Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization
Closed Pre-Solicitation Posted
- Solicitation number
- HT9425-24-RFI-TJK3
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Frederick, Maryland 21702, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
Paragraph 1:
The U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Protection and Acute Care Project Management Office (WPAC) is seeking to procure generic, ready-to-inject ketamine for intramuscular injection to treat severe acute pain associated with battlefield injuries. The purpose of this Request for Information (RFI) is to conduct market research to determine the feasibility of securing a manufacturer for this product, which must be an FDA-approved generic drug available for immediate purchase from the open market. The injectable ketamine will be used to gain an FDA-approved Emergency Use Authorization (EUA) for analgesic ketamine, with the Department of Defense (DoD) as the sponsor. Responses to the RFI should provide details on the candidate products, regulatory status, manufacturing capabilities, ability to meet demand, and EUA experience, as well as rough order of magnitude pricing and supply estimates.
Paragraph 2:
This opportunity is not set aside for any specific business category. The RFI does not mention any potential incumbents or current contractors. While the RFI does not provide an estimated award value or budget range, it notes that the analgesic ketamine EUA is expected to result in a large demand for the product across the Joint Service Military Health System. The RFI requires responses to be limited to 30 pages and due by October 7, 2024.
Notice text
The purpose of this RFI is to address the USAMMDA WPAC requirement for the development of analgesics for acute severe pain associated with battlefield injuries. The WPAC PMO of USAMMDA is conducting market research to determine the feasibility of securing a manufacturer for the procurement of generic ready-to-inject ketamine for intramuscular injection (IM) for analgesia. No other route of ketamine administration or combination product(s), including autoinjectors, will be considered. In addition, the injectable ketamine must be available for immediate purchase from the open market. The generic ketamine will be used to gain an FDA approved Emergency Use Authorization (EUA) for analgesic ketamine with a subsequent proposed label indication for acute pain via the 505(b)(2) pathway. The sponsor for the EUA will be the Department of Defense (DoD). The analgesic ketamine EUA will allow the DoD to formulate policies on analgesic ketamine use which is expected to result in a large demand for ketamine throughout the Joint Service Military Health System.
Files
| File | Type | Posted |
|---|---|---|
| HT9425-24-RFI-TJK3 RFI.docx | DOCX document |
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