HHS Home > OCIO Home > Capital Planning & Budget > Exhibit 300

Exhibit 300 (BY2010) - PHIN: BioSense

PART ONE

OVERVIEW

1. Date of Submission:: 2009-04-10

2. Agency:: 009

3. Bureau:: 20

4. Name of this Capital Asset:: CDC PHIN: BioSense

5. Unique Project Identifier:: 009-20-01-03-01-1163-00

6. What kind of investment will this be in FY2010?: Mixed Life Cycle

7. What was the first budget year this investment was submitted to OMB?: FY2004

8. Provide a brief summary and justification for this investment, including a brief description of how this closes in part or in whole an identified agency performance gap.: BioSense is a national program intended to improve the nation's capabilities for disease detection, monitoring, and near real-time health situational awareness. Routine public health (PH) surveillance and investigations involve the manual reporting of cases to PH agencies and phone calls to healthcare providers for more detailed patient chart information. In PH emergencies these methods can be slow and incomplete. BioSense is a CDC developed and hosted web-based system that accesses existing data from healthcare organizations across the country. BioSense surveillance methods use advanced algorithms for data analysis to address the needs of PH at all levels for identification, tracking, and management of naturally occurring and potential bioterrorism events. Today, BioSense is a working system that supports over 500 registered users and receives an average of 175,000 real-time messages per day from 530+ hospitals. Data are also received daily from approximately 1200 DoD and VA hospitals and healthcare facilities. Microbiology tests and results are received from two of the nation's largest commercial laboratories, LabCorp and Quest Diagnosis, and outpatient retail anti-infective prescription data are being received from Per-Se. While BioSense has achieved important successes, new approaches are needed for continued progress. The new BioSense strategy focuses on the development of local, state and national real time biosurveillance capabilities, enhancement of communications across all levels of the public health system and jurisdictions, and enhancement of linkages between public health and the clinical care system. The target is for BioSense to reflect the structure and operational realities of the public health system. Namely, the system should be a federation of national, state, and local components. Each organizational entity will retain control of its own data, and share this data on an aggregate level across jurisdictions. CDC will work with its stakeholders to develop the appropriate open source tools to enable this level of collaboration. The need for a national biosurveillance system remains critical to national security. With the advancement of both technology and PH informatics, CDC is leading the charge towards an integrated, open, and collaborative PH environment for biosurveillance. A new Alternatives Analysis was completed as part of the strategic planning process on 1/31/2009.

9. Did the Agency's Executive/Investment Committee approve this request?: yes

9.a. If "yes," what was the date of this approval?: 2008-07-11

10. Did the Project Manager review this Exhibit?: yes

11.a. What is the current FAC-P/PM certification level of the project/program manager?: Waiver Issued

11.b. When was the Program/Project Manager Assigned?: 2007-12-01

11.c. What date did the Program/Project Manager receive the FACP/PM certification? If the certification has not been issued, what is the anticipated date for certification?: 2009-07-31

12. Has the agency developed and/or promoted cost effective, energy-efficient and environmentally sustainable techniques or practices for this project.: yes

12.a. Will this investment include electronic assets (including computers)?: yes

12.b. Is this investment for new construction or major retrofit of a Federal building or facility? (answer applicable to non-IT assets only): no

13. Does this investment directly support one of the PMA initiatives?: yes

If yes, select the initiatives that apply:

Initiative Name
Expanded E-Government

13.a. Briefly and specifically describe for each selected how this asset directly supports the identified initiative(s)? (e.g. If E-Gov is selected, is it an approved shared service provider or the managing partner?): BioSense is a web-based system that was architected to provide states and local health departments a national repository for visualizing real-time situational awareness thus creating a single point of access to Biosurveillance aggregated data. This single access point allows public health and healthcare professionals direct retrieval of healthcare data, reducing the need for redundant reporting and streamlining the manual efforts of the public and government entities that own the data.

14. Does this investment support a program assessed using the Program Assessment Rating Tool (PART)?: yes

14.a. If yes, does this investment address a weakness found during the PART review?: yes

14.b. If yes, what is the name of the PARTed program?: 10003541 - Bioterrorism: Biosurveillance

14.c. If yes, what rating did the PART receive?: Results Not Demostrated

15. Is this investment for information technology?: yes

16. What is the level of the IT Project (per CIO Council's PM Guidance)?: Level 3

17. What project management qualifications does the Project Manager have? (per CIO Council's PM Guidance): (1) Project manager has been validated as qualified for this investment

18. Is this investment identified as high risk on the Q4 - FY 2007 agency high risk report (per OMB memorandum M-05-23)?: yes

19. Is this a financial management system?: no

19.a.2. If no, what does it address?: BioSurveillance

20. What is the percentage breakout for the total FY2009 funding request for the following? (This should total 100%)

Area	Percentage
Hardware	10
Software	5
Services	80
Other	5

21. If this project produces information dissemination products for the public, are these products published to the Internet in conformance with OMB Memorandum 05-04 and included in your agency inventory, schedules and priorities?: no

22. Contact information of individual responsible for privacy related questions.

Name	Felicia Kittles
Phone Number	770.488.8919
Title	IT Security Project Manager
Email	ice8@cdc.gov

23. Are the records produced by this investment appropriately scheduled with the National Archives and Records Administration's approval?: yes

24. Does this investment directly support one of the GAO High Risk Areas?: no

SUMMARY OF SPEND

1. Provide the total estimated life-cycle cost for this investment by completing the following table. All amounts represent budget authority in millions, and are rounded to three decimal places. Federal personnel costs should be included only in the row designated Government FTE Cost, and should be excluded from the amounts shown for Planning, Full Acquisition, and Operation/Maintenance. The total estimated annual cost of the investment is the sum of costs for Planning, Full Acquisition, and Operation/Maintenance. For Federal buildings and facilities, life-cycle costs should include long term energy, environmental, decommissioning, and/or restoration costs. The costs associated with the entire life-cycle of the investment should be included in this report. All amounts represent Budget Authority Note: For the cross-agency investments, this table should include all funding (both managing partner and partner agencies). Government FTE Costs should not be included as part of the TOTAL represented.

Cost Type	Py-1 & Earlier -2007	PY 2008	CY 2009	BY 2010
Planning Budgetary Resources	0.300	0.000	0.000	0.000
Acquisition Budgetary Resources	133.650	19.805	16.832	28.300
Maintenance Budgetary Resources	4.880	2.400	4.548	2.400
Government FTE Cost	10.070	6.000	2.840	6.000
# of FTEs	45	45	25	45

2. Will this project require the agency to hire additional FTE's?: yes

2.a. If "yes," how many and in what year?: In 2007 this investment had 30 FTEs, an additional 4 have been hired bringing the total to 34 as of 03/31/08. Leadership believes the current need for the remainder of '09 is to hire an additional 10-11 FTEs bringing the total up to 45. The Summary of Spending indicated 45 FTE positions by the end of 2010 and through 2013. The BioSense leadership believes this staffing level will yield the highest return on investment and allow for efficient development and operations.

3. If the summary of spending has changed from the FY2008 President's budget request, briefly explain those changes.: The total investment funding for 2009 continued at approximately the same amount as in FY 2008. However, it had to be distributed between intramural and extramural. This effectively decreased the intramural funding to the level as indicated in the Summary of Spending table above. The intramural investment funding for 2008 has been decreased by $8.5 Million as a result of final FY 2008 appropriations. The total investment decrease from plan was $19.9 Million (From $49.094M to 29.137M, including extramural), with the remaining decrease effecting the extramural business case. A replanning effort is underway to determine the change of scope that is required due to the funding decrease and the Milestone table will be updated with the new scope. Note, total milestone cost and schedule table and the Summary of Spending are not in balance at this time due to final appropriation for FY 2008 resulting in a decrease in funding level.

PERFORMANCE

In order to successfully address this area of the exhibit 300, performance goals must be provided for the agency and be linked to the annual performance plan. The investment must discuss the agency's mission and strategic goals, and performance measures (indicators) must be provided. These goals need to map to the gap in the agency's strategic goals and objectives this investment is designed to fill. They are the internal and external performance benefits this investment is expected to deliver to the agency (e.g., improve efficiency by 60 percent, increase citizen participation by 300 percent a year to achieve an overall citizen participation rate of 75 percent by FY 2xxx, etc.). The goals must be clearly measurable investment outcomes, and if applicable, investment outputs. They do not include the completion date of the module, milestones, or investment, or general goals, such as, significant, better, improved that do not have a quantitative measure.

Agencies must use the following table to report performance goals and measures for the major investment and use the Federal Enterprise Architecture (FEA) Performance Reference Model (PRM). Map all Measurement Indicators to the corresponding Measurement Area and Measurement Grouping identified in the PRM. There should be at least one Measurement Indicator for each of the four different Measurement Areas (for each fiscal year). The PRM is available at www.egov.gov. The table can be extended to include performance measures for years beyond FY 2009.

Row	Fiscal Year	Strategic Goal Supported	Measurement Area	Measurement Grouping	Measurement Indicator	Baseline	Planned Improvement to the Baseline	Actual Results
1	2006	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to the early detection and quantification of possible bioterrorism events.	30,143,598 records	Increase by 10% over the previous year's volume the number of health interactions related to the early detection and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	As of April 2006: Achieved more than 20% over the previous year's volume
2	2006	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	TBD	33% of State and local public health agencies in key jurisdictions have access to BioSense data	March 2007: 124 public health jurisdictions had access to BioSense data
3	2006	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	7 data sources	CDC acquires sources from 8 potential data sources	Sept 2006: 46 real time data sources and 466 DoD and 863 VA healthcare facilities sending data to BioSense
4	2006	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	Data completeness varies by Source from 2-4 days	BioSense data is updated within 24 hours of receipt from data providers	Sept 2006: Average 2.81 hours from "Time of Visit" to "Viewable in BioSense application" for real time data sources
5	2007	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	2.81 hours from "Time of Visit" to "Viewable in BioSense application"	No more than 2 hours from "Time of Visit" to "Viewable in BioSense application"	Due to the addition of new patient classes and data types to BioSense, average hours from "Time of Visit" to "Viewable in BioSense Application" have increased to 4.7. New Hardware has since been implemented that will increase processing ability.
6	2007	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to early detection and quantification of possible bioterrorism events.	36 million records	Increase by 10% over the previous year's volume the number of health interactions related to the early detection and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	147,406,021 health interactions were reported in key jurisdictions in FY 2007.
7	2007	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of eligible customer services	50% of State and local public health agencies in key jurisdictions have to access BioSense data	75% of State and local public health agencies in key jurisdictions have to access BioSense data	July 2007: 137 public health jurisdictions had access to BioSense data.
8	2007	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	11 data sources and 39 hospitals sending foundational data	CDC acquires sources from 60 potential data sources and 1100 hospitals	Aug 2007: 357 real time data sources, 466 DoD and 863 VA healthcare facilities and 2 special data sources for a total of 1688 data sources sending data to BioSense
9	2008	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	147.4 million records	Increase by 10% over the previous year's volume the number of health interactions related to situational awareness and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	9/08: 190,892,510 health interactions were reported in key jurisdictions for FY2008, an increase of 29.5% from FY2007
10	2008	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	50% of State and local public health agencies in key jurisdictions have to access BioSense data	75% of State and local public health agencies in key jurisdictions have to access BioSense data	9/08: 121 jurisdictions accessed BioSense. As focus shifts to building state & local biosurveillance capacity, users may reduce temporarily. Strategic planning efforts will increase jurisdictions by providing an infrastructure to publish & view data
11	2008	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	11 data sources and 39 hospitals sending foundational data	CDC acquires sources from 100 potential data sources and 1100 hospitals	9/08: 551 RT, 466 DoD, 863 VA healthcare facilities & 2 national data sources (total: 1864). Moving forward, increasing coverage will be obtained by building biosurveillance capacity at state & local PH departments
12	2008	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	4.7 hours from "Time of Visit" to "Viewable in BioSense application"	No more than 2 hours from "Time of Visit" to "Viewable in BioSense application	9/08: Since adding new patient classes and data types to BioSense, average hrs from "Time of Visit" to "Viewable in BioSense Application" have increased to 4.7. New h/w is being implemented with the capability to increase processing ability.
13	2009	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	162.1 million records	Increase by 10% over the previous year's volume the number of health interactions related to situational awareness and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	TBD
14	2009	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	50% of State and local public health agencies in key jurisdictions have to access BioSense data	75% of State and local public health agencies in key jurisdictions have to access BioSense data	3/09: 121 jurisdictions accessed BioSense. As focus shifts to building state & local biosurveillance capacity, users may reduce temporarily. Strategic planning efforts will increase jurisdictions by providing an infrastructure to publish & view data
15	2009	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	TBD	CDC acquires sources from 200 potential data sources and 3200 hospitals and shares data with existing State and Local agencies and HIE partners.	3/09: 551 RT, 466 DoD, 863 VA healthcare facilities & 2 national data sources (total: 1864).
16	2009	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	TBD	No more than 2 hours from "Time of Visit" to "Viewable in BioSense application	TBD
17	2010	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	TBD	Increase by 10% over the previous year's volume the number of health interactions related to situational awareness and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	TBD
18	2010	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	TBD	75% of State and local public health agencies in key jurisdictions have to access BioSense data	TBD
19	2010	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	TBD	CDC acquires sources from 50 potential data sources and	TBD
20	2010	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	TBD	No more than 2 hours from "Time of Visit" to "Viewable in BioSense application	TBD
21	2011	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	TBD	Increase by 10% over the previous year's volume the number of health interactions related to situational awareness and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	TBD
22	2011	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	TBD	80% of State and local public health agencies in key jurisdictions have to access BioSense data	TBD
23	2011	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	TBD	CDC acquires sources from 18 potential data sources	TBD
24	2011	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	TBD	No more than 2 hours from "Time of Visit" to "Viewable in BioSense application	TBD
25	2012	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	TBD	Increase by 10% over the previous year's volume the number of health interactions related to situational awareness and quantification of possible bioterrorism events that are made available for analysis to local, state, federal public health agencies	TBD
26	2012	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	TBD	88% of State and local public health agencies in key jurisdictions have to access BioSense data	TBD
27	2012	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	TBD	CDC acquires sources from 22 potential data sources	TBD
28	2012	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	TBD	No more than 2 hours from "Time of Visit" to "Viewable in BioSense application	TBD
29	2013	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	TBD	TBD	TBD
30	2013	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	TBD	TBD	TBD
31	2013	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	TBD	TBD	TBD
32	2013	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	TBD	TBD	TBD
33	2014	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Mission and Business Results	Population Health Management and Consumer Safety	# of health interactions in key jurisdictions related to situational awareness and quantification of possible bioterrorism events.	TBD	TBD	TBD
34	2014	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Customer Results	New Customers and Market Penetration	% of state and local Public Health Department's serviced in key jurisdictions	TBD	TBD	TBD
35	2014	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Technology	External Data Sharing	# of data sources	TBD	TBD	TBD
36	2014	S.O. 2.4 - Prepare for and respond to natural and man-made disasters	Processes and Activities	Cycle Time	Time required to update BioSense data	TBD	TBD	TBD

Enterprise Architecture

In order to successfully address this area of the business case and capital asset plan you must ensure the investment is included in the agency's EA and Capital Planning and Investment Control (CPIC) process, and is mapped to and supports the FEA. You must also ensure the business case demonstrates the relationship between the investment and the business, performance, data, services, application, and technology layers of the agency's EA.

1. Is this investment included in your agency's target enterprise architecture?: yes

2. Is this investment included in the agency's EA Transition Strategy?: yes

2.a. If yes, provide the investment name as identified in the Transition Strategy provided in the agency's most recent annual EA Assessment.: CDC PHIN: BioSense

3. Is this investment identified in a completed (contains a target architecture) and approved segment architecture?: no

4. Identify the service components funded by this major IT investment (e.g., knowledge management, content management, customer relationship management, etc.). Provide this information in the format of the following table. For detailed guidance regarding components, please refer to http://www.whitehouse.gov/omb/egov/. Component: Use existing SRM Components or identify as NEW. A NEW component is one not already identified as a service component in the FEA SRM. Reused Name and UPI: A reused component is one being funded by another investment, but being used by this investment. Rather than answer yes or no, identify the reused service component funded by the other investment and identify the other investment using the Unique Project Identifier (UPI) code from the OMB Ex 300 or Ex 53 submission. Internal or External Reuse?: Internal reuse is within an agency. For example, one agency within a department is reusing a service component provided by another agency within the same department. External reuse is one agency within a department reusing a service component provided by another agency in another department. A good example of this is an E-Gov initiative service being reused by multiple organizations across the federal government. Funding Percentage: Please provide the percentage of the BY requested funding amount used for each service component listed in the table. If external, provide the funding level transferred to another agency to pay for the service.

