Intramuscular Injectable Generic Ketamine for use in an FDA Approved Emergency Use Authorization (EUA)

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.