewall, VPN, IDS.
Administrative controls: system security plan, contingency plan, files are backed up regularly, backups are stored offsite, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Microsoft Office SharePoint Services (MOSS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0216 "Administration: NIH Electronic Directory (NED), HHS/NIH"
5. OMB Information Collection Approval Number: none
6. Other Identifying Number(s): none
7. System Name (Align with system Item name): NIH NIA Microsoft Office SharePoint Services (MOSS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Mike Valdez
10. Provide an overview of the system: The NIH NIA MOSS is a Microsoft Office SharePoint Services-based NIA Intranet portal. MOSS will provide collaboration and data organization tools for users at the NIA Office of the Director (OD) and Office of Administrative Management (OAM). MOSS will facilitate sharing of OD and OAM business processes, including employee administration, purchase ordering, and asset management tracking. MOSS document workflow sites will support management of administrative policies and procedures as well as administrative requests and actions. MOSS search capabilities will enable cross-site searching that speeds access to critical administrative documentation.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0216 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0216.htm for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: All IIF in the system is queried from the NIH Enterprise Directory (NED) system. IIF needed to facilitate NIA Office of the Director (OD) and Office of Administrative Management (OAM) collaboration includes name, work phone number, and work email address of NIA employees and contractors. Submission of information to NED is mandatory.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system. All IIF in the system is queried from the NIH Enterprise Directory (NED) system.
Refer to the system of record notice 09-25-0216 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for a summary of the notice of uses of NED information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: guards, identification badges, key cards and closed circuit TV.
Technical controls: user IDs, passwords, firewall, VPN, encryption, IDS.
Administrative controls: system security plan, contingency plan, files are backed up regularly, backups are stored offsite, user manual, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA NACAnet
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-03-00-02-4399-00-304-104
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0217 "NIH Business System (NBS), HHS/NIH"
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): National Advisory Council on Aging Network (NACAnet)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robin Barr
10. Provide an overview of the system: NACAnet is an NIA web application that supports the National Advisory Council on Aging (NACA) by providing a repository of council-related documents. No transactions are collected or accomplished on the website, only display of NACA information. NACAnet users comprise NIA employees and the current NACA council members, some of whom are located outside NIH at academic facilities. Appointment and authority is given to the National Institute on Aging under Public Service Act, 42 U.S.C. 241, 242, 248, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the Privacy Act systems notice 09-25-0217 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Grantee (NIH grant recipient) personal information maintained comprises: name, mailing address, phone number, financial account information, and employment status. The data is used for NACA planning
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose IIF is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
When applying for grants or contracts, applicants are informed that personal information is collected for accurate identification, referral and review by program managers. Refer to the system of record 09-25-0217 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for a summary of the notice of uses of information..
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: guards, identification badges, key cards and closed circuit TV.
Technical controls: user IDs, passwords, firewall, VPN.
Administrative controls: system security plan, contingency plan, files are backed up regularly, backups are stored offsite, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski 301-451-8413
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: Yes
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Position and Employee Tracking (PET)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0216 "Administration: NIH Electronic Directory (NED), HHS/NIH"; 09-90-0018 “Personnel Records in Operating Offices, HHS/OS/ASPER”
5. OMB Information Collection Approval Number: none
6. Other Identifying Number(s): none
7. System Name (Align with system Item name): NIH NIA Position and Employee Tracking (PET)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Melissa Fraczowski
10. Provide an overview of the system: The NIA Position and Employee Tracker (PET) application is owned and maintained by the Workforce Strategic and Planning Branch (WSPB) of the NIA Office of Administrative Management (OAM) and is located in Building 31 on the NIH main campus in Bethesda, MD. The PET application consolidates NIA personnel information into one location, reducing WSPB reliance on maintaining separate Microsoft Excel spreadsheets for different categories of personnel information. The PET will be used to maintain administrative and status information on NIA federal FTE and non-FTE contractors, special volunteers, intramural research training award recipients (IRTAs), visiting fellows, guest researchers, and detailees.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Some PII in the system is queried from the NIH Enterprise Directory (NED) and the HHS Capital HR systems and entered into the PET application. Additional PII comes from spreadsheets maintained by the Workforce Strategy and Performance Branch (WSPB). Types of PII include name, NIH badge number, Capital HR Employee ID, and start and separation dates of NIA employees and contractors.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose PII is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system. All PII in the system is queried from the NIH Enterprise Directory (NED) and HHS Capital HR systems and entered into the PET application.
Refer to the system of record notice 09-25-0216 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for a summary of the notice of uses of NED information.
