A02 JA FAR Part 6 (AUG 2022) JA_23_01_1275 Published_Redacted.pdf

CUI//SP-SSEL

Control Number: JA-23-01-1275

(Source Selection information - See FAR 2.101 and 3.104-4) CUI//SP-SSEL

1 AUG 2022

Justification Review Document for Other than Full and Open Competition - FAR Part 6

Program/Equipment: Non-Personal Clinical Biomedical Research and Surveillance Support Services in the Philippines

Authority: 10 United States Code 3204(a)(1 as implemented in Federal Acquisition Regulation 6.302-1( )( ), Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount: $2,172,160.91

Prepared by:

Typed Name: DSN: _____________________

Title: Date: ___ _______

E-mail: ____

Contracting Officer:

Typed Name: DSN:

Date Reviewed: __________E-Mail:

Technical Representative:

Typed Name: DSN: _____________________

Title: Date: ___ _______

Requirements Representative:

Typed Name: DSN: _____________________

Title: Date: __ ________

(Source Selection Information - See FAR 2.101 and 3.104-4) CUI//SP-SSEL

AUG 2022

Reviews

Legal Counsel

Typed Name: DSN:

Signature: _________________________________ Date: _______________________

AUG 2022

Justification and Approval for Other than Full and Open Competition – FAR Part 6

1. Contracting Activity: The Contracting Activity responsible for this action is the United States Army Research Acquisition Activity (USAMRAA), Fort Detrick, Maryland on behalf of the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand.

2. Description of Action: Approval is being requested for a new Firm Fixed Price contract using FY2023 Research, Development, Test and Evaluation funds.

3. Description of Supplies/Services: This procurement is for technical/scientific and administrative support services necessary for Clinical Biomedical Research and Surveillance support in the Philippines. Non-personal services associated with scientific/technical, regulatory, epidemiological, clinical, laboratory, administrative, database management, quality assurance and logistical support to the Philippines AFIRMS Virology Research Unit (PAVRU) for the conduct of epidemiological, clinical and laboratory activities related to biomedical research, surveillance projects and public health support to take place within the Philippines.

The period of performance will be five (5) years with one (1) twelve (12) month base period and four (4) twelve (12) month option periods.

Period of Performance Value (US Dollars) Base Period

Total $2,172,160.91

4. Authority Cited: 10 United States Code 3204(a)(1 as implemented in Federal Acquisition Regulation 6.302-1( )( ), Only one responsible source and no other supplies or services will satisfy agency requirements

AUG 2022

5. Reason for Authority Cited: The Cebu Velez General Hospital (CVGH) is the only source in the Philippines that can meet this requirement. This proposed action is for a new contract for biomedical, clinical and surveillance study support in the Philippines.

This requirement requires a contractor with the capability and the authority to perform in the Philippines, lab space, a certified institutional review board, and access to hospital subject data that can be shared with AFRIMS. CVGH meets the requirements for the execution of regulated studies that are planned in this contract. More specifically, CVGH meets the requirements set by the Philippines Ministry of Public Health (MOPH) for the execution of human clinical studies, and it currently maintains an Institutional Review Board IRB that is certified to review, approve and follow these types of studies. These factors make CVGH the only hospital that can meet the requirements of this effort.

6. Efforts to Obtain Competition:

a. Effective competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any responses received shall be considered. A Request for Information (RFI) was posted on SAM.gov on 10 January 2023 for 15 days.

The responses evaluated by the Technical Representative for the program office. The assessment of the responses resulted in that both contractors did not demonstrate the capability to meet the Governments requirement.

A notice of intent to sole source was published on 23 February 2023 for 15 days and the only response received was from the suggested source.

b. Subcontracting competition: There are no subcontracting possibilities with this requirement.

7. Actions to Increase Competition: Competition of the requirement is not possible

AUG 2022

because CVGH is the only contractor that has the capability to perform in the Philippines meeting regulatory requirements and access to subject data.

Actions to increase competition are not possible since the proposed Vendor, CVGH, is the only one capable of meeting the requirement. No steps can be taken to increase competition as a result of CVGH is the only source with access to the surveillance study data.

8. Market Research: The AFRIMS COR conducted market research on 01 October 2022. The COR conducted an internet search, assessed potential vendors located in and around the Philippines and relied upon the experience of local study staff in consultation with clinicians and scientists with local collaborators. No other Vendors were identified to have the capabilities to support this requirement.

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: This a new requirement with no contract history

b. Other facts: N/A

AUG 2022

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.

Signature: _ __Date: __ __________

Typed Name: Title: ___

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.

__Date: ___ _________

Typed Name: Title:

AUG 2022

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.

The determination will be made using a price/cost analysis utilizing the IGE. As part of the basis, certified cost or pricing data will not be required.

Typed Name: Title:

14. Contracting Officer Certification:

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

Signature:

Date: 2023.04.04 08:07:22 -04'00'

AUG 2022

Approval

Based on the foregoing justification, I hereby approve the procurement of Non-Personal Clinical Biomedical Research and Surveillance Support Services estimated at $2,172,160.91 on an “other than full and open competition” basis pursuant to the authority of 10 U.S.C. 3204(a)(1) as implemented in FAR Part 6.302-1 subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for this acquisition.

Signature: _ Date: __________________________

Typed Name: