Exhibit 300 (BY2010) for FDA Mission Accomplishments and Regulatory Compliance Services (MARCS)

1. Date of Submission:

2009-04-10

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Mission Accomplishments and Regulatory Compliance Services (MARCS)

5. Unique Project Identifier:

009-10-01-03-01-8021-00

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

Mixed Life Cycle

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

FY2004

8. Provide a brief summary and justification for this investment, including a brief description of how this closes in part or in whole an identified agency performance gap.

The MARCS program manages the integration, reengineering and enhancement of seven legacy systems to better support FDA's mission. It aligns directly with Obj. 2.2 of the HHS strategic plan: Protect the Public Against Injuries and Environmental Threats, enables FDA Centers to meet FDA Goal 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain, and helps support PMA Expanded E-Government. FDA uses MARCS' applications to: plan FDA field activities and assign staff to inspections, investigations, recalls and other compliance activities; track and control samples and the results of laboratory analysis; collect and maintain information from field activities; collect performance data, particularly that related to FDAAA; send Prior Notice for food imports to Customs and accept import product information from Customs for screening; screen 18 million import lines a year based on calculated risk; collect information about the facilities FDA regulates and those in the import supply chain for risk-based targeting; provide FDA Centers with information on inspections, compliance actions, recalls, laboratory analysis and facilities. Although legacy systems help meet current performance goals, their weaknesses pose increasing risk. HW/SW platforms are aging and inconsistent with EA standards. Import functionality has outgrown platforms, degrading performance; as imports increase, this gap widens. Platforms don't support 24/7 operation--a Bioterrorism Act requirement. The paradigm on which import screening was based has changed; new technologies make an expert system risk-based approach possible. Interfaces with FDA labs are inadequate, and sample tracking inefficient. Enhancements are delayed due to the high cost of maintaining the legacy framework. MARCS is addressing these problems through a combination of technical upgrades, redesign of core components, and enhancements to existing functionality. Migration of MARCS' legacy systems to the Web is complete and migration to Sun/Solaris platforms on track for 2008. Integration, reduced maintenance, and increased functionality will be accomplished through a reusable service-based approach. A planned alignment to FDA-wide Product Quality investment and Import Safety Workgroup's recommendations, including a system inventory required for interoperability, continuity of operations, and implementation, will enable FDA to move away from stove-piped and redundant systems across the enterprise.

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?

2006-12-11

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?)

MARCS supports Expanded E-Government. MARCS breaks down bureaucratic divisions by combining activities and interfaces for domestic and import operations, and will support dynamic work assignment to produce a nation-wide rather than region focused workforce. MARCS supports information sharing with USDA, states (eSAF), internationally (PNSI, COMSTAT), and within FDA through automated and interactive applications. MARCS automates internal processes (expert system PREDICT, sample distribution).

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 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

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

MARCS provides automated support to the compliance operations that ensure food, drugs, and medical devices are safe and effective, whether made in the US or abroad. It screens 18 million imports every year using data from Customs to decide whether they can enter. It allows FDA to use the findings of state food investigators, tracks samples to and from FDA labs, manages recall activities and consumer complaints. In short, it gives field staff the integrated tools it needs to protect the public.

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	91
Other	9

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	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?

yes

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	3.585	0.700	1.291	1.301
Acquisition Budgetary Resources	23.292	10.919	11.221	9.014
Maintenance Budgetary Resources	6.131	2.217	5.747	9.094
Government FTE Cost	2.480	0.960	1.232	1.297
# of FTEs	8	8	10	8

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. The total increase due to the supplemental is $5.000M. This is for Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). This is reflected in the Summary of Spending in FY08 in the acquisition section as follows: an additional $4.010M in Contract Services (development, data sharing, imports modernization, deployment, PM, CPIC, EA) for a new total of $13.070M, and $0.340M in Security for a new total of $0.640M. And in the maintenance section as follows: an additional $0.600M in Contract Services (Current Events Intelligence, data clean up, PM, CPIC, EA) for a new total of $5.780M, and an additional $0.0.50M in Security for a new total of $0.300M. In addition, funds have been added to FY10 in order to provide for the operations and maintenance of PREDICT. This is reflected in the Summary of Spending in FY10 in the maintenance section as follows: an additional $2.760M in Contract Services for a new total of $8.604M, and an additional $0.240M in Security for a new total of $0.490M. An additional $1.200M in a further supplemental for FY09 is included. This is reflected in the Summary of Spending in FY09 in the acquisition section as follows: an additional $1.080M in Contract Services for a new total of $10.801M, and $0.120M in Security for a new total of $0.420M. As the timeframe for incorporating these funds into this investment has been short, this adjustment was not accomplished before the HHS deadline for submission.

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	Technology	Standards Compliance and Deviations	% of Infrastructure brought to Current Standard (Web from C/S). Outcome: Improved application maintainability and reduced cost	0% of infrastructure	100% of infrastructure	Success. 100% of existing legacy converted from C/S to Web
2	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	# of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk food products	0 food product types	development of pilot for screening	Success. Completed
3	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Complaints	% Reduction in Complaints about printing capabilities in the field. Outcome: Increased customer satisfaction and productivity for field employees	Ongoing complaints	100% reduction	Success. 100% --Release of enhancements packaged with Web Version of FACTS/OASIS eliminated all print complaints
4	2006	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Workforce Planning	# of districts that have automated support for assignment & scheduling. Outcome: Improved management of worker resources	0 districts	19 districts	Success. 19 districts. Completed
5	2007	Effective Management of Human Capital/Information Technology/Resources	Technology	External Data Sharing	# of Center Registration Systems Accessed via Center Views. Outcome: Greater efficiency of import reviewers due to faster information sharing	0 systems	4 systems	Success. 4 Center systems accessed via web through Center Views
6	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	# of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk food products	0 food product types	1 food product type	Success. 1 Product Type (Seafood) tested
7	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products screened per year within a window of two hours. Outcome: Meeting the two hour time window available for screening from Customs and Border Patrol operations as required by law. Reduced impact on commerce (cost to industry)	14,000,000 imported products	15,000,000 imported products	Success. 15,000,000 imported products
8	2007	Effective Management of Human Capital/Information Technology/Resources	Technology	External Data Sharing	% of Interfaces with Center Databases standardized. Outcome: Greater workflow efficiency and more effective decision making resulting in stronger enforcement cases	20% of interfaces	70% of interfaces	Failure. Goal not met. Work delayed.
9	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	# of states that have access to an automated checklist for BSE threat analysis. Outcome: Enables the states to conduct effective BSE inspections	0 states	50 states	Success. 50 states
10	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	Standards Compliance and Deviations	% of Infrastructure brought to Current Standard (VMS to Unix). Outcome: Reliable infrastructure supporting key agency missions	20% of infrastructure	80% of infrastructure	Success. UNIX I implemented. All major systems and databases now at current standard.
11	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	External Data Sharing	# of Center Registration Systems Accessed via Center Views. Outcome: Greater efficiency of import reviewers due to faster information sharing	4 systems	6 systems	Success. Center Views accesses 8 Center systems.
12	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	Internal Data Sharing	% disparate functionality harmonized between legacy systems. Outcome: Greater efficiency for investigators, analysts, and compliance officers	0% of functionality	20% of functionality	Success. Single Sign On and Firm Finder.
13	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	# of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk food products	1 food product type	3 food product types	Failure. PREDICT Pilot supports 1 food product type.
14	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products screened per year within a window of two hours. Outcome: Meeting the two hour time window available for screening from Customs and Border Patrol operations as required by law. Reduced impact on commerce (cost to industry)	15,000,000 imported products	16,000,000 imported products	Success. More than 16,000,000 imported products.
15	2008	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Complaints	% comments are complaints about screens. Outcome: Increased user satisfaction and productivity.	65% of comments are complaints	60% of comments are complaints	Success. Complaints reduced to less than 60%.
16	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	# of sources automatically mined for bioterrorism food processing. Outcome: Lower risk of imminent threats due to food	0 sources	1 source	Success. PREDICT Pilot automatically mines 1 source.
17	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Criminal Investigation and Surveillance	% of compliance actions share automated workflow actions and evidence captured with Centers. Outcome: Increased efficiency and speed in producing successful performance cases	0% of compliance actions	20% of compliance actions	Success. Data pulled from Domestics into Case Management System
18	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of Workforce Planning/scheduling functions in current stovepipes integrated. Outcome: Decreased cost of assigning staff to inspections	20% of workforce functions	25% of workforce functions	Success. National Sample Distributor implemented.
19	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of work functions available on mobile devices. Outcome: Decreased amount of time needed to perform inspections, investigations, exams, and collections	2 work functions	3 work functions	Success. Establishment Inspection Report, 483 (adverse observations), and International Mail Facility
20	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Standards Compliance and Deviations	% of infrastructure brought to current standard (VMS to Unix). Outcome: Reliable infrastructure supporting key agency missions	80% of infrastructure	100% of infrastructure	TBD
21	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	External Data Sharing	% of Interfaces with Center Databases standardized. Outcome: Greater workflow efficiency and more effective decision making resulting in stronger enforcement cases	0% of interfaces	20% of interfaces	TBD
22	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	Internal Data Sharing	% disparate functionality harmonized between legacy systems. Outcome: Greater efficiency for investigators, analysts, and compliance officers	20% of functionality	36% of functionality	TBD
23	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	# of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk food products	3 food product types	80% of food product types	TBD
24	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products screened per year within a window of two hours. Outcome: Meeting the two hour time window available for screening from Customs and Border Patrol operations as required by law. Reduced impact on commerce (cost to industry)	16,000,000 imported products	17,000,000 imported products	TBD
25	2009	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Complaints	% comments are complaints about screens. Outcome: Increased user satisfaction and productivity.	60% of comments are complaints	55% of comments are complaints	TBD
26	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	# of sources automatically mined for bioterrorism food processing. Outcome: Lower risk of imminent threats due to food	1 source	2 sources	TBD
27	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Criminal Investigation and Surveillance	% of compliance actions share automated workflow actions and evidence captured with Centers. Outcome: Increased efficiency and speed in producing successful performance cases	20% of compliance actions	30% of compliance actions	TBD
28	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of Workforce Planning/scheduling functions in current stovepipes integrated. Outcome: Decreased cost of assigning staff to inspections	25% of workforce functions	30% of workforce functions	TBD
29	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of work functions available on mobile devices. Outcome: Decreased amount of time needed to perform inspections, investigations, exams, and collections	3 work functions	4 work functions	TBD
30	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	Standards Compliance and Deviations	% of Infrastructure 24/7 compliant that is required to be 24/7 Compliant. Outcome: Compliance with Bioterrorism Act to check every food product and conformation to Customs and Border Patrol's two hour time window	0% of infrastructure	100% of infrastructure	TBD
31	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	External Data Sharing	% of Interfaces with Center Databases standardized. Outcome: Greater workflow efficiency and more effective decision making resulting in stronger enforcement cases	20% of interfaces	70% of interfaces	TBD
32	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	Internal Data Sharing	% disparate functionality harmonized between legacy systems. Outcome: Greater efficiency for investigators, analysts, and compliance officers	36% of functionality	48% of functionality	TBD
33	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	% of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk drug products	0% of drug product types	80% of drug product types	TBD
34	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products screened per year within a window of two hours. Outcome: Meeting the two hour time window available for screening from Customs and Border Patrol operations as required by law. Reduced impact on commerce (cost to industry)	17,000,000 imported products	18,000,000 imported products	TBD
35	2010	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Complaints	% of comments are complaints about screens. Outcome: Increased user satisfaction and productivity.	55% of comments are complaints	50% of comments are complaints	TBD
36	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	# of sources automatically mined for bioterrorism food processing. Outcome: Lower risk of imminent threats due to food	2 sources	3 sources	TBD
37	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Criminal Investigation and Surveillance	% of compliance actions share automated workflow actions and evidence captured with Centers. Outcome: Increased efficiency and speed in producing successful performance cases	30% of compliance actions	40% of compliance actions	TBD
38	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	40% of compliance actions	30% of workforce functions	45% of workforce functions	TBD
39	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of work functions available on mobile devices. Outcome: Decreased amount of time needed to perform inspections, investigations, exams, and collections	4 work functions	5 work functions	TBD
40	2011	Effective Management of Human Capital/Information Technology/Resources	Technology	External Data Sharing	% of Interfaces with Center Databases standardized. Outcome: Greater workflow efficiency and more effective decision making resulting in stronger enforcement cases	70% of interfaces	80% of interfaces	TBD
41	2011	Effective Management of Human Capital/Information Technology/Resources	Technology	Internal Data Sharing	% disparate functionality harmonized between legacy systems. Outcome: Greater efficiency for investigators, analysts, and compliance officers	48% of functionality	60% of functionality	TBD
42	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	% of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk device products	0% of device product types	80% of device product types	TBD
43	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products screened per year within a window of two hours. Outcome: Meeting the two hour time window available for screening from Customs and Border Patrol operations as required by law. Reduced impact on commerce (cost to industry)	18,000,000 imported products	19,000,000 imported products	TBD
44	2011	Effective Management of Human Capital/Information Technology/Resources	Customer Results	Customer Complaints	% of comments are complaints about screens. Outcome: Increased user satisfaction and productivity.	50% of comments are complaints	45% of comments are complaints	TBD
45	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of Workforce Planning/scheduling functions in current stovepipes integrated. Outcome: Decreased cost of assigning staff to inspections	45% of workforce functions	60% of workforce functions	TBD
46	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of work functions available on mobile devices. Outcome: Decreased amount of time needed to perform inspections, investigations, exams, and collections	5 work functions	6 work functions	TBD
47	2012	Effective Management of Human Capital/Information Technology/Resources	Technology	Internal Data Sharing	% disparate functionality harmonized between legacy systems. Outcome: Greater efficiency for investigators, analysts, and compliance officers	60% of functionality	68% of functionality	TBD
48	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Risk	% of import product types screened based on calculated risk factors. Outcome: Higher may proceed rate for low risk products, more resources for higher risk other regulated products	0% of other regulated product types	80% of other regulated product types	TBD
49	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Complaints	% of comments are complaints about screens. Outcome: Increased user satisfaction and productivity.	45% of comments are complaints	40% of comments are complaints	TBD
50	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of Workforce Planning/scheduling functions in current stovepipes integrated. Outcome: Decreased cost of assigning staff to inspections	60% of workforce functions	70% of workforce functions	TBD

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 Mission Accomplishments and Regulatory Compliance Services (MARCS). Migration to Web (complete in 2006) Migration to Unix (underway) upgrade to Oracle 10G (inconjunction with Unix migration)

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	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Security Management	Access Control			No Reuse	2
2	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Human Capital / Workforce Management	Resource Planning and Allocation			No Reuse	2
3	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Routing and Scheduling	Inbound Correspondence Management			No Reuse	2
4	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Management	Knowledge Engineering			No Reuse	2
5	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Document Management	Document Review and Approval			No Reuse	1
6	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Tracking and Workflow	Case Management			No Reuse	2
7	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Discovery	Data Mining			No Reuse	2
8	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Management	Categorization			No Reuse	2
9	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Visualization	Mapping / Geospatial / Elevation / GPS			No Reuse	0
10	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Search	Query			No Reuse	1
11	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Customer Relationship Management	Customer Analytics			No Reuse	1
12	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Data Classification			No Reuse	0
13	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Management	Knowledge Distribution and Delivery			No Reuse	2
14	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Security Management	Audit Trail Capture and Analysis			No Reuse	2
15	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Management of Processes	Risk Management			No Reuse	4
16	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Customer Preferences	Alerts and Notifications			No Reuse	2
17	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Investment Management	Strategic Planning and Mgmt			No Reuse	1
18	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Forms Management	Forms Modification			No Reuse	2
19	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Tracking and Workflow	Conflict Resolution			No Reuse	2
20	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Customer Initiated Assistance	Online Help			No Reuse	0
21	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Organizational Management	Workgroup / Groupware			No Reuse	2
22	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Document Management	Document Revisions			No Reuse	1
23	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Investment Management	Performance Management			No Reuse	2
24	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Loading and Archiving			No Reuse	0
25	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Human Capital / Workforce Management	Team / Org Management			No Reuse	2
26	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Extraction and Transformation			No Reuse	0
27	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Development and Integration	Legacy Integration			No Reuse	3
28	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Human Resources	Time Reporting			No Reuse	0
29	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Business Intelligence	Demand Forecasting / Mgmt			No Reuse	3
30	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Security Management	Digital Signature Management			No Reuse	2
31	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Meta Data Management			No Reuse	1
32	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Data Exchange			No Reuse	1
33	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Management of Processes	Business Rule Management			No Reuse	3
34	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Management	Knowledge Capture			No Reuse	2
35	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Development and Integration	Data Integration			No Reuse	2
36	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Search	Pattern Matching			No Reuse	2
37	Firm Management Services	Find information on firms in FDA databases	Knowledge Management	Information Retrieval	Information Retrieval		Internal	2
38	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Data Cleansing			No Reuse	2
39	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Security Management	Identification and Authentication			No Reuse	2
40	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Tracking and Workflow	Process Tracking			No Reuse	2
41	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Data Management	Data Recovery			No Reuse	0
42	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Document Management	Document Referencing			No Reuse	1
43	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Forms Management	Forms Creation			No Reuse	2
44	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Records Management	Document Classification			No Reuse	2
45	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Development and Integration	Enterprise Application Integration			No Reuse	2
46	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Routing and Scheduling	Outbound Correspondence Management			No Reuse	2
47	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Collaboration	Document Library			No Reuse	2
48	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Human Capital / Workforce Management	Contingent Workforce Management			No Reuse	2
49	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Business Intelligence	Decision Support and Planning			No Reuse	3
50	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Management	Information Sharing			No Reuse	2
51	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Management of Processes	Quality Management			No Reuse	2
52	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Customer Relationship Management	Contact and Profile Management			No Reuse	1
53	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Reporting	Ad Hoc			No Reuse	1
54	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Collaboration	Task Management			No Reuse	2
55	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Customer Relationship Management	Partner Relationship Management			No Reuse	2
56	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Management of Processes	Governance / Policy Management			No Reuse	2
57	FDA Mission Accomplishments and Regulatory Compliance Services	The MARCS program is a comprehensive integration and reengineering of nine legacy systems with two major objectives: upgrading their technical infrastructure and better integrating and enhancing their business functionality to support FDA's expanding operational needs.	Knowledge Discovery	Modeling			No Reuse	2

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	Access Control	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
2	Resource Planning and Allocation	Service Platform and Infrastructure	Software Engineering	Modeling	Rational Rose by: International Business Machines Corp.
3	Inbound Correspondence Management	Service Platform and Infrastructure	Software Engineering	Integrated Development Environment	Macromedia RoboHelp by: Adobe Systems
4	Knowledge Engineering	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Windows XP by: Microsoft Corporation
5	Document Review and Approval	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle Application Server by: Oracle Corporation
6	Case Management	Service Platform and Infrastructure	Database / Storage	Database	Microsoft Office Access by: Microsoft Corporation
7	Data Mining	Service Interface and Integration	Interoperability	Data Format / Classification	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
8	Categorization	Service Platform and Infrastructure	Delivery Servers	Web Servers	Microsoft Windows 2000 by: Microsoft Corporation
9	Mapping / Geospatial / Elevation / GPS	Component Framework	User Presentation / Interface	Content Rendering	Cascading Style Sheets, level 1 by: World Wide Web Consortium
10	Query	Component Framework	Security	Supporting Security Services	PVCS Tracker by: Synergex
11	Customer Analytics	Service Platform and Infrastructure	Support Platforms	Dependent Platform	OpenVMS by: Hewlett-Packard Corporation
12	Data Classification	Service Interface and Integration	Integration	Enterprise Application Integration	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
13	Knowledge Distribution and Delivery	Service Interface and Integration	Interoperability	Data Format / Classification	Document Type Definition by: TBD
14	Audit Trail Capture and Analysis	Component Framework	Security	Supporting Security Services	Entrust Authority by: Entrust
15	Risk Management	Service Interface and Integration	Integration	Enterprise Application Integration	Universal Description, Discovery and Integration by: Organization for the Advancement of Structured Information Standards
16	Alerts and Notifications	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
17	Strategic Planning and Mgmt	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
18	Forms Modification	Component Framework	Business Logic	Platform Independent Technologies	Enterprise Java Beans by: Sun Microsystems, Inc.
19	Conflict Resolution	Service Interface and Integration	Interoperability	Data Format / Classification	Microsoft Office Word by: Microsoft Corporation
20	Online Help	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Rational RequisitePro by: International Business Machines Corp.
21	Workgroup / Groupware	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle Application Server by: Oracle Corporation
22	Document Revisions	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
23	Performance Management	Service Platform and Infrastructure	Software Engineering	Test Management	Quick Test Professional by: Hewlett-Packard Development Company, L.P.
24	Loading and Archiving	Component Framework	User Presentation / Interface	Content Rendering	Dynamic Hypertext Markup Language by: TBD
25	Team / Org Management	Service Interface and Integration	Integration	Enterprise Application Integration	XML Linking Language (XLink) Version 1.0 by: World Wide Web Consortium
26	Extraction and Transformation	Service Platform and Infrastructure	Database / Storage	Database	Documentum by: EMC Corporation
27	Legacy Integration	Service Interface and Integration	Integration	Middleware	PL/SQL by: Oracle Corporation
28	Time Reporting	Service Platform and Infrastructure	Software Engineering	Test Management	Mercury Interactive WinRunner by: Hewlett-Packard Corporation
29	Demand Forecasting / Mgmt	Service Platform and Infrastructure	Software Engineering	Integrated Development Environment	Oracle JDeveloper by: Oracle Corporation
30	Digital Signature Management	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
31	Meta Data Management	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Asynchronous Transfer Mode by: ITU Telecommunication Standardization Sector (ITU-T)
32	Data Exchange	Service Interface and Integration	Interface	Service Description / Interface	Oracle by: Oracle Corporation
33	Business Rule Management	Component Framework	Data Management	Reporting and Analysis	eXtensible Business Reporting Language by: XBRL International, Inc.
34	Knowledge Capture	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Apache Ant by: Apache Software Foundation
35	Data Integration	Component Framework	Business Logic	Platform Independent Technologies	JavaScript by: Sun Microsystems, Inc.
36	Pattern Matching	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	PVCS Version Manager by: Synergex
37	Information Retrieval	Service Interface and Integration	Interoperability	Data Transformation	Business Objects XI by: SAP AG
38	Data Cleansing	Component Framework	Data Management	Reporting and Analysis	Oracle Enterprise Manager by: Oracle Corporation
39	Identification and Authentication	Service Platform and Infrastructure	Software Engineering	Test Management	LoadRunner by: Hewlett-Packard Development Company, L.P.
40	Process Tracking	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Java Server Pages by: Sun Microsystems, Inc.
41	Data Recovery	Service Platform and Infrastructure	Software Engineering	Integrated Development Environment	Oracle Forms by: Oracle Corporation
42	Document Referencing	Component Framework	User Presentation / Interface	Content Rendering	Adobe Acrobat by: Adobe Systems
43	Document Referencing	Component Framework	Data Management	Database Connectivity	Object Linking and Embedding, Database by: Microsoft Corporation
44	Document Referencing	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Integrated Services Digital Network (ISDN) - Core Aspects of Frame Protocol for Use with Frame Relay Bearer Service by: ANSI
45	Document Referencing	Service Platform and Infrastructure	Software Engineering	Integrated Development Environment	Oracle JDeveloper by: Oracle Corporation
46	Forms Creation	Service Platform and Infrastructure	Database / Storage	Database	Oracle Enterprise Manager 10g Grid Control by: Oracle Corporation
47	Document Classification	Service Interface and Integration	Integration	Middleware	IBM Websphere MQ by: International Business Machines Corp.
48	Enterprise Application Integration	Service Platform and Infrastructure	Delivery Servers	Portal Servers	Oracle Portal by: Oracle Corporation
49	Outbound Correspondence Management	Service Access and Delivery	Service Transport	Service Transport	Point-to-Point Protocol (PPP) by: The Internet Engineering Task Force
50	Document Library	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
51	Contingent Workforce Management	Component Framework	Data Management	Reporting and Analysis	OLAP Services by: Microsoft Corporation
52	Decision Support and Planning	Component Framework	User Presentation / Interface	Static Display	Hyper Text Markup Language by: International Organization for Standardization
53	Information Sharing	Service Platform and Infrastructure	Software Engineering	Test Management	Mercury Interactive Test Director by: Hewlett-Packard Corporation
54	Quality Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris 9 by: Sun Microsystems, Inc.
55	Contact and Profile Management	Component Framework	Business Logic	Platform Dependent Technologies	Microsoft Visual Basic by: Microsoft Corporation
56	Ad Hoc	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
57	Task Management	Service Interface and Integration	Interoperability	Data Types / Validation	XML Schema by: World Wide Web Consortium
58	Partner Relationship Management	Component Framework	User Presentation / Interface	Static Display	Portable Document Format by: Adobe Systems
59	Governance / Policy Management	Component Framework	Security	Supporting Security Services	Lightweight Directory Access Protocol by: The Internet Engineering Task Force
60	Modeling	Component Framework	Data Interchange	Data Exchange	Electronic Data Interchange (EDI) by: National Institute of Standards and Technology

