Exhibit 300 (BY2010) for FDA Automated Laboratory Management

1. Date of Submission:

2008-09-08

2. Agency:

009

3. Bureau:

10

4. Name of this Capital Asset:

FDA Automated Laboratory Management

5. Unique Project Identifier:

009-10-01-03-01-8013-00

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?

FY2003

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.

Automated Laboratory Management (ALM) is a program and a portfolio that encompasses the current eLEXNET; the interface with National Bio-surveillance Integration System (NBIS) (DHS); the PAR LABSAN (Storage Area Network), the ongoing Laboratory Information Management Systems lab automation effort (LIMS), Business Process Modeling, Sample Accountability, and maintenance for the National Sample Distributor (NSD). ALM, including eLEXNET integration, is a key FDA program working to improve the efficiency of the staff at FDA laboratories, the quality and quantity of the information the labs provide, and the ability of FDA to share and assess information from and with its own centers, third party, and other public health labs. (eLEXNET is exchanging laboratory analysis data with over 100 public health lab at the Federal, state and local government levels.) To optimize FDA lab capabilities and to improve the capture and reporting of data for analysis and review, ALM short-term goals include increasing analytical and data mining and reporting capabilities in eLEXNET and the NEIS, improving and streamlining sample flow and distribution through the implementation of a NSD system, and upgrading hardware for implementation of LabSAN, a system providing functionality to meet ISO/IEC 17025; 1000(E), beyond the PAR. The LabSAN upgrade will provide the infrastructure to support a long-term goal of the ALM program; i.e., to implement a commercially-available LIMS in FDA laboratories, customizing it as necessary to accommodate unique requirements of individual labs. The LIMS will enable FDA labs to improve chain-of custody tracking, including assignments and sample status; automate collection and processing of analytical data; and track calibration and scheduling to improve the quality of the data produced. Ultimately, the ALM program will expand FDA's scientific and research capabilities and improve FDA's ability to share the results of that research with federal, state, local, and international officials and agencies, facilitating improved management of risks associated with FDA-regulated products.

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?

2007-12-03

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?)

ALM supports Expanded e-Government by improving information sharing and automating lab processes. ALM allows coordination and sharing of information for federal, state, and local food safety agencies and their users. ALM will automate business processes and workflows including calibration, bar coding, laboratory methods, specific work functions, and quality, resulting in a much higher throughput. Not funding ALM hamstrings FDA labs and quality management efficacy.

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?

The critical need for a seamless, integrated, web-based information network that enables health officials at multiple government agencies engaged in food safety activities to compare, share and coordinate laboratory analysis findings.

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

Area	Percentage
Hardware	13
Software	6
Services	78
Other	3

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	0.000	0.000	0.036	0.036
Acquisition Budgetary Resources	8.905	1.484	1.900	5.021
Maintenance Budgetary Resources	11.302	0.541	2.272	3.614
Government FTE Cost	0.087	0.180	0.160	0.236
# of FTEs	6	2	1	2

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.

FY2008 funding is increased by H.R. 2642, the "Supplemental Appropriations Act, 2008", signed into law on June 30, 2008. The appropriation increases the budget authority in FY2008 for increasing food protection, enhancing the safety of drugs, medical devices and biologics, and boosting the strength of the agency's workforce. Per the appropriation, the funds are to remain available until September 30, 2009. The total increase due to the supplemental is $2.000M. This is reflected in the Summary of Spending in FY08 in the acquisition section as follows: an additional $0.559M in Contract Services (installation, configuration, project management, CPIC, EA) for a new total of $0.870M, an additional $1.341M in Hardware (file and application servers, wiring, table PCs, laptops, barcode readers, printers, etc.) for a new total of $1.430M, and $0.200M for Security. In addition, funds ($2.150M) have been added to FY10 in order to complete LabSAN upgrades and provide for the operations and maintenance of hardware acquired. This is reflected in the Summary of Spending in FY10 in the acquisition section as follows: an additional $0.588M in Contract Services (installation, configuration, project management, CPIC, EA) for a new total of $3.117M, an additional $1.116M in Hardware (file and application servers, wiring, table PCs, laptops, barcode readers, printers, etc.) for a new total of $1.172M, and $0.175M for Security. This is reflected in the Summary of Spending in FY10 in the maintenance section as follows: an additional $0.360M in Contract Services for a new total of $3.574M, and $0.040M in Security. An additional $0.500M in a further supplemental for FY09 is included for Electronic Data Capture. This is reflected in the Summary of Spending in FY09 in the acquisition section as follows: an additional $0.500M in Contract Services for a new total of $1.804M. FDA currently plans to adjust the milestone plan of ALM due to the additional supplemental funds. As the timeframe for incorporating these funds into this investment has been short, this adjustment was not accomplished before the HHS deadline for submission.

