Exhibit 300 (BY2009) for FDA Mission Accomplishments and Regulatory Compliance Services (MARCS)

1. Date of Submission:

2008-02-04

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Mission Accomplishments and Regulatory Compliance Services (MARCS) (FY09)

5. Unique Project Identifier:

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

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

Mixed Life Cycle

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

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 eight legacy systems to better support FDA's mission. It aligns directly with Obj. 2.2 of HHS draft strategic plan for FY07-2012, enables FDA Centers to meet Obj. 4.3, and helps ensure effective management of Human Capital and IT technology. 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 resulting from field activities; collect performance data, particularly that related to PDUFA and MDUFMA; 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 a risk-based approach possible. Interfaces with FDA labs are inadequate, and sample tracking inefficient. Enhancements are "backed" up behind 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, component by component. 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?

2007-06-26

10. Did the Project Manager review this Exhibit?

yes

11.a. What is the current FAC-P/PM certification level of the project/program manager?

Senior/Expert-level

12. Has the agency developed and/or promoted cost effective, energy-efficient and environmentally sustainable techniques or practices for this project.

yes

12.a. Will this investment include electronic assets (including computers)?

yes

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
Competitive Sourcing
Expanded E-Government
Human Capital

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?)

Manage Human Capital: Automates scheduling & assignment of investigators, reviewers, and compliance officers. Captures time spent on activities. Relates activities to ORA PART, PDUFA and other performance goals. Expand EGov: 1. Allows FDA to use state inspectors by providing an interface that gives them electronic access to MARCS to input inspection results 2. Gives the public an interface to input Prior Notice on food imports directly to FDA when not required to file with Customs

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

yes

14.a. If yes, does this investment address a weakness found during the PART review?

no

14.b. If yes, what is the name of the PARTed program?

2005: FDA - Overall FDA

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

Moderately Effective

15. Is this investment for information technology?

yes

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

Level 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	96
Other	4

21. If this project produces information dissemination products for the public, are these products published to the Internet in conformance with OMB Memorandum 05-04 and included in your agency inventory, schedules and priorities?

yes

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

Name	Betty Dorsey
Phone Number	301-827-6500
Title	FDA Privacy Act Officer
Email	betty.dorsey@fda.hhs.gov

23. Are the records produced by this investment appropriately scheduled with the National Archives and Records Administration's approval?

yes

24. Does this investment directly support one of the GAO High Risk Areas?

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 -2006	PY 2007	CY 2008	BY 2009
Planning Budgetary Resources	2.985	0.750	0.700	0.491
Acquisition Budgetary Resources	13.738	9.310	9.360	10.020
Maintenance Budgetary Resources	0.785	5.440	5.440	5.747
Government FTE Cost	1.520	0.960	0.960	1.033
# of FTEs	5	8	8	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.

Summary of spending has not changed. MARCS did rebaseline in June 2007 to realign funding for some projects based on Business and Investement Review Board Priorities, and changed the names based on requests from management, but total funding did not change.

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	Measure- ment Area	Measure- ment Grouping	Measure- ment Indicator	Baseline	Planned Improvement to the Baseline	Actual Results
1	2006	Effective Management of Human Capital / Information Technology / Resources	Technology	Compliance and Deviations	% of Infrastructure brought to Current Standard (Web from C/S)	0%	100%	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	0	development of pilot for screening	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	Ongoing Complaints	100% reduction	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 assingment & scheduling	0	19	Completed
5	2007	Effective Management of Human Capital / Information Technology / Resources	Technology	External Data Sharing	# of Center Registration Systems Accessed via single sign on	0 Systems	4	4 Center Views 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	0	1 Food Product type	Seafood products in parallel test as of 08/15/07
7	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products successfully screened in 2 hour window via automated screening process	14 Million	15 Million	15 million projected
8	2007	Effective Management of Human Capital / Information Technology / Resources	Customer Results	Customer Complaints	% of Interfaces with Center DBs standardized	20% standardized, each unique	70%	Goal will not be met. Work on screens was delayed because continuing resolution delayed funding and other priorities were higher
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 autoamted checklist for BSE threat analysis	0 %	100%	100%
10	2008	Effective Management of Human Capital / Information Technology / Resources	Technology	Compliance and Deviations	% of Infrastructure brought to Current Standard (VMS to Unix)	20%	80%	TBD
11	2008	Effective Management of Human Capital / Information Technology / Resources	Technology	External Data Sharing	# of Center Registration systems accessed via single sign on	4	6	TBD
12	2008	Effective Management of Human Capital / Information Technology / Resources	Technology	Internal Data Sharing	% Data and Process Redudancy/Data discrepancy between legacy systems reduced	0% (estimated) of code/data isduplication	10% reduction	TBD
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	1	3 Food Product Types	TBD
14	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products successfully screened in 2 hour window via automated screening processes	15 Million	16 Million	TBD
15	2008	Effective Management of Human Capital / Information Technology / Resources	Customer Results	Customer Complaints	% Reduction in complaints about screens	65% of comments are complaints	60%	TBD
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	0	1 source	TBD
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	0%	20% compliance info iintegration w centers	TBD
18	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of WF Planning/scheduling functions in current stovepipes integrated	20%	25%	TBD
19	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of operations available on mobile devices	2	3	TBD
20	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Compliance and Deviations	% of ifrastructure brought to current standard (VMS to Unix)	80%	100%	TBD
21	2009	Effective Management of Human Capital / Information Technology / Resources	Technology	External Data Sharing	% of Interfaces with Center DBs standardized	0 standardized, each unique	20%	TBD
22	2009	Effective Management of Human Capital / Information Technology / Resources	Technology	Internal Data Sharing	% Data and Process Redudancy/Data discrepancy between legacy systems	20% (estimated) of code/data is duplicative	16%	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	3	80% of Food products	TBD
24	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products successfully screened in 2 hour window via automated screening processes	16 Million	17 Million	TBD
25	2009	Effective Management of Human Capital / Information Technology / Resources	Customer Results	Customer Complaints	% Reduction in complaints about screens	60% of comments are complaints	55%	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	1	2	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	20%	30% compliance info integrated with centers	TBD
28	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of WF Planning/scheduling functions in current stovepipes integrated	25%	30%	TBD
29	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of operations available on mobile devices	3	4	TBD
30	2010	Effective Management of Human Capital / Information Technology / Resources	Technology	Compliance and Deviations	% of Infrastructure 24/7 compliant that is required to be 24/7 Compliant	0%	100%	TBD
31	2010	Effective Management of Human Capital / Information Technology / Resources	Technology	External Data Sharing	% of Interfaces with Center DBs standardized	20% standardized, each unique	70%	TBD
32	2010	Effective Management of Human Capital / Information Technology / Resources	Technology	Internal Data Sharing	% Data and Process Redudancy/Data discrepancy between legacy systems	16% (estimated) of code/data is duplicative	13%	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	0% Drugs	80% Drugs	TBD
34	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products successfully screened in 2 hour window via automated screening processes	17 Million	18 Million	TBD
35	2010	Effective Management of Human Capital / Information Technology / Resources	Customer Results	Customer Complaints	% Reduction in complaints about screens	55% of comments are complaints	50%	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	2	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	30%	40% compliance infor integrated w centers	TBD
38	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of WF Planning/scheduling functions in current stovepipes integrated	30%	45%	TBD
39	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of operations available on mobile devices	4	5	TBD
40	2011	Effective Management of Human Capital / Information Technology / Resources	Technology	External Data Sharing	% of Interfaces with Center DBs standardized	70% standardized, each unique	80%
41	2011	Effective Management of Human Capital / Information Technology / Resources	Technology	Internal Data Sharing	% Data and Process Redudancy/Data discrepancy between legacy systems	13% (estimated) of code/data is duplicative	10%	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	0% Devices	80% Devices	TBD
43	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	# of imported products successfully screened in 2 hour window via automated screening processes	18 Million	19 Million	TBD
44	2011	Effective Management of Human Capital / Information Technology / Resources	Customer Results	Customer Complaints	% Reduction in complaints about screens	50% of comments are complaints	45%	TBD
45	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of WF Planning/scheduling functions in current stovepipes integrated	45%	60%	TBD
46	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	# of operations available on mobile devices	5	6	TBD
47	2012	Effective Management of Human Capital / Information Technology / Resources	Technology	Internal Data Sharing	% Data and Process Redudancy/Data discrepancy between legacy systems	10% (estimated) of code/data is duplicative	8%	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	0% Regulated Products	80% Regulated Products	TBD
49	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Complaints	% Reduction in complaints about screens	45% of comments are complaints	40%	TBD
50	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Workforce Planning	% of WF Planning/scheduling functions in current stovepipes integrated	60%	70%	TBD

1. Is this investment included in your agency's target enterprise architecture?

yes

2. Is this investment included in the agency's EA Transition Strategy?

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	Partner Relationship Management	Defines the set of capabilities that provide a framework to promote the effective collaboration between an organization and its business partners, particularly members of the distribution chain (e.g., channel and alliance partners, resellers, agents, brokers, and dealers) and other third parties that support operations and service delivery to an organization's customers; includes performance evaluation of partners, if necessary.	Customer Relationship Management	Partner Relationship Management	Partner Relationship Management	009-02-01-02-02-1020-00	Internal	3
2	Online Help	Defines the set of capabilities that provide an electronic interface to customer assistance.	Customer Initiated Assistance	Online Help	Online Help	009-02-01-02-02-1020-00	Internal	1
3	Online Tutorials	Defines the set of capabilities that provide an electronic interface to educate and assist customers.	Customer Initiated Assistance	Online Tutorials	Online Tutorials	009-02-01-02-02-1020-00	Internal	1
4	Process Tracking	Defines the set of capabilities that allow the monitoring of activities within the business cycle.	Tracking and Workflow	Process Tracking			No Reuse	3
5	Case Management	Defines the set of capabilities that manage the life cycle of a particular claim or investigation within an organization to include creating, routing, tracing, assignment and closing of a case as well as collaboration among case handlers.	Tracking and Workflow	Case Management			No Reuse	4
6	Conflict Resolution	Defines the set of capabilities that support the conclusion of contention or differences within the business cycle.	Tracking and Workflow	Conflict Resolution			No Reuse	1
7	Outbound Correspondence Management	Defines the set of capabilities that manage internally initiated communication between an organization and its stakeholders.	Routing and Scheduling	Outbound Correspondence Management			No Reuse	1
8	Modeling	Defines the set of capabilities that develop descriptions to adequately explain relevant data for the purpose of prediction, pattern detection, exploration or general organization of data.	Knowledge Discovery	Modeling	Modeling	009-02-01-02-02-1020-00	Internal	1
9	Mathematical	Defines the set of capabilities that support the formulation and mathematical analysis of probabilistic models for random phenomena and the development and investigation of methods and principles for statistical inference.	Analysis and Statistics	Mathematical			No Reuse	1
10	Ad Hoc	Defines the set of capabilities that support the use of dynamic reports on an as needed basis.	Reporting	Ad Hoc			No Reuse	1
11	Decision Support and Planning	Defines the set of capabilities that support the analyze information and predict the impact of decisions before they are made.	Business Intelligence	Decision Support and Planning	Decision Support and Planning	009-02-01-02-02-1020-00	Internal	4
12	Configuration Management	Defines the set of capabilities that control the hardware and software environments, as well as documents of an organization.	Management of Processes	Configuration Management			No Reuse	1
13	Change Management	Defines the set of capabilities that control the process for updates or modifications to the existing documents, software or business processes of an organization.	Management of Processes	Change Management			No Reuse	1
14	Requirements Management	Defines the set of capabilities that gather, analyze and fulfill the needs and prerequisites of an organization's efforts.	Management of Processes	Requirements Management			No Reuse	1
15	Loading and Archiving	Defines the set of capabilities that support the population of a data source with external data.	Data Management	Loading and Archiving			No Reuse	1
16	Governance / Policy Management	Defines the set of capabilities that influence and determine decisions, actions, business rules and other matters within an organization.	Management of Processes	Governance / Policy Management			No Reuse	4
17	Quality Management	Defines the set of capabilities that help determine the level that a product or service satisfies certain requirements.	Management of Processes	Quality Management			No Reuse	3
18	Business Rule Management	Defines the set of capabilities that manage the enterprise processes that support an organization and its policies.	Management of Processes	Business Rule Management	Business Rule Management	009-02-01-02-02-1020-00	Internal	4
19	Risk Management	Risk Management - support the identification and probabilities or chances of hazards as they relate to a task, decision or long-term goal; includes risk assessment and risk mitigation.	Management of Processes	Risk Management	Risk Management	009-02-01-02-02-1020-00	Internal	4
20	Workgroup / Groupware	Defines the set of capabilities that support multiple users working on related tasks.	Organizational Management	Workgroup / Groupware			No Reuse	1
21	Content Review and Approval	Defines the capabilities that allow for the approval of interactive programs.	Content Management	Content Review and Approval			No Reuse	1
22	Content Publishing and Delivery	Defines the set of capabilities that allow for the propagation of interactive programs.	Content Management	Content Publishing and Delivery			No Reuse	1
23	Document Referencing	Defines the set of capabilities that support the redirection to other documents and information for related content.	Document Management	Document Referencing			No Reuse	1
24	Document Revisions	Defines the set of capabilities that support the versioning and editing of content and documents.	Document Management	Document Revisions			No Reuse	1
25	Library / Storage	Defines the set of capabilities that support document and data warehousing and archiving.	Document Management	Library / Storage			No Reuse	1
26	Document Review and Approval	Defines the set of capabilities that support the editing and commendation of documents before releasing them.	Document Management	Document Review and Approval			No Reuse	1
27	Knowledge Capture	Defines the set of capabilities that facilitate collection of data and information.	Knowledge Management	Knowledge Capture			No Reuse	3
28	Knowledge Distribution and Delivery	Defines the set of capabilities that support the transfer of knowledge to the end customer.	Knowledge Management	Knowledge Distribution and Delivery			No Reuse	1
29	Information Retrieval	Defines the set of capabilities that allow access to data and information for use by an organization and its stakeholders.	Knowledge Management	Information Retrieval	Information Retrieval	009-02-01-02-02-1020-00	Internal	1
30	Information Sharing	Defines the set of capabilities that support the use of documents and data in a multi-user environment for use by an organization and its stakeholders.	Knowledge Management	Information Sharing	Information Sharing	009-02-01-02-02-1020-00	Internal	1
31	Contact and Profile Management	Defines the set of capabilities that provide a comprehensive view of all customer interactions, including calls, email, correspondence and meetings; also provides for the maintenance of a customer's account, business and personal information.	Customer Relationship Management	Contact and Profile Management	Contact and Profile Management	009-02-01-02-02-1020-00	Internal	1
32	Customer Analytics	Defines the set of capabilities that allow for the analysis of an organizations customers as well as the scoring of third party information as it relates to an organization's customers.	Customer Relationship Management	Customer Analytics	Customer Analytics	009-02-01-02-02-1020-00	Internal	4
33	Scheduling	Defines the set of capabilities that support the plan for performing work or services to meet the needs of an organization's customers.	Customer Initiated Assistance	Scheduling			No Reuse	1
34	Data Mining	Defines the set of capabilities that provide for the efficient discovery of non-obvious, valuable patterns and relationships within a large collection of data.	Knowledge Discovery	Data Mining			No Reuse	5
35	Simulation	Defines the set of capabilities that utilize models to mimic real-world processes.	Knowledge Discovery	Simulation			No Reuse	1
36	Legacy Integration	Defines the set of capabilities that support the communication between newer generation hardware/software applications and the previous, major generation of hardware/software applications.	Development and Integration	Legacy Integration			No Reuse	5
37	Data Integration	Defines the set of capabilities that support the organization of data from separate data sources into a single source using middleware or application integration and the modification of system data models to capture new information within a single system.	Development and Integration	Data Integration			No Reuse	1
38	Instrumentation and Testing	Defines the set of capabilities that support the validation of application or system capabilities and requirements.	Development and Integration	Instrumentation and Testing			No Reuse	5
39	Software Development	Defines the set of capabilities that support the creation of both graphical and process application or system software.	Development and Integration	Software Development			No Reuse	1
40	Identification and Authentication	Defines the set of capabilities that support obtaining information about those parties attempting to log on to a system or application for security purposes and the validation of those users.	Security Management	Identification and Authentication			No Reuse	1
41	Access Control	Access Control - Support the management of permissions for logging onto a computer, application, service, or network; includes user management and role/privilege management.	Security Management	Access Control			No Reuse	1
42	Digital Signature Management	Defines the set of capabilities that guarantee the unaltered state of a file.	Security Management	Digital Signature Management			No Reuse	1
43	Audit Trail Capture and Analysis	Audit Trail Capture and Analysis - Support the identification and monitoring of activities within an application, system, or network.	Security Management	Audit Trail Capture and Analysis			No Reuse	1
44	Document Library	Defines the set of capabilities that support the grouping and archiving of files and records on a server.	Collaboration	Document Library			No Reuse	1
45	Query	Defines the set of capabilities that support retrieval of records that satisfy specific query selection criteria.	Search	Query			No Reuse	1
46	Precision / Recall Ranking	Defines the set of capabilities that support selection and retrieval of records ranked to optimize precision against recall.	Search	Precision / Recall Ranking			No Reuse	1
47	Classification	Defines the set of capabilities that support selection and retrieval of records organized by shared characteristics in content or context.	Search	Classification			No Reuse	1
48	Pattern Matching	Defines the set of capabilities that support retrieval of records generated from a data source by imputing characteristics based on patterns in the content or context.	Search	Pattern Matching			No Reuse	5
49	Issue Tracking	Defines the set of capabilities that receive and track user-reported issues and problems in using IT systems, including help desk calls.	Systems Management	Issue Tracking			No Reuse	2
50	Activity-Based Management	Defines the set of capabilities that support a defined, specific set of finance-related tasks for a given objective.	Financial Management	Activity-Based Management			No Reuse	1
51	Content Authoring	Defines the capabilities that allow for the creation of tutorials, CBT courseware, web sites, CD-ROMs and other interactive programs.	Content Management	Content Authoring			No Reuse	1
52	Data Exchange	Defines the set of capabilities that support the interchange of information between multiple systems or applications; includes verification that transmitted data was received unaltered.	Data Management	Data Exchange			No Reuse	2
53	Document Imaging and OCR	Defines the set of capabilities that support the scanning of documents.	Document Management	Document Imaging and OCR			No Reuse	1
54	Forms Creation	Defines the set of capabilities that support the design and generation of electronic or physical forms and templates for use within the business cycle by an organization and its stakeholders.	Forms Management	Forms Creation			No Reuse	1
55	Forms Modification	Defines the set of capabilities that support the maintenance of electronic or physical forms, templates and their respective elements and fields.	Forms Management	Forms Modification			No Reuse	1
56	Inbound Correspondence Management	Defines the set of capabilities that manage externally initiated communication between an organization and its stakeholders.	Routing and Scheduling	Inbound Correspondence Management			No Reuse	1
57	Internal Controls	Support the methods and procedures used by the organization to safeguard its assets, produce accurate accounting data and reports, contribute to efficient operations, and encourage staff to adhere to management policies and mission requirements	Financial Management	Internal Controls			No Reuse	5

5. To demonstrate how this major IT investment aligns with the FEA Technical Reference Model (TRM), please list the Service Areas, Categories, Standards, and Service Specifications supporting this IT investment.

FEA SRM Component: Service Components identified in the previous question should be entered in this column. Please enter multiple rows for FEA SRM Components supported by multiple TRM Service Specifications.

Service Specification: In the Service Specification field, Agencies should provide information on the specified technical standard or vendor product mapped to the FEA TRM Service Standard, including model or version numbers, as appropriate.

Row	SRM Component	>Service Area	Service Category	Service Standard	Service Specification (i.e., vendor and product name)
1	Information Retrieval	Service Access and Delivery	Access Channels	Web Browser	Internet Explorer
2	Digital Signature Management	Component Framework	Security	Certificates / Digital Signatures	Entrust
3	Identification and Authentication	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Oracle
4	Process Tracking	Service Access and Delivery	Delivery Channels	Intranet	Oracle, J2EE
5	Case Management	Service Access and Delivery	Service Requirements	Legislative / Compliance	508, Accessibility, Security, Privacy
6	Process Tracking	Service Platform and Infrastructure	Support Platforms	Platform Independent	Solaris
7	Process Tracking	Service Platform and Infrastructure	Support Platforms	Wireless / Mobile	Dell Notebooks
8	Process Tracking	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle
9	Quality Management	Component Framework	Business Logic	Platform Independent	Oracle
10	Instrumentation and Testing	Service Platform and Infrastructure	Software Engineering	Test Management	Mercury Interactive Road Runner
11	Configuration Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	PVCS, Rational Requisite Pro
12	Modeling	Service Platform and Infrastructure	Software Engineering	Modeling	Rational
13	Data Integration	Service Platform and Infrastructure	Database / Storage	Database	Oracle
14	Audit Trail Capture and Analysis	Service Platform and Infrastructure	Database / Storage	Storage	Storage Area Network
15	Loading and Archiving	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sunfire 6800
16	Loading and Archiving	Service Platform and Infrastructure	Hardware / Infrastructure	Embedded Technology Devices	Various
17	Ad Hoc	Service Platform and Infrastructure	Hardware / Infrastructure	Peripherals	Various
18	Information Retrieval	Service Platform and Infrastructure	Hardware / Infrastructure	Local Area Network (LAN)	Virtual Lan
19	Information Retrieval	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	PPP and Dial Up
20	Information Sharing	Service Platform and Infrastructure	Hardware / Infrastructure	Network Devices / Standards	2Gb Fiber Channel San connect
21	Access Control	Component Framework	Security	Certificates / Digital Signatures	Entrust
22	Information Retrieval	Component Framework	Presentation / Interface	Static Display	Hyper Text Markup Language (HTML)
23	Pattern Matching	Component Framework	Data Management	Reporting and Analysis	OLE/DB, JDBC
24	Issue Tracking	Component Framework	Business Logic	Platform Independent	Enterprise Java Beans
25	Query	Component Framework	Data Interchange	Data Exchange	MQ
26	Document Library	Service Platform and Infrastructure	Database / Storage	Database	Documentum
27	Information Retrieval	Component Framework	Data Management	Reporting and Analysis	Documentum, Business Objects, Adobe
28	Information Retrieval	Service Interface and Integration	Integration	Middleware	PL/SQL
29	Precision / Recall Ranking	Service Interface and Integration	Interoperability	Data Format / Classification	XML, PDF
30	Knowledge Capture	Service Interface and Integration	Interoperability	Data Types / Validation	XLM Schema, DTD
31	Online Tutorials	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Oracle, J2EE
32	Online Help	Service Access and Delivery	Access Channels	Web Browser	xml, pdf
33	Partner Relationship Management	Component Framework	Data Interchange	Data Exchange	Oracle, J2EE
34	Contact and Profile Management	Component Framework	Data Interchange	Data Exchange	Oracle, J2EE
35	Customer Analytics	Component Framework	Data Interchange	Data Exchange	Oracle, J2EE
36	Scheduling	Service Interface and Integration	Integration	Enterprise Application Integration	Oracle, J2EE
37	Conflict Resolution	Service Interface and Integration	Integration	Enterprise Application Integration	Oracle, J2EE
38	Outbound Correspondence Management	Service Interface and Integration	Integration	Enterprise Application Integration	Oracle
39	Mathematical	Component Framework	Data Management	Reporting and Analysis	ORACLE
40	Software Development	Service Platform and Infrastructure	Software Engineering	Integrated Development Environment	SOA
41	Change Management	Component Framework	Data Interchange	Data Exchange	Oracle, J2EE
42	Requirements Management	Component Framework	Data Interchange	Data Exchange	Oracle, J2EE
43	Quality Management	Service Platform and Infrastructure	Software Engineering	Test Management	Mercury Test Suite
44	Governance / Policy Management	Service Access and Delivery	Service Requirements	Legislative / Compliance	Oracle, J2EE
45	Business Rule Management	Component Framework	Business Logic	Platform Independent	Oracle, J2EE
46	Risk Management	Component Framework	Security	Supporting Security Services	PKI, Entrust
47	Content Review and Approval	Service Interface and Integration	Integration	Enterprise Application Integration	Documentum, Oracle
48	Document Referencing	Service Interface and Integration	Interoperability	Data Format / Classification	Documentum
49	Document Revisions	Service Interface and Integration	Interoperability	Data Format / Classification	Documentum
50	Library / Storage	Service Interface and Integration	Interoperability	Data Format / Classification	Documentum
51	Document Review and Approval	Service Interface and Integration	Integration	Enterprise Application Integration	Documentum
52	Knowledge Distribution and Delivery	Service Platform and Infrastructure	Hardware / Infrastructure	Wide Area Network (WAN)	Frame Relay, ATM
53	Information Retrieval	Service Platform and Infrastructure	Database / Storage	Database	Oracle
54	Case Management	Service Interface and Integration	Interoperability	Data Format / Classification	XML, XML Linking, EDI, DTD, SCL Schema
55	Workgroup / Groupware	Service Interface and Integration	Integration	Enterprise Application Integration	PBM, Transformation & Formatting,
56	Decision Support and Planning	Component Framework	Data Management	Reporting and Analysis	OLAP, XBRL, Business Objects
57	Content Publishing and Delivery	Service Access and Delivery	Delivery Channels	Internet	Oracle, J2EE
58	Data Mining	Component Framework	Data Management	Reporting and Analysis	OLAP, XBRL, Business Objects
59	Simulation	Component Framework	Data Management	Reporting and Analysis	OLAP, XBRL, Business Objects
60	Legacy Integration	Service Interface and Integration	Integration	Enterprise Application Integration	XML, XML Linking, EDI, DTD, SCL Schema

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.

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 accomated quickly. Where possible, higher risk projects are scheduled without time critical dependencies so that a schedule delay will not impact other projects, e.g. the Project Manager risk-adjusted the project and contractor team's schedule and costs for the Web and Unix conversions - two projects considered high risk due to the potential adverse impact on the field by adding more testing and modification than originally planned. For the Document Management project, project management planned/spent extra time developing a concept of operations and documenting high level requirements to ensure that the project's scope and contract delivery estimates were realistic. The combination of these approaches--risk-adjusted costs and substantial planning - have been applied to contracts, in addition to project managers applying risk mitigation strategies to the individual projects.

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

yes

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

no

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

no