A02. JA FAR Part 6 - Biomarkers - FINAL_Redacted.pdf

Control Number: JA-24-06-1584

OCT 2023

Understanding the factors that may protect against development of SD is paramount for USAF readiness and mitigation of SD-associated complications that have negative effects on optimal functioning of pilots. The main objectives of this study include:

a. Evaluate the contribution of genetic variants to resilience against development of

SD;

b. Evaluate the interaction between these genetic variants and environmental influences (e.g., exposure to aeroallergens) and the combinatorial effect on SD;

and

c. Evaluate immunologic biomarkers of resilience against development of SD.

4. Authority Cited: 10 USC 3204(a)(1) as implemented in Federal Acquisition Regulation (FAR) 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)(i) � Supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal.

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 the Department of Defense, National Aeronautics and Space Administration, and the United States 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. (i) Furthermore, FAR 6.302-1(a)(2)(i) states that supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal that-

(A) Demonstrates a unique and innovative concept or demonstrates a unique capability of the source to provide the particular research services proposed;

(B) Offers a concept or services not otherwise available to the Government;

and

(C) Does not resemble the substance of a pending competitive acquisition.

c. (i) Due to prior collaborative experience on other unrelated projects, FAVHR submitted an unsolicited research proposal to the 59 MDW/ST Office in which FAVHR proposes that the two entities continue their collaborative relationship. In the opinion

(D) Includes sufficient detail to permit a determination that Government support could be worthwhile and the proposed work could benefit the agency�s research and development or other mission responsibilities. The 59 MDW/ST Office initially reviewed the proposal and considered it to have enough merit to be submitted to DHA�s Funding Call for Research Proposals where it was further reviewed and deemed worthy of being funded;

(E) Was not a proposal submitted in advance for a known agency requirement that can be acquired by competitive methods. This is a unique and innovative research project developed solely by FAVHR; and

(F) Does not address a previously published agency requirement.

e. In addition, soliciting this specific protocol from other vendors would be an infringement on FAVHR�s intellectual property rights as they are the creators of the research protocol.

f. Based on the information provided above, FAVHR is the only source that can provide the required research and development services. This research study was submitted as an unsolicited research proposal which requires collaboration between the 59 MDW/ST Office and FAVHR. The proposal demonstrates a unique and innovative concept developed by FAVHR scientists which has been supported by the 59 MDW/ST Directors and approved for funding by DHA. Based on the requirements of FAR 6.302- 1(a)(2)(i) and FAR 15.603, this justification fully supports awarding a sole source contract to FAVHR for the work in this unsolicited research proposal.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted to the Government Point of Entry (GPE), SAM.gov, on 21 May 2024 for a period of 3 days.

Two responses to the sources sought notice were received from Rubex and Phronetik.

While both vendors appeared to have research experience and may be capable of executing a research project, neither vendor has the intellectual property rights to the design of the study which was created by FAVHR scientists. This study is only executable by FAVHR and competing the requirement would infringe upon FAVHR�s data rights. The requirement was synopsized to the GPE (SAM.gov) via a Notice of Intent to Sole Source (NOI) on 31 May 2024 for a period of 15 days. No qualified responses to the sources sought notice were received.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. FAVHR 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. In addition, FAVHR has proposed Biogenics Research Chamber and Savidj as subcontractors on this project. Biogenics Research Chamber will be used to expose participants to the allergens proposed in the statement of work and Savidj will perform the assessment of the spatial disorientation factors. As this is an unsolicited research proposal, these subcontractors are engrained into the technical approach as stated in the statement of work and were specifically selected by FAVHR due to the specialized services they provide. These vendors were considered by DHA when funding was approved and requiring FAVHR to compete this work would go against the approved unsolicited research proposal.

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 unsolicited nature of this requirement, no actions have been taken to increase competition as FAVHR is the only source available to provide these unique and innovative research services. The USAF 59 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 59 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 for 3 days and received two unacceptable responses, as mentioned above in Section 6. As a result, the Contracting Office posted a NOI to FAVHR on SAM.gov for 15 days on 31 May 2024. No correspondence was received in response to this notice. No additional market research was conducted for this contract, as FAVHR is the only contractor that can provide these highly specialized research services based on the information provided in Section 5, above.

9. Interested Sources: The notices required by FAR 5.201 have been published and no acceptable correspondence was received in response to the RFI nor the NOI. 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 FAR 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. This is a new unsolicited research proposal with no procurement history; therefore, no prior justifications were completed nor is there any prior competitive status to report. No unusual patterns have been revealed.

b. Other facts. Not applicable.