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	Disaster Monitoring and Prediction	Number of laboratories actively exchanging data with eLEXNET. Outcome: Leverage of laboratory resources to expand protection capability. Measured continually.	0 laboratories	95 laboratories actively exchanging data.	Success. 113 laboratories in 50 states have agreed to participate in eLEXNET, with 95 laboratories actively exchanging data.
2	2005	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of systems interoperating with eLEXNET, using public health standards for messaging, terminologies or vocabularies. Outcome: Standardized communications to improve efficiency. Measured annually.	0 systems	1 system	Failure. HL-7 Implementation Guide was developed and is provided to participating laboratories. None have expressed an interest to change to HL-7 format.
3	2006	Effective Management of Human Capital/Information Technology/Resources	Technology	Availability	Number of hours the system is down. Outcome: Greater system availability. Measured annually.	48 hours of unplanned downtime in FY 2004.	12 hours of unplanned downtime in FY 2006.	Success. Fewer than 12 hours of unplanned downtime in FY 2006.
4	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Availability	Percentage of time where completion of laboratory test and submission of results to eLEXNET's Data Entry module is more than 3 days. Outcome: More current eLEXNET data for sharing to be leveraged for protection. Measured annually.	59% of Data Entry laboratories wait more than 3 days to enter laboratory test result data into eLEXNET.	50% of Data Entry laboratories wait more than 3 days to enter laboratory test result data into eLEXNET.	Success. In FY06, 37% of Data Entry laboratories entered data more than 3 days (on average) after the final result date.
5	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Satisfaction	Number of satisfactory eLEXNET user experiences, as reported within web-based survey. Outcome: Improved user experience results in better protection. Measured continually.	As of July 2003, user satisfaction is not measured.	Improved user satisfaction over baseline percentage, to be measured after web-based survey is implemented.	Success. As an alternative to a web-based survey, user satisfaction is monitored via Help Desk calls. A user satisfaction survey was developed in the 4th quarter of FY 07.
6	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of concrete examples where accessing information in eLEXNET prevents foodborne illness. Outcome: Increased public protection. Measured annually.	1 concrete example	10-15 documented examples, based on user feedback, of how the data available in eLEXNET is used to prevent foodborne illness.	Success. 12 concrete examples. Data captured in eLEXNET was used in the food safety and food defense activities. These activities are designed to prevent food borne illness.
7	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of laboratories actively exchanging data with eLEXNET. Outcome: Leverage of laboratory resources to expand protection capability	Assuming FY 2004 performance goals are met, 105 laboratories will be actively exchanging data.	Expand laboratory participation in eLEXNET to include 105 laboratories actively exchanging data.	Success. Exceeded target by two labs, 107 labs were exchanging data by 9/30/06
8	2006	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Preparedness and Planning	Number of analytes and select agents routinely tested and evaluated using pattern detecting algorithms and/or other data analysis mechanisms. Outcome: Improved automation to leverage resources for protection. Measured continuously as operational	0 analytes and select agents	10 analytes and select agents	Success. Automated reporting of analyte data to DFS is in place. Human review and evaluation of patterns and trends are in process.
9	2007	Effective Management of Human Capital/Information Technology/Resources	Technology	Availability	Number of hours the system is down. Outcome: Greater system availability. Measured annually.	12 hours of unplanned downtime	10 hours of unplanned downtime	Success. 1 hour of unplanned downtime
10	2007	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of workflows available through the User Interface. Outcome: Decrease in time to wait for an analysis to start and allows for balancing work between labs and individuals. Measured quarterly	0 workflows	1 workflow	Success. Implemented Business Process Management for Food Emergency Response Network interface.
11	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of analytes and select agents routinely tested and evaluated using pattern detecting algorithms and/or other data analysis mechanisms. Outcome: Improved automation to leverage resources for protection. Measured continuously as operational	10 analytes and select agents	300 analytes and select agents	Success. All analytes and select agents (more than 300)
12	2008	Effective Management of Human Capital/Information Technology/Resources	Technology	Availability	Number of hours the system is down. Outcome: Greater system availability. Measured annually.	10 hours of unplanned downtime	9 hours of unplanned downtime	Success. Less than 9 hours of unplanned downtime
13	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of workflows available through the User Interface. Outcome: Decrease in time to wait for an analysis to start and allows for balancing work between labs and individuals. Measured quarterly	1 workflow	2 workflows	Failure. 1 workflow available. Second workflow expected February, 2009
14	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Availability	% of labs equipped with LabSAN servers. Outcome: Improved managing of equipment maintenance and data backup. Measured annually.	0% of labs have LabSAN servers	100% of labs have LabSAN servers	Success. 100% of labs have labSAN Servers
