| | Exhibit 300 (BY2009) for Food and Drug Administration (FDA) MedWatch Plus PART ONE
OVERVIEW
- 1. Date of Submission:
- 2008-02-04
- 2. Agency:
- 009
- 3. Bureau:
- 10
- 4. Name of this Capital Asset:
- FDA MedWatch Plus (FY09)
- 5. Unique Project Identifier:
- 009-10-01-03-01-0042-00
- 6. What kind of investment will this be in FY2009?
- Planning
- 7. What was the first budget year this investment was submitted to OMB?
- FY2009
- 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 FDA receives more than 600,000 voluntary post-marketing adverse event (AE) reports annually from manufacturers, health care professionals and consumers for all FDA-regulated products. The reports are analyzed by FDA safety evaluators for product risk assessment. Currently, a variety of computer programs enter the AE report into various databases that contain an archive of more than 3 million AE reports. Not all AE reports are submitted electronically, and there are many paper and data entry steps at this time. Reviewers lack the most up-to-date signal detection technology in order to find patterns that could be buried in the massive amount of data being reviewed. The MedWatch Plus Investment will close the current performance gap to create a fully automated system that possesses up-to-date data with seamless integration points facilitating data sharing and more efficient reviews by the safety evaluators. This investment specifically aligns to the eGov PMA initiative. All FDA AE systems are being reviewed and considered for migration to the MedWatch Plus investment. This will allow the Agency to move away from the current environment of numerous disparate systems and position the FDA toward a fully electronic reporting process. As a result, the average unit cost to prepare and process AE reports will be reduced. It will also increase the consistency and timeliness of reports by utilizing standardized data collection processes. Moving towards an efficient fully electronic process, instituting a user-friendly website encouraging voluntary reports, consolidating the databases into a single data warehouse, and developing powerful tools for risk detection aligns the MedWatch Plus investment with the FDA strategic goal of improving patient and consumer safety and also with the DHHS strategic objective of improving health care quality, safety, cost, and value. The MedWatch Plus initiative will institute a single Internet portal with a user-friendly electronic submission capability for all who provide AE and product information to FDA, encouraging the reporting of information in a quality and uniform manner. Behind the portal will be a single agency-wide data warehouse of AE reports instead of various separate databases. This will enable data sharing through the seamless integration of data. FDA safety evaluators will possess the ability to make vital connections to AE data and strengthen risk detection by finding patterns in data.
- 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 |
---|
Expanded E-Government |
- 13.a. Briefly and specifically describe for each selected how this asset directly supports the identified initiative(s)? (e.g. If E-Gov is selected, is it an approved shared service provider or the managing partner?)
- This investment supports expanded e-gov by providing the public and industry with a single, web-enabled focal point to report adverse events. Once implemented, this system will triage the reports to the appropriate Center electronically for investigation providing the Agency with an enterprise-wide system for tracking and signal detection of adverse events. Currently, adverse events are collected by each Center, maintained in disparate databases and information exchanged manually.
- 14. Does this investment support a program assessed using the Program Assessment Rating Tool (PART)?
- no
- 15. Is this investment for information technology?
- yes
- 16. What is the level of the IT Project (per CIO Council's PM Guidance)?
- Level 2
- 17. What project management qualifications does the Project Manager have? (per CIO Council's PM Guidance)
- (1) Project manager has been validated as qualified for this investment
- 18. Is this investment identified as high risk on the Q4 - FY 2007 agency high risk report (per OMB memorandum M-05-23)?
- no
- 19. Is this a financial management system?
- no
- 19.a.2. If no, what does it address?
- The FDA receives more than 600,000 post-marketing adverse event reports annually. These reports are analyzed for safety problems and manually routed between Centers. All FDA adverse event systems are being reviewed and considered for migration to the MedWatch Plus investment to provide the Agency with an enterprise-wide system for tracking and signal detection of adverse events in FDA regulated products.
- 20. What is the percentage breakout for the total FY2009 funding request for the following? (This should total 100%)
Area | Percentage |
---|
Hardware | 0 | Software | 1 | Services | 72 | Other | 27 |
- 21. If this project produces information dissemination products for the public, are these products published to the Internet in conformance with OMB Memorandum 05-04 and included in your agency inventory, schedules and priorities?
