A02 JA 21_12_00240 Heat Study Redacted.pdf

Control No:21-12-00240 Contractor: University of Birmingham

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate oxidation during steady-state aerobic exercise

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Research and Development for, “Effects of acute heat stress and heat acclimatization on exogenous carbohydrate oxidation during steady-state aerobic exercise.”

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $1,337,754.46

Prepared by:

Contracting Officer:

l

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Typed Name:

Legal Counsel:

Typed Name:

DSN:

Signature:

Version – September 2018 FOR OFFICIAL USE ONLY

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

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

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702

2. Description of Action: The Military Nutrition Division of US Army Research Institute of Environmental Medicine (USARIEM) requests a new Cost Type contract with the University of Birmingham, Chancellors Court, Edgbaston, Birmingham, West Midlands, B152TT, United Kingdom. The Government projects award for April 2021 and fiscal year 2021 Research, Development, Test and Evaluation (RDT&E) funds will be used.

3. Description of Supplies/Services: The USARIEM in Natick, MA, has a need to collaborate and conduct a research clinical trial assessing the effects of heat acclimatization on exogenous glucose oxidation and glucose turnover during exercise, and subsequent impact on physical performance. To achieve this need, USARIEM requires a study be conducted in human volunteers taking part in three experimental trials each involving 90 minutes of steady-state aerobic exercise followed by a performance test. The trials will need to be conducted under: 1) non-heat acclimatized, temperate/dry (20°C, 20%humidity); 2) non-heat acclimatized, hot/ dry (40°C, 20% humidity) and; 3) heat acclimatized, hot/dry (40°C, 20% humidity). Isothermic heat acclimatization to exercise-heat stress will need to take place over nine consecutive days. Within each experimental trial stable isotope methodologies and muscle biopsies will be used to assess changes in glucose oxidation and turnover, glycogen content, and molecular regulation of carbohydrate metabolism. The Contractor shall provide this study and intellectual services to support the USARIEM Military Nutrition Division research programs that conducts research on substrate oxidation and physical performance. The Contractor shall be responsible for managing and overseeing the activities of all Contractor personnel used in performance of this contract. The Contractor's management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective research in accordance with the requirements indicated within the period of performance below.

Period of Performance: 15 April 2021 – 14 April 2024 Total Value:

Base Period: 15 April 2021 to 14 April 2022 Value:

Option Period 1: 15 April 2022 to 14 April 2023 Value:

Option Period 2: 15 April 2023 to 14 April 2024 Value:

FAR Clause 52.217-8: 15 April 24 to 14 Oct 2024 Value:

Total:

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

4. Authority Cited: 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited:

(a) As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

USARIEM requires research for a Clinical Trial at the University of Birmingham to conduct a study that looks how heat acclimatization affects exogenous carbohydrate oxidation, glucose turnover, molecular regulation of substrate metabolism, and exercise performance.

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

(b) Alternatives: The Government looked at two alternatives (suspended operations or in-house personnel/expertise) and neither are options for meeting the requirement. The Military Operational Medicine Research Program (MOMRP), funding source needs the research to be conducted in a timely manner to meet programmed schedule and costs.

Therefore, suspended operations is not a possibility. USARIEM does not have the capabilities to perform mass spectrometry analysis in-house. If the study was conducted at USARIEM it would require the samples to be shipped out for analysis and may result in delays of study completion.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. A Request for Information (RFI) was posted on “Contracting Opportunities” on www.beta.SAM.gov on 16 December 2020. No responses were received to this RFI by the time it expired on 4 January 2021.

a. Effective competition: Because this is a sole source action, effective competition is not applicable.

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

7. Actions to Increase Competition:

For any subsequent acquisition in the topic area, USARIEM will research to see if any new sources with the technology and facilities are available for open competition.

8. Market Research: USARIEM conducted market research 28 September 2020 using internet searches, GSA , literature review (PubMed) and discussion with colleagues. This market research resulted in no additional viable sources aligning to this requirement.

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information was posted to beta.SAM.gov on 16 December 2020 for 15 days and the results were no other sources provided a response.

The Government’s notice of intent was posted on beta.SAM.gov on 5 January 2021 for 30 days with no responses received.

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 the last several contracts for these same requirements. Not Applicable, first time procurement.

(2) The competitive status of these actions. Not Applicable

(3) Authority previously cited if less than full and open competition was used. Not Applicable

(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. Not Applicable

(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. Not Applicable

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

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.

Typed Name: Date:

Title: Nutrition Signature:

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.

Title: Nutrition Signature:

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: cost analysis price analysis should cost IGCE audit: other:

As a part of this basis, certified cost or pricing data:

will be required.

will not be required and the following exception applies (FAR 15.403):

Prices that will be agreed upon are based on adequate price competition.

Prices that will be agreed upon are based on prices set by law or regulation.

A commercial item is being acquired.

A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

The contract action is a modification to a contract or subcontract for commercial item(s).

The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Title: Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Signature:

Program/Equipment: Effects of acute heat stress and heat acclimatization on exogenous carbohydrate

Approval

Based on the foregoing justification, I hereby approve the procurement of research in support of Effects of acute heat stress and heat acclimatization on exogenous carbohydrate oxidation during steady sate aerobic exercise for the estimated amount of $1,337,754.46 on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1), as implemented by 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 or property herein described have otherwise been authorized for acquisition.

Date:

Signature: