HT9425-24-C-0091-Redacted-JA_Redacted.pdf

Control Number: JA-24-04-1531

OCT 2023

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

1. Contracting Activity: U.S. Medical Research Acquisition Activity (USAMRAA), 808 Schreider Street, Fort Detrick, MD 21702-5014

2. Description of Action: The United States Air Force (USAF) 59th Medical Wing, Science and Technology (MDW/ST) Office located at Joint Base San Antonio Lackland Air Force Base, Texas requests a sole source non-commercial firm-fixed price contract with Wake Forest University Health Sciences (WFUHS) for the Advancement of Military Medicine for a research and development requirement.

3. Description of Supplies/Services: The USAF 59th MDW/ST Office requires a contract for research and development services with WFUHS. This research study is titled

Thermoresponsive, Bioadhesive Topical Gel for Prevention of Combat-Related Extremity Wound Infections (ST1176 Poloxamer Gel).

Military personnel who experience traumatic combat wounds and require hospitalization for medical management are at high risk of developing combat-related extremity wound infections (CEWI). CEWIs are often caused by antibiotic resistant bacteria, including Acinetobacter baumanii and Methicillin-resistant Staphylococcus aureus (MRSA). The choice of omadacycline and polymyxin B to include in the gel is specifically to target such pathogens. Antimicrobial resistance (AMR) is a global problem and is disproportionately found in Asia, Africa, and Eastern Europe, regions that are potentially future sites of conflict and deployment. Wound infections complicated by AMR organisms will continue to be an increasing problem for deployed personnel and combat readiness will be significantly impacted if there is a failure to develop safer, easier treatment approaches.

The aims of this study are to develop a novel thermoresponsive, bioadhesive, antibiotic gel that can be applied by topical spray directly to open combat-related wounds during hospitalization to prevent infection and to evaluate effects of the antibiotic gel to prevent infections in a modified animal model of wound infection.

4. Authority Cited: 10 USC 3204(a)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements with application at FAR 6.302-1(a)(2).

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.

b. This requirement is an intramural research project at the 59th MDW/ST Office which will use WFUHS as an extramural collaborator. WFUHS is the only extramural source that can collaborate on this project as they own the Intellectual Property (IP) rights to the project idea as well as the poloxamer gel technology being tested. In addition, the subject research protocol was designed by WFUHS. This protocol was approved by the 59th MDW/ST Directors and the Defense Health Agency (DHA) who approved and funded the research study. Funds were received from DHA to support the protocol as written with the intent to work with WFUHS and the use of any other vendor would conflict with the programmatic funding decision.

In addition, award to a collaborator other than WFUHS would infringe on their IP rights and it would result in unacceptable delays and duplication of cost and effort for another vendor to develop a similar product. Award of the subject requirement to any source except for WFUHS would lead to unacceptable outcomes for the Government.

6. Efforts to Obtain Competition: A Request for Information (RFI) was published to SAM.gov on 16 April 2024 with a closing date of 19 April 2024. No responses were received. Please reference Paragraph 8 of this document, for further discussion of market research.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. WFUHS is acting as the prime contractor on this contract; however, the contract is being put in place so that they may serve as an extramural collaborator with the researchers at the 59th MDW/ST Office. Since WFUHS is already serving in a subcontractor-like role with the 59th MDW/ST Office, no additional subcontracting opportunities exist. Based on these facts, no further subcontracting competition is expected.

7. Actions to Increase Competition: Based on the results of the market research and the known history of this requirement, there have been no further actions taken to increase competition for this research and development requirement. This research is a joint effort between the 59th MDW/ST Office and WFUHS. The 59th MDW/ST office will continue to monitor the marketplace for contractors with the necessary knowledge base to provide the unique research services required. If similar or related requirements in the future may be fulfilled via competitive acquisition procedures, the USAF 59th MDW/ST Office and USAMRAA will pursue the appropriate level(s) of competition.

8. Market Research: The Contracting Office posted an RFI on SAM.gov, as discussed above in Section 6, and received no responses. As a result, the Contracting Office posted a Notice of Intent to Sole Source to WFHUS on SAM.gov on 19 April 2024 which closed on 06 May 2024. No correspondence was received in response to this notice. No additional market research was conducted for this contract, as WFHUS is the only contractor that can provide these services.

9. Interested Sources: The notices required by FAR 5.201 have been published and no correspondence was received in response to the Request for Information nor the Notice of Intent to Sole Source. In addition, this justification shall be posted to SAM.gov within 14 days after contract award in accordance with FAR 6.305(a). In accordance with 5.207(c)(16)(ii), inquiries from any interested offerors would have been evaluated accordingly prior to issuance of the sole source contract.

10. Other Facts:

a. Procurement history.

There is no prior procurement history for this requirement. WFUHS scientists independently developed this product and research protocol and, based on prior relationships on other projects, approached the 59th MDW/ST Office about collaborating together on the project.

b. Other facts. Not applicable.

Approval

Based on the foregoing justification, I hereby approve the aforementioned procurement of research and development services in the amount of on an other than full and open competition basis pursuant to the authority of 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for this acquisition.