Exhibit 300 (BY2010) for FDA Regulatory Business Information Services

1. Date of Submission:

2008-09-08

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Regulatory Business Information Services

5. Unique Project Identifier:

009-10-01-03-01-8033-00

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.

Regulatory Business Information Services (RBIS) manages ORA's reporting and information management projects. These include: a centralized data warehouse, the Online Reporting, Analysis, and Decision Support System (ORADSS), implemented to provide integrated information for regulatory compliance and risk-based analysis; the Firms Master List Services (FMLS), to manage, improve the quality of, and standardize data on firms; and, the ORA Data Marts, providing secure storage of and access to electronic documents such as inspection reports and exhibits. ORA and Center staff access these integrated systems for analysis and decision-making used to protect public health and safety and communicate to the public. Over 5,000 users throughout FDA use ORADSS in regulatory compliance and risk-based analysis. ORADSS uses a commercially available user interface that allows access to standardized reports and simplifies the creation of ad-hoc reports without specialized knowledge of the underlying data. Without ORADSS, only a small group of users were able to access critical data. ORADSS provides decision support covering all aspects of FDA's mission, from work planning to performance measurement and reporting to Congress. The FMLS system provides services to manage the demographic data on firms doing business with and/or required to register with the FDA. These tools maintain accurate data in the warehouse and clean up the operational databases. FMLS standardizes and validates the facility name and address data received from imports, registration and listing systems, and inspections. Much of the data on firms is received from outside the Agency in non-standard and often inaccurate form. Without FMLS, the Agency would be limited in protecting the public by evaluating risks using data on firms in the supply chain. The ORA Data Marts provide storage of critical Agency documents including inspection documentation, digital photographs, and scanned documents. Currently the electronic documents are hard to find and not fully secured, while hard copies are stored in file rooms in each District requiring copying and shipping for use at HQ. Enhancements to the RBIS systems, including integration across FDA, provide staff with critical data, improving their ability to make risk-based decisions. Staff will be able to respond more rapidly and effectively to public health crises, such as a salmonella outbreak, to save lives and reduce the cost to industry.

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?

2002-01-01

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.

no

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?)

Expansion of E-Government is supported through the FMLS system, which reduces the burden on filers during electronic submission of Prior Notice and Registration data. ORADSS will support E-gov by providing a mechanism to report data on FDA regulated products and firms to the public, expanding public access to health and safety information. The Firm Finder will also support industry by facilitating public access to firm information via the Broker Import Communications system.

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 2

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

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

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

no

19. Is this a financial management system?

no

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

Regulatory Business Information Systems: decision support, data quality, and information management systems. The RBIS systems provide information for FDA staff that is used to ensure product safety and regulatory compliance, protect the public from health threats, and combat the threat of bioterrorism. RBIS systems also improve the quality of data in systems throughout the Agency, particularly for firms doing business with FDA.

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

Area	Percentage
Hardware	0
Software	3
Services	78
Other	19

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?

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	4.530	0.000	1.893	0.000
Acquisition Budgetary Resources	18.681	9.650	2.660	2.166
Maintenance Budgetary Resources	5.280	1.655	2.181	2.715
Government FTE Cost	1.446	0.450	0.432	0.406
# of FTEs	4	4	3	3

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.

The funding for FY 2010 is increased from the FY 2009 budget request. The FY 2009 request was based on the funding projected to be available in FY 2010. Since that time, additional funding for RBIS in FY 2010 has been identified, and will be used to address some of the new scope identified in areas such as imports, food safety, and drug safety.

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. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	Response time to validate that manufacturer data identified in Prior Notice submittals is consistent with FFRM data, as required by the Prior Notice Interim Final Rule	Two independent databases with no linkage and no real-time ability to verify Manufacturer's data.	Link that allows validation and reconciliation of data from PN submissions against Registration, with response to user within 3 seconds (PNSI) and without delaying response > 5 sec for ACS submittals.	System is in Production and functioning within these specifications. Load testing completed with response <2.5 seconds.
2	2005	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Knowledge Management	Number of duplicate firms identified and resolved.	FIRMS data was poor with many duplicates (est. 50,000 duplicates); no process exists to prevent continued introduction of additional duplicates	Use data quality tool to clean up and maintain better data on firms - identify and merge 30,000 duplicates.	Nightly process to maintain clean data has been implemented to identify and clean duplicates, as planned ~40,000 duplicates merged.
3	2005	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Internal Data Sharing	Number of years of historical data available for queries, reporting, and trend analysis.	Current system provides access to 1 year of data	Provide access to 4 years of data	Migration of historical data into Production is complete. System is available to users. Up to 11 years of data is available.
4	2005	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Accuracy of Service or Product Delivered	% of new FFRM records validated.	None, new system (no method currently exists to validate electronically)	FMLS will provide validation of address information, determine existence of firm, and update as needed, for >99% of new FFRM records	Batch process for validation is in Production for FFRM and OASIS. Real time validation is in Production for PNSI. All (100%) FFRM records are validated by FMLS.
5	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	Number of PN reports available.	Reporting dependent on time-consuming SQL queries and manipulation of data in Excel; no standard reports available.	Expanded range of PN reports allow users to rapidly obtain critical information; 2 initial reports and PN Datamart available.	PN Data Mart and 3 reports are now available using Production system. ~10 additional relevant reports available through Imports menu
6	2006	Effective Management of Human Capital / Information Technology / Resources	Processes and Activities	Productivity	Number of modules/reports with OLAP capabilities enabled	Reporting requires custom development of SQL code	5 modules/ >50 reports	New system is available for target program areas & reports
7	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Impact or Burden	Number of canned reports available to allow easy retrieval of data	Data resides in database designed for operations, not queries. All reports require custom coding.	Organize FACTS \ OASIS data into pre summarized, aggregated subject area data marts, with at least 200 reports available.	Initial OASIS data marts are complete. >500 Domestic reports are available.
8	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Internal Data Sharing	Interface with new MARCS database. Measure length of time for extraction job.	Data extracted from legacy databases; time will be remeasured just prior to migration.	Migration from new system with no significant impact on system performance	MARCS plans to move to UNIX prior to database redesign; work will proceed once MARCS is ready.
9	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	Number of Data Marts available for user queries.	Data resides in legacy database designed for operations, not queries.	Develop and deploy average of 1 new Data Mart/year, including Firms, Products, Organizations, and Program Assignments, to ensure consistent reporting across ORA enabling broader analysis and trending	Deferred to FY 2008-9 due to changing priorities. Firms and Laboratory Data Marts are in development. Additional data marts will be developed following completion.
10	2007	Effective Management of Human Capital / Information Technology / Resources	Processes and Activities	Security	Number of separate user accounts required for ORA systems	System-specific independent login requires separate account for each system	One user ID and password allows user access to all RBIS systems along with other ORA systems.	Single Sign-On implemented 6/06. Users now login to FDA network and have full access to ORADSS without additional login.
11	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	New Customers and Market Penetration	Number of ORADSS system users	ORADSS current number of users 100	ORADSS will allow additional users to access data from multiple data sources in a timely fashion; expected number of users is 400.	Measure successfully completed. Over 4000 users have logged into ORADSS
12	2007	Effective Management of Human Capital / Information Technology / Resources	Technology	Operations and Maintenance Costs	Number of versions of Business Objects in use in Agency	Initial deployment is independent, with an older version of Business Objects.	Integrate ORADSS Business Objects user interface with FDA consolidated Architecture to reduce hardware cost and maintenance, so only one version is in use.	ORADSS has migrated to Agency standard version of Business Objects and meets architecture standards.
13	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	Time required to locate (map) domestic firms of interest	Est. 10 min - using manual address/map lookup in Google Maps	<2 min to generate report and create map using Business Objects/MapInfo	Load test confirms 1-2 min to generate report + map. Pilot of MapInfo underway.
14	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Productivity	Ability to find Firm records provided by new Firm Finder, measured by number of parameters available for search.	Limited search screens are available in FACTS & OASIS, using 22 parameters and limited Boolean combinations	Increase available search parameters by 50% to improve specificity and flexibility in searches	Firm Finder will be implemented in July, 2008. Users can select from over 50 parameters with expanded Boolean combinations.