Row	Agency Component Name	Agency Component Description	Service Type	Component	Internal or External Reuse?	Funding %
1	BioSense (1163)	An initiative to significantly improve the nation's capabilities for early detection of a bioterrorism event in the US through public health surveillance activities focused on prediagnostic indicators of disease in population through syndromic surveillance.	Knowledge Discovery	Data Mining	No Reuse	20
2	BioSense (1163)	An initiative to significantly improve the nation's capabilities for early detection of a bioterrorism event in the US through public health surveillance activities focused on prediagnostic indicators of disease in population through syndromic surveillance.	Analysis and Statistics	Mathematical	No Reuse	25
3	BioSense (1163)	An initiative to significantly improve the nation's capabilities for early detection of a bioterrorism event in the US through public health surveillance activities focused on prediagnostic indicators of disease in population through syndromic surveillance.	Reporting	Ad Hoc	No Reuse	10
4	BioSense (1163)	An initiative to significantly improve the nation's capabilities for early detection of a bioterrorism event in the US through public health surveillance activities focused on prediagnostic indicators of disease in population through syndromic surveillance.	Knowledge Discovery	Modeling	No Reuse	20
5	BioSense (1163)	An initiative to significantly improve the nation's capabilities for early detection of a bioterrorism event in the US through public health surveillance activities focused on prediagnostic indicators of disease in population through syndromic surveillance.	Reporting	Standardized / Canned	No Reuse	25

5. To demonstrate how this major IT investment aligns with the FEA Technical Reference Model (TRM), please list the Service Areas, Categories, Standards, and Service Specifications supporting this IT investment. FEA SRM Component: Service Components identified in the previous question should be entered in this column. Please enter multiple rows for FEA SRM Components supported by multiple TRM Service Specifications. Service Specification: In the Service Specification field, Agencies should provide information on the specified technical standard or vendor product mapped to the FEA TRM Service Standard, including model or version numbers, as appropriate.

