Exhibit 300 (BY2010) for NIH NCI Cancer Therapy Evaluation Program (CTEP)

1. Date of Submission:

2009-03-13

2. Agency:

009

3. Bureau:

25

4. Name of this Capital Asset:

NIH NCI Cancer Therapy Evaluation Program (CTEP)

5. Unique Project Identifier:

009-25-01-05-01-4902-00

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 Cancer Therapy Evaluation Program Enterprise System (CTEP-ESYS) project is the primary data collection mechanism for NCI's vast clinical trials program. CTEP-ESYS collects safety and clinical results data on 1,500 ongoing cancer clinical trials (trials not yet completed) that monitor more than 30,000 patients per year in more than 17 disease areas. Data reporting and analysis in real time is critical to ensuring adequate monitoring of the ongoing clinical research. Timely data reporting and analysis also assures effective planning for the required successor studies, thus accelerating the evaluation of promising new agents and regimens for patients with cancer. An effective CTEP-ESYS allows investigators and researchers to focus on scientific opportunity, patient safety and reducing the burden of cancer on the public by finding better ways to treat, control and cure cancer. There are more than 13 integrated components that support CTEP needs including protocol tracking, drug authorization and tracking, clinical data reporting, adverse event reporting and processing, clinical trials auditing, financial management, IND and disease management and tracking, annual report generation, regulatory activities, account management, investigator registration, reporting and analysis, and more. CTEP-ESYS is an integrated flexible modular user-friendly IT system that supports the cancer-clinical trials infrastructure. CTEP-ESYS includes an effective and well-constructed management tool that mines complex drug, disease and clinical data into meaningful information and knowledge for decision-making. The goals of CTEP-ESYS are to: - Provide reliable clinical results and toxicity data for the largest sponsor of cancer clinical trials in the U.S. - Shift focus from administrative tasks to science - Improve patient/trial safety - Assure the security and confidentially of proprietary and patient information - Eliminate data redundancy throughout the oncology community - Empower staff to make educated decisions by improving access, quality and timeliness of data - Enhance staff efficiency and capabilities - Provide a Cost Effective Approach to Addressing Administrative, Scientific and Regulatory Concerns

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

yes

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

2008-05-27

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?

2007-08-01

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.

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?)

eGOV: secure use of the Internet for data communication. Data reuse & sharing, process automation, and secure systems delivered on time/on budget are all key aspects. COMPETITIVE SOURCING: CTEP-ESYS was competitively outsourced.

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

no

15. Is this investment for information technology?

yes

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

Level 2

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

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

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

no

19. Is this a financial management system?

no

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

Area	Percentage
Hardware	3
Software	3
Services	94
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	Karen Pla
Phone Number	301-402-6201
Title	NIH Privacy Act Officer
Email	plak@mail.nih.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	12.302	0.465	0.384	0.356
Acquisition Budgetary Resources	28.704	1.086	0.895	2.593
Maintenance Budgetary Resources	18.263	4.654	5.114	5.432
Government FTE Cost	0.431	0.153	0.158	0.163
# of FTEs	4	1	1	1

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.

You will notice an increase in our BY2010 costs. This is due to the fact that our new contract was recently awarded and the first 3 months of the award have been dedicated primarily to IT planning. We have a number of new development projects that will take place in 2010 (+ a couple of additional years afterwards). This increased development activity for 2010 has contributed to the increase of budgeted costs.

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	2006	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Mission and Business Results	Health Care Research and Practitioner Education	Increase by 30% the percentage of NCI oncology community members who can collaborate in protocol authoring using the system	0%	Percentage of NCI oncology community members who can collaborate in protocol authoring using the system	5/26/2006 Data analysis was performed
2	2006	S.O. 1.3 - Improve health care quality, safety, cost and value	Customer Results	Response Time	Reduce by 2% the number of AE's reported that do not meet expedited reporting requirements	>50% of Adverse Events do not require expedited reporting	Percentage of reported expedited AEs that don't required expedited reporting	2%
3	2007	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	Reduce by 10% the average number of days to approved protocol from concept of LOI receipt	>320 days to approved protocol from concept or LOI (clinical trial idea) receipt.	Mean number of days to develop a clinical trial from idea to approved trial	280 days
4	2007	S.O. 4.2 - Increase basic scientific knowledge to improve human health and development	Customer Results	New Customers and Market Penetration	Increase by 50% the number of drug orders processed per FTE on the PMB support project	20,000 drug orders processed per FTE by PMB support contract staff	Number of drug orders processed per FTE	30,000 orders per FTE
5	2008	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA)	30 calendar days	Reduce the number of days to submit annual reports to the FDA by1 business day	Achieved target number of submission days on 5/15/2008.
6	2008	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	60% (8,178) of adverse events reported to AdEERS meet the expedited reporting requirements	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	Target number was achieved on 5/30/2008.
7	2008	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	48 hours	Reduce the abstraction time by 4%	Abstraction time was successfully reduced by 4% by 6/16/2008.
8	2008	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	14,886	Increase the number of active PI's by 2%	Number of PI's was successfully increased by 2% by 6/30/2008.
9	2008	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	367	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	Protocol approval date was successfully reduced by 2% on 6/30/2008.
10	2009	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA) by 10% the percentage of trials completed on time by early identification of poorly accruing trials	TBD based on the actual results of the prior year.	Reduce the number of days to submit annual reports to the FDA by1 business day	TBD
11	2009	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	TBD based on the actual results of the prior year.	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	TBD
12	2009	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	TBD based on the actual results of the prior year.	Reduce the abstraction time by 4%	TBD
13	2009	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	TBD based on the actual results of the prior year.	Increase the number of active PI's by 2%	TBD
14	2009	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	TBD based on the actual results of the prior year.	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	TBD
15	2010	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA)	TBD based on the actual results of the prior year.	Reduce the number of days to submit annual reports to the FDA by1 business day	TBD
16	2010	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	TBD based on the actual results of the prior year.	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	TBD
17	2010	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	TBD based on the actual results of the prior year.	Reduce the abstraction time by 4%	TBD
18	2010	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	TBD based on the actual results of the prior year.	Increase the number of active PI's by 2%	TBD
19	2010	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	TBD based on the actual results of the prior year.	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	TBD
20	2011	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA)	TBD based on the actual results of the prior year.	Reduce the number of days to submit annual reports to the FDA by1 business day	TBD
21	2011	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	TBD based on the actual results of the prior year.	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	TBD
22	2011	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	TBD based on the actual results of the prior year.	Reduce the abstraction time by 4%	TBD
23	2011	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	TBD based on the actual results of the prior year.	Increase the number of active PI's by 2%	TBD
24	2011	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	TBD based on the actual results of the prior year.	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	TBD
25	2012	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA)	TBD based on the actual results of the prior year.	Reduce the number of days to submit annual reports to the FDA by1 business day	TBD
26	2012	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	TBD based on the actual results of the prior year.	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	TBD
27	2012	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	TBD based on the actual results of the prior year.	Reduce the abstraction time by 4%	TBD
28	2012	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	TBD based on the actual results of the prior year.	Increase the number of active PI's by 2%	TBD
29	2012	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	TBD based on the actual results of the prior year.	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	TBD
30	2013	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA)	TBD based on the actual results of the prior year.	Reduce the number of days to submit annual reports to the FDA by1 business day	TBD
31	2013	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	TBD based on the actual results of the prior year.	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	TBD
32	2013	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	TBD based on the actual results of the prior year.	Reduce the abstraction time by 4%	TBD
33	2013	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	TBD based on the actual results of the prior year.	Increase the number of active PI's by 2%	TBD
34	2013	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	TBD based on the actual results of the prior year.	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	TBD
35	2014	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	Time to submit annual report to the Food and Drug Administration (FDA)	TBD based on the actual results of the prior year.	Reduce the number of days to submit annual reports to the FDA by1 business day	TBD
36	2014	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Mission and Business Results	Health Care Research and Practitioner Education	The number of expedited adverse events reported to the Adverse Event Expedited Reporting System (AdEERS) that do not meet applicable reporting requirements	TBD based on the actual results of the prior year.	Reduce the number of adverse events that do not meet expedited reporting requirements reported to AdEERS by an additional 2%	TBD
37	2014	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Customer Results	Delivery Time	The amount of time it takes to abstract a protocol into the Protocol Authorization and Tracking System (PATS)	TBD based on the actual results of the prior year.	Reduce the abstraction time by 4%	TBD
38	2014	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Processes and Activities	Efficiency	The number of active principal investigators (PI) registered by CTEP	TBD based on the actual results of the prior year.	Increase the number of active PI's by 2%	TBD
39	2014	S.O. 4.3 - Conduct and oversee applied research to improve health and well-being	Technology	IT Contribution to Process, Customer, or Mission	The mean number of days to approve a protocol from receipt of concept or letter of intent (LOI) through the use of the Document Authoring, Review, and Tracking system (Docu-MART)	TBD based on the actual results of the prior year.	Reduce the number of days to approve a protocol from receipt of concept or LOI by 2% annually	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?

no

2.b. If no, please explain why?

Not one of the 12 investments hihglighted in the HHS Enterprise Transition Plan, however it is a core system at NIH and will be part of any future transition or consolidation at NIH.

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	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Data Management	Data Cleansing			No Reuse	3
2	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Management of Processes	Quality Management			No Reuse	3
3	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Systems Management	System Resource Monitoring			No Reuse	3
4	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Security Management	Audit Trail Capture and Analysis			No Reuse	3
5	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Content Management	Content Publishing and Delivery			No Reuse	3
6	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Knowledge Management	Categorization			No Reuse	3
7	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Development and Integration	Software Development			No Reuse	3
8	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Data Management	Data Classification			No Reuse	3
9	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Search	Query			No Reuse	3
10	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Security Management	Access Control			No Reuse	3
11	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Data Management	Data Exchange			No Reuse	3
12	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Management of Processes	Requirements Management			No Reuse	3
13	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Management of Processes	Configuration Management			No Reuse	3
14	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Knowledge Management	Information Retrieval			No Reuse	3
15	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Development and Integration	Data Integration			No Reuse	3
16	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Knowledge Management	Knowledge Distribution and Delivery			No Reuse	3
17	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Data Management	Extraction and Transformation			No Reuse	3
18	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Collaboration	Email			No Reuse	3
19	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Management of Processes	Change Management			No Reuse	3
20	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Data Management	Data Mart			No Reuse	3
21	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Knowledge Discovery	Data Mining			No Reuse	3
22	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Data Management	Data Recovery			No Reuse	3
23	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Security Management	Identification and Authentication			No Reuse	3
24	NIH NCI Cancer Therapy Evaluation Program (CTEP)	Contract for informatics and computer support involving aspects of cancer clinical trials. Integrated systems include the Clinical Data Update System, the Common Toxicity Criteria, and the Adverse Drug Experience Electronic Reporting System.	Knowledge Management	Knowledge Capture			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	Data Cleansing	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
2	Quality Management	Service Platform and Infrastructure	Software Engineering	Test Management	Bobby by: International Business Machines Corp.
3	System Resource Monitoring	Service Access and Delivery	Service Transport	Supporting Network Services	Simple Network Management Protocol (SNMP) by: CISCO
4	Audit Trail Capture and Analysis	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
5	Content Publishing and Delivery	Service Access and Delivery	Access Channels	Web Browser	Netscape Communicator by: Netscape Communications Corporation
6	Content Publishing and Delivery	Service Access and Delivery	Delivery Channels	Internet	Windows Internet Explorer by: Microsoft Corporation
7	Categorization	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
8	Software Development	Component Framework	Business Logic	Platform Independent Technologies	C++ by: IEC
9	Software Development	Component Framework	Business Logic	Platform Independent Technologies	C by: ANSI
10	Software Development	Component Framework	User Presentation / Interface	Static Display	Hyper Text Markup Language by: International Organization for Standardization
11	Software Development	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Java Server Pages by: Sun Microsystems, Inc.
12	Software Development	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle 9i Application Server by: Oracle Corporation
13	Software Development	Service Platform and Infrastructure	Support Platforms	Independent Platform	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
14	Software Development	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Active Server Pages by: Microsoft Corporation
15	Software Development	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Windows 2000 by: Microsoft Corporation
16	Software Development	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Visual Basic by: Microsoft Corporation
17	Data Classification	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
18	Query	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
19	Access Control	Service Access and Delivery	Delivery Channels	Virtual Private Network (VPN)	Cisco Systems VPN Client 4.6.00.0045 by: Cisco Systems, Inc.
20	Data Exchange	Component Framework	Data Management	Database Connectivity	Open Database Connectivity by: Microsoft Corporation
21	Data Exchange	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
22	Data Exchange	Service Access and Delivery	Service Transport	Service Transport	Transmission Control Protocol by: The Internet Engineering Task Force
23	Data Exchange	Service Access and Delivery	Service Transport	Service Transport	Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force
24	Data Exchange	Service Access and Delivery	Service Transport	Service Transport	File Transfer Protocol (FTP) by: The Internet Engineering Task Force
25	Data Exchange	Service Access and Delivery	Service Transport	Service Transport	Internet Protocol by: The Internet Engineering Task Force
26	Data Exchange	Component Framework	Data Management	Database Connectivity	XML Schema by: World Wide Web Consortium
27	Requirements Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Rational RequisitePro by: International Business Machines Corp.
28	Configuration Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Rational ClearCase by: International Business Machines Corp.
29	Information Retrieval	Service Platform and Infrastructure	Delivery Servers	Web Servers	Microsoft Internet Information Services by: Microsoft Corporation
30	Data Integration	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
31	Knowledge Distribution and Delivery	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
32	Knowledge Distribution and Delivery	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Visual Basic by: Microsoft Corporation
33	Knowledge Distribution and Delivery	Service Platform and Infrastructure	Support Platforms	Independent Platform	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
34	Knowledge Distribution and Delivery	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
35	Knowledge Distribution and Delivery	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle 9i Application Server by: Oracle Corporation
36	Knowledge Distribution and Delivery	Service Access and Delivery	Delivery Channels	Internet	Windows Internet Explorer by: Microsoft Corporation
37	Knowledge Distribution and Delivery	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Active Server Pages by: Microsoft Corporation
38	Knowledge Distribution and Delivery	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Java Server Pages by: Sun Microsystems, Inc.
39	Extraction and Transformation	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
40	Email	Service Access and Delivery	Access Channels	Collaboration / Communications	Microsoft Office Outlook by: Microsoft Corporation
41	Email	Service Access and Delivery	Service Transport	Supporting Network Services	Simple Mail Transfer Protocol by: The Internet Engineering Task Force
42	Email	Service Access and Delivery	Service Transport	Supporting Network Services	Multipurpose Internet Mail Extensions by: The Internet Engineering Task Force
43	Change Management	Service Platform and Infrastructure	Software Engineering	Software Configuration Management	Rational ClearQuest by: International Business Machines Corp.
44	Data Mart	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
45	Data Mining	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
46	Data Recovery	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
47	Identification and Authentication	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle 9i Application Server by: Oracle Corporation
48	Identification and Authentication	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
49	Knowledge Capture	Service Platform and Infrastructure	Database / Storage	Database	Oracle by: Oracle Corporation
50	Knowledge Capture	Service Platform and Infrastructure	Support Platforms	Dependent Platform	Microsoft Visual Basic by: Microsoft Corporation
51	Knowledge Capture	Service Platform and Infrastructure	Support Platforms	Independent Platform	Java 2 Enterprise Edition by: Sun Microsystems, Inc.
52	Knowledge Capture	Component Framework	Data Management	Database Connectivity	Java Database Connectivity by: Sun Microsystems, Inc.
53	Knowledge Capture	Service Platform and Infrastructure	Delivery Servers	Application Servers	Oracle 9i Application Server by: Oracle Corporation
54	Knowledge Capture	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Active Server Pages by: Microsoft Corporation
55	Knowledge Capture	Component Framework	User Presentation / Interface	Dynamic Server-Side Display	Java Server Pages by: Sun Microsystems, Inc.

6. Will the application leverage existing components and/or applications across the Government (i.e., FirstGov, Pay.Gov, etc)?

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?

2008-12-01

1.b. Has the Risk Management Plan been significantly changed since last year's submission to OMB?

yes

1.c. If yes, describe any significant changes:

To date we have incorporated several safe guards to mitigate future risk to this enterprise investment. First, we have worked with contracts to upgrade the provisions of the contract to a performance based cost plus award fee contract where significant monitoring will be maintained and coordinated with COTR via a quality assurance surveillance plan (QASP) to ensure effective performance by the contractor. Second, since 2004 the CTEP investment has successfully passed two (2) Certification & Accreditation (C & A) audits which encompasses risk management, disaster recovery, information security, FISMA compliance, and privacy data security system safe guards. The CTEP-ESYS stands currently as one of the most secured systems in the NCI portfolio based on recent communications from the NCI ISSO. In addition, CTEP has incorporated best practice to the IT investment for development, operations & maintenance, and IT governance. The contractor has institutionalized CMMI Level 3 best practice for process management, project management, and software and system development. This institutionalization of best practice has resulted in IT project deliverables and asset management to be on time and within budget to meets the growing information management needs of the Cancer Therapy Evaluation Program.

3. Briefly describe how investment risks are reflected in the life cycle cost estimate and investment schedule:

Our risk analysis mitigation and contingency planning have been incorporated into the lifecycle cost estimate and investment schedule. The investment has a performance based Quality Assurance Surveillance Plan (QASP) that incorporates performance measures with scheduled activities for development, maintenance & operation, overall contract performance efficiency and IT support. This QASP is evaluated quarterly with the contractor to ensure schedule and cost performance are in alignment with the lifecycle cost and schedule.

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