A02 JA 21_22_00230 Redacted 2-11-21.pdf

Control No.

Contractor: A&J Compounding, Inc.

Program/Equipment: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20-

07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical performance”

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20- 07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical performance.”

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Typed Name:

DSN:

Signature:

-05'00'

Program/Equipment: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20-

07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

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 Firm Fixed Priced with A & J Compounding, Inc. The Government projects award for January 2021 and fiscal year 2021,DHP Research, Development Test and Evaluation funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: Provide stable isotope compounding services in support of USARIEM’s MND protocol. A & J Compounding, Inc. shall obtain stable isotope to be used for compounding of the infusate. The isotope will be compounded into

100 mL IV bags of 6,6-2H2 glucose for pickup by USARIEM personnel. Additionally, A & J Compounding, Inc. shall maintain documentation and file retention of the infusate.

Quantities needed are based upon project needs and study over the next year.

Base Period: 08 February 2021 to 07 February 2022 Value:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C.1901 as implemented by FAR Subpart 13.5:

Unusual and compelling Urgency

Exclusive Licensing agreements

Industrial mobilization

Other: One responsible source per FAR 13.501(a)(1)(i).

5. Reason for Authority Cited:

(a) USARIEM requires compounding of isotopes which will be used for the measurement of glucose turnover during an exercise protocol. USARIEM has acquired past

Program/Equipment: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20-

07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical compounding isotopes from A&J using the Government Credit Card. This requirement is a continuation of that materiel acquired. The data of the past compounds and future research must be comparable, as they will be included in a single data base. Potential differences in compounding of isotopes would compromise the ability to confidentially calculate glucose turnover. This would require USARIEM to complete additional data collection on new volunteers, resulting in delay of study completion and waste of study funds.

(b) Alternatives: The Government looked at three alternatives:

USARIEM does not have any in-house technical personnel with experience to compound the isotopes.

The only known source to meet the requirement is A&J Compounding, Inc. Replacing rather than upgrading an existing system is not an option for USARIEM.

6. Efforts to Obtain Competition:

In accordance with FAR 5.201 a Request for Information (RFI) was posted to BETA SAM on 24 November 2020 and closed on 04 December 2020. No response was received. In addition the Notice of Intent was posted on 10 December 2020 and was closed on 28 December 2020 and no response was received.

7. Actions to Increase Competition:

No actions were taken to increase competition due to A&J being the only source that would all data from past and future compounded isotopes to be comparable.

8. Market Research:

USARIEM conducted market research on 25 SEP 2020 based on internet (FedBizOpps.gov, SAM, and GSA Advantage) and database searches. No companies were found that provided the specific analysis required. In addition a RFI was posted on beta.SAM for eleven days and know responses were received.

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: Not Applicable

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

Program/Equipment: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20-

07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical

(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: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20-

07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical

C

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.

Typed Name: Date:

Title: Nutritional Physiologist by

Program/Equipment: Compounding of 6,6-2H2-glucose to generate stable isotope infusates to be used for the measurement of glucose turnover in USARIEM protocol 20-

07-HC, “Impact of ketone ester supplementation on substrate oxidation and physical

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: price analysis cost analysis IGCE audit: (identify the audit type) other: (identify the methodology or combination of methodologies that will be used)

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Title: Contracting Officer Signature:

JAC 2

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

Title: Contracting Officer Signature: