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Exhibit 300 (BY2009) for FDA Financial Enterprise Solutions (FES)

PART ONE

OVERVIEW

1. Date of Submission:: 2008-02-04

2. Agency:: 009

3. Bureau:: 10

4. Name of this Capital Asset:: FDA Financial Enterprise Solutions (FES) (FY09)

5. Unique Project Identifier:: 009-10-01-01-01-7068-00

6. What kind of investment will this be in FY2009?: Mixed Life Cycle

7. What was the first budget year this investment was submitted to OMB?: FY2005

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.: MISSION SUPPORT: DHHS and FDA missions depend upon efficient and effective use of public funds. Financial management ensures control and accounting of public funds, enforces administrative spending controls and standardizes transactions. FES integrates with the HHS Unified Financial Management System (UFMS) and supports over 10,000 FDA employees. FES is Mission Critical. PART remediation and financial performance gaps addressed are: Improve Financial Performance - FES ensures that allocated public funds support the FDA mission with fiduciary integrity in compliance with applicable laws, accounting standards and federal guidelines through administrative spending controls while reducing costs and improving efficiency of financial management processes. Process automation replaces or eliminates many manual tasks. Eliminate redundancies and increase collaboration - FDA 2002 & 2003 eGovernment strategy reviews identified duplicate IT systems in FDA Centers. Example: National Center for Toxicological Research (NCTR) had a Contracts and Procurement Support System (CAPSS) to generate task orders and delivery orders similar to FES PRISM. Other Centers had duplicate manual processes for the same purpose. Use of FES PRISM as a standard procurement document generator and workflow manager eliminated redundancies and fostered collaboration across Centers. Bring Technology to Bear to Improve Services to Citizens - Financial systems are enablers for delivery of Services to Citizens. Example: FES PRISM provides faster, less costly automated processing of procurement orders for medical research supplies critical to public health research. HHS UFMS supports the production of financial statements and financial reporting. FES works with UFMS bringing technology to bear in financial systems that enable and, ultimately, result in improved health-related services to citizens. GOAL SUPPORT: FES reduced requirements for an estimated 22 full-time staff and supports the DHHS Strategic Goal to Achieve Excellence in Management Practices, the FDA Strategic Goal - A Strong FDA, and Outcome Goal - Reduce administrative overhead by reducing the number of administrative staff. Currently development (Financial Reporting, User Fees) and maintenance (AMS, Financial Reporting, PRISM) projects managed by the FDA Office of Financial Management (OFM) are included. FDA funding for HHS global financial IT are not funded by FES.

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

9.a. If "yes," what was the date of this approval?: 2007-06-23

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

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
Financial Performance

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?): FES provides FDA organizations with financial controls, oversight, management and reporting. FES aligns with the Financial Performance initiative by integrating financial data with performance information, improving the quality and timeliness of Federal financial data and providing summary financial data that is auditable at the transaction level for FDA. Through FES, FDA has received clean audit opinions for seven years and zero reportable material weaknesses in financial reporting to HHS.

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?: no

14.b. If yes, what is the name of the PARTed program?: 2005: FDA - Overall FDA

14.c. If yes, what rating did the PART receive?: Moderately Effective

15. Is this investment for information technology?: yes

16. What is the level of the IT Project (per CIO Council's PM Guidance)?: Level 2

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?: yes

19.a. If yes, does this investment address a FFMIA compliance area?: yes

19.a.1. If yes, which compliance area:: Financial Systems and Processes

19.b. If yes, please identify the system name(s) and system acronym(s) as reported in the most recent financial systems inventory update required by Circular A11 section 52.: Financial Enterprise Solutions (FES)

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

Area	Percentage
Hardware	0
Software	13
Services	70
Other	17

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	Betty Dorsey
Phone Number	301 827 6567
Title	FDA Privacy Act Officer
Email	betty.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

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 -2006	PY 2007	CY 2008	BY 2009
Planning Budgetary Resources	0.000	0.000	0.000	0.000
Acquisition Budgetary Resources	4.756	3.474	0.150	0.000
Maintenance Budgetary Resources	42.038	12.989	7.925	5.559
Government FTE Cost	9.676	0.752	0.593	0.463
# of FTEs	4	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.: Additions of approved DME activities and shifts in planned work to earlier fiscal periods for the FDA Financial Enterprise Solutions (FES), Major IT investment have resulted in changes to the investment phase from Steady State to Mixed-Life Cycle for FY2007 and FY2008. Changes are documented in a pending rebaseline request with approval expected in August 2007 and result in the following updates to spending plans for the investment: FY2007 increased spending of 52% ($ 5.897M) . FY2008 decreased spending of 15% ($ 1.567M). FY2009 decreased spending of 48% ($ 5.638M).

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	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	0
2	2006	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	80	78
3	2006	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness qualifiers resulting from annual external audit of FDA finanical books.	0	0	0
4	2006	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0 - prior to UFMS deployment on April 25, 2005	-2	0
5	2007	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	0 estimated as of 7/31/2007
6	2007	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	82	79 estimated as of 7/31/2007
7	2007	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	0 estimated as of 7/31/2007
8	2007	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-2	-5 estimated as of 7/31/2007
9	2008	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
10	2008	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	81	TBD at end of the period.
11	2008	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
12	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-3	TBD at end of the period.
13	2009	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
14	2009	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	83	TBD at end of the period.
15	2009	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
16	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-4	TBD at end of the period.
17	2010	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
18	2010	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	84	TBD at end of the period.
19	2010	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
20	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-5	TBD at end of the period.
21	2011	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
22	2011	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	85	TBD at end of the period.
23	2011	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
24	2011	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-6	TBD at end of the period.
25	2012	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
26	2012	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	86	TBD at end of the period.
27	2012	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
28	2012	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-7	TBD at end of the period.
29	2013	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
30	2013	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% user fee customer satisfaction with online service	75	87	TBD at end of the period.
31	2013	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	Number of weakness citations (qualified opinions) resulting from annual external audit of FDA finanical books.	0	0	TBD at end of the period.
32	2013	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in FDA financial transaction IT unit costs	0	-8	TBD at end of the period.

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.: FDA Financial Enterprise Solutions

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	Activity-Based Management	Defines the set of capabilities that support a defined, specific set of finance-related tasks for a given objective.	Financial Management	Activity-Based Management	No Reuse	5
2	Expense Management	Defines the set of capabilities that support the management and reimbursement of costs paid by employees or an organization.	Financial Management	Expense Management	No Reuse	25
3	Billing and Accounting	Defines the set of capabilities that support the charging, collection and reporting of an organization's accounts.	Financial Management	Billing and Accounting	No Reuse	25
4	Revenue Management	Defines the set of capabilities that support the allocation and re-investment of earned net credit or capital within an organization.	Financial Management	Revenue Management	No Reuse	5
5	Auditing	Defines the set of capabilities that support the examination and verification of records for accuracy.	Financial Management	Auditing	No Reuse	15
6	Internal Controls	Support the methods and procedures used by the organization to safeguard its assets, produce accurate accounting data and reports, contribute to efficient operations, and encourage staff to adhere to management policies and mission requirements	Financial Management	Internal Controls	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	Activity-Based Management	Service Access and Delivery	Service Requirements	Hosting	Sun Microsystems
2	Activity-Based Management	Service Access and Delivery	Service Requirements	Legislative / Compliance	Web Access
3	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	Business Objects.
4	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	COBOL
5	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	Compusearch
6	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	Gelco
7	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	Hyperion
8	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	Oracle
9	Activity-Based Management	Component Framework	Data Management	Reporting and Analysis	PeopleSoft
10	Auditing	Service Platform and Infrastructure	Database / Storage	Storage	Sun Servers
11	Auditing	Service Platform and Infrastructure	Database / Storage	Storage	Cisco Servers
12	Auditing	Component Framework	Data Management	Reporting and Analysis	Business Objects
13	Auditing	Component Framework	Data Management	Reporting and Analysis	COBOL
14	Auditing	Component Framework	Data Management	Reporting and Analysis	Compusearch
15	Auditing	Component Framework	Data Management	Reporting and Analysis	Gelco
16	Auditing	Component Framework	Data Management	Reporting and Analysis	Hyperion
17	Auditing	Component Framework	Data Management	Reporting and Analysis	Oracle
18	Auditing	Component Framework	Data Management	Reporting and Analysis	PeopleSoft
19	Billing and Accounting	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Oracle Financials 9i
20	Billing and Accounting	Component Framework	Business Logic	Platform Dependent	PeopleSoft
21	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	Business Objects
22	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	COBOL
23	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	Compusearch
24	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	Gelco
25	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	Hyperion
26	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	Oracle
27	Billing and Accounting	Component Framework	Data Management	Reporting and Analysis	PeopleSoft
28	Expense Management	Service Access and Delivery	Access Channels	Web Browser	MS Internet Explorer
29	Expense Management	Service Access and Delivery	Access Channels	Other Electronic Channels	Ethernet LAN
30	Expense Management	Service Access and Delivery	Access Channels	Other Electronic Channels	PointSec
31	Expense Management	Service Access and Delivery	Service Requirements	Hosting	Sun Microsystems
32	Expense Management	Service Platform and Infrastructure	Database / Storage	Storage	Sun Servers
33	Expense Management	Service Platform and Infrastructure	Database / Storage	Storage	Cisco Servers
34	Internal Controls	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Oracle Financials 9i
35	Internal Controls	Service Access and Delivery	Access Channels	Web Browser	MS Internet Explorer
36	Internal Controls	Service Access and Delivery	Access Channels	Collaboration / Communications	Blackberry
37	Internal Controls	Service Access and Delivery	Access Channels	Collaboration / Communications	Email
38	Internal Controls	Service Access and Delivery	Delivery Channels	Internet	Wireless Cards
39	Internal Controls	Service Access and Delivery	Delivery Channels	Intranet	Blackberry
40	Internal Controls	Service Access and Delivery	Service Requirements	Hosting	Sun Microsystems
41	Internal Controls	Service Platform and Infrastructure	Database / Storage	Storage	Sun Servers
42	Internal Controls	Service Platform and Infrastructure	Database / Storage	Storage	Cisco Servers
43	Revenue Management	Service Access and Delivery	Access Channels	Collaboration / Communications	Email
44	Revenue Management	Service Access and Delivery	Delivery Channels	Internet	Wireless Cards
45	Revenue Management	Service Access and Delivery	Delivery Channels	Intranet	Blackberry
46	Revenue Management	Service Access and Delivery	Service Requirements	Hosting	Sun Microsystems
47	Revenue Management	Service Platform and Infrastructure	Database / Storage	Storage	Sun Servers
48	Revenue Management	Service Platform and Infrastructure	Database / Storage	Storage	Cisco Servers

6. Will the application leverage existing components and/or applications across the Government (i.e., FirstGov, Pay.Gov, etc)?: no

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?: 2007-06-30

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:: Investment risks and opportunity impacts were quantified by multiplying probability of occurence times the project cost impacts in terms of dollars. The resulting factors were used in cost estimates and schedules for the related work breakdown structure elements. As a result, both potential negative risks impacts as well as likely opportunities for improvements have been factored into both investment costs and scheduled.

COST & SCHEDULE

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