Intramuscular Injectable Generic Ketamine for use in an FDA Approved Emergency Use Authorization (EUA)
Closed Pre-Solicitation Posted
- Solicitation number
- HT9425-25-RFI-Ketamine-EUA
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- Not on record
- PSC
- Not on record
- Place of performance
- Frederick, Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The United States Army Medical Research and Development Command (USAMRDC) is conducting market research to identify a manufacturer for generic intramuscular injectable ketamine through a Request for Information (RFI). The Defense Health Agency is seeking a partner to supply ketamine for a potential FDA Emergency Use Authorization (EUA) targeting battlefield medical applications. Specific requirements for the ketamine include a 50 mg/mL multidose vial format, FDA approval, ready-to-inject configuration, room temperature stability, and immediate availability for purchase. The RFI emphasizes that the product cannot be part of a combination product like an autoinjector and must have sufficient manufacturing capacity for large quantities. Responses are due by January 3, 2025, with the government clarifying that this is a market research effort and not a formal solicitation.
No specific set-aside categories are designated for this opportunity, and no incumbent contractors are mentioned in the documentation. While the precise award value is not specified, the RFI suggests the potential for a substantial procurement across the Joint Service Military Health System following EUA approval. The Department of Defense will serve as the EUA sponsor, which could potentially lead to widespread adoption if approved. The market research aims to determine manufacturing feasibility and partner capabilities for large-scale ketamine production. Interested manufacturers are requested to provide detailed capabilities statements addressing manufacturing capacity, intellectual property, government connections, EUA experience, and pricing structures, with the ultimate goal of supporting battlefield medical treatment protocols.
Notice text
2 versions
Update #2 · Latest ·
In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of the Unites States Army Medical Research and Development Command (USAMRDC), USAMRAA, USAMMDA or any collaborative Department of Defense (DoD) activities.
This RFI is for information and planning purposes only and is neither to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents are solely responsible for all expenses associated with responding to this RFI. No evaluation letters and/or results will be issued to the respondents. Currently, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS WILL BE ACCEPTED OR RETURNED
Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.
USAMMDA WPAC PMO is conducting market research to determine the feasibility of securing and partnering with a manufacturer(s) for the procurement of generic ketamine for intramuscular injection (IM). No other route of ketamine administration or combination product(s), including autoinjectors and pre-filled syringes, will be considered. In addition, the injectable ketamine must currently be available for purchase from the partnered manufacturer. The generic ketamine will be used to apply for a potential FDA approved Emergency Use Authorization (EUA) for battlefield use. The sponsor for the EUA will be the Department of Defense (DoD). The EUA will allow the DoD to formulate policies on ketamine use which is expected to result in a large demand for ketamine throughout the Joint Service Military Health System.
WPAC has a requirement for a generic ketamine manufacturing partner to supply intramuscular injectable generic ketamine and work with WPAC to apply for a potential FDA approved EUA. If the EUA is approved, the partnership will continue as the EUA is executed. The Intramuscular Injectable Generic Ketamine shall have the following characteristics:
(1) It is not part of a combination product (e.g. autoinjector or pre-filled syringe).
(2) It is ready to inject and does not require reconstitution.
(3) It is available in 50 mg/mL multidose vial.
(4) It is currently available for immediate purchase from the partnered manufacturer.
(5) It is currently approved by the FDA.
(6) Sufficient Manufacturing Lead Time for large quantities.
(7) Stability at room temperature.
Please see attachment titled "A.02 Ketamine EUA RFI SAM" for full RFI including submission instructions.
* NOTE: RFI close date has been extended to 03 JAN 2025.
Update #1 ·
In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of the Unites States Army Medical Research and Development Command (USAMRDC), USAMRAA, USAMMDA or any collaborative Department of Defense (DoD) activities.
This RFI is for information and planning purposes only and is neither to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents are solely responsible for all expenses associated with responding to this RFI. No evaluation letters and/or results will be issued to the respondents. Currently, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS WILL BE ACCEPTED OR RETURNED
Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.
USAMMDA WPAC PMO is conducting market research to determine the feasibility of securing and partnering with a manufacturer(s) for the procurement of generic ketamine for intramuscular injection (IM). No other route of ketamine administration or combination product(s), including autoinjectors and pre-filled syringes, will be considered. In addition, the injectable ketamine must currently be available for purchase from the partnered manufacturer. The generic ketamine will be used to apply for a potential FDA approved Emergency Use Authorization (EUA) for battlefield use. The sponsor for the EUA will be the Department of Defense (DoD). The EUA will allow the DoD to formulate policies on ketamine use which is expected to result in a large demand for ketamine throughout the Joint Service Military Health System.
WPAC has a requirement for a generic ketamine manufacturing partner to supply intramuscular injectable generic ketamine and work with WPAC to apply for a potential FDA approved EUA. If the EUA is approved, the partnership will continue as the EUA is executed. The Intramuscular Injectable Generic Ketamine shall have the following characteristics:
(1) It is not part of a combination product (e.g. autoinjector or pre-filled syringe).
(2) It is ready to inject and does not require reconstitution.
(3) It is available in 50 mg/mL multidose vial.
(4) It is currently available for immediate purchase from the partnered manufacturer.
(5) It is currently approved by the FDA.
(6) Sufficient Manufacturing Lead Time for large quantities.
(7) Stability at room temperature.
Please see attachment titled "A.02 Ketamine EUA RFI SAM" for full RFI including submission instructions.
Files
| File | Type | Posted |
|---|---|---|
| A. 02 Ketamine EUA RFI SAM.docx | DOCX document |
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