Exhibit 300 (BY2010) for FDA Automated Drug Information Management System

1. Date of Submission:

2008-09-08

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Automated Drug Information Management System

5. Unique Project Identifier:

009-10-01-03-01-2016-00

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?

FY2004

8. Provide a brief summary and justification for this investment, including a brief description of how this closes in part or in whole an identified agency performance gap.

The Automated Drug Information Management System (ADIMS) is being developed as an integrated, fully electronic information management system for the receipt, validation, evaluation, and dissemination of drug safety and effectiveness data. As the core enterprise architecture for FDA's pre-market drug review process, all systems involved in that process will either be replaced or integrated into ADIMS. The system will be seamless, with single sign-on access to information and tools used in daily decision-making. The Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) will be the backbone of the system. Over fifty current large and small systems will be integrated as ADIMS, including the Corporate Oracle Management Information System (COMIS), the Electronic Document Room (EDR), the Division File System (DFS), and systems within the FACTS@FDA program. As the volume of technologically advanced electronic information coming into FDA increases, the need for a robust information management system increases. In addition to facilitating drug review and approval, an integrated data management system to collect and evaluate electronic clinical data facilitates the identification of trends and other critical information (i.e., potential product safety issues). Also, the validation and back-up capabilities of ADIMS will facilitate data verification and correction with increased efficiency. Currently all systems across FDA are being reviewed for potential migration to the MedWatch Plus, FASTAR, EDSR, Product Quality Program investment in FY10. Consolidating current stovepipe and stand-alone drug information systems into a cohesive, easily supportable platform will allow reviewers to be able to access information from one place and will improve accessibility and reduce redundancy. Reducing redundant manual data entry and consolidating access to data will improve data quality and improve performance objectives as well as save time and resources required to keep multiple systems updated. Thus, ADIMS directly supports the goal of e-Government by creating efficient electronic access to the most up-to-date and complete information within the Agency and the HHS strategic goal of Improve health care quality, safety, cost and value by allowing real-time transfer of information. This, plus the system's capabilities of accepting electronic submission, will improve the FDA's responsiveness to consumers, industry, and healthcare providers.

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?

2005-07-28

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
Competitive Sourcing
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?)

Expanded e-Gov ADIMS provides web-based access to electronic drug product information. It improves the FDA's responsiveness to consumers and healthcare providers. Competitive Sourcing ADIMS utilizes contracts that continue to foster competitive agreements, ensure the best price and quality, and provide opportunities to minority contractors and small businesses.

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

yes

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

no

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

10001057 - Food and Drug Administration

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

Moderately Effective

15. Is this investment for information technology?

yes

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

Level 3

17. What project management qualifications does the Project Manager have? (per CIO Council's PM Guidance)

(1) Project manager has been validated as qualified for this investment

18. Is this investment identified as high risk on the Q4 - FY 2007 agency high risk report (per OMB memorandum M-05-23)?

no

19. Is this a financial management system?

no

19.a.2. If no, what does it address?

ADIMS directly supports the Expanded E-Government goal of the PMA by providing accessibility and real-time transfer of the most complete, up-to-date electronic safety and efficacy information about reviewed products, thus improving the Agency's responsiveness to consumers, healthcare providers, and industry as help to identify performance goal data.

20. What is the percentage breakout for the total FY2009 funding request for the following? (This should total 100%)

Area	Percentage
Hardware	4
Software	1
Services	95
Other	0

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	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?

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 -2007	PY 2008	CY 2009	BY 2010
Planning Budgetary Resources	1.531	0.339	2.524	0.000
Acquisition Budgetary Resources	6.317	4.910	0.000	4.000
Maintenance Budgetary Resources	4.845	1.884	3.462	1.671
Government FTE Cost	7.723	3.729	3.388	2.083
# of FTEs	20	31	26	15

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

no

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	2005	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Number of eCTD submissions received per year	30 official eCTD submissions plus 25 in testing	Encourage Industry to submit more eCTDs by the end of FY 2005 (Goal=100)	91 official eCTD submissions.
2	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Productivity	Reduce three systems to one in order to save time and increase productivity	Currently, users must log on to three systems, using different passwords. Integrated reports can not be generated from just one system.	Once the systems are fully integrated, users will have only one password and will be able to generate reports from one point of entry. Increased efficiency and improved accuracy will increase productivity.	INDs are no longer processed in legacy application.
3	2005	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Security	First release of system will be 100% C&A'd and have a completed PIA.	Currently, system has no PIA or security controls in place.	Ensure PIA is completed and all security measures have been taken to meet federal guidelines.	PIA was completed and system C&A'd on January 26, 2006.
4	2005	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Availability	Ensure system is reliable and available 95% of scheduled time.	No quantifiable baseline has been established (other than system should be available during working hours)	Document the metric as part of the operational plan. Ensure that adequate backup and business resumption activities are in place for production.	Backup and business resumption activities are in place and documented in the system contingency plan. Contingency plan is tested annually.
5	2006	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Number of eCTD submissions received per year	300 eCTD submissions projected this year based on prior year submission history and Industry contact regarding eCTD preparation	Coordinate efforts with Industry to double expected submissions	Over 2000 eCTDs received
6	2006	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Delivery Time	Electronic signatures will expedite drug approval process	Routing completed documentation and action letters for sign-off can take a week or more.	Electronic signatures will allow routing of documentation and action letters to occur within minutes.	With the release of DARRTS 1.0 the drug review process has increased by 25%.
7	2007	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Policies	CCB in place by end of FY 2007.	Currently, no CCB or governance installed	Draft CCB documentation, select participants and set up framework.	CCB was established and documentation completed and put into PVCS.
8	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Overall Costs	Project costs will be within 10% of budget estimates.	Project and cost schedule are in place,	Variances are targeted to be within .1 +/- of the baselined Planned Value (PV) Scheduled Performance Indicator (SPI) of 1.0.	Baseline costs are within 10% of the 1.0 SPI target. Project is in line with meeting AA objective of achieving $175M in cost avoidance/cost benefits.
9	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Productivity	Support the increase of electronic submissions without compromising processing speed	Currently approximately 800 eCTD's are received in DARRTS each the year.	An average increase of 25% more electronic eCTD submissions (~ 1,000 by CY 2009) will be processed without compromising the current processing rate.
10	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Technology Improvement	Eliminate 2 stovepipe systems ( COMIS NDA/ANDA & DFS) and integrated them with DARRTS	Currently COMIS NDA/ANDA and DFS are of 17 systems that is managed as a separate legacy application.	100% of NDAs, ANDAs, and all DFS functionality will be processed via the DARRTS application.
11	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Tracking all drug application types (TPD INDs, INDs, NDAs, and ANDAs) in a single system.	Drug Applications are tracked in three different systems.	100% of all drug application types (TPD INDs, INDs, NDAs, and ANDAs) are tracked centrally in a single system (DARRTS).
12	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Technology Improvement	Eliminate 1 of 17 stovepipe systems (IMTS) and integrate it into DARRTS.	Currently IMTS is one of 17 systems that are managed separately as components of the drug review process. .	100% of IMTS functionality will be supported within the DARRTS system.
13	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Population Health Management and Consumer Safety	Track Structured Product Labeling (SPL) within the DARRTS application.	Currently all SPL is tracked using the ELIPS standalone application.	100% of drug SPL will be tracked via DARRTS.
14	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Productivity	Support the increase of electronic submissions without compromising processing speed	Currently approximately 800 eCTD's are received each the year.	An average increase of 25% more electronic submissions (~ 1,250 by CY 2010) will be processed without compromising the current processing rate.
15	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Technology Improvement	Eliminate 1 of 17 stovepipe systems ( INVAS)	Currently INVAS one of 17 systems that are managed separately as components of the drug review process.	100% of INVAS functionality will be supported within the DARRTS system.
16	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Efficiency	Eliminate 1 of 17 stovepipe systems ( SPOTS)	Currently SPOTS one of 17 systems that are managed separately as components of the drug review process..	100% of SPOTS functionality will be supported within the DARRTS system.