Refer to the system of record notice 09-90-0018 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for a summary of the notice of uses of Capital HR information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls for Building 31 and the Gateway Building include: guards, identification badges, key cards and closed circuit TV. Technical controls for the server and PET applications include: user ID, passwords.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Publications Ordering System (NPOS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? Yes
If this is an existing PIA, please provide a reason for revision: -
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0005 ”Administration: Library Operations and NIH Library User I.D. File, HHS/NIH”
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA Publications Ordering System (NPOS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Karen Pocinki
10. Provide an overview of the system: The NIH NIA Publications Ordering System (NPOS) is a web application that enables the public to browse, search, and order NIA publications, all of which are free. The NPOS application features an online shopping cart and checkout. Publications can be browsed online by categories or viewed in the downloadable NIA Publications Catalog. Appointment and authority is given to the National Institutes of Health under Section 301 of the Public Health Service Act, describing the general powers and duties of the Public Health Service relating to research and investigation (42 U.S.C. 241).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0005 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0005.htm for the allowed disclosures of PII.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system stores sensitive data for publication orders. The information is used to support NIA processing of orders. PII in the system comprises name, mailing address, phone numbers, email address, job title, organization name, organization type, gender, and order number. Submission of personal information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify or obtain consent from the individuals whose PII is in the system regarding what information is being collected from them or when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
Refer to the system of record 09-25-0005 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0005.htm for a summary of uses of the information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: guards, identification badges, key cards and closed circuit TV.
Technical controls: user ID, passwords, firewall.
Administrative controls: files are backed up regularly, backups are stored offsite, user manuals, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 14, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Rodent Ordering System (ROS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: -
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0036 "Extramural Awards and Chartered Advisory Committees (IMPAC 2), Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH
5. OMB Information Collection Approval Number: none
6. Other Identifying Number(s): none
7. System Name (Align with system Item name): NIH NIA Rodent Ordering System (ROS)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Nancy Nadon
10. Provide an overview of the system: The NIA Rodent Ordering System (ROS) is a Web application that supports NIA’s program to make aged rodent colonies available to NIA grantees at academic and non-profit research institutions. The ROS enables NIA grantees to order aged rodents and related materials online. The system also supports NIA review and approval of orders and NIA aged rodent vendor processing of orders. However, the ROS doesn’t manage inventory or directly process orders or payments and only stores sensitive billing data for each order until that order is processed by a vendor. Although the ROS is linked from the NIA public Web, it is functionally independent from the NIA public Web site.
13. Indicate if the system is new or an existing one being modified: New
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the system of record 09-25-0036 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: The system stores sensitive billing data for each order until that order is processed by a vendor. The information is used to support NIA review and approval of orders and NIA aged rodent vendor processing of orders. PII in the system comprises name, mailing address, email address, telephone number, financial account information, grant and/or contract number, and unique user name. Submission of personal information is voluntary.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) notify and obtain consent from individuals regarding what PII is being collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]) No processes are in place to notify and obtain consent from the individuals whose PII is in the system when major changes, as defined in Section 208 of the E-Government Act of 2002, occur to the system.
When applying for grants, applicants are informed that personal information is collected for accurate identification, referral and review by grants program managers. Refer to the system of record 09-25-0036 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm, for a summary of the notice of uses of information.
32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII): Yes
37. Does the website have any information or pages directed at children under the age of thirteen?: -
50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN): -
54. Briefly describe in detail how the IIF will be secured on the system using administrative, technical, and physical controls.: Physical controls: Guards, Identification badges, key cards and closed circuit TV.
Technical controls: User ID, passwords, firewall.
Administrative controls: draft SSP, files are backed up regularly, user manuals, contract clauses ensuring adherence to privacy provisions and practices, least privilege through role-based access, and policies for retention and destruction of PII.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Melissa Fraczkowski
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: Aug 12, 2009
Approved for Web Publishing: -
Date Published: September 1, 2009
_____________________________________________________________________________
06.3 HHS PIA Summary for Posting (Form) / NIH NIA Status of Funds Internet Edition (SOFie)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: Aug 11, 2009
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: 009-25-01-09-02-3199-00
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN number is required for Q.4): 09-25-0217 "NIH Business System (NBS), HHS/NIH"
5. OMB Information Collection Approval Number: No
6. Other Identifying Number(s): No
7. System Name (Align with system Item name): NIH NIA Status of Funds Internet Edition (SOFie)
9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed: Robert Feaga
10. Provide an overview of the system: SOFie is a Web-based financial reporting/tracking tool that enables NIH ICs to manipulate and report on financial transactions downloaded from the Budget & Finance database in the NIH Data Warehouse. (The NIH DW Budget & Finance database comprises data downloaded from the NIH Business System.) Appointment and authority is given to the National Institutes of Health under 5 U.S.C. 301 and 302, 44 U.S.C. 3101 and 3102, Executive Order 9397.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?): Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21 must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s): No sharing or disclosures at this time. Refer to the Privacy Act systems notice 09-25-0217 section entitled ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES for the allowed disclosures of IIF.
30. Please describe in detail: (1) the information the agency will collect, maintain, or disseminate; (2) why and for what purpose the agency will use the information; (3) in this description, explicitly indicate whether the information contains PII; and (4) whether submission of personal information is voluntary or mandatory: Grantee and contractor (NIH grant recipient and contractor) personal information maintained comprises: name and financial account information. User (NIH employee) personal information maintained comprises: name, phone numbers, email addresses. NIA accounting transactions are downloaded from the Budget & Finance database in the NIH Data Warehouse. (The NIH DW Budget & Finance database comprises data downloaded from the NIH Business System.) The data is used to plan, track, and report on NIA fis |