JOFOC_CCCT Support_072524 signed.pdf

NCI Template and Instructions for a Justification and Approval

Completion Instructions: Use this template for preparation of a Justification and Approval (J&A) for non-Federal Supply Schedule acquisitions exceeding the simplified acquisition threshold. Prepare the template in accordance with these completion instructions. (NOTE: The Program Manager (PM) has responsibility for completing all of the information items included in the template, with any necessary assistance from the cognizant Contracting Officer (CO) and Contract Specialist (CS) -- especially for items 3.(b), 4., 6., 7., 8., and 10 listed below.

The instructions for preparing a J&A are specified in “red” and should be deleted prior to processing the document for review and approval. Also, do not include the completion instructions in the final document.

A completed J&A must contain all the applicable bolded headings in the order specified.

Place the required information directly next to, or under, the applicable heading. If a heading does not apply to a specific J&A, indicate “not applicable” (N/A) next to it.

Reference and attach any additional information necessary to support the J&A.

Justification and Approval for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. HHS-NIH

b. Sponsoring organization. NCI – OD – Coordinating Center for Clinical Trials

c. Program Manager information.

Program Manager’s name. Iris Castro

Mailing address. 9609 Medical Center Drive, Rm. 6W630, Rockville, MD 20850

E-mail address. iris.castro@nih.gov

Telephone number. 240-620-0571

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The task order will be in support of NCI’s Coordinating Center for Clinical Trials (CCCT). The objective of this task order is to support NCI with specialized research, strategic support, and technical analysis for CCCT’s clinical trials activities with the goal of enabling NCI and CCCT leadership to strategically plan, formulate, and implement policies, programs, and procedures to strengthen the NCI clinical trials enterprise.

b. Project background. The mission of NCI’s Coordinating Center for Clinical Trials is to facilitate the integration of NCI’s clinical trials enterprise and associated translational research to advance science and patient care. NCI’s clinical trials program includes but is not limited to the National Clinical Trials Network (NCTN), Early Therapeutics Clinical Trials Network (ETCTN), NCI Community Oncology Research Program (NCORP) trials, trials taking place through NCI's Center for Cancer Research (CCR), and trials taking place with NCI support (either in NCI-designated cancer centers or through NCI-funded grants).

CCCT plays a key role in the coordination and collaboration among NCI’s various divisions, offices, and centers to support clinical trials and translational research activities across the Institute. Because CCCT’s work complements and bolsters cross-institute clinical trial activities, CCCT works closely with the Office of the Director, the Division of Cancer Treatment and Diagnosis, the Cancer Therapy Evaluation Program, and the Division of Cancer Prevention, among many other offices and divisions. CCCT also convenes extramural advisors to provide advice and insight on NCI’s clinical trials and translational research enterprise.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Strategic Planning and Analytic Support for CCCT’s Clinical Trials Activities

b. Project description. Refer to the attached SOW.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N/A

c. Total estimated dollar value and performance/delivery period.

Total estimated dollar value of the acquisition: $398,034.65 Total estimated performance/delivery period: 09/01/2024-08/31/2027 (36 months from the date of award)

The period of performance proposed (3 years from the date of award) is the minimum acceptable period given the constantly evolving and fluid nature of the clinical trials landscape and functioning of NCI FACA advisory board committees, however, due to internal program requirements, we are not requesting option years.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1_.- Only one responsible source and no other supplies or services will satisfy agency requirements.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Institute for Defense Analyses/Science and Technology Policy Institute, 730 East Glebe Road, Alexandria, VA 22305

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Please see attached FFRDC justification.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. This task order will be using the Federally Funded Research and Development Center single award IDIQ NSFOIA0408601.

In accordance with FAR 5.202 (a)(6), The Contracting Officer need not submit the notice required by FAR 5.201 when the proposed contract action is an order placed under subpart 16.5.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. An Independent Government Cost Estimate (IGCE) was developed using historical data on costs incurred on the current, active IDA Task Order, NSFOIA0408601_75N91021F00141, as well as the COR’s knowledge of salary information for the services being requested.

In accordance with FAR 15.403-1 (b)(1), Certified cost or pricing data shall not be required when the CO determines that prices agreed upon are based on adequate price competition. As there was adequate price competition at the time the Base IDIQ was negotiated, the labor and indirect cost rates included in the Base IDIQ, which are the rates that will be used for any resulting Task Order, have already been established as fair and reasonable. The CO will ensure that the proposed labor and indirect cost rates comply with the pricing incorporated via the most recent IDIQ modification.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The COR reviewed market research conducted for the Base IDIQ and verified that the use of the proposed pre-existing contract vehicle is still the most appropriate method of fulfilling the current requirement. See attached FFRDC justification for more information.

9. Any other facts supporting the use of other than full and open competition.

Please see attached FFRDC justification.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. Not applicable.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. Not applicable. Please see attached FFRDC justification.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Program Manager (PM) Iris Castro, Scientific Program Specialist

PM’s Immediate Supervisor

Sheila Prindiville, Director, Coordinating Center for Clinical Trials

Head of the Sponsoring Program Office

Sheila Prindiville, Director, Coordinating Center for Clinical Trials

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer Kelly J. Fowler, Contracting Officer

Contracting Officer Rich Taylor, Acting Team Lead Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting

Office

Not applicable

Head of the Contracting

Activity

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive Not applicable

06/2021