15	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of standardized LabSAN servers for all FDA labs. Outcome: Improved data sharing and transfer, reduced maintenance for geographically dispersed locations, and leverage of best practices. Measured annually.	0 servers	8 servers	Success. More than 8 servers
16	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of LabSAN installations with field interconnectivity. Outcome: Improved availability of data, methods, and equipment status. Results in reduced time for emergency response. Measured annually.	0 installations	8 installations	Failure. 2 installations
17	2008	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Satisfaction	% of user requirements accomplished for portal configuration. Outcome: Increased user satisfaction and system usage which reduces the use of telephone, etc. This results in greater staff efficiency. Measured annually	0% of portal user requirements	10% of portal user requirements	Success. 10% of portal user requirements accomplished
18	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of workflows available through the User Interface. Outcome: Decrease in time to wait for an analysis to start and allows for balancing work between labs and individuals. Measured quarterly	2 workflows	3 workflows	TBD
19	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	Availability	Number of hours the system is down. Outcome: Greater system availability. Measured annually.	9 hours unplanned downtime	8 hours unplanned downtime	TBD
20	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Satisfaction	Number of standard reports with map. Outcome: Allows a visual correlation of events using geospatial data to support trend identification and analysis. Measured annually	0 standard reports with map	1 standard report with map	TBD
21	2009	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Satisfaction	% of user requirements accomplished for portal configuration. Outcome: Increased user satisfaction and system usage which reduces the use of telephone, etc. This results in greater staff efficiency. Measured annually	10% of portal user requirements	25% of portal user requirements	TBD
22	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	Data Reliability and Quality	% of hardware installed for LabSAN. Outcome: Enhanced data collection of instrument data and improved data quality and accountability. Measured annually	0% of hardware	60% of hardware	TBD
23	2009	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Record Retention	Additional GB of data on-line. Outcome: Greater data access to support protection. Measured annually.	0 GB	100 GB	TBD
24	2009	Effective Management of Human Capital/Information Technology/Resources	Technology	Internal Data Sharing	% ORA employees access to Quality system for doc control, corrective actions, complaints, record control, mgmt review, audits, nonconformance, preventive action, cont improvement. Outcome: Quality emphasized in everyday activities.	0 % of ORA employees	95 % of ORA employees	TBD
25	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	IT Contribution to Process, Customer, or Mission	% of labs that are bar code enabled. Outcome: Automation of tracking samples, etc. Measured annually.	0% of labs are bar code enabled	100% of labs are bar code enabled	TBD
26	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Data Reliability and Quality	Error rate percentage of sample identification when logging samples. Outcome: Better sample identification and tracking resulting in better and faster corrective actions. Measured annually	5% error rate	0.5% error rate	TBD
27	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Number of workflows available through the User Interface. Outcome: Decrease in time to wait for an analysis to start and allows for balancing work between labs and individuals. Measured quarterly	3 workflows	4 workflows	TBD
28	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Customer Satisfaction	% of user requirements accomplished for portal configuration. Outcome: Increased user satisfaction and system usage which reduces the use of telephone, etc. This results in greater staff efficiency. Measured annually	25% of portal user requirements met in portal configuration	50% of portal user requirements met in portal configuration	TBD
29	2010	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	Record Retention	Additional GB of data on-line. Outcome: Greater data access to support protection. Measured annually.	100 GB	500 GB	TBD
30	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Accuracy of Service or Product Delivered	Number of functional discrepancies resolved. Outcome: Identification and standardization of common functions of different groups. Measured annually	0 functional discrepancies	3 functional discrepancies	TBD
31	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Innovation and Improvement	Number of new functions to improve scientific research to help safeguard the public. Outcome: Standardization and refinement of workflows through specific functions of different groups. Measured annually	0 new functions	100% of new functions	TBD
32	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Efficiency	Duplicative result entry. Outcome: Reduction in FTEs required to perform this function and a reduction in errors. Measured annually	Minimum 2 times using hard copy, often 3 times	Single on-line entry	TBD
33	2010	Effective Management of Human Capital/Information Technology/Resources	Technology	Data Reliability and Quality	% of hardware installed for LabSAN. Outcome: Enhanced data collection of instrument data and improved data quality and accountability. Measured annually	60% of hardware	100% of hardware	TBD
34	2010	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Errors	% of ORA labs and District Offices with consistent and well-defined national quality factors. Outcome: Defined, accepted, universal culture of quality with reduced errors.	0 % of ORA labs and District Offices	95 % of ORA labs and District Offices	TBD
35	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	% of labs with LIMS functionality. Outcome: improved tracking of inventory (such as reagents) and equipment calibration, resulting in cost savings. Provides equipment calibration records for legal actions. Measured annually	0% of labs with LIMS functionality	100% of labs with LIMS functionality	TBD
36	2011	Effective Management of Human Capital/Information Technology/Resources	Mission and Business Results	System Maintenance	Number of hours of operational downtime for maintenance. Outcome: Greater system availability. Measured annually	60 hours	45 hours	TBD
37	2011	Effective Management of Human Capital/Information Technology/Resources	Technology	Data Reliability and Quality	% of IT infrastructure upgraded to satisfy future security and performance requirements. Outcome: More secure and better user experience to support improved protection. Measured annually.	0% of IT infrastructure	100% of IT infrastructure	TBD
38	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Delivery Time	Time to correct critical functional errors. Outcome: Faster corrective actions. Measured annually	5 days	4 days	TBD
39	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Cycle Time	% of labs converted from manual to automated data entry into eLEXNET. Outcome: Reduction in FTE time required and improved response to changing conditions to support protection. Measured annually	30% of labs	50% of labs	TBD
40	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	% of labs with software workflow. Outcome: Reduced time needed to analyze and report on samples. Fast status reporting for compliance functions. Measured annually	0% of labs have software workflow	100% of labs have software workflow	TBD
41	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	IT Contribution to Process, Customer, or Mission	% of analytical processes controlled by software. Outcome: Reduction in data entry errors. Measured quarterly	0% of analytical processes are software controlled	50% of analytical processes are software controlled	TBD
42	2011	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Errors	% improvement in consistent and uniform quality products and process (Quality in conjunction with lab management). Outcome: improvement in consistently valid results.	0 % improvement	20% improvement	TBD
43	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Interoperability	Number of interoperating laboratories. Outcome: Software interoperation to improve data exchange and communication. Measured annually	0 laboratories	1 laboratory	TBD
44	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Frequency and Depth	% increase in use because of improved system performance to accommodate an increase in the number of system users. Outcome: Real-time collaboration. Measured annually	0% increase in use	10% increase in use	TBD
45	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Knowledge Management	% of systems consolidated to provide full access to data to support regulatory decisions. Outcome: Improved compliance officer productivity. Measured annually	0% of systems	20% of systems	TBD
46	2012	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of laboratories with a mechanism for read only access to non-laboratory users with some reporting capabilities. Outcome: Improved information sharing and access for FDA (ex: investigations) and non-FDA (ex: states) groups. Measured annually	0 laboratories	5 laboratories	TBD
47	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Interoperability	Number of interoperating laboratories. Outcome: Software interoperation to improve data exchange and communication. Measured annually	1 laboratory	5 laboratories	TBD
48	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Frequency and Depth	% increase in use because of improved system performance to accommodate an increase in the number of system users. Outcome: Real-time collaboration. Measured annually	10% increase in use	20% increase in use	TBD
49	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Knowledge Management	% of systems consolidated to provide full access to data to support regulatory decisions. Outcome: Improved compliance officer productivity. Measured annually	20% of systems	50% of systems	TBD
50	2013	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of laboratories with a mechanism for read only access to non-laboratory users with some reporting capabilities. Outcome: Improved information sharing and access for FDA (ex: investigations) and non-FDA (ex: states) groups. Measured annually	5 laboratories	10 laboratories	TBD
51	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Technology	Interoperability	Number of interoperating laboratories. Outcome: Software interoperation to improve data exchange and communication. Measured annually	5 laboratories	10 laboratories	TBD
52	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Customer Results	Frequency and Depth	% increase in use because of improved system performance to accommodate an increase in the number of system users. Outcome: Real-time collaboration. Measured annually	20% increase in use	25% increase in use	TBD
53	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Processes and Activities	Knowledge Management	% of systems consolidated to provide full access to data to support regulatory decisions. Outcome: Improved compliance officer productivity. Measured annually	50% of systems	100% of systems	TBD
54	2014	S.O. 2.2 - Protect the public against injuries and environmental threats	Mission and Business Results	Disaster Monitoring and Prediction	Number of laboratories with a mechanism for read only access to non-laboratory users with some reporting capabilities. Outcome: Improved information sharing and access for FDA (ex: investigations) and non-FDA (ex: states) groups. Measured annually	10 laboratories	13 laboratories	TBD

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 Automated Laboratory Management

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	ALM eLEXNET/NBIS	Provides the ability to compare and communicate data from laboratory analyses of food products as well as to detect unusual results and identify potentially harmful products. Multi-agency national data & information fusion for agency specific data and information monitoring at city, state and federal levels providing improved national situational awareness.	Search	Pattern Matching			No Reuse	12
2	ALM eLEXNET/NBIS	Provides the ability to compare and communicate data from laboratory analyses of food products as well as to detect unusual results and identify potentially harmful products. Multi-agency national data & information fusion for agency specific data and information monitoring at city, state and federal levels providing improved national situational awareness.	Human Resources	Health and Safety			No Reuse	13
3	ALM LabSAN/LIMS	Development of a real-time network-based storage system for raw lab data with all relevant field offices. Used to track and monitor laboratory data.	Asset / Materials Management	Computers / Automation Management			No Reuse	13
4	ALM LabSAN/LIMS	Development of a real-time network-based storage system for raw lab data with all relevant field offices. Used to track and monitor laboratory data.	Document Management	Library / Storage			No Reuse	12
5	Methods Module Service	Methods Repository Service and Methods Review Processes provide the middleware and database repository for use by USDA.	Data Management	Data Exchange			No Reuse	13
6	Geospatial Mapping Service	To enable users to customize or filter map data, theGIS subsystem receives query or parameter input from the Report_Parameters module or directly from a report module.	Visualization	Mapping / Geospatial / Elevation / GPS			No Reuse	12
7	ALM eLEXNET/NBIS	Provides the ability to compare and communicate data from laboratory analyses of food products as well as to detect unusual results and identify potentially harmful products. Multi-agency national data & information fusion for agency specific data and information monitoring at city, state and federal levels providing improved national situational awareness.	Knowledge Discovery	Data Mining			No Reuse	13
8	ALM LabSAN/LIMS	Development of a real-time network-based storage system for raw lab data with all relevant field offices. Used to track and monitor laboratory data.	Organizational Management	Workgroup / Groupware			No Reuse	12

