Exhibit 300 (BY2010) for FDA User Fee and Financial Reporting System

1. Date of Submission:

2008-09-08

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA User Fee and Financial Reporting System

5. Unique Project Identifier:

009-10-01-01-01-7068-00

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?

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: HHS 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. FDA User Fees and Financial Management Reporting systems integrate with the HHS Unified Financial Management System (UFMS) and support over 10,000 FDA employees. The systems are Mission Critical. PART remediation and financial performance gaps addressed are: Improved Financial Performance - Ensures that allocated public funds support the FDA mission with fiduciary integrity in compliance with applicable laws, accounting standards and guidelines through supporting spending control administration with reduced costs and improved efficiency. Process automation replaces or eliminates many manual tasks. Eliminate redundancies and increase collaboration - eGovernment strategy reviews identified many duplicate systems in FDA Centers. Example: National Center for Toxicological Research (NCTR) had local systems for processing and collecting industry fees for drug/device applications similar to the FDA User Fees system. Other Centers had duplicate processes and system for similar purposes. Bring Technology to Bear to Improve Services to Citizens - Financial systems enable delivery of Services to Citizens. Example: The User Fees system provides faster, less costly automated processing of industry drug/device applications critical to public and animal health. FDA User Fees and Financial Reporting systems integrate with UFMS in bringing technology to bear that enables and, ultimately, results in improved health-related services to citizens. GOAL SUPPORT: Along with UFMS, FDA User Fees and Financial Reporting systems reduced requirements for an estimated 22 full-time staff and supports the HHS 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. This business case requests funding for bureau-wide FDA User Fees and Financial Reporting IT managed by the FDA Office of Financial Management (OFM) including the legacy FDA Asset Management planned for replacement by HHS Sunflower in 1Q FY2009. Other FDA funding support for HHS global financial systems including UFMS are reported in a separate schedule and not included in this Exhibit 300.

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?

2005-04-01

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
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?)

FDA User Fee and Financial Reporting System investments provide FDA organizations with financial controls, oversight, management and reporting. The investment 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.

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?

10001057 - Food and Drug Administration

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.

FDA Financial Enterprise Solutions (FES) prior to BY2010. Renamed FDA User Fee and Financial Reporting System beginning with BY2010.

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

Area	Percentage
Hardware	0
Software	9
Services	76
Other	15

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	1.515	2.150	1.800
Acquisition Budgetary Resources	8.230	1.293	0.142	0.119
Maintenance Budgetary Resources	55.027	7.482	5.391	5.918
Government FTE Cost	10.428	0.720	0.774	0.812
# of FTEs	56	6	6	6

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.

Changes in planning have occurred since the BY2009 submission. Improving Financial Performance is both an HHS Departmental objective and a President's Management agenda initiative. Investment in FDA User Fees and Financial Reporting enables improvements through consolidation and standardization of financial reporting resulting in reduced costs and more accurate financial information. As Improving Financial Performance initiatives evolve, FDA must modify and adjust project plans for User Fees and Financial Reporting to maintain alignment with the direction and vision. The investment has been updated to reflect Department driven major project plan changes: Department-wide iProcurement system plans for transitioning to a Department-wide system accelerated resulting in earlier transfer of the FDA managed iProcurement system to HHS. Department-wide Sunflower initiative plans for replacement of the FDA Asset Management System were delayed from FY2008 to FY2009. Launch of a new FDA initiative for an HHS Unified Financial Management System (UFMS) Business Intelligence technology data warehouse to fill reports gaps. Expanded stakeholder requirements resulting in additional enhancements to the FDA Financial Reporting (Hyperion) system. Planning for these changes has been underway for several months. As plans have evolved, incremental funding approval was obtained and availability of budget funds was confirmed in advance. Project plan changes have resulted in the following investment changes: Addition of new DME tasks causing change in the investment life-cycle phase from Steady State to Mixed-Life Cycle for FY2009 and FY2010 Net 28.33% increase in planned FY2008 spending Net 32.33% increase in planned FY2009 spending Net 42.80% increase in planned FY2010 spending