15	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Response Time	Response time to retrieve an inspection report.	Obtaining documents requires logging into District Servers with widely varying response times	Documents can be retrieved from local/regional storage at all ORA locations with delays beyond network bandwidth limitations of no greater than 30 seconds.	Load test confirms 1-2 min to generate report + map. Pilot of MapInfo underway.
16	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Internal Data Sharing	Number of documents in available in Documentum repository.	Documents must be obtained by logging into District Servers, not connected to the reporting system, none are in repository	4 years of inspection documents in Repository (80,000 documents)	Will be addressed once MARCS components of SERS are in Production.
17	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	Percentage of new firm records created due to inability to match	Current process introduces ~10,000 records/week, including both new firms and duplicates	Reduce the % of new records created by 25% through improved tools and processes	2009 Metric
18	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of instances of duplicated data with differing identifiers across Agency	TBD - data is scattered across Centers, requiring assessment during integration phase	Mapping to single identifier reduces instances of duplicates by 75%	2009 Metric
19	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	New Customers and Market Penetration	Number of Users from Centers other than ORA	TBD - usage will be assessed at time of implementation	Incorporation of data from Centers other than ORA allows usage by non-ORA users (25% increase in users)	2009 Metric
20	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	System Response Time	Time to access non-ORA documents	TBD - current system requires login to multiple systems	Reduce access time by 75% by integration with other DM systems	2009 Metric
21	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Border and Transportation Security	Percentage of duplicate firm records created from Customs feed	TBD - currently data from CBP does not contain a reliable and unique standard identifier	Implementation of FHA standard identifier eliminates 99% of duplicate records	2010 Metric
22	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Response Time	Response time for most used queries	TBD - measure response times at start of FY	Tune queries and improve system to reduce top 20 queries to meet customer specifications (100%)	2010 Metric
23	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Timeliness	Time Lag	Data is available in warehouse after next nightly extract (up to 24 hr delay)	Near Real-time availability - lag no more than 15 min for all critical data	2010 Metric
24	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Reliability	Amount of system downtime	Current system outages occur for both planned (upgrades) and unscheduled (problem) outages	Improve redundancy and processes to reduce by 25%	2010 Metric
25	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Data Reliability and Quality	Number of Systems Using Data Standardization / Validation Service	1 System in Production in FY 2007	All Critical Agency Systems in Production (number TBD once assessment complete)	2011 Metric
26	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Knowledge Management	Data Mining Reports; number of reports available	No predictive analysis capability; no reports available	Data mining capability provides risk-based indicators for at least 2 critical areas (e.g., Firms and Shipments) with at least 1 report each	2012 Metric
27	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	Number of Queries (avg)/day	TBD - tool to audit to be procured	5% increase/year	2011 Metric
28	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Retention	Number of ORADSS users	4000 user accounts in FY 2007	At least as many user accounts, adjusted for FDA staffing levels	2011 Metric
29	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Reliability	System Availability	SLA's not established	SLA's established; all RBIS systems meet SLA's	2012 Metric - systems are in Steady State (no new DME metrics)
30	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	Number of Queries (avg)/day	TBD - tool to audit to be procured	5% increase/year	2012 Metric
31	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Retention	Number of ORADSS users	4000 user accounts in FY 2007	At least as many user accounts, adjusted for FDA staffing levels	2012 Metric
32	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Timeliness	Help desk response time	User calls are resolved in TBD days or less	All user calls are resolved in 5 business days or less	2012 Metric
33	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	Number of user report requests met	Requests are currently deferred due to competing priorities	100% of valid requests for report maintenance met	2013 Metric
34	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Retention	Number of ORADSS users	4000 user accounts in FY 2007	At least as many user accounts, adjusted for FDA staffing levels	2013 Metric
35	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Reliability	System Availability	SLA's not established	SLA's established; all RBIS systems meet SLA's	2013 Metric
36	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Timeliness	Help desk response time	User calls are resolved in TBD days or less	All user calls are resolved in 5 business days or less	2013 Metric
37	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Population Health Management and Consumer Safety	Number of user report requests met	Requests are currently deferred due to competing priorities	100% of valid requests for report maintenance met	2014 Metric
38	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Retention	Number of ORADSS users	4000 user accounts in FY 2007	At least as many user accounts, adjusted for FDA staffing levels	2014 Metric
39	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Reliability	System Availability	SLA's not established	SLA's established; all RBIS systems meet SLA's	2014 Metric
40	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Timeliness	Help desk response time	User calls are resolved in TBD days or less	All user calls are resolved in 5 business days or less	2014 Metric

