Exhibit 300 (BY2010) for FDA Information and Computing Technologies for the 21st Century (ICT21)

1. Date of Submission:

2008-09-08

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Information and Computing Technologies for the 21st Century (ICT21)

5. Unique Project Identifier:

009-10-01-03-01-0031-00

6. What kind of investment will this be in FY2010?

Full-Acquisition

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

FY2009

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.

Development of new information technologies, driven by accelerating computational processing & substantial growth in data volume, is causing transformation to all aspects of the FDA operations. New types & vastly larger quantities of data to be processed by the FDA, from multiple clinical & diagnostic endpoints from industry submissions & collaborations with other research sources, reuse of existing data within & among the FDA centers & other government agencies (i.e. NIH, CMS, CDC, VA, DoD, etc.), & outside entities including foreign countries, are examples of the complexity & number of information sources the FDA handles today. The number of sources & data elements increases as the need for complex inputs for safety evidence & efficacy information, genomics, metabolic network & clinical trials modeling, data markers type data, integrated data & networks, & food imports expands. The FDA is increasing its use of electronic health records data to acquire pertinent information for its pharmacovigilance efforts causing expanded participation in programs & initiatives to define of the records standards & networks to assure appropriate data are gathered for use in such activities as safety & efficacy, & genomics & data markers. To meet these challenges, the FDA is modernizing its capacity & communication capabilities by creating an agency-wide bioinformatics IT platform. The ICT21 Initiative designs & builds this purpose driven, data centric environment for the FDA. The imitative increases the Agency's capabilities to: respond to emerging technologies & challenges, strengthen product development & approval, improve manufacturing & product quality, strengthen post-approval surveillance & safety, support electronic prescribing, & improve clinical decision making. Results are achieved by collecting & combining clinical & other important & pertinent data from industry, government agencies & outside entities into integrated databases & networks to expand the scientific computations & computational sciences at the FDA. The FDA continues to widen the use of analytics for large datasets which integrate multiple clinical & diagnostic endpoints, through increased use of clustering & grid computing to improve collaboration among & within entities interacting with the FDA. The new ICT21 bioinformatics platform supports the FDA's growing mission within 2-10 years & the PMA goal-Expanded e-Government - Disaster Management, & the DHHS goal of increasing scientific R&D.

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

yes

9.a. If "yes," what was the date of this approval?

2008-07-21

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?

2008-02-11

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?)

This investment directly supports the Expanded Electronic Government PMA goal - Disaster Management Initiative by improving FDA's safety response through improved interoperable data communications and information sharing as well as continuity of critical operations.

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

no

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?

Establishment of a new bioinformatics and scientific computational sciences IT computing platform.

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

Area	Percentage
Hardware	0
Software	0
Services	93
Other	7

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?

n/a

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

Name	Fred Sadler
Phone Number	301-827-6567
Title	FDA Privacy Act Officer
Email	frederick.sadler@fda.hhs.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

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	0.000	6.356	16.400	2.252
Acquisition Budgetary Resources	0.000	17.644	68.028	15.791
Maintenance Budgetary Resources	0.000	0.000	16.750	5.000
Government FTE Cost	0.000	0.480	0.916	0.959
# of FTEs	2	4	4	4

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

no

3. If the summary of spending has changed from the FY2008 President's budget request, briefly explain those changes.

Funding is increased by P.L. 110-252, the "Supplemental Appropriations Act, 2008", signed into law on June 30, 2008. The appropriation increases the budget authority for increasing food protection, enhancing the safety of drugs, medical devices and biologics, and boosting the strength of the agency's workforce. Due to the short time between receiving the appropriation and submitting the FY2010 President's Budget Request, a full impact analysis is not complete. Once the analysis is complete, the Business Case will be updated to reflect the additional funding.

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	2008	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Mission and Business Results	Scientific and Technological Research and Innovation	% of Bioinformatics platform requirements and design documented and approved.	25%	100%	100%
2	2008	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Service Availability	% of Bioinformatics customer availability requirements documented.	25%	95%	95%
3	2008	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of external Bioinformatics collaboration opportunities identified.	0	2	2
4	2008	S.O. 4.4 - Communicate and transfer research results into clinical, public health and human services practice	Technology	Data Standardization or Tagging	% of electronic safety reports for FDA regulated products utilizing HL7 individual case safety report.	10%	25%	25%
5	2009	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Mission and Business Results	Scientific and Technological Research and Innovation	% of Bioinformatics platform phase 1 migration complete.	0%	100%	0%
6	2009	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Service Availability	% of electronic Product Safety information available	5%	20%	0%
7	2009	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of Bioinformatics collaboration internal initiatives piloted	0	2	0
8	2009	S.O. 4.4 - Communicate and transfer research results into clinical, public health and human services practice	Technology	Data Standardization or Tagging	% of electronic safety reports for FDA regulated products utilizing HL7 individual case safety report.	25%	50%	0%
9	2010	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Mission and Business Results	Scientific and Technological Research and Innovation	% of Bioinformatics platform phase 2 migration complete.	10%	100%	0%
10	2010	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Service Availability	% of electronic Product Safety information available	20%	60%	0%
11	2010	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of Bioinformatics collaboration external initiatives piloted	0	2	0
12	2010	S.O. 4.4 - Communicate and transfer research results into clinical, public health and human services practice	Technology	Data Standardization or Tagging	% of electronic safety reports for FDA regulated products utilizing HL7 individual case safety report.	50%	75%	0%
13	2011	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Mission and Business Results	Scientific and Technological Research and Innovation	% of Bioinformatics platform phase 3 migration complete.	30%	100%	0%
14	2011	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Service Availability	% of electronic Product Safety information available	60%	95%	0%
15	2011	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of Bioinformatics collaboration internal and external initiatives in production.	0	4	0
16	2011	S.O. 4.4 - Communicate and transfer research results into clinical, public health and human services practice	Technology	Data Standardization or Tagging	% of electronic safety reports for FDA regulated products utilizing HL7 individual case safety report.	75%	95%	0%

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.

FDA Information and Computer Technologies for the 21st Century (ICT21)

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	Reused Component Name	Reused UPI	Internal or External Reuse?	Funding %
1	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Data Management	Data Cleansing			No Reuse	5
2	Disaster Recovery	Establish a disaster recovery plan and strategy that is executable in FDA's environment. Because of the composition, complexity, and age of the infrastructure, and the design of our applications, a disaster recovery capability is not feasible or affordable. This project will take advantage of the ITX Program to develop a disaster recovery capability	Security Management	Intrusion Detection			No Reuse	4
3	Disaster Recovery	Establish a disaster recovery plan and strategy that is executable in FDA's environment. Because of the composition, complexity, and age of the infrastructure, and the design of our applications, a disaster recovery capability is not feasible or affordable. This project will take advantage of the ITX Program to develop a disaster recovery capability	Knowledge Management	Information Sharing			No Reuse	4
4	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Data Management	Extraction and Transformation			No Reuse	5
5	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Data Management	Data Classification			No Reuse	5
6	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Systems Management	System Resource Monitoring			No Reuse	5
7	Disaster Recovery	Establish a disaster recovery plan and strategy that is executable in FDA's environment. Because of the composition, complexity, and age of the infrastructure, and the design of our applications, a disaster recovery capability is not feasible or affordable. This project will take advantage of the ITX Program to develop a disaster recovery capability	Asset / Materials Management	Facilities Management			No Reuse	4
8	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Management of Processes	Governance / Policy Management			No Reuse	4
9	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Development and Integration	Legacy Integration			No Reuse	5
10	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Development and Integration	Data Integration			No Reuse	5
11	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Management of Processes	Configuration Management			No Reuse	5
12	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Development and Integration	Enterprise Application Integration			No Reuse	5
13	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Communication	Community Management			No Reuse	4
14	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Data Management	Data Exchange			No Reuse	4
15	Disaster Recovery	Establish a disaster recovery plan and strategy that is executable in FDA's environment. Because of the composition, complexity, and age of the infrastructure, and the design of our applications, a disaster recovery capability is not feasible or affordable. This project will take advantage of the ITX Program to develop a disaster recovery capability	Data Management	Data Exchange			No Reuse	4
16	Disaster Recovery	Establish a disaster recovery plan and strategy that is executable in FDA's environment. Because of the composition, complexity, and age of the infrastructure, and the design of our applications, a disaster recovery capability is not feasible or affordable. This project will take advantage of the ITX Program to develop a disaster recovery capability	Security Management	Incident Response			No Reuse	4
17	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Data Management	Data Warehouse			No Reuse	5
18	Disaster Recovery	Establish a disaster recovery plan and strategy that is executable in FDA's environment. Because of the composition, complexity, and age of the infrastructure, and the design of our applications, a disaster recovery capability is not feasible or affordable. This project will take advantage of the ITX Program to develop a disaster recovery capability	Security Management	Intrusion Prevention			No Reuse	4
19	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Knowledge Management	Information Retrieval			No Reuse	5
20	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Document Management	Indexing			No Reuse	5
21	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Search	Query			No Reuse	4
22	Bioinformatics Platform	FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services through this agency-wide bioinformatics initiative to fulfill its core public health responsibilities and respond to emerging challenges.	Knowledge Management	Information Sharing			No Reuse	5