- n/a
- 22. Contact information of individual responsible for privacy related questions.
Name | Brenda Dorsey | Phone Number | 301-827-6549 | Title | PROGRAM SUPPORT SPECIALIST | Email | Brenda.dorsey@fda.hhs.gov |
- 23. Are the records produced by this investment appropriately scheduled with the National Archives and Records Administration's approval?
- no
- 24. Does this investment directly support one of the GAO High Risk Areas?
- no
SUMMARY OF SPEND
- 1. Provide the total estimated life-cycle cost for this investment by completing the following table. All amounts represent budget authority in millions, and are rounded to three decimal places. Federal personnel costs should be included only in the row designated Government FTE Cost, and should be excluded from the amounts shown for Planning, Full Acquisition, and Operation/Maintenance. The total estimated annual cost of the investment is the sum of costs for Planning, Full Acquisition, and Operation/Maintenance. For Federal buildings and facilities, life-cycle costs should include long term energy, environmental, decommissioning, and/or restoration costs. The costs associated with the entire life-cycle of the investment should be included in this report.
All amounts represent Budget Authority
Note: For the cross-agency investments, this table should include all funding (both managing partner and partner agencies).
Government FTE Costs should not be included as part of the TOTAL represented. Cost Type | Py-1 & Earlier -2006 | PY 2007 | CY 2008 | BY 2009 |
---|
Planning Budgetary Resources | 0.000 | 0.384 | 1.901 | 3.298 | Acquisition Budgetary Resources | 0.000 | 1.087 | 11.893 | 5.350 | Maintenance Budgetary Resources | 0.000 | 0.000 | 0.000 | 1.721 | Government FTE Cost | 0.000 | 0.226 | 0.994 | 1.189 | # of FTEs | 0 | 2 | 8 | 9 |
- 2. Will this project require the agency to hire additional FTE's?
- no
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 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Technology | Interoperability | Percentage of adverse event reports submitted electronically compared to all adverse event reports - the first step toward fully electronic processing | 45% | 55% | | 2 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Costs | Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database | | | | 3 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Population Health Management and Consumer Safety | Increase in the total number of voluntary reports received for FDA regulated products submitted by subject matter professionals | 15,105 | 15,558 | | 4 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Customer Impact or Burden | Percentage of voluntary reports received over the internet compared to the total number of voluntary reports - this should increase when the user-friendly website is implemented | 51% | 53% | | 5 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Technology | Interoperability | Percentage of adverse event reports submitted electronically compared to all adverse event reports - the first step toward fully electronic processing | 55% | 60% | | 6 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Costs | Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database | | | | 7 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Population Health Management and Consumer Safety | Increase in the total number of voluntary reports received for FDA regulated products submitted by subject matter professionals | 15,558 | 16,336 | | 8 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Customer Impact or Burden | Percentage of voluntary reports received over the internet compared to the total number of voluntary reports - this should increase when the user-friendly website is implemented | 53% | 55% | | 9 | 2010 | S.O. 1.3 - Improve health care quality, safety, cost and value | Technology | Interoperability | Percentage of adverse event reports submitted electronically compared to all adverse event reports - the first step toward fully electronic processing | 60% | 70% | | 10 | 2010 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Costs | Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database | | | | 11 | 2010 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Population Health Management and Consumer Safety | Increase in the total number of voluntary reports received for FDA regulated products submitted by subject matter professionals | 16,336 | 17,153 | | 12 | 2010 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Customer Impact or Burden | Percentage of voluntary reports received over the internet compared to the total number of voluntary reports - this should increase when the user-friendly website is implemented | 55% | 56% | | 13 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Technology | Interoperability | Percentage of adverse event reports submitted electronically compared to all adverse event reports - the first step toward fully electronic processing | 70% | 77.50% | | 14 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Costs | Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database | | | | 15 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Population Health Management and Consumer Safety | Increase in the total number of voluntary reports received for FDA regulated products submitted by subject matter professionals | 17,153 | 18,011 | | 16 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Customer Impact or Burden | Percentage of voluntary reports received over the internet compared to the total number of voluntary reports - this should increase when the user-friendly website is implemented | 56% | 65% | | 17 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Technology | Interoperability | Percentage of adverse event reports submitted electronically compared to all adverse event reports - the first step toward fully electronic processing | 77.50% | 80% | | 18 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Costs | Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database | | | | 19 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Population Health Management and Consumer Safety | Increase in the total number of voluntary reports received for FDA regulated products submitted by subject matter professionals | 18,011 | 18,551 | | 20 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Customer Impact or Burden | Percentage of voluntary reports received over the internet compared to the total number of voluntary reports - this should increase when the user-friendly website is implemented | 65% | 66% | | 21 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Technology | Interoperability | Percentage of adverse event reports submitted electronically compared to all adverse event reports - the first step toward fully electronic processing | 80% | 81% | | 22 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Costs | Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database | | | | 23 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Population Health Management and Consumer Safety | Increase in the total number of voluntary reports received for FDA regulated products submitted by subject matter professionals | 18,551 | 19,107 | | 24 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Customer Impact or Burden | Percentage of voluntary reports received over the internet compared to the total number of voluntary reports - this should increase when the user-friendly website is implemented | 66% | 67% | |
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?