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 Regulatory Business Information Services

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	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Knowledge Discovery	Data Mining			No Reuse	4
2	Firm Management Services	Find information on firms in FDA databases	Knowledge Management	Knowledge Capture			No Reuse	6
3	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Reporting	Standardized / Canned			No Reuse	4
4	Integration of Documentum DocBase with Oracle Database applications	Ability to store all documents that relate to a record in an Oracle database application in Documentum DocBase. The user has the ability to search, retrieve and manage the documents from the Oracle application.	Knowledge Management	Information Sharing	Information Sharing	009-10-01-09-02-1010-00	Internal	0
5	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Data Management	Data Mart			No Reuse	4
6	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Data Management	Extraction and Transformation			No Reuse	4
7	SERS Data Mart	The RBIS investment will provide a data mart that provides secure storage and gives users easy access to a wide variety of ORA electronic materials ORA and Center staff will have access to documents, digital photographs, and scanned documents.	Document Management	Document Revisions			No Reuse	0
8	SERS Data Mart	The RBIS investment will provide a data mart that provides secure storage and gives users easy access to a wide variety of ORA electronic materials ORA and Center staff will have access to documents, digital photographs, and scanned documents.	Document Management	Library / Storage			No Reuse	1
9	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Business Intelligence	Decision Support and Planning			No Reuse	4
10	Firms Master List Services	providing services to manage and standardize data on the firms doing business with the FDA.	Data Management	Data Cleansing			No Reuse	15
11	Business Objects	Business Intelligence reporting tool	Reporting	Ad Hoc	Ad Hoc		Internal	0
12	Firms Master List Services	providing services to manage and standardize data on the firms doing business with the FDA.	Visualization	Mapping / Geospatial / Elevation / GPS			No Reuse	4
13	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Reporting	OLAP			No Reuse	4
14	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Knowledge Management	Information Sharing			No Reuse	4
15	Address Standardization	Standardize address formats & data for firms	Data Management	Data Cleansing			No Reuse	4
16	Integration of Documentum DocBase with Oracle Database applications	Ability to store all documents that relate to a record in an Oracle database application in Documentum DocBase. The user has the ability to search, retrieve and manage the documents from the Oracle application.	Records Management	Document Classification	Document Classification	009-10-01-09-02-1010-00	Internal	0
17	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Visualization	Mapping / Geospatial / Elevation / GPS			No Reuse	4
18	Firms Master List Services	providing services to manage and standardize data on the firms doing business with the FDA.	Knowledge Management	Information Retrieval			No Reuse	10
19	Firm Management Services	Find information on firms in FDA databases	Knowledge Management	Information Retrieval			No Reuse	6
20	SERS Data Mart	The RBIS investment will provide a data mart that provides secure storage and gives users easy access to a wide variety of ORA electronic materials ORA and Center staff will have access to documents, digital photographs, and scanned documents.	Document Management	Indexing			No Reuse	1
21	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Data Management	Data Warehouse			No Reuse	4
22	SERS Data Mart	The RBIS investment will provide a data mart that provides secure storage and gives users easy access to a wide variety of ORA electronic materials ORA and Center staff will have access to documents, digital photographs, and scanned documents.	Document Management	Document Referencing			No Reuse	1
23	ORA Reporting Analysis Decision Support System	provide integrated decision support for regulatory compliance.	Knowledge Management	Information Retrieval			No Reuse	4
24	Integration of Captiva Input Accell scan software with Documentum DocBase.	Ability to scan documents directly into a Documentum DocBase and sync them to a record in an Oracle application.	Document Management	Document Imaging and OCR	Document Imaging and OCR	009-10-01-09-02-1010-00	Internal	0

