A02 Part 06 - JA FAR Part 6 - V3 OCT 2023 -Final _Redacted.pdf

CUI

Control Number:

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

7. Actions to Increase Competition: Competition of the requirement is not possible because KPPH is the only contractor able to continue performance with the existing patient cohort without interruption to the study. KPPH is the only medical facility in the entire province that has access to a large pool of patients from which to draw ill study volunteers, and is also the only facility that can provide higher level medical care to ill study volunteers.

8. Market Research: Market Research was conducted on 3 April 2023 in accordance with FAR Part 10 based on historical contracts, internet searches, and consultation with subject matter experts (SMEs) for information on comparable services from indigenous people and organizations within the performance region. It was determined that there are no practical alternatives for the provision of the required services in Kamphaeng Phet, Thailand. KPPH is the only uniquely qualified contractor to perform these services. KPPH has been conducting the clinical trial in Kamphaeng Phet, Thailand since 2012. KPPH is the only contractor able to continue performance with the existing patient cohort without interruption to the study. The study participants must continue in this study for safety and ethical requirements. Attempting to choose a new vendor at this time would require additional time and effort that would be detrimental to the mission of AFRIMS Department of Virology and would far exceed the current costs for the contract.

9. Interested Sources: See Paragraph 6 for the synopsis information. To date, no other sources have written to express interest in the acquisition.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of all awarded contracts for these same requirements.

W81XWH17P0117 – 4 March 2017 W81XWH22C0064 – 13 July 2023 currently in Option Period 1

(2) The competitive status of these actions.

Other than full and open competition

(3) Authority previously cited if less than full and open competition was used.

FAR 6.302-1(a)(2).

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

Competition is not possible to compete the acquisition, as KPPH is the only capable contractor with the Kamphaeng Phet, Thailand region.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Not Applicable

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

Not Applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

The basis of the justification and prior Justifications was to support the previous procurement was for ethical and safety requirements. KPPH was the only contractor able to continue the performance with the existing patient cohort without interruption to the study. The participants must continue in the study for safety and ethical requirements. Research required continuity for the protocol to be in compliance with Federal medical Research in accordance with 32 CFR 219.11 – Criteria for Institutional Review Board (IRB). There have been no significant changes.

b. Other facts. Not Applicable

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval

Based on the foregoing justification, I hereby approve the procurement of LOE increase modification for contract W81XWH22C0064, Clinical Study Support for Biomedical Research and Surveillance in Kamphaeng Phet, Thailand on an other than full and open competition basis pursuant to the authority of 10 United States Code (U.S.C.)

3204(a)(1) as implemented in Federal Acquisition Regulation (FAR) 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for this acquisition.