- no
- 2.b. If no, please explain why?
- This is a new investment, which did not exist at the time of the last EA Assessment.
- 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 | 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 | 3 | 2 | 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 | 3 | 3 | 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 | 3 | 4 | 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 | 3 | 5 | 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 | 3 | 6 | Query | Defines the set of capabilities that support retrieval of records that satisfy specific query selection criteria. | Search | Query | | | No Reuse | 3 | 7 | 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 | 3 | 8 | 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 | 3 | 9 | Document Conversion | Defines the set of capabilities that support the changing of files from one type of format to another. | Document Management | Document Conversion | | | No Reuse | 3 | 10 | Document Imaging and OCR | Defines the set of capabilities that support the scanning of documents. | Document Management | Document Imaging and OCR | | | No Reuse | 3 | 11 | Indexing | Defines the set of capabilities that support the rapid retrieval of documents through a structured numbering construct. | Document Management | Indexing | | | No Reuse | 3 | 12 | Library / Storage | Defines the set of capabilities that support document and data warehousing and archiving. | Document Management | Library / Storage | | | No Reuse | 3 | 13 | 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 | 3 | 14 | Document Revisions | Defines the set of capabilities that support the versioning and editing of content and documents. | Document Management | Document Revisions | | | No Reuse | 3 | 15 | 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 | 3 | 16 | Content Review and Approval | Defines the capabilities that allow for the approval of interactive programs. | Content Management | Content Review and Approval | | | No Reuse | 3 | 17 | Categorization | Defines the set of capabilities that allow classification of data and information into specific layers or types to support an organization. | Knowledge Management | Categorization | | | No Reuse | 3 | 18 | 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 | | | No Reuse | 3 | 19 | 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 | | | No Reuse | 3 | 20 | Standardized / Canned | Defines the set of capabilities that support the use of pre-conceived or pre-written reports. | Reporting | Standardized / Canned | | | No Reuse | 3 | 21 | Ad Hoc | Defines the set of capabilities that support the use of dynamic reports on an as needed basis. | Reporting | Ad Hoc | | | No Reuse | 3 | 22 | Imagery | Defines the set of capabilities that support the creation of film or electronic images from pictures or paper forms | Visualization | Imagery | | | No Reuse | 3 | 23 | Data Classification | Defines the set of capabilities that allow the classification of data. | Data Management | Data Classification | | | No Reuse | 3 | 24 | Data Cleansing | Defines the set of capabilities that support the removal of incorrect or unnecessary characters and data from a data source. | Data Management | Data Cleansing | | | No Reuse | 3 | 25 | Extraction and Transformation | Defines the set of capabilities that support the manipulation and change of data. | Data Management | Extraction and Transformation | | | No Reuse | 3 | 26 | 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 | 3 | 27 | 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 | 3 | 28 | 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 | 3 | 29 | 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 | 3 | 30 | 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 | | | No Reuse | 3 | 31 | 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 | 3 | 32 | 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 | 3 | 33 | Alerts and Notifications | Defines the set of capabilities that allow a customer to be contacted in relation to a subscription or service of interest. | Customer Preferences | Alerts and Notifications | | | No Reuse | 3 | 34 | Online Help | Defines the set of capabilities that provide an electronic interface to customer assistance. | Customer Initiated Assistance | Online Help | | | No Reuse | 3 | 35 | Certification and Accreditation | Certification and Accreditation - Supports the certification and accreditation (C&A) of federal information systems, as described in NIST SP800-37. | Security Management | Certification and Accreditation | | | No Reuse | 3 | 36 | Intrusion Prevention | Intrusion Prevention - Includes penetration testing and other measures to prevent unauthorized access to a government information system. | Security Management | Intrusion Prevention | | | No Reuse | 3 |
- 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 | Audit Trail Capture and Analysis | Service Platform and Infrastructure | Software Engineering | Software Configuration Management | TBD | 2 | Identification and Authentication | Component Framework | Security | Certificates / Digital Signatures | TBD | 3 | Access Control | Service Access and Delivery | Service Requirements | Authentication / Single Sign-on | TBD | 4 | Precision / Recall Ranking | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 5 | Pattern Matching | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 6 | Query | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 7 | Classification | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 8 | Document Library | Service Platform and Infrastructure | Database / Storage | Database | TBD | 9 | Document Conversion | Service Interface and Integration | Interoperability | Data Transformation | TBD | 10 | Document Imaging and OCR | Component Framework | Data Management | Database Connectivity | TBD | 11 | Indexing | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 12 | Library / Storage | Service Platform and Infrastructure | Database / Storage | Database | TBD | 13 | Document Review and Approval | Component Framework | Data Management | Reporting and Analysis | TBD | 14 | Document Revisions | Component Framework | Data Interchange | Data Exchange | TBD | 15 | Content Authoring | Service Interface and Integration | Interoperability | Data Format / Classification | TBD | 16 | Content Review and Approval | Component Framework | Presentation / Interface | Content Rendering | TBD | 17 | Categorization | Service Interface and Integration | Interoperability | Data Format / Classification | TBD | 18 | Information Sharing | Component Framework | Presentation / Interface | Content Rendering | TBD | 19 | Information Retrieval | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 20 | Standardized / Canned | Component Framework | Data Management | Reporting and Analysis | TBD | 21 | Ad Hoc | Component Framework | Data Management | Reporting and Analysis | TBD | 22 | Imagery | Component Framework | Data Management | Reporting and Analysis | TBD | 23 | Data Classification | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 24 | Data Cleansing | Service Platform and Infrastructure | Interoperability | Data Transformation | TBD | 25 | Extraction and Transformation | Service Platform and Infrastructure | Interoperability | Data Transformation | TBD | 26 | Loading and Archiving | Service Platform and Infrastructure | Database / Storage | Database | TBD | 27 | Data Exchange | Service Access and Delivery | Service Transport | Service Transport | TBD | 28 | Legacy Integration | Service Platform and Infrastructure | Delivery Servers | Application Servers | TBD | 29 | Data Integration | Component Framework | Data Management | Reporting and Analysis | TBD | 30 | Business Rule Management | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 31 | Governance / Policy Management | Service Platform and Infrastructure | Interoperability | Data Format / Classification | TBD | 32 | Configuration Management | Service Platform and Infrastructure | Software Engineering | Software Configuration Management | TBD | 33 | Alerts and Notifications | Component Framework | Data Interchange | Data Exchange | TBD | 34 | Online Help | Component Framework | Presentation / Interface | Content Rendering | TBD | 35 | Certification and Accreditation | Component Framework | Security | Supporting Security Services | TBD | 36 | Intrusion Prevention | Component Framework | Data Management | Reporting and Analysis | TBD |
- 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.
- The MedWatch Plus initiative will initially utilize adverse event reporting systems from three FDA Centers (CDER, CBER & CDRH). As planning continues, assessments will be made as to further identify and leverage other applications across the agency.
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?
- 2007-08-09
- 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:
- The lifecycle costs for this investment are risk-adjusted and the investment schedule has been developed in incremental phases with built in stage-gate reviews to provide opportunities to adjust the schedule accordingly and rebaseline based on previous development increments.
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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