Exhibit 300 (BY2010) for FDA MedWatch Plus

1. Date of Submission:

2008-09-08

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA MedWatch Plus

5. Unique Project Identifier:

009-10-01-03-01-0042-00

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

Mixed Life Cycle

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

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. Additionally, 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 includes two system components, the MedWatch Plus Portal to receive and process AE reports, and the FDA Adverse Events Reporting System (FAERS) to allow for scientific and quantitative analysis of received reports. The MedWatch Plus Portal will institute a single Internet portal with a user-friendly electronic submission capability, encouraging the reporting of information in a quality and uniform manner. Behind the portal will be FAERS, 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. Medwatch Plus specifically aligns to the eGov PMA initiative. An outcome of this investment will be to reduce, the average unit cost to prepare and process AE reports. 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.

9. Did the Agency's Executive/Investment Committee approve this request?

yes

9.a. If "yes," what was the date of this approval?

2008-07-21

10. Did the Project Manager review this Exhibit?

yes

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

Waiver Issued

11.b. When was the Program/Project Manager Assigned?

2007-03-19

11.c. What date did the Program/Project Manager receive the FACP/PM certification? If the certification has not been issued, what is the anticipated date for certification?

2009-07-31

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

yes

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

yes

12.b. Is this investment for new construction or major retrofit of a Federal building or facility? (answer applicable to non-IT assets only)

no

13. Does this investment directly support one of the PMA initiatives?

yes

If yes, select the initiatives that apply:

Initiative Name
Expanded E-Government

13.a. Briefly and specifically describe for each selected how this asset directly supports the identified initiative(s)? (e.g. If E-Gov is selected, is it an approved shared service provider or the managing partner?)

The MedWatchPlus Initiative is to improve the collection and processing of adverse event information for all FDA-regulated products. The primary goal is to develop a user-friendly electronic submission capability for all who provide safety information to FDA. This capability will facilitate submission of safety reports and better allow FDA to use the information to promote and protect the public health. Currently, the majority of this data is submitted to the FDA in paper format.

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)?

yes

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	6
Services	81
Other	12

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

yes

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

Name	Fred Sadler
Phone Number	301-827-6567
Title	FDA Privacy Act Officer
Email	frederick.sadler@fda.hhs.gov

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

yes

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

yes

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

All amounts represent Budget Authority

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

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

Cost Type	Py-1 & Earlier -2007	PY 2008	CY 2009	BY 2010
Planning Budgetary Resources	0.508	1.901	3.790	2.400
Acquisition Budgetary Resources	2.525	11.893	20.199	13.789
Maintenance Budgetary Resources	0.000	0.000	2.500	4.630
Government FTE Cost	0.226	0.960	1.080	1.373
# of FTEs	2	8	9	10

2. Will this project require the agency to hire additional FTE's?

no

3. If the summary of spending has changed from the FY2008 President's budget request, briefly explain those changes.

Funding is increased by P.L. 110-252, the "Supplemental Appropriations Act, 2008", signed into law on June 30, 2008. The appropriation increases the budget authority for increasing food protection, enhancing the safety of drugs, medical devices and biologics, and boosting the strength of the agency's workforce. Due to the short time between receiving the appropriation and submitting the FY2010 President's Budget Request, a full impact analysis is not complete. Once the analysis is complete, the Business Case will be updated to reflect the additional funding.

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	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted electronically compared to all AE reports submitted	45%	55%	55%
2	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	$15	$13	$13
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	19,038
4	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	51%	53%	na
5	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted to all AE reports submitted	45%	55%
6	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	$13	12.50
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 percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	15,105	15,558
8	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	51%	53%
9	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted electronically compared to all AE reports submitted	60%	70%
10	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	12.50	$10
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 percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	16,336	17,153
12	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	55%	56%
13	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted electronically compared to all AE reports submitted	70%	77.50%
14	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	$10	$8
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 percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	17,153	18,011
16	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	56%	65%
17	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted electronically compared to all AE reports submitted	77.50%	80%
18	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	$8	$7.50
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 percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	18,011	18,551
20	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	65%	66%
21	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted electronically compared to all AE reports submitted	80%	81%
22	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	$7.50	$7.25
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 percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	18,551	19,107
24	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	66%	67%
25	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Accessibility	Increase in the percentage of all Adverse Event (AE) reports submitted electronically compared to all AE reports submitted	81%	82%
26	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Reduce unit cost associated with turning a submitted Adverse Event Report into a verified record in a database	$7.25	$7.00
27	2014	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 percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	19,107	19,698
28	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Customer Impact or Burden	Increase in the percentage of reports via the user friendly, web-based, single-step rational questionnaire vs. the percentage submitted via the multi-step paper process by voluntary reporters	67%	68%
29	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Efficiency	Decreased time converting a voluntarily submitted AE report into a verified/useable record in a database	6.5 days	5 days

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 MedWatch Plus

3. Is this investment identified in a completed (contains a target architecture) and approved segment architecture?

no

4. Identify the service components funded by this major IT investment (e.g., knowledge management, content management, customer relationship management, etc.). Provide this information in the format of the following table. For detailed guidance regarding components, please refer to http://www.whitehouse.gov/omb/egov/.

Component: Use existing SRM Components or identify as NEW. A NEW component is one not already identified as a service component in the FEA SRM.

Reused Name and UPI: A reused component is one being funded by another investment, but being used by this investment. Rather than answer yes or no, identify the reused service component funded by the other investment and identify the other investment using the Unique Project Identifier (UPI) code from the OMB Ex 300 or Ex 53 submission.

Internal or External Reuse?: Internal reuse is within an agency. For example, one agency within a department is reusing a service component provided by another agency within the same department. External reuse is one agency within a department reusing a service component provided by another agency in another department. A good example of this is an E-Gov initiative service being reused by multiple organizations across the federal government.

Funding Percentage: Please provide the percentage of the BY requested funding amount used for each service component listed in the table. If external, provide the funding level transferred to another agency to pay for the service.

Row	Agency Component Name	Agency Component Description	Service Type	Component	Reused Component Name	Reused UPI	Internal or External Reuse?	Funding %
1	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Library / Storage			No Reuse	2
2	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Security Management	Identification and Authentication			No Reuse	3
3	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Development and Integration	Enterprise Application Integration			No Reuse	1
4	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Data Warehouse			No Reuse	1
5	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Loading and Archiving			No Reuse	1
6	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Library / Storage			No Reuse	1
7	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Document Review and Approval			No Reuse	2
8	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Knowledge Management	Categorization			No Reuse	1
9	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Customer Initiated Assistance	Online Help			No Reuse	2
10	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Development and Integration	Legacy Integration			No Reuse	2
11	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Collaboration	Document Library			No Reuse	1
12	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Data Cleansing			No Reuse	1
13	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Knowledge Management	Information Sharing			No Reuse	4
14	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Search	Query			No Reuse	1
15	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Document Conversion			No Reuse	1
16	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Content Management	Content Review and Approval			No Reuse	1
17	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Loading and Archiving			No Reuse	3
18	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Search	Classification			No Reuse	3
19	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Content Management	Content Publishing and Delivery			No Reuse	1
20	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Search	Classification			No Reuse	1
21	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Search	Pattern Matching			No Reuse	3
22	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Extraction and Transformation			No Reuse	3
23	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Security Management	Intrusion Detection			No Reuse	1
24	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Customer Preferences	Alerts and Notifications			No Reuse	1
25	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Management of Processes	Business Rule Management			No Reuse	3
26	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Content Management	Content Authoring			No Reuse	1
27	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Security Management	Identification and Authentication			No Reuse	1
28	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Visualization	Imagery			No Reuse	1
29	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Development and Integration	Enterprise Application Integration			No Reuse	3
30	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Reporting	Ad Hoc			No Reuse	1
31	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Indexing			No Reuse	2
32	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Development and Integration	Data Integration			No Reuse	3
33	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Customer Initiated Assistance	Online Help			No Reuse	1
34	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Search	Query			No Reuse	4
35	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Systems Management	License Management			No Reuse	1
36	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Reporting	Standardized / Canned			No Reuse	4
37	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Security Management	Intrusion Prevention			No Reuse	1
38	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Data Exchange			No Reuse	1
39	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Customer Relationship Management	Surveys			No Reuse	1
40	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Knowledge Management	Information Retrieval			No Reuse	4
41	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Customer Preferences	Alerts and Notifications			No Reuse	3
42	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Document Review and Approval			No Reuse	1
43	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Knowledge Management	Information Retrieval			No Reuse	1
44	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Routing and Scheduling	Inbound Correspondence Management			No Reuse	1
45	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Reporting	Ad Hoc			No Reuse	4
46	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Customer Initiated Assistance	Reservations / Registration			No Reuse	1
47	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Security Management	Audit Trail Capture and Analysis			No Reuse	3
48	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Management of Processes	Business Rule Management			No Reuse	1
49	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Security Management	Audit Trail Capture and Analysis			No Reuse	1
50	FDA Adverse Event Reporting System	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Document Revisions			No Reuse	2
51	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Document Imaging and OCR			No Reuse	1
52	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Indexing			No Reuse	1
53	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Development and Integration	Legacy Integration			No Reuse	1
54	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Search	Pattern Matching			No Reuse	1
55	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Extraction and Transformation			No Reuse	1
56	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Knowledge Management	Information Sharing			No Reuse	1
57	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Document Management	Document Revisions			No Reuse	1
58	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Data Management	Data Classification			No Reuse	1
59	MedWatch Plus Portal	The MedWatch Plus system's mission is to provide FDA and other stakeholders, such as the general public and other federal agencies (e.g. USDA, NIH, CDC) with an efficient modern method for collecting, processing and disseminating information about adverse events reported to FDA. The FDA receives more than 600,000 post-marketing adverse event reports annually from manufacturers by regulation and from health care professionals and consumers voluntarily for all FDA-regulated products.	Reporting	Standardized / Canned			No Reuse	1