17	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Service Efficiency	Support the increase of electronic submissions without compromising processing speed	Currently approximately 800 eCTD's are received each the year.	An average increase of 25% more electronic submissions (~ 1,550 by CY 2011) will be processed without compromising the current processing rate.
18	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Service Availability	Track all NDA's and ANDA's in one system, DARRTS	Currently these applications are tracked in separate applications	100% of NDA's and ANDA's are tracked in DARRTS
19	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Track all IND's, MF's, and EUA's in one system, DARRTS	Currently these applications are tracked in separate applications	100% IND's, MF's, and EUA's are tracked in DARRTS	As of FY08, 100% of IND's, MF's and EUA's are tracked in DARRTS
20	2008	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Response Time	Decrease the number of systems that a reviewer has to look at to obtain information from 50+ to 1.	Currently reviewers have to look at multiple systems to obtain information.	Reduce the number of systems reviewers have to look at by 75%.	As of FY08, the number of systems reviewers have to look at have been reduced to 17.
21	2010	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Service Availability	Track all CDER/CBER BLA's in one system, DARRTS	Currently these applications are tracked in separate applications	100% of CDER/CBER BLA's are tracked in DARRTS
22	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Response Time	The response time that the reviewers are notified of incoming submissions will reduce to minutes, rather than days.	Due to manual receipt, processing, and filing, currently it may upwards of three days for reviewers to receive notification of submissions.	Reviewers are notified of 100% of incoming submissions within 30 minutes of entry by the Document Room.
23	2011	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Decrease the number of systems that a reviewer has to look at to obtain information from 13+ to 1	Currently reviewers have to look at multiple systems to obtain information.	Reduce the number of systems reviewers have to look at by 85% (3 systems to remain).
24	2009	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Decrease the number of systems that a reviewer has to look at to obtain information from 50+ to 13	Currently reviewers have to look at multiple systems to obtain information.	Reduce the number of systems reviewers have to look at by 75% (13 systems to remain at years end).
25	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Tracking all application types in one system.	Applications are tracked in various different systems.	100% of application types (IND, NDA, ANDA, DRUG MASTER FILE) will be tracked centrally in one system (DARRTS).
26	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Efficiency	All stovepipe systems used for reviewing drug applications are integrated into DARRTS.	50 systems are used to do similar functions	100% of stovepipe systems (50) will be integrated into DARRTS
27	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Productivity	Support the increase of transactions without compromising processing speed.	Currently approximately 15,000 transactions are processed in DARRTS daily.	An average increase of 50% (7.500) more transactions will be processed daily (22,500 in all) without compromising the current processing rate.
28	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Track the newly conceived Regulated Product Submission System (RPS) in DARRTS	RPS will be a new standard for submitted electronic applications and will need to be incorporated into DARRTS. Approximately 1,400 RPS are expected in this FY.	100% of RPS (estimated at 1,400 in 2014) will be tracked in DARRTS
29	2012	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Overall Costs	Eliminate 1 of 17 stovepipe systems (DRLS)	Currently DRLS one of 17 systems that are managed separately as components of the drug review process.	100% of DRLS functionality will be supported within the DARRTS system.
30	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Overall Costs	Eliminate 1 of 17 stovepipe systems ( DPRF)	Currently DPRF one of 17 systems that are managed separately as components of the drug review process.	100% of DPRF functionality will be supported within the DARRTS system.
31	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Mission and Business Results	Information Management	Ability to track 100% of initial Regulated Product Submission System (RPS) (300 estimated during the first year) in DARRTS	Currently, RPS is not a supported within the FDA.	FDA willl have an IT capability to process RPS beginning in 2013 using the DARRTS application.
32	2013	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Response Time	Reduce processing time for DARRTS complex reporting queries and Satellite integrations.	Complex reporting queries and satellite integrations often take 60 seconds or more.	Reduce transaction time for complex reporting queries and 100% of satellite integrations by 75% (no more than 15 seconds per transaction.)
33	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Access	2,000 users can simultaneously use the application	Due to increased functionality, the application will need to support at least 2,000 concurrent users (up from approximately 200 in 2008)	2,000 users can concurrently use the application without noticeable system degradation
34	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Processes and Activities	Productivity	Eliminate 1 of 17 stovepipe systems (MACMIS)	Currently MACMIS one of 17 systems that are managed separately as components of the drug review process.	100% of MACMIS functionality will be supported within the DARRTS system.
35	2014	S.O. 1.3 - Improve health care quality, safety, cost and value	Technology	Technology Improvement	Eliminate 1 of 17 stovepipe systems (ADMIS)	Currently ADMIS one of 17 systems that are managed separately as components of the drug review process.	100% of ADMIS functionality will be supported within the DARRTS system.

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.

Automated Drug Information Management System

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	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Document Management	Document Review and Approval			No Reuse	4
2	Electronic Common Technical Document	electronic Common Technical Document is an electronic data exchange transfer standard used to receive electronic submissions and includes the GSReview too. The eCTD contains two components, a processor and a viewer. The processor is used by document room staff to load and validate submissions against the standard and make the data available to the viewer module. The viewer provides a user interface to reviewers in CDER, CBER and ORA that allow them to define multiple views of the ma	Data Management	Data Exchange			No Reuse	1
3	Patent and Exclusivity System	Tracks patent, exclusivity and extensions and records patent length	Tracking and Workflow	Process Tracking			No Reuse	3
4	Drug Registration and Listing System	Used by OC - Provides information on manufacturers and sites registration and on the drug product and its inactive ingredients.	Knowledge Management	Information Retrieval			No Reuse	4
5	CDER Electronic Document Room	EDR facilitates receipt and review of New Drug Applications in an electronic mode. The Automated Submission Receipt (ASR) will be implemented to receive and process electronic submissions through the agency Gateway.	Routing and Scheduling	Inbound Correspondence Management			No Reuse	2
6	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Routing and Scheduling	Outbound Correspondence Management			No Reuse	3
7	Developers and Distributors System	DADS is a comprehensive collection of names and addresses of pharmaceutical manufacturers and distributors; individual and commercial IND sponsors; NDA and ANDA applicant holders; and DMF holders.	Knowledge Management	Knowledge Capture			No Reuse	3
8	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Search	Classification			No Reuse	3
9	Electronic Common Technical Document	electronic Common Technical Document is an electronic data exchange transfer standard used to receive electronic submissions and includes the GSReview too. The eCTD contains two components, a processor and a viewer. The processor is used by document room staff to load and validate submissions against the standard and make the data available to the viewer module. The viewer provides a user interface to reviewers in CDER, CBER and ORA that allow them to define multiple views of the ma	Document Management	Document Review and Approval			No Reuse	1
10	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Knowledge Management	Information Retrieval			No Reuse	3
11	Decision Support System	DSS permits retrieval on COMIS applications, documents, and assignments, on Charge and History documents and assignments, and on Phase 4 documents.	Knowledge Management	Information Retrieval			No Reuse	4
12	CDER Electronic Document Room	EDR facilitates receipt and review of New Drug Applications in an electronic mode. The Automated Submission Receipt (ASR) will be implemented to receive and process electronic submissions through the agency Gateway.	Knowledge Management	Information Retrieval			No Reuse	2
13	Biological Researcher Monitoring System	BrmIS contains the names, addresses, and Investigational New Drugs (IND) for clinical investigators, Institutional Review Boards (IRB), and Contract Research Organizations (CRO). The information is collected from the IND protocols received in the Center	Knowledge Management	Knowledge Capture			No Reuse	4
14	Orange Book	Provides a list of drugs that can be generically substituted for each other. Used by medical personnel and industry.	Knowledge Management	Information Retrieval			No Reuse	3
15	Drug Registration and Listing System	Used by OC - Provides information on manufacturers and sites registration and on the drug product and its inactive ingredients.	Knowledge Management	Knowledge Capture			No Reuse	3
16	IND/NDA Volume Accountability System	The primary purpose of INVAS is to track the physical location of IND, NDA, and ANDA volumes, which could be in the Division Document Room, with a specific reviewer, or in the Central Document Room.	Tracking and Workflow	Process Tracking			No Reuse	4
17	Electronic Common Technical Document	electronic Common Technical Document is an electronic data exchange transfer standard used to receive electronic submissions and includes the GSReview too. The eCTD contains two components, a processor and a viewer. The processor is used by document room staff to load and validate submissions against the standard and make the data available to the viewer module. The viewer provides a user interface to reviewers in CDER, CBER and ORA that allow them to define multiple views of the ma	Knowledge Management	Information Retrieval			No Reuse	1
18	CDER Electronic Document Room	EDR facilitates receipt and review of New Drug Applications in an electronic mode. The Automated Submission Receipt (ASR) will be implemented to receive and process electronic submissions through the agency Gateway.	Document Management	Document Review and Approval			No Reuse	2
19	Drug Data Entry	DDE facilitates the data entry of Drug information (Established names, approved names, and updates erroneous drug names on the Application and Drug COMIS tables).	Knowledge Management	Information Sharing			No Reuse	3
20	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Management of Processes	Program / Project Management			No Reuse	3
21	Post Apporval Commitment Tracking	Used to track studies that OGD requires applicants to undertake in connection with an approved or nearly approved original applications or supplements.	Tracking and Workflow	Process Tracking			No Reuse	3
22	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Tracking and Workflow	Case Management			No Reuse	3
