36C24522Q1072.docx

SUBJECT*

Services of the University Institutional Review Board (VA-23-00008720)

GENERAL INFORMATION

BASE NOTICE TYPE

VAMC (613)

VISN 5 Contract Satellite Office 510 Butler Avenue, Building 306A Martinsburg WV 25405

POINT OF CONTACT*

Contract Specialist Christopher R Tate Christopher.Tate2@va.gov 304-263-0811

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

UNIVERSITY OF MARYLAND

Z9CRZKD42ZT1

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:_______ 36C24522AP3554__________________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 05, VA Maryland Health Care System, Research & Development Service.

2. Nature and/or Description of the Action Being Processed: The proposed procurement is for reviewing of human protocols. Services include: initial and continued review of human subject protocols and review of amendments, advertisements, adverse event reports and revised consent forms. The enrollment of patients into protocols need approval by the IRB at the University of MD and Veterans Administration Research Service under HIPAA Guidelines. Research Service requirement for the review of all the Research and Development human protocols for enrollment of patients for studies and need to be approved by the University of Maryland IRB Committee under the HIPAA guidelines.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Research Service requirement for the review of all the Research and Development human protocols for enrollment of patients for studies and need to be approved by the University of Maryland IRB Committee under the HIPAA guidelines.

The period of performance for the base year is October 1, 2022 – September 30, 2023 The period of performance for option year one is October 1, 2023 – September 30, 2024 The period of performance for option year two is October 1, 2024 – September 30, 2025 The period of performance for option year three is October 1, 2025 – September 30, 2026

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( X ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( X ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): All the Research and Development protocols must be reviewed by the University of Maryland IRB Committee for approval for the studies that are to be performed at the University of Maryland and at the VA Maryland Health Care System.

‐ Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302‐3

‐ Authorized or Required by Statute FAR 6.302‐5 In accordance with statutory authority 38 U.S.C. § 8153 (a)(3)(A) “Sharing of Healthcare Resources” to include research, when the statute authorizes but does not require that the procurement be made from a specified source, the requested actions are permissible when supported by a written justifications and approval. The affiliate agreement between VA and the University of Maryland which was issued subject to the cited statutory authority, supports this justification, and is attached.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Offers were not solicited from other sources due to the requirement being for R&D with University of MD.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Cost data were provided by the VA’s Research & Development office. Considering the importance of research to our Veterans the review of all the protocols for patients studies are a referral sources under the HIPAA Guidelines.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was not conducted due to the fact that all we conduct were optimized for use review of the Research and Development protocols. Therefore, the Internal Review Board that is required for the VAMHCS‐Research Service to be affricated to use the IRB Committee.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: n/a

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: n/a

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Agreement between the Department of Veterans Affairs and University of Maryland IRB will continue to for the foreseeable future.

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

Effective Date: 02/01/2022 Page 5 of 5