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 Cleansing	Service Interface and Integration	Integration	Middleware	Structured Query Language by: International Organization for Standardization
2	Intrusion Detection	Service Platform and Infrastructure	Database / Storage	Storage	Veritas NetBackup by: Symantec Corporation
3	Information Sharing	Service Platform and Infrastructure	Database / Storage	Storage	Veritas NetBackup by: Symantec Corporation
4	Extraction and Transformation	Service Access and Delivery	Access Channels	Web Browser	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
5	Extraction and Transformation	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
6	Extraction and Transformation	Component Framework	Data Management	Reporting and Analysis	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
7	Extraction and Transformation	Service Interface and Integration	Integration	Enterprise Application Integration	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
8	Data Classification	Service Interface and Integration	Interoperability	Data Format / Classification	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
9	Data Classification	Component Framework	Data Management	Reporting and Analysis	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
10	System Resource Monitoring	Service Interface and Integration	Integration	Enterprise Application Integration	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
11	System Resource Monitoring	Component Framework	Data Management	Reporting and Analysis	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
12	Facilities Management	Service Access and Delivery	Access Channels	Web Browser	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
13	Facilities Management	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
14	Governance / Policy Management	Service Access and Delivery	Access Channels	Web Browser	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
15	Governance / Policy Management	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
16	Legacy Integration	Service Interface and Integration	Integration	Enterprise Application Integration	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
17	Legacy Integration	Component Framework	Data Management	Reporting and Analysis	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
18	Data Integration	Service Platform and Infrastructure	Database / Storage	Database	Structured Query Language by: International Organization for Standardization
19	Configuration Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Windows by: Microsoft Corporation
20	Configuration Management	Component Framework	Data Management	Reporting and Analysis	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
21	Configuration Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris 10 by: Sun Microsystems, Inc.
22	Configuration Management	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
23	Enterprise Application Integration	Service Interface and Integration	Integration	Enterprise Application Integration	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
24	Community Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris 10 by: Sun Microsystems, Inc.
25	Community Management	Component Framework	Data Management	Reporting and Analysis	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
26	Community Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Windows by: Microsoft Corporation
27	Community Management	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
28	Data Exchange	Component Framework	Data Interchange	Data Exchange	SOAP by: World Wide Web Consortium
29	Incident Response	Service Access and Delivery	Access Channels	Web Browser	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
30	Incident Response	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
31	Data Warehouse	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
32	Data Warehouse	Component Framework	Data Management	Reporting and Analysis	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
33	Intrusion Prevention	Service Platform and Infrastructure	Database / Storage	Storage	Veritas NetBackup by: Symantec Corporation
34	Information Retrieval	Service Platform and Infrastructure	Database / Storage	Storage	Veritas NetBackup by: Symantec Corporation
35	Indexing	Service Interface and Integration	Integration	Middleware	Structured Query Language by: International Organization for Standardization
36	Indexing	Service Platform and Infrastructure	Database / Storage	Database	Structured Query Language by: International Organization for Standardization
37	Query	Service Interface and Integration	Integration	Middleware	Structured Query Language by: International Organization for Standardization
38	Query	Service Platform and Infrastructure	Database / Storage	Database	Structured Query Language by: International Organization for Standardization

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.

Obtain and share clinical data with DHHS-CMS, VA and DoD-Medical, share clinical trial data with DHHS-CDC, and collaborate with DHS/CBP to receive prior notice submissions for imports, including foods. Interact frequently with DHHS-NIH in the following collaborations: the Federal Investigator Registry for Bioinformatics Research Data (FIREBIRD) project to manage clinical investigator information including electronic registration, the Clinical Research Information Exchange (CRIX) and the Cancer Bioinformatics Grid (caBIG) initiatives, with the NCI. Janus (a NCI clinical trials database) shares clinical trial, data models and standards information with the FDA. .

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?

2007-02-15

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

no

3. Briefly describe how investment risks are reflected in the life cycle cost estimate and investment schedule:

This investment has adjusted risk based cost and schedule through utilizing a phased approach for migration and implementation of the bioinformatics platform. This provides flexibility to the program team to utilize lessons learned from each phase and delay migration of critical mission applications to the bioinformatics platform if necessary. Each phase includes a detailed test and evaluation period to ensure that the mission of the FDA will not be adversely affected when production migration occurs. In addition, the program is establishing a Program Management Office (PMO) to address risk and program issues throughout all aspects of the program lifecycle. The PMO works closely with Independent Verification & Validation and contracted Program Management Support to assess investment risks for the program and incorporates these into their cost estimates and work schedule. Project-level IT and business risks are tracked continuously by the Project Officer, and the status is included in periodic project reports to the Program Manager. Project-level risk status is also reviewed during the stage gate process at the end of each life cycle phase. The resources applied to, and the timetable for, conducting these meetings are documented in program planning artifacts. The combination of program level management and substantial preplanning where needed are being applied as appropriate as contracts are initiated, along with the mitigation strategies applied by the project managers themselves relative to the individual efforts.

1. Does the earned value management system meet the criteria in ANSI/EIA Standard 748?

yes

2. Is the CV% or SV% greater than ± 10%?

no

2.b. If yes, explain the variance.

Though not outside the 10% variance overall, some milestones are behind due to lack of funding . This initiative's milestones will be reviewed in the near future as supplemental funding is received, which will allow the FDA to develop more comprehensive plans and make necessary updates to address phases and tasks that have been delayed, or incomplete tasks which have extended beyond the initial end date estimates.

3. Has the investment re-baselined during the past fiscal year?

no