Exhibit 300 (BY2009) for Food and Drug Administration Information and Computer Technologies for the 21st Century (ICT 21)

1. Date of Submission:

2008-02-04

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Information and Computer Technologies for the 21st Century (ICT 21) (FY09)

5. Unique Project Identifier:

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

6. What kind of investment will this be in FY2009?

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.

The Information and Computer Technologies for the 21st Century (ICT21) investment will enable the FDA, through the development of an agency-wide bioinformatics initiative, to strengthen product development and approval, improve manufacturing and product quality, strengthen post-approval surveillance and safety, support electronic prescribing, and improve clinical decision support. FDA expects the development of new information technologies, driven by increases in computational power and sheer volumes of data, to continue to accelerate, and transform nearly every aspect of FDA operations, from scientific computing to adverse event detection. The next few years will bring new types and new quantities of data to FDA, both in submissions and from collaborations and other research. The information technologies of the 21st century will also create new resources to support FDA's public health mission within 5-10 years. In support of the PMA goal to expand e-Government, FDA expects to see mature electronic health records, personal health records, and networks that connect them. The statistics for large datasets which integrate multiple clinical and diagnostic endpoints will continue to be a challenge. In the coming years, sophisticated software packages will likely be used by companies to analyze data as evidence for safety and efficacy. Together, these tools and resources could enable earlier detection of safety signals and efficacy information. The increasing complexity of products and manufacturing methods will require qualitative changes in every aspect of FDA regulatory science, from toxicology to product characterization, quality assessment to safety surveillance. To meet these challenges and requirements, FDA must modernize its capacity and communication capabilities by establishing a standardized approach for delivering IT services. Through this agency-wide bioinformatics initiative, FDA will fulfill its core public health responsibilities, support the HHS goal of increasing scientific research and development, and respond to emerging challenges. In FY07, ICT21 will gather the bioinformatics capacity and data requirements. Based on these requirements, FDA will design the bioinformatics platform capability and will implement a 3 year migration plan to incorporate electronic submission functionality and provide a mechanism to collaborate with external stakeholders

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

yes

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

2007-06-26

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?

Senior/Expert-level

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

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 initiative directly supports the Expanding Electronic Government PMA goal by providing the foundation for Federal Heath Architecture and Health Informatics implementation at the FDA. The ICT 21 program will maximize interoperability and minimize redundancy by creating a simplified platform that complies with Health IT standards. This will enable information sharing across FDA and HHS, which will assist in decision making and the delivery of FDA services.

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)?

no

19. Is this a financial management system?

no

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

Area	Percentage
Hardware	45
Software	12
Services	42
Other	2

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?

yes

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

Name	Betty Dorsey
Phone Number	301-827-6500
Title	FDA Privacy Act Officer
Email	brenda.dorsey@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 -2006	PY 2007	CY 2008	BY 2009
Planning Budgetary Resources	0.000	2.761	1.550	0.300
Acquisition Budgetary Resources	0.000	1.500	18.450	14.667
Maintenance Budgetary Resources	0.000	0.000	0.000	3.750
Government FTE Cost	0.000	0.300	0.480	0.516
# of FTEs	0	2	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.

The FY2009 submission is the first budget request submitted for the ICT21 investment.

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	2007	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 documented.	0%	25%	10% (7/27/07)
2	2007	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Availability	% of Bioinformatic customer availability requirements documented.	0%	25%	0% (07/27/07)
3	2007	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of agency Bioinformatics collaboration opportunities identified.	0	4	1 (07/27/07)
4	2007	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.	0%	5%	2% (7/27/07)
5	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%	TBD
6	2008	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Availability	% of Bioinformatic customer availability requirements documented.	25%	95%	TBD
7	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	TBD
8	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%	TBD
9	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%	TBD
10	2009	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Availability	% of electronic Product Safety information available	5%	20%	TBD
11	2009	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of Bioinformatic collaboration internal initiatives piloted	0	2	TBD
12	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%	TBD
13	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%	TBD
14	2010	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Availability	% of electronic Product Safety information available	20%	60%	TBD
15	2010	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of Bioinformatic collaboration external initiatives piloted	0	2	TBD
16	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%	TBD
17	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%	TBD
18	2011	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	Availability	% of electronic Product Safety information available	60%	95%	TBD
19	2011	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Processes and Activities	Innovation and Improvement	Number of Bioinformatic collaboration internal and external initiatives in production.	0	4	TBD
20	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%	TBD

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?

no

2.b. If no, please explain why?

Investment identified as major after the recent transition plan and will be included in the next release.

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	Community Management	Defines the set of capabilities that support the administration of online groups that share common interests.	Communication	Community Management			No Reuse	15
2	Inbound Correspondence Management	Defines the set of capabilities that manage externally initiated communication between an organization and its stakeholders.	Routing and Scheduling	Inbound Correspondence Management			No Reuse	10
3	Outbound Correspondence Management	Defines the set of capabilities that manage internally initiated communication between an organization and its stakeholders.	Routing and Scheduling	Outbound Correspondence Management			No Reuse	10
4	Information Sharing	Defines the set of capabilities that support the use of documents and data in a multi-user environment for use by an organization and its stakeholders.	Knowledge Management	Information Sharing			No Reuse	20
5	Data Exchange	Defines the set of capabilities that support the interchange of information between multiple systems or applications; includes verification that transmitted data was received unaltered.	Data Management	Data Exchange			No Reuse	15
6	Data Integration	Defines the set of capabilities that support the organization of data from separate data sources into a single source using middleware or application integration and the modification of system data models to capture new information within a single system.	Development and Integration	Data Integration			No Reuse	30

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 Exchange	Service Interface and Integration	Interoperability	Data Format / Classification	Extensible Markup Language (XML) 1.1
2	Information Sharing	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer
3	Data Exchange	Component Framework	Data Interchange	Data Exchange	SOAP
4	Community Management	Service Access and Delivery	Access Channels	Other Electronic Channels	System to System
5	Inbound Correspondence Management	Service Access and Delivery	Delivery Channels	Internet	Internet Explorer 7.0
6	Outbound Correspondence Management	Service Access and Delivery	Delivery Channels	Internet	Internet Explorer 7.0
7	Data Integration	Service Interface and Integration	Integration	Middleware	SQL

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.

As the program progresses analysis will be performed to determine how existing components and/or applications within the government can be leveraged.

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

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

no