Row	SRM Component	>Service Area	Service Category	Service Standard	Service Specification (i.e., vendor and product name)
1	Data Mining	Component Framework	Data Interchange	Data Exchange	Electronic Business using XML by: Organization for the Advancement of Structured Information Standards
2	Data Mining	Service Access and Delivery	Service Transport	Supporting Network Services	T3 Carrier by: ANSI
3	Data Mining	Service Access and Delivery	Service Transport	Supporting Network Services	T1 Carrier by: ANSI
4	Data Mining	Component Framework	Security	Certificates / Digital Signatures	VeriSign SSL Certificates by: Verisign
5	Data Mining	Service Interface and Integration	Interoperability	Data Format / Classification	Health Level 7 (HL7) by: Health Level Seven, Inc.
6	Data Mining	Service Interface and Integration	Interoperability	Data Format / Classification	HITSP IS02 Biosurveillance by: American National Standards Institute (ANSI)
7	Data Mining	Service Interface and Integration	Interoperability	Data Format / Classification	Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) by: International Health Terminology Standards Development Organisation
8	Data Mining	Service Interface and Integration	Interoperability	Data Transformation	Informatica by: Informatica Corporation
9	Data Mining	Service Interface and Integration	Interoperability	Data Format / Classification	International Classification of Diseases by: World Health Organization
10	Data Mining	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Synchronous Optical Networking by: ANSI
11	Data Mining	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer 6.0 by: Microsoft Corporation
12	Data Mining	Service Interface and Integration	Interoperability	Data Format / Classification	Logical Observation Identifier Names and Codes by: Regenstrief Institute, Inc
13	Mathematical	Component Framework	Data Interchange	Data Exchange	Electronic Business using XML by: Organization for the Advancement of Structured Information Standards
14	Mathematical	Service Access and Delivery	Service Transport	Supporting Network Services	T3 Carrier by: ANSI
15	Mathematical	Service Access and Delivery	Service Transport	Supporting Network Services	T1 Carrier by: ANSI
16	Mathematical	Component Framework	Security	Certificates / Digital Signatures	VeriSign SSL Certificates by: Verisign
17	Mathematical	Service Interface and Integration	Interoperability	Data Format / Classification	Health Level 7 (HL7) by: Health Level Seven, Inc.
18	Mathematical	Service Interface and Integration	Interoperability	Data Format / Classification	HITSP IS02 Biosurveillance by: American National Standards Institute (ANSI)
19	Mathematical	Service Interface and Integration	Interoperability	Data Format / Classification	Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) by: International Health Terminology Standards Development Organisation
20	Mathematical	Service Interface and Integration	Interoperability	Data Transformation	Informatica by: Informatica Corporation
21	Mathematical	Service Interface and Integration	Interoperability	Data Format / Classification	International Classification of Diseases by: World Health Organization
22	Mathematical	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Synchronous Optical Networking by: ANSI
23	Mathematical	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer 6.0 by: Microsoft Corporation
24	Mathematical	Service Interface and Integration	Interoperability	Data Format / Classification	Logical Observation Identifier Names and Codes by: Regenstrief Institute, Inc
25	Ad Hoc	Service Access and Delivery	Service Transport	Supporting Network Services	T1 Carrier by: ANSI
26	Ad Hoc	Component Framework	Security	Certificates / Digital Signatures	VeriSign SSL Certificates by: Verisign
27	Ad Hoc	Service Interface and Integration	Interoperability	Data Format / Classification	Health Level 7 (HL7) by: Health Level Seven, Inc.
28	Ad Hoc	Service Interface and Integration	Interoperability	Data Format / Classification	HITSP IS02 Biosurveillance by: American National Standards Institute (ANSI)
29	Ad Hoc	Service Interface and Integration	Interoperability	Data Format / Classification	Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) by: International Health Terminology Standards Development Organisation
30	Ad Hoc	Service Access and Delivery	Service Transport	Supporting Network Services	T3 Carrier by: ANSI
31	Ad Hoc	Service Interface and Integration	Interoperability	Data Transformation	Informatica by: Informatica Corporation
32	Ad Hoc	Component Framework	Data Interchange	Data Exchange	Electronic Business using XML by: Organization for the Advancement of Structured Information Standards
33	Ad Hoc	Service Interface and Integration	Interoperability	Data Format / Classification	International Classification of Diseases by: World Health Organization
34	Ad Hoc	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Synchronous Optical Networking by: ANSI
35	Ad Hoc	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer 6.0 by: Microsoft Corporation
36	Ad Hoc	Service Interface and Integration	Interoperability	Data Format / Classification	Logical Observation Identifier Names and Codes by: Regenstrief Institute, Inc
37	Modeling	Service Interface and Integration	Interoperability	Data Format / Classification	HITSP IS02 Biosurveillance by: American National Standards Institute (ANSI)
38	Modeling	Component Framework	Security	Certificates / Digital Signatures	VeriSign SSL Certificates by: Verisign
39	Modeling	Service Access and Delivery	Service Transport	Supporting Network Services	T3 Carrier by: ANSI
40	Modeling	Service Interface and Integration	Interoperability	Data Format / Classification	Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) by: International Health Terminology Standards Development Organisation
41	Modeling	Service Interface and Integration	Interoperability	Data Format / Classification	Logical Observation Identifier Names and Codes by: Regenstrief Institute, Inc
42	Modeling	Component Framework	Data Interchange	Data Exchange	Electronic Business using XML by: Organization for the Advancement of Structured Information Standards
43	Modeling	Service Interface and Integration	Interoperability	Data Transformation	Informatica by: Informatica Corporation
44	Modeling	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Synchronous Optical Networking by: ANSI
45	Modeling	Service Interface and Integration	Interoperability	Data Format / Classification	International Classification of Diseases by: World Health Organization
46	Modeling	Service Access and Delivery	Service Transport	Supporting Network Services	T1 Carrier by: ANSI
47	Modeling	Service Interface and Integration	Interoperability	Data Format / Classification	Health Level 7 (HL7) by: Health Level Seven, Inc.
48	Modeling	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer 6.0 by: Microsoft Corporation
49	Standardized / Canned	Service Interface and Integration	Interoperability	Data Format / Classification	HITSP IS02 Biosurveillance by: American National Standards Institute (ANSI)
50	Standardized / Canned	Component Framework	Security	Certificates / Digital Signatures	VeriSign SSL Certificates by: Verisign
51	Standardized / Canned	Service Access and Delivery	Service Transport	Supporting Network Services	T3 Carrier by: ANSI
52	Standardized / Canned	Service Interface and Integration	Interoperability	Data Format / Classification	Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) by: International Health Terminology Standards Development Organisation
53	Standardized / Canned	Service Interface and Integration	Interoperability	Data Format / Classification	Logical Observation Identifier Names and Codes by: Regenstrief Institute, Inc
54	Standardized / Canned	Component Framework	Data Interchange	Data Exchange	Electronic Business using XML by: Organization for the Advancement of Structured Information Standards
55	Standardized / Canned	Service Interface and Integration	Interoperability	Data Transformation	Informatica by: Informatica Corporation
56	Standardized / Canned	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Synchronous Optical Networking by: ANSI
57	Standardized / Canned	Service Interface and Integration	Interoperability	Data Format / Classification	International Classification of Diseases by: World Health Organization
58	Standardized / Canned	Service Access and Delivery	Service Transport	Supporting Network Services	T1 Carrier by: ANSI
59	Standardized / Canned	Service Interface and Integration	Interoperability	Data Format / Classification	Health Level 7 (HL7) by: Health Level Seven, Inc.
60	Standardized / Canned	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer 6.0 by: Microsoft Corporation