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	Pattern Matching	Service Platform and Infrastructure	Delivery Servers	Application Servers	BEA WebLogic Platform by: BEA Systems, Inc.
2	Pattern Matching	Service Interface and Integration	Integration	Enterprise Application Integration	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
3	Pattern Matching	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG
4	Health and Safety	Component Framework	Data Management	Reporting and Analysis	OLAP Services by: Microsoft Corporation
5	Computers / Automation Management	Service Access and Delivery	Access Channels	Web Browser	Windows Internet Explorer by: Microsoft Corporation
6	Computers / Automation Management	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
7	Library / Storage	Service Platform and Infrastructure	Delivery Servers	Application Servers	BEA WebLogic Platform by: BEA Systems, Inc.
8	Library / Storage	Service Interface and Integration	Integration	Enterprise Application Integration	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
9	Library / Storage	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG
10	Data Exchange	Service Platform and Infrastructure	Delivery Servers	Web Servers	Apache by: Apache Software Foundation
11	Data Exchange	Service Interface and Integration	Interface	Service Description / Interface	Web Services Description Language (WSDL) by: World Wide Web Consortium
12	Data Exchange	Service Interface and Integration	Integration	Middleware	Java Message Service by: Sun Microsystems, Inc.
13	Data Exchange	Component Framework	Data Interchange	Data Exchange	SOAP by: World Wide Web Consortium
14	Data Exchange	Service Platform and Infrastructure	Delivery Servers	Application Servers	BEA WebLogic Platform by: BEA Systems, Inc.
15	Data Exchange	Component Framework	Business Logic	Platform Independent Technologies	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
16	Data Exchange	Component Framework	Business Logic	Platform Independent Technologies	Java Servlet (JSR 53) by: Sun Microsystems, Inc.
17	Data Exchange	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
18	Data Exchange	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
19	Data Exchange	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG
20	Data Exchange	Component Framework	Data Management	Reporting and Analysis	Business Objects by: SAP AG
21	Data Exchange	Service Platform and Infrastructure	Database / Storage	Database	Business Objects by: SAP AG
22	Data Exchange	Service Interface and Integration	Interface	Service Description / Interface	Business Objects by: SAP AG
23	Data Exchange	Component Framework	Data Management	Database Connectivity	Business Objects by: SAP AG
24	Data Exchange	Service Access and Delivery	Service Requirements	Authentication / Single Sign-on	Business Objects by: SAP AG
25	Data Exchange	Component Framework	Data Interchange	Data Exchange	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
26	Data Exchange	Service Interface and Integration	Integration	Enterprise Application Integration	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
27	Data Exchange	Service Platform and Infrastructure	Support Platforms	Independent Platform	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
28	Data Exchange	Service Access and Delivery	Service Requirements	Legislative / Compliance	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
29	Data Exchange	Service Access and Delivery	Delivery Channels	Intranet	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
30	Data Exchange	Component Framework	Data Management	Reporting and Analysis	Java Database Connectivity by: Sun Microsystems, Inc.
31	Mapping / Geospatial / Elevation / GPS	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG
32	Data Mining	Service Platform and Infrastructure	Delivery Servers	Application Servers	BEA WebLogic Platform by: BEA Systems, Inc.
33	Data Mining	Service Interface and Integration	Integration	Enterprise Application Integration	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
34	Data Mining	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG
35	Workgroup / Groupware	Service Platform and Infrastructure	Delivery Servers	Application Servers	BEA WebLogic Platform by: BEA Systems, Inc.
36	Workgroup / Groupware	Service Interface and Integration	Integration	Enterprise Application Integration	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
37	Workgroup / Groupware	Component Framework	Business Logic	Platform Dependent Technologies	Business Objects by: SAP AG

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

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?

2006-08-01

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:

Project-level IT and business risks are tracked continuously by Project Officers, and the status is included in periodic project reports to the ALM manager. Project-level risk status is also typically reviewed during the stage gate process at the end of each life cycle phase. The resources applied to and the timetable for conducting these meetings is documented in program planning artifacts. Risk is also a factor in the prioritization and scheduling of projects; higher risk projects are scheduled without time critical dependencies where possible so a schedule delay will not affect other projects. The combination of program level management reserve and substantial preplanning where needed are being applied as appropriate as contracts are initiated, along with the mitigation strategies applied by the project managers themselves relative to the individual efforts. Costs and schedules for work in ALM are risk-adjusted based on analogous estimating. eLEXNET tends to have a smaller risk-adjustment as the functionality of this area is mostly self-contained and it is hosted off site. While other areas that require more coordination have a higher risk adjustment. This includes such items as interfaces for sample distribution due to its dependencies on MARCS, NEIS due its dependencies on organizations outside of FDA, and quality management as this involves a significant number of stakeholders. Based on past experience, the costs and schedules associated with these elements of ALM are adjusted to account for risks particular to these activities.

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