FAR-Part6-JA-W81XWH21C0067 -Protein Kinetic Response to Calorie Deprivation _Redacted.pdf

Version September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Research and Development: Protein Kinetic Response to Calorie Deprivation

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: $781,220.44

Prepared by:

Contracting Officer:

Technical:

Requirements:

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

Program Manager:

Signature:

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 U.S. Army Research Institute of Environmental Medicine (USARIEM) requests a new Cost Reimbursable Research and Development (R&D) contract with the University of Arkansas for Medical Sciences (UAMS), Center for Translational Research in Aging and Longevity(CTRAL); (University of Arkansas 4301 W Markham St Slot 812 BIO-MED Bldg 1 STE, Little Rock AR 72205-7101). The Government projects award for February 2021 and FY 2021, RDTE Funds will be used.

3. Description of Supplies/Services:

This requirement is for the procurement of the technical expertise and scientific services to determine whole-body and muscle protein kinetic responses to high-quality protein intake during graded levels of calorie deficiency with UAMS, CTRAL. Calorie deficiency and its catabolic effects on whole-body protein status and muscle mass is often unavoidable when subsisting primarily on combat rations during sustained military operations in austere environments. Understanding the effects of graded calorie deficit on whole-body and muscle protein kinetics is critical for USARIEM to devise and test optimized dietary strategies that overcome the catabolic effects of calorie deficit. The knowledge gained from this effort will inform Army Regulation 40-25 (Nutrition and Menu Standards for Human Performance Optimization) and the U.S. Army Combat Capabilities Development Command Soldier Center, Combat Feeding Directorate in their efforts to develop and optimize next generation combat rations for use in future Multi-Domain Operations. This R&D effort will require the procurement of stable isotopes (1-13C-leucine, 2H5-phenylalanine, NaH-13CO3) and biological sample (blood and muscle) analyses to calculate whole-body protein turnover, muscle protein synthesis, and essential amino acid concentrations.

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:

USARIEM requires the University of Arkansas Medical Sciences (UAMS) to assist with the development and execution of a clinical research trial for Protein Kinetic Response to Calorie Deprivation in support of its research study through other than full and open competition. Only one responsible source, UAMS, and no other contractor will satisfy agency requirements due to its unique capability.

(a) Unique Capability: UAMS possesses the experience, expertise, and unique testing and validating abilities to meet this requirement. UAMS capabilities will aid in generation ration products and situation-specific feeding recommendations. More specifically, UAMS is solely responsible for the origination, optimization, and validation of analytical and computational approaches to isotopically trace human substrate metabolism in response to disease, stress, exercise, and nutrition.

UAMS is the only source capable of maintaining consistency with analytical methods from study to study, which is critical for comparative purposes. UAMS has provided stable isotope kinetic measurement for eight clinical research trials conducted by USARIEM over the past decade. Awarding to any other source would impact the integrity of the current data, disrupt the research process, and ultimately the timeline.

Competition of this requirement would not recoup the cost, work or knowledge, developed over the last ten years.

(b) Alternatives: The Government looked at three potential alternatives including suspending operations, hiring in-house personnel/expertise, and replacing existing system, all of which are not options to meet this requirement.

USARIEM needs the research to be conducted for isotope kinetic measurements and suspending operations is not a possibility. USARIEM does not have any in-house technical personnel with experience or equipment to determine whole-body and muscle protein kinetic responses to high-quality protein intake during graded levels of calorie deficiency. Replacing the existing process would impact the integrity of research conducted at USARIEM for the past 10 years used for comparative analysis.

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. 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: Competition of the requirement is not possible since the proposed contractor, UAMS is the only source that has the capability to provide Protein Kinetic Response to Calorie Deprivation research. The Government will continue to seek out potential sources that are capable providing these services.

8. Market Research: Market research was conducted using internet searches, literature review and discussion with colleagues during August 2020 by Claire C. Whitney. This service is offered by a select limited number of contactors to allow for third party data validation of analytical reports. Protein tracing analysis conducted at USARIEM across several clinical research trials is specific to a method developed by UAMS for the past 10 years. To allow for comparative analysis, the market research conducted took into consideration previous data collected to allow for integrity of research. As a result of this research, no other contractor was identified to have the capabilities to support this requirement due to the necessity to avoid inherent discrepancies in analysis between laboratories/facilities and maintain the analytical consistency of this established USARIEM research line.

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 sources sought was posted by the Contracting Office on Beta.SAM.gov for 45 days; however, no responses or inquiries were received. At this time, market research conducted found only one source, UAMS, with the capability to meet USARIEM continued need for stable isotope kinetic measurements.

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

10. Other Facts:

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements. N/A

(2) The competitive status of these actions. N/A

(3) Authority previously cited if less than full and open competition was used. FAR Part 6.302-1

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 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: Comparison of proposed prices to historical prices paid

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.

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

Typed Name: Sharew Hailu Date:

Title: Contracting Officer Signature:

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