23	Drug Product Reference File	DPRF contains drug product information for INDs, NDAs, and ANDAs. Information includes proprietary name, current approval status, dosage form, ingredients (both active and inactive), ingredient potencies, route of administration, pharmacological activity	Knowledge Management	Information Retrieval			No Reuse	3
24	User Access Control		Security Management	Access Control			No Reuse	3
25	General Counsel	System tracks center issues, regulations, guidance documents and citizens' petitions handled by General Counsel in CDER.	Tracking and Workflow	Process Tracking			No Reuse	3
26	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Routing and Scheduling	Inbound Correspondence Management			No Reuse	3
27	Biological Researcher Monitoring System	BrmIS contains the names, addresses, and Investigational New Drugs (IND) for clinical investigators, Institutional Review Boards (IRB), and Contract Research Organizations (CRO). The information is collected from the IND protocols received in the Center	Knowledge Management	Information Retrieval			No Reuse	3
28	Document Archiving, Reporting and Regulatory Tracking System	The DARRTS system is designed for FDA/CDER personnel manage the drug/therapeutics review process, perform reviews, or manage and maintain the systems supporting the review process. DARRTS provides a data management and reporting tool that will provide a flexible, integrated database application that supports CDER's core business functions	Tracking and Workflow	Process Tracking			No Reuse	3
29	Orange Book	Provides a list of drugs that can be generically substituted for each other. Used by medical personnel and industry.	Knowledge Management	Knowledge Capture			No Reuse	4
30	Time Reporting System	The CDER Time Reporting System is an on-line web-based system designed to capture the time spent by persons who are working to accomplish CDER's mission and goals. This data is used by the Center Director to match resource usage to priority goals and justify CDER's budget to FDA and Congress. The data are also used to track CDER's time spent on PDUFA-related activity.	Human Resources	Time Reporting			No Reuse	4
31	Comments	Permits entry and query of information on comments entered for different applications and documents.	Knowledge Management	Information Sharing			No Reuse	3
32	Drug Product Reference File	DPRF contains drug product information for INDs, NDAs, and ANDAs. Information includes proprietary name, current approval status, dosage form, ingredients (both active and inactive), ingredient potencies, route of administration, pharmacological activity	Knowledge Management	Knowledge Capture			No Reuse	3
33	Developers and Distributors System	DADS is a comprehensive collection of names and addresses of pharmaceutical manufacturers and distributors; individual and commercial IND sponsors; NDA and ANDA applicant holders; and DMF holders.	Knowledge Management	Information Retrieval			No Reuse	3
34	CDER Standard Letters	CSL is an application to generate standard letters, forms, and reviews created during the review of a new drug application. Although Project Managers and Chemist primarily use CSL, some of the standard GRP reviews for the other disciplines (e.g., Clinical	Forms Management	Forms Creation			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	Document Review and Approval	Component Framework	Business Logic	Platform Independent Technologies	Sun Solaris 9 by: Sun Microsystems, Inc.
2	Document Review and Approval	Service Platform and Infrastructure	Software Engineering	Modeling	Oracle Designer by: Oracle Corporation
3	Document Review and Approval	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
4	Document Review and Approval	Service Platform and Infrastructure	Database / Storage	Database	Documentum Application Xtender by: EMC Corporation
5	Document Review and Approval	Service Platform and Infrastructure	Database / Storage	Database	Documentum by: EMC Corporation
6	Data Exchange	Service Platform and Infrastructure	Support Platforms	Dependent Platform	.NET 2.0 Framework by: Microsoft Corporation
7	Process Tracking	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
8	Information Retrieval	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
9	Inbound Correspondence Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	.NET 2.0 Framework by: Microsoft Corporation
10	Inbound Correspondence Management	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
11	Inbound Correspondence Management	Service Access and Delivery	Service Transport	Service Transport	FTP, Secure, Bluezone by: Seagull Software Systems, Inc.
12	Inbound Correspondence Management	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Microsoft Internet Information Server 5.0 by: Microsoft Corporation
13	Outbound Correspondence Management	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
14	Knowledge Capture	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
15	Classification	Service Platform and Infrastructure	Database / Storage	Database	DB Artisan by: Embarcadero Technologies, Inc
16	Classification	Service Access and Delivery	Access Channels	Web Browser	Java Runtime Environment by: Sun Microsystems, Inc.
17	Classification	Service Platform and Infrastructure	Delivery Servers	Application Servers	Microsoft Windows 2003 Server by: Microsoft Corporation
18	Classification	Service Platform and Infrastructure	Support Platforms	Dependent Platform	VMware by: VMware, Inc.
19	Classification	Service Platform and Infrastructure	Database / Storage	Database	Documentum by: EMC Corporation
20	Classification	Service Platform and Infrastructure	Delivery Servers	Application Servers	Microsoft Windows 2000 Server by: Microsoft Corporation
21	Classification	Component Framework	Data Management	Database Connectivity	NET8 by: Oracle Corporation
22	Classification	Service Platform and Infrastructure	Delivery Servers	Web Servers	Microsoft Internet Information Server 5.0 by: Microsoft Corporation
23	Document Review and Approval	Component Framework	Business Logic	Platform Dependent Technologies	Microsoft Windows 2003 Server by: Microsoft Corporation
24	Information Retrieval	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Java Server Pages by: Sun Microsystems, Inc.
25	Information Retrieval	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle Application Server 10g by: Oracle Corporation
26	Information Retrieval	Component Framework	Business Logic	Platform Dependent Technologies	Microsoft Windows 2003 Server by: Microsoft Corporation
27	Information Retrieval	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Windows 2003 Server by: Microsoft Corporation
28	Knowledge Capture	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
29	Process Tracking	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
30	Document Review and Approval	Service Access and Delivery	Service Transport	Service Transport	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
31	Document Review and Approval	Service Platform and Infrastructure	Software Engineering	Test Management	Microsoft Internet Information Server 5.0 by: Microsoft Corporation
32	Document Review and Approval	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Microsoft Internet Information Server 5.0 by: Microsoft Corporation
33	Information Sharing	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
34	Program / Project Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Rational RequisitePro by: International Business Machines Corp.
35	Program / Project Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	PVCS Tracker by: Synergex
36	Program / Project Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	PVCS Version Manager by: Synergex
37	Program / Project Management	Service Platform and Infrastructure	Software Engineering	Test Management	Rational ROBOT by: International Business Machines Corp.
38	Program / Project Management	Service Platform and Infrastructure	Software Engineering	Test Management	Rational TestManager by: International Business Machines Corp.
39	Program / Project Management	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
40	Case Management	Component Framework	Business Logic	Platform Independent Technologies	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
41	Case Management	Component Framework	Business Logic	Platform Independent Technologies	Java by: Sun Microsystems, Inc.
42	Information Retrieval	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
43	Access Control	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Java Server Pages by: Sun Microsystems, Inc.
44	Access Control	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	PVCS Version Manager by: Synergex
45	Access Control	Service Platform and Infrastructure	Software Engineering	Modeling	Oracle Designer by: Oracle Corporation
46	Process Tracking	Service Platform and Infrastructure	Database / Storage	Database	Microsoft Office Access by: Microsoft Corporation
47	Process Tracking	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
48	Inbound Correspondence Management	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
49	Process Tracking	Component Framework	Business Logic	Platform Dependent Technologies	Macromedia RoboHelp by: Adobe Systems
50	Process Tracking	Service Platform and Infrastructure	Software Engineering	Modeling	Oracle Designer by: Oracle Corporation
51	Process Tracking	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle 9i Application Server by: Oracle Corporation
52	Process Tracking	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Rational RequisitePro by: International Business Machines Corp.
53	Process Tracking	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	PVCS Version Manager by: Synergex
54	Time Reporting	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
55	Time Reporting	Component Framework	Business Logic	Platform Dependent Technologies	Microsoft Windows 2000 Server by: Microsoft Corporation
56	Time Reporting	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris by: Sun Microsystems, Inc.
57	Information Sharing	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Sun Solaris by: Sun Microsystems, Inc.
58	Information Sharing	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition by: Oracle Corporation
59	Forms Creation	Service Platform and Infrastructure	Database / Storage	Database	Oracle Database 10g Release 2 Enterprise Edition 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.

Yes. The goal of the ADIMS program is to identify and integrate systems involved in the receipt, evaluation, and dissemination of human drug safety and effectiveness data coming into the FDA through investigational and marketing applications and related submissions.

You should perform a risk assessment during the early planning and initial concept phase of the investment's life-cycle, develop a risk-adjusted life-cycle cost estimate and a plan to eliminate, mitigate or manage risk, and be actively managing risk throughout the investment's life-cycle.

Answer the following questions to describe how you are managing investment risks.

1. Does the investment have a Risk Management Plan?

yes

1.a. If yes, what is the date of the plan?

2007-03-31

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:

Received approval from the PDUFA Working Group to move ahead with obligating funds and beginning the work. This will allow work to proceed without impacting current scope and cost. The ADIMS team is continuing to seek additional funding sources this fiscal year to remain on schedule. While additional funding is being sought, the ADIMS team is evaluating several alternative approaches for applying current resources. In the event additional funds are not identified during this fiscal year, the schedule and future budget requests may need to be reexamined.

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