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	Library / Storage	Component Framework	Data Interchange	Data Exchange	Oracle by: Oracle Corporation
2	Identification and Authentication	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Business Objects by: SAP AG
3	Enterprise Application Integration	Service Interface and Integration	Integration	Enterprise Application Integration	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
4	Data Warehouse	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
5	Loading and Archiving	Service Interface and Integration	Interoperability	Data Format / Classification	NCI Thesaurus by: National Cancer Institute
6	Library / Storage	Service Access and Delivery	Service Transport	Service Transport	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
7	Document Review and Approval	Service Access and Delivery	Service Transport	Supporting Network Services	Lightweight Directory Access Protocol by: The Internet Engineering Task Force
8	Categorization	Component Framework	Business Logic	Platform Dependent Technologies	Oracle by: Oracle Corporation
9	Online Help	Service Access and Delivery	Service Transport	Service Transport	Internet Protocol v4 by: The Internet Engineering Task Force
10	Online Help	Service Access and Delivery	Service Transport	Service Transport	Internet Protocol v6 by: The Internet Engineering Task Force
11	Legacy Integration	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
12	Document Library	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Oracle by: Oracle Corporation
13	Data Cleansing	Component Framework	Data Management	Database Connectivity	Business Objects by: SAP AG
14	Information Sharing	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
15	Query	Service Interface and Integration	Integration	Middleware	Structured Query Language by: International Organization for Standardization
16	Document Conversion	Service Platform and Infrastructure	Hardware / Infrastructure	Local Area Network (LAN)	Ethernet by: Institute of Electrical and Electronics Engineers
17	Content Review and Approval	Service Access and Delivery	Service Transport	Service Transport	Internet Protocol v6 by: The Internet Engineering Task Force
18	Loading and Archiving	Service Access and Delivery	Delivery Channels	Internet	Hypertext Transfer Protocol -- HTTP/1.1 by: The Internet Engineering Task Force
19	Classification	Service Interface and Integration	Interoperability	Data Format / Classification	NCI Thesaurus by: National Cancer Institute
20	Content Publishing and Delivery	Service Access and Delivery	Service Transport	Service Transport	Internet Protocol v4 by: The Internet Engineering Task Force
21	Classification	Service Access and Delivery	Delivery Channels	Internet	Hypertext Transfer Protocol -- HTTP/1.1 by: The Internet Engineering Task Force
22	Pattern Matching	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Dynamic Hypertext Markup Language by: TBD
23	Extraction and Transformation	Component Framework	User Presentation / Interface	Static Display	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
24	Intrusion Detection	Service Access and Delivery	Service Transport	Supporting Network Services	Lightweight Directory Access Protocol by: The Internet Engineering Task Force
25	Alerts and Notifications	Service Access and Delivery	Service Transport	Service Transport	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
26	Business Rule Management	Service Interface and Integration	Interoperability	Data Format / Classification	HL7 Messaging Standard Version 3.0 by: Health Level Seven, Inc.
27	Content Authoring	Component Framework	User Presentation / Interface	Content Rendering	Dynamic Hypertext Markup Language by: TBD
28	Identification and Authentication	Component Framework	Business Logic	Platform Dependent Technologies	Oracle by: Oracle Corporation
29	Imagery	Service Access and Delivery	Access Channels	Web Browser	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
30	Ad Hoc	Service Platform and Infrastructure	Database / Storage	Database	Structured Query Language by: International Organization for Standardization
31	Indexing	Service Interface and Integration	Interface	Service Description / Interface	Business Objects by: SAP AG
32	Data Integration	Component Framework	Data Management	Database Connectivity	Oracle by: Oracle Corporation
33	Online Help	Service Interface and Integration	Interoperability	Data Format / Classification	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
34	Query	Service Platform and Infrastructure	Database / Storage	Database	Structured Query Language by: International Organization for Standardization
35	License Management	Service Interface and Integration	Interface	Service Description / Interface	Oracle by: Oracle Corporation
36	Standardized / Canned	Service Interface and Integration	Interface	Service Description / Interface	Oracle by: Oracle Corporation
37	Intrusion Prevention	Component Framework	Security	Supporting Security Services	Lightweight Directory Access Protocol by: The Internet Engineering Task Force
38	Data Exchange	Component Framework	Data Interchange	Data Exchange	Oracle by: Oracle Corporation
39	Surveys	Service Access and Delivery	Service Transport	Service Transport	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
40	Information Retrieval	Service Interface and Integration	Interoperability	Data Format / Classification	Extensible Markup Language (XML) 1.1 by: World Wide Web Consortium
41	Alerts and Notifications	Service Interface and Integration	Interoperability	Data Format / Classification	Codes for the representation of names of countries and their subdivisions by: International Organization for Standardization
42	Alerts and Notifications	Service Interface and Integration	Interoperability	Data Format / Classification	Codes for the Identification of the States, the District of Columbia and the Outlying Areas of the United States, and Associated Areas by: National Institute of Standards and Technology
43	Document Review and Approval	Component Framework	Data Management	Reporting and Analysis	Oracle by: Oracle Corporation
44	Information Retrieval	Service Interface and Integration	Interoperability	Data Format / Classification	Codes for the representation of names of countries and their subdivisions by: International Organization for Standardization
45	Inbound Correspondence Management	Service Interface and Integration	Interface	Service Description / Interface	Business Objects by: SAP AG
46	Ad Hoc	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
47	Reservations / Registration	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
48	Audit Trail Capture and Analysis	Component Framework	User Presentation / Interface	Content Rendering	Dynamic Hypertext Markup Language by: TBD
49	Business Rule Management	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Dynamic Hypertext Markup Language by: TBD
50	Audit Trail Capture and Analysis	Service Interface and Integration	Interface	Service Description / Interface	Oracle by: Oracle Corporation
51	Document Revisions	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG
52	Document Imaging and OCR	Component Framework	User Presentation / Interface	Static Display	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
53	Indexing	Component Framework	Data Management	Database Connectivity	Oracle by: Oracle Corporation
54	Legacy Integration	Service Platform and Infrastructure	Database / Storage	Database	Business Objects by: SAP AG
55	Pattern Matching	Component Framework	User Presentation / Interface	Static Display	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
56	Extraction and Transformation	Service Interface and Integration	Interoperability	Data Transformation	Oracle by: Oracle Corporation
57	Information Sharing	Service Access and Delivery	Service Transport	Service Transport	Internet Protocol v6 by: The Internet Engineering Task Force
58	Data Classification	Service Interface and Integration	Interoperability	Data Format / Classification	Codes for the Identification of the States, the District of Columbia and the Outlying Areas of the United States, and Associated Areas by: National Institute of Standards and Technology
59	Data Classification	Service Interface and Integration	Interoperability	Data Format / Classification	HL7 Messaging Standard Version 3.0 by: Health Level Seven, Inc.
60	Standardized / Canned	Service Interface and Integration	Interoperability	Data Format / Classification	Oracle by: Oracle Corporation

