Exhibit 300 (BY2009) for Food and Drug Administration (FDA) MedWatch Plus

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	Frederick Sadler
Phone Number	301-827-6548
Title	Director, Division of Freedom of Information
Email	frederick.sadler@fda.hhs.gov

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

no

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

no

1. Provide the total estimated life-cycle cost for this investment by completing the following table. All amounts represent budget authority in millions, and are rounded to three decimal places. Federal personnel costs should be included only in the row designated Government FTE Cost, and should be excluded from the amounts shown for Planning, Full Acquisition, and Operation/Maintenance. The total estimated annual cost of the investment is the sum of costs for Planning, Full Acquisition, and Operation/Maintenance. For Federal buildings and facilities, life-cycle costs should include long term energy, environmental, decommissioning, and/or restoration costs. The costs associated with the entire life-cycle of the investment should be included in this report.

All amounts represent Budget Authority

Note: For the cross-agency investments, this table should include all funding (both managing partner and partner agencies).

Government FTE Costs should not be included as part of the TOTAL represented.

Cost Type	Py-1 & Earlier -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

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%

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.

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.

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