6. Will the application leverage existing components and/or applications across the Government (i.e., FirstGov, Pay.Gov, etc)?: yes

6.a. If yes, please describe.: Optimal use of government funds is achieved by sharing CDC IT Infrastructure, CDC Secure Data Network (SDN) and PHIN Vocabulary Services. BioSense receives and displays data from BioWatch, the bioterroism detection system funded and administered by the Department of Homeland Security, with participation from CDC, EPA, and FBI. The received BioWatch data is Intra-agency data.

PART TWO

RISK

You should perform a risk assessment during the early planning and initial concept phase of the investment's life-cycle, develop a risk-adjusted life-cycle cost estimate and a plan to eliminate, mitigate or manage risk, and be actively managing risk throughout the investment's life-cycle.

Answer the following questions to describe how you are managing investment risks.

1. Does the investment have a Risk Management Plan?: yes

1.a. If yes, what is the date of the plan?: 2008-01-15

1.b. Has the Risk Management Plan been significantly changed since last year's submission to OMB?: yes

1.c. If yes, describe any significant changes:: BioSense underwent an Independent Verification and Validation (IV&V) assessment in order to ensure the chosen architecture and implementation approach is in alignment with industry best practices. This assessment began in May 2006 with the intent to do a thorough review of all aspects of the BioSense technical architecture, platform and operations. The study provided strengths and weaknesses as well recommendations to CDC on refining the vision, establishing goals, outcomes and performance metrics for BioSense. As a result of the IV&V, an updated risk management plan was implemented in September 2006. This risk management plan was reviewed and updated in January 2008.

3. Briefly describe how investment risks are reflected in the life cycle cost estimate and investment schedule:: The BioSense scope and budget planning using a work breakdown structure technique that decomposes each work element into its fundamental components. Each component is evaluated based on a risk assessment and the appropriate level of funding is assigned based on the work element's risk value. The budget for each element is derived based on the most likely scenario that has been risk adjusted. The total of each element comprises the full budget for BioSense. BioSense reviews its risks on a weekly basis and evaluates any potential changes to the budget plan.

COST & SCHEDULE

1. Does the earned value management system meet the criteria in ANSI/EIA Standard 748?: no

2. Is the CV% or SV% greater than ± 10%?: no

3. Has the investment re-baselined during the past fiscal year?: no