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 systems will accept HL7 electronic submissions as well as have the capability to transfer AE data to other agencies including the National Institutes of Health (NIH), the Centers for Disease Control (CDC) and the United States of Department of Agriculture (USDA) as needed.

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?

2008-06-27

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 MedWatch Plus investment is a new investment currently in the concept stage. The milestones for the investment were developed at a high-level for planning purposes. The project is currently finalizing the requirements and in the process of selecting a commercial-off-the-shelf (COTS) product for integration and configuration. As part of the project plan, a final COTS product will be selected in November 2008. Once the final COTs product is selected, the investment will develop a more conscice and detailed plan utilizing year to year milestones whenever possible. In the meantime, a project boundary document and concept of operations has been developed and approved to assist in managing project scope. The project scope plan is under review by senior management and describes the approach for serial releases over a three year period. The releases will group functionality based on agency priorities and recent laws and regulations related to post market safety surveillance. As such, 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.

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

2.b. If yes, explain the variance.

The MedWatch Plus investment is a new investment currently in the concept stage. The milestones for the investment were developed at a high-level for planning purposes. The project is currently finalizing the requirements and in the process of selecting a commercial-off-the-shelf (COTS) product for integration and configuration. As part of the project plan, a final COTS product will be selected in November 2008. Once the final COTs product is selected, the investment will develop a more conscice and detailed plan utilizing year to year milestones whenever possible. The current cost and schedule variances for the investment are a result of contract acquisition delays, as described below. Cost variance: Milestone 3 (MW+ Phase I Release), Milestone 5 (AERS II Phase I Release) and Milestone 8 (2008 AERS II C&A and Security Activities) were scheduled to start in August 2007, October 2007, and January 2008, respectively. The task order request was awarded on March 26, 2008, with a contract start of April 1, 2008. Therefore, the projects did not incur costs until April, 2008, and thus at this point is reflecting an under utilization of project funds. In addition, the contractor is not fully staffed and is incurring lower costs than projected. Schedule variance: MedWatchPlus estimated that the MedWatchPlus Portal Requirements Analysis task (Milestone 4) would begin on August 30, 2007 and that the PM Support for AERS II (Milestone 6) would begin on October 1, 2007. The Contract Award for these tasks did not occur until September 10, 2007 and the Contractor took longer than planned to staff these tasks. The two contractor resources for Milestone 4 were not in place until December, 2007, and the contractor resource for Milestone 6 was not in place until December, 2007. Milestone 4 has since been completed; however, Milestone 6 is ongoing and a schedule variance remains. The milestones for the design, development, build, training and implementation of the MedWatchPlus Portal and the FAERS application was originally estimated to be awarded in August of 2007. The Contract was awarded on March 26, 2008, with a contract start date of April 1, 2008. As a result, the project activities are not aligned with the schedules for the milestones.

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

Cost variance: As the project becomes fully staffed, the labor costs will align more closely with projected costs. As part of the project plan, a final COTS product will be selected in November 2008. Once the final COTS product is selected, the investment will develop a more concise and detailed plan utilizing year to year milestones whenever possible. Funding is increased by P.L. 110-252, the "Supplemental Appropriations Act, 2008", signed into law on June 30, 2008. The appropriation increases the budget authority for increasing food protection, enhancing the safety of drugs, medical devices and biologics, and boosting the strength of the agency's workforce. Due to the short time between receiving the appropriation and submitting the FY2010 President's Budget Request, a full impact analysis is not complete. Once the analysis is complete, the Business Case will be updated to reflect the additional funding. Schedule variance: The PM Support for AERS II (Milestone 6) is a project management activity. The FTEs on the project have carried on these tasks in addition to their regular duties while waiting for the contractor to staff this task. The late start of Milestone 6 will not affect the overall schedule and will not impact future milestones. The milestones for the design, development, build, training and implementation of the MedWatchPlus Portal and the FAERS application were originally estimated to be awarded in August of 2007. The Contract was awarded on March 26, 2008, with a contract start date of April 1, 2008, resulting in the schedule variance. As part of the project plan, a final COTS product will be selected in November 2008. Once the final COTs product is selected, the investment will develop a more concise and detailed plan utilizing year to year milestones whenever possible.

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

no