JA Redacted Version Redacted.pdf

OCT 2023

The main objectives of this study include:

1. Validate a small-scale, multiple blast-induced hearing injury and characterize the features of auditory dysfunction in the rat model.

2. Investigate the effects of NVG-291 on mitigating sensorineural hearing damage following a precise blast-induced hearing injury.

4. Authority Cited: 10 United States Code (USC) 3204(a)(1) as Implemented in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(i)(A), “demonstrates a unique and innovative concept, or, demonstrates a unique capability of the source to provide the particular research services proposed.”

5. Reason for Authority Cited:

The Geneva Foundation is the only source that can provide the required services. The research protocol was originally proposed via an unsolicited research proposal from the Geneva Foundation and received a favorable evaluation. The research protocol was approved by the USAF 59 MDW/ST Directors and the 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 the Geneva Foundation.

The findings from this study will be critical in the advancement of NVG-291 in clinical trials using patients with blast-induced sensorineural hearing loss, providing hope of mitigation from this irreversible condition. Collected data may also help identify types of hearing loss that NVG-291 may be most efficacious in treating. Successful translation to the clinic has the potential to impact the millions of service members and civilians living with sensorineural hearing loss. Therefore, award of the subject requirement to any source except for the Geneva Foundation will result in unacceptable inferior outcomes for the Government.

6. Efforts to Obtain Competition: Extensive market research to identify potential sources was completed by the USAF 59th MDW/ST and USAMRAA to identify potential sources in the marketplace that could meet the Government’s requirement. Please reference Paragraph 8 of this document, for further discussion of market research.

A Request for Information (RFI) was posted to the Government Point of Entry (GPE, SAM.gov) on 03 July 2024 for a period of 3 days. No responses to the sources sought notice were received.

CUI

Control Number: JA-24-07-1605

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

The requirement was synopsized to the GPE (SAM.gov) via a notice of intent (NOI) on 09 July 2024 for a period of 15 days. No responses to the sources sought notice were received.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. This study was written by the Geneva Foundation and submitted as an unsolicited research proposal. Partnerships are chosen during the preproposal stage based on supplies/ services/labor expertise and research capability and experience. It is not anticipated that any subcontracting opportunities will be available, but wherever possible, subcontracting competition will be promoted to the maximum extent possible.

7. Actions to Increase Competition: No actions have been taken to increase competition. The research protocol was originally proposed via an unsolicited research proposal from the Geneva Foundation, and it received a favorable evaluation. Funds were received from DHA to support the protocol as written with the intent to work with the Geneva Foundation. The USAF 59 MDW/ST will continue to monitor the marketplace for contractors with the necessary knowledge base to provide the unique support services required. If similar or related requirements in the future may be fulfilled via competitive acquisition procedures, the USAF 59 MDW/ST and USAMRAA will pursue the appropriate level(s) of competition.

8. Market Research: The USAF 59th MDW/ST and USAMRAA conducted extensive market research to identify potential sources that could meet the Government’s requirement. Market research consisted of querying online search engines, attendance of scientific conferences, examination of historical contracts and discussions with key collaborators and trusted Government and academic contacts, and the posting of a RFI.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition.

A RFI and NOI were posted to GPE, SAM.gov for 3 days and 15 days, respectively. No responses to the RFI or NOI were received.

10. Other Facts:

a. Procurement history. This is a new research proposal with no procurement history.

b. Other facts. Not applicable.