| | Exhibit 300 (BY2009) for FDA Mission Accomplishments and Regulatory Compliance Services (MARCS)PART ONE
OVERVIEW
- 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
SUMMARY OF SPEND
- 1. Provide the total estimated life-cycle cost for this investment by completing the following table. All amounts represent budget authority in millions, and are rounded to three decimal places. Federal personnel costs should be included only in the row designated Government FTE Cost, and should be excluded from the amounts shown for Planning, Full Acquisition, and Operation/Maintenance. The total estimated annual cost of the investment is the sum of costs for Planning, Full Acquisition, and Operation/Maintenance. For Federal buildings and facilities, life-cycle costs should include long term energy, environmental, decommissioning, and/or restoration costs. The costs associated with the entire life-cycle of the investment should be included in this report.
All amounts represent Budget Authority
Note: For the cross-agency investments, this table should include all funding (both managing partner and partner agencies).
Government FTE Costs should not be included as part of the TOTAL represented. Cost Type | Py-1 & Earlier -2006 | PY 2007 | CY 2008 | BY 2009 |
---|
Planning Budgetary Resources | 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.
PERFORMANCE In order to successfully address this area of the exhibit 300, performance goals must be provided for the agency and be linked to the annual performance plan. The investment must discuss the agency's mission and strategic goals, and performance measures (indicators) must be provided. These goals need to map to the gap in the agency's strategic goals and objectives this investment is designed to fill. They are the internal and external performance benefits this investment is expected to deliver to the agency (e.g., improve efficiency by 60 percent, increase citizen participation by 300 percent a year to achieve an overall citizen participation rate of 75 percent by FY 2xxx, etc.). The goals must be clearly measurable investment outcomes, and if applicable, investment outputs. They do not include the completion date of the module, milestones, or investment, or general goals, such as, significant, better, improved that do not have a quantitative measure.
- Agencies must use the following table to report performance goals and measures for the major investment and use the Federal Enterprise Architecture (FEA) Performance Reference Model (PRM). Map all Measurement Indicators to the corresponding Measurement Area and Measurement Grouping identified in the PRM. There should be at least one Measurement Indicator for each of the four different Measurement Areas (for each fiscal year). The PRM is available at www.egov.gov. The table can be extended to include performance measures for years beyond FY 2009.
Row | Fiscal Year | Strategic Goal Supported | Measurement Area | Measurement Grouping | Measurement Indicator | Baseline | Planned Improvement to the Baseline | Actual Results |
---|
1 | 2006 | Effective Management of Human Capital/Information Technology/Resources | 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 |
Enterprise Architecture In order to successfully address this area of the business case and capital asset plan you must ensure the investment is included in the agency's EA and Capital Planning and Investment Control (CPIC) process, and is mapped to and supports the FEA. You must also ensure the business case demonstrates the relationship between the investment and the business, performance, data, services, application, and technology layers of the agency's EA. - 1. Is this investment included in your agency's target enterprise architecture?
- yes
- 2. Is this investment included in the agency's EA Transition Strategy?
- yes
- 2.a. If yes, provide the investment name as identified in the Transition Strategy provided in the agency's most recent annual EA Assessment.
- FDA 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) |
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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.
PART TWO
RISK You should perform a risk assessment during the early planning and initial concept phase of the investment's life-cycle, develop a risk-adjusted life-cycle cost estimate and a plan to eliminate, mitigate or manage risk, and be actively managing risk throughout the investment's life-cycle.
Answer the following questions to describe how you are managing investment risks. - 1. Does the investment have a Risk Management Plan?
- yes
- 1.a. If yes, what is the date of the plan?
- 2007-05-22
- 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.
COST & SCHEDULE
- 1. Does the earned value management system meet the criteria in ANSI/EIA Standard 748?
- yes
- 2. Is the CV% or SV% greater than ± 10%?
- no
- 3. Has the investment re-baselined during the past fiscal year?
- no
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