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	Data Mining	Component Framework	Data Management	Reporting and Analysis	Business Objects XI by: SAP AG
2	Knowledge Capture	Service Platform and Infrastructure	Support Platforms	Independent Platform	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
3	Standardized / Canned	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle Application Server by: Oracle Corporation
4	Standardized / Canned	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris 10 by: Sun Microsystems, Inc.
5	Standardized / Canned	Service Platform and Infrastructure	Database / Storage	Database	Oracle 9i Database R2 by: Oracle Corporation
6	Standardized / Canned	Component Framework	Data Management	Reporting and Analysis	Business Objects XI by: SAP AG
7	Data Mart	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris 10 by: Sun Microsystems, Inc.
8	Data Mart	Service Platform and Infrastructure	Database / Storage	Database	Oracle 9i Database R2 by: Oracle Corporation
9	Data Mart	Service Interface and Integration	Integration	Enterprise Application Integration	Informatica by: Informatica Corporation
10	Extraction and Transformation	Component Framework	Data Management	Reporting and Analysis	Informatica by: Informatica Corporation
11	Document Revisions	Service Interface and Integration	Interoperability	Data Transformation	Microsoft Office by: Microsoft Corporation
12	Library / Storage	Service Platform and Infrastructure	Database / Storage	Storage	Documentum by: EMC Corporation
13	Library / Storage	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris 10 by: Sun Microsystems, Inc.
14	Decision Support and Planning	Component Framework	Data Management	Reporting and Analysis	Business Objects XI by: SAP AG
15	Data Cleansing	Service Interface and Integration	Interoperability	Data Types / Validation	DataFlux by: DataFlux
16	Data Cleansing	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris 10 by: Sun Microsystems, Inc.
17	Ad Hoc	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
18	Mapping / Geospatial / Elevation / GPS	Service Interface and Integration	Interoperability	Data Transformation	IBM Websphere QualityStage by: International Business Machines Corp.
19	OLAP	Component Framework	Data Management	Reporting and Analysis	OLAP Services by: Microsoft Corporation
20	Information Sharing	Component Framework	Data Management	Reporting and Analysis	Business Objects XI by: SAP AG
21	Data Cleansing	Service Interface and Integration	Interoperability	Data Types / Validation	IBM Websphere QualityStage by: International Business Machines Corp.
22	Data Cleansing	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle Application Server by: Oracle Corporation
23	Document Classification	Service Interface and Integration	Interoperability	Data Types / Validation	Documentum by: EMC Corporation
24	Mapping / Geospatial / Elevation / GPS	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle Application Server by: Oracle Corporation
25	Mapping / Geospatial / Elevation / GPS	Component Framework	Data Management	Reporting and Analysis	Business Objects XI by: SAP AG
26	Mapping / Geospatial / Elevation / GPS	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris 10 by: Sun Microsystems, Inc.
27	Mapping / Geospatial / Elevation / GPS	Component Framework	Data Management	Reporting and Analysis	MapInfo by: Pitney Bowes, Inc.
28	Mapping / Geospatial / Elevation / GPS	Component Framework	User Presentation / Interface	Content Rendering	MapInfo by: Pitney Bowes, Inc.
29	Mapping / Geospatial / Elevation / GPS	Service Interface and Integration	Interoperability	Data Transformation	DataFlux by: DataFlux
30	Information Retrieval	Service Interface and Integration	Interoperability	Data Transformation	Business Objects XI by: SAP AG
31	Indexing	Service Interface and Integration	Interoperability	Data Types / Validation	Documentum by: EMC Corporation
32	Data Warehouse	Service Platform and Infrastructure	Hardware / Infrastructure	Servers / Computers	Sun Solaris 10 by: Sun Microsystems, Inc.
33	Data Warehouse	Service Platform and Infrastructure	Database / Storage	Database	Oracle 9i Database R2 by: Oracle Corporation
34	Data Warehouse	Component Framework	Data Interchange	Data Exchange	Informatica by: Informatica Corporation
35	Document Referencing	Service Interface and Integration	Interoperability	Data Format / Classification	Documentum by: EMC Corporation
36	Information Retrieval	Component Framework	Data Management	Reporting and Analysis	FAST RetrievalWare by: FAST, a Microsoft Subsidiary
37	Document Imaging and OCR	Service Interface and Integration	Integration	Enterprise Application Integration	EMC Captiva by: EMC Corporation
38	Document Imaging and OCR	Service Interface and Integration	Interoperability	Data Transformation	EMC Captiva by: EMC 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.

no

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

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

1. Does the investment have a Risk Management Plan?

yes

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

2007-08-17

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 life cycle cost and schedule estimates were revised in conjunction with the Alternatives Analysis conducted in FY 2007. The estimates were developed based on the historical data from the ORADSS project (primarily FY 2003-FY 2007). That experience included significant changes in scope and schedule due to the introduction of the Prior Notice requirements. The biggest impacts to cost and schedule for this project have been due to this and similar changes in business needs. Thus, the project expects that the current estimates include a reasonable contingency for the impact of the risks identified on both budget and schedule. In addition, although there is considerable interdependency with other systems, most of the identified tasks do not have fixed deadlines. Many tasks can also be addressed without dependency on the completion of other tasks. Therefore, the investment risks can be managed in part by adjusting the order in which tasks are undertaken, based on changing business priorities.

1. Does the earned value management system meet the criteria in ANSI/EIA Standard 748?

no

2. Is the CV% or SV% greater than ± 10%?

no

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

no