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.

Yes. Through its interfaces with CBP's systems, MARCS will continue to enable FDA staff to work collaboratively at the U.S. borders with CBP to screen, review, hold, or seize FDA regulated products that might cause harm to humans or other animals. Neither CBP nor FDA could accomplish the full mission by themselves, but the automated systems that are currently in place provide limited support to this funciton. As FDA evolves to MARCS and CBP implements ACE this interaction should be even tighter. In addition to providing more effective screening for safety, this collaborarion reduces the impact on trade that would be the result of separate systems.

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?

2007-05-22

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:

Risk was one of the major factors in selecting the overall MARCS approach (the alternative to migrate to web and rebuild over time) because FDA's regulatory environment is dynamic and cannot be put in position where change cannot be accommodated quickly. Where possible, higher risk projects are scheduled without follow on dependencies so that a schedule delay will not impact other projects. Cost and schedule are risk adjusted based on the particulars of a project. This is done through an analogous and experience-based approach. For example, the Web Migration project was risk adjusted in both cost and schedule. In particular, the amount of time and money allocated to address issues that might arise after implementation was increased due to the risk of implementing this major infrastructure change across the entire United States and a total base of close to 5,000 users. The original cost and time estimates for this portion of the project were doubled. Due to a phased implementation approach, the number of issues after implementation was surprisingly low. This meant that this project was below budget and ahead of schedule because anticipated risks did not materialize into issues. Another example is the UNIX Migration project. An estimate was produced for this by a contractor. This estimate was essentially doubled in both time and cost. The MARCS management team felt that the estimate did not take into full account the risks from organizational and platform dependencies. This is a critical path project since effective future development is reliant upon upgraded infrastructure. The Standardized Evidence and Reference Services (SERS) project was also risk adjusted. Additional time and money has been included in its plan. This component will be accessed by almost every application within MARCS, so it is the source of a number of dependencies. This has also resulted in risk adjustments being made in the planning of other projects (such as Mobile Automated Regulatory Services) that are dependent on SERS. Each project in MARCS is approached on its individual merits and risk adjusted as appropriate as illustrated in the examples above.

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%?

yes

2.a. If yes, was it the?

Both

2.b. If yes, explain the variance.

As a whole, the investment is not outside of the +/-10% variance threshold. SS Cost Variance is greater than allowable threshold but the overall cost variance is within 10%. When the Web Migration project began, monies were set aside in Steady State to address expected post implementation issues. Due to the size of the user base, the applications involved, and the geographical distribution of the user base, it was expected that a number of issues would be discovered after rolling out the web interface. However, a strategy of incremental deployment was utilized during development. This allowed early deployment to field locations as test implementations. The tests conducted during this time revealed a number of shortcomings that were corrected. This was all tracked as DME spending. Upon implementation of the entire project, the number of errors that were discovered had been significantly reduced due to the early deployment and testing. This resulted in a lower SS level of spending than was expected. The lower level of SS spending resulted in the SS Operations FY06- milestone variance of $0.247M. Monies were also earmarked for dealing with issues that were expected to arise after implementation of the DME milestone UNIX Migration Phase I in FY07. Implementation of this project has been delayed until August of 2008 as the scope was expanded due to an EA requirement to upgrade to Oracle 10g. The implementation was delayed as additional work was added to this milestone. This additional work included migrating to Oracle 10g and moving some elements from Phase II into Phase I. As a result, SS funds that were expected to be spent in FY07 have not been spent. These funds represent cost variance in the milestone SS Operations FY07 of $0.800 of the total $1.016M. Monies were also earmarked for dealing with issues that were expected to arise after implementation of the DME milestone UNIX Migration Phase II in FY08. This has been delayed due to the slippage in UNIX 1 and is expected to be completed in March of 2009. This accounts for $0.600M of the current cost variance of SS Operations FY08 of $0.844M.

2.c. If yes, what corrective actions are being taken?

As a whole, the investment is not outside of the +/- 10% variance threshold. Due to supplemental funding received and changes in planning MARCS, the investment milestones will be adjusted. This will be done for three main reasons. The first is to address the added supplemental funds. The second is to address new requirements placed on MARCS due to the initiatives of the Harmonized Inventory investment. The third is to address the SS Cost Variance. The SS Cost Variance will be addressed directly by re-categorizing the current DME expenses for UNIX 1 and UNIX II to SS. These were originally classified as DME expenses based on a strict interpretation of what constitutes DME. As this was not just bug fixes, this was classified as such. In reality, these two projects are infrastructure upgrades that do not add new functionality. UNIX 1 is currently scheduled to be implemented during September, 2008. This implementation should produce an increase in SS spending that will also help to address the variance. Because of all the new work being added to MARCS, over time, the current SS variance will be reduced as the amount of SS spending increases.

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

no