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. 1.1 - Broaden health insurance and long-term care coverage	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2008.
2	2008	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	80	Will be reported in December 2008.
3	2008	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	20	18	Will be reported in December 2008.
4	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	Estimated $5.50 per transaction will be confirmed in October 2008.	5	Will be reported in December 2008.
5	2009	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2009.
6	2009	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	81	Will be reported in December 2009.
7	2009	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	18	16	Will be reported in December 2009.
8	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	5	6	Will be reported in December 2009.
9	2010	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2010.
10	2010	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	82	Will be reported in December 2010.
11	2010	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	16	14	Will be reported in December 2010.
12	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	6	7	Will be reported in December 2010.
13	2011	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2011.
14	2011	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	83	Will be reported in December 2011.
15	2011	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	14	12	Will be reported in December 2011.
16	2011	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	7	8	Will be reported in December 2011.
17	2012	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2012.
18	2012	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	84	Will be reported in December 2012.
19	2012	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	12	10	Will be reported in December 2012.
20	2012	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	8	9	Will be reported in December 2012.
21	2013	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2013.
22	2013	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	85	Will be reported in December 2013.
23	2013	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	10	8	Will be reported in December 2013.
24	2013	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	9	10	Will be reported in December 2013.
25	2014	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Reporting and Information	# FDA internal controls financial management system deficiencies reported in the Federal Financial Managers Integrity Act of 1982 (FMFIA) annual assessment	0	0	Will be reported in December 2014.
26	2014	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Satisfaction	% customer satisfaction among industry user fee applicants as reported in annual surveys	75	86	Will be reported in December 2014.
27	2014	Effective Management of Human Capital/Information Technology/Resources	Processes and Activities	Financial Management	# external and internal audit/assessment deficiencies attributable to FDA as reported in the Departmental Consolidated Financial Audit	8	6	Will be reported in December 2014.
28	2014	Effective Management of Human Capital/Information Technology/Resources	Technology	Overall Costs	% decrease in overall FDA IT costs per financial transaction as reported in annual expenditure and processing reports	10	11	Will be reported in December 2014.

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 User Fee and Financial Reporting System

3. Is this investment identified in a completed (contains a target architecture) and approved segment architecture?

yes

3.a. If yes, provide the name of the segment architecture as provided in the agency’s most recent annual EA Assessment.

032-000

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	FDA User Fee System	FDA system that automates, centralizes and standardized billings and collections of industry paid user fees to FDA Centers.	Financial Management	Billing and Accounting			No Reuse	60
2	Data Exchange - Web Server	The HHS PKI web server contains numerous tutorials, FAQs, and configuration guides.	Data Management	Data Exchange	Data Exchange	009-00-01-01-01-0001-00	External	5
3	Standardized/Canned	Defines the set of capabilities that support the use of pre-conceived or pre-written reports.	Reporting	Standardized / Canned	Standardized / Canned	009-00-01-01-01-0001-00	External	35

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	Billing and Accounting	Service Platform and Infrastructure	Hardware / Infrastructure	Embedded Technology Devices	Windows Internet Explorer by: Microsoft Corporation
2	Billing and Accounting	Service Platform and Infrastructure	Hardware / Infrastructure	Embedded Technology Devices	Oracle E-Business Suite 11i by: Oracle Corporation
3	Billing and Accounting	Service Platform and Infrastructure	Hardware / Infrastructure	Embedded Technology Devices	Oracle Jinitiator by: Oracle Corporation
4	Billing and Accounting	Component Framework	Business Logic	Platform Dependent Technologies	Oracle 9i Application Server by: Oracle Corporation
5	Billing and Accounting	Service Platform and Infrastructure	Database / Storage	Storage	Oracle Database 10g Standard Edition by: Oracle Corporation
6	Billing and Accounting	Service Platform and Infrastructure	Hardware / Infrastructure	Embedded Technology Devices	VeriSign SSL Certificates by: Verisign
7	Billing and Accounting	Component Framework	Business Logic	Platform Dependent Technologies	The Java Development Kit by: Sun Microsystems, Inc.

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

no

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.

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?

yes

3.a. If yes, when was it approved by the agency head?

2008-08-12