B01-Analgesic-Ketamine-RFI-20251208-Final.docx

REQUEST FOR INFORMATION (RFI)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT/ORDER WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

Disclaimer: The purpose of this RFI notice is to gain market knowledge. This notice does not obligate the Government to award a contract/order or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a synopsis and/or solicitation may or may NOT be published at a future date and time.

1.0 RFI NUMBER: HT9427-26-RFI-701

2.0 RFI ISSUING OFFICE: Defense Health Agency Contracting Activity (DHACA), Medical Research & Development Contracting Division 2, Contracts Branch 7

3.0 RFI TITLE: Analgesic Ketamine for Battlefield Use

4.0 AGENCY: Operational Medical Systems (OPMED)

5.0 OFFICE: Warfighter Protection and Acute Care Project Management Office (WPAC PMO)

6.0 LOCATION: Fort Detrick, MD

7.0 Contract/Order Type: Unknown

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 Defense Health Agency (DHA), DHACA, OPMED, WPAC PMO 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 offer 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.

8.0 BACKGROUND: The purpose of this RFI is to address the OPMED WPAC PMO’s requirement for Tactical Combat Casualty Care (TCCC) solutions for acute severe pain from battlefield injuries. The OPMED WPAC PMO is conducting market research to determine the feasibility to collaborate with industry to develop, manufacturer, and receive U.S. Food and Drug Administration (FDA) approval of an analgesic ketamine product for procurement. All ketamine products for any route of administration will be considered, for example: autoinjectors, oral capsules, pumps, topical creams and patches, etc. OPMED WPAC PMO plans to release a request for proposals for the analgesic ketamine product in Fiscal Year 2026.

9.0 OBJECTIVE AND SCOPE: OPMED WPAC PMO has a requirement for a partner to supply an analgesic ketamine product. The analgesic ketamine product shall have the following characteristics:

(1) The product has a form that is usable for austere, pre-hospital conditions.

(2) It does not require reconstitution.

(3) The dose delivered is sufficient to induce analgesia given the proposed route of administration.

(4) Shelf life of 2-3 years at controlled room temperature

(5) The product or device shall be operable in cold, cool, warm, and excessive heat temperatures, as defined in USP <659> and perform under MIL-STD-810H.

(6) Large scale manufacturing capability and ability to surge production.

(7) It does not require refrigeration at any point after procurement.

(8) The product will be indicated for moderate to severe or severe acute pain upon FDA approval. The analgesic indication shall not be added to the product after FDA approval for another indication (e.g. anesthesia induction).

(9) Meet statutory and regulatory requirements to manufacture, store, and distribute controlled drug substances.

10.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a Capabilities Statement. The subject header of the email for submission of questions and/or the RFI response shall be “RFI Response: HT9427-26-RFI-701 Analgesic Ketamine for Battlefield Use.” All information regarding capabilities statements or any other proprietary information related to this RFI shall be marked appropriately. Electronic files shall not exceed 20MB. All submissions become Government property and will not be returned. Submission shall include the following information:

10.1 Capabilities Statement: The Capabilities Statement shall clearly address the following topics:

a. Please provide information about one or more candidates that have the desired characteristics (the 9 characteristics identified in Section 9.0).

b. For each candidate, please provide information about the (a) status and ownership of intellectual property; (b) manufacturing lead time for large quantities; (c) ability to meet the additional product demand for procurement surges; (d) any company experience with obtaining FDA approval for any product (e) any past or present connections to U.S. government organizations, programs, or personnel; (f) the strategy for FDA approval and anticipated date of approval, (g) any progress on FDA approval requirements (e.g. completion of non-clinical or clinical studies, End of Phase 2 meeting) (h) a description of the product (i) concept of use at the point of injury during TCCC, and (j) any other information that may be relevant in a business sense to the product and EUAs.

c. Please discuss the ability to, or potential ability to, have the desired characteristics (the 8 characteristics identified in Section 9.0). Please address each of the 9 characteristics. If a desired characteristic is thought to be unattainable or irrelevant to intended use, please explain why.

d. Please provide a rough order of magnitude (ROM) for obtaining FDA approval including all direct and indirect costs. Please provide a ROM for the per unit cost of the analgesic ketamine product and the anticipated monthly supply that can be provided.

10.2 Required Information: Fill in the table below when responding to this RFI.

RFI Number

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

CAGE Code

Unique Entity ID

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program

Please list Government Contracts, Grants, Assistance Agreements, Other Transaction Authority (OTAs), etc. held.

Does the company hold any patents or intellectual property related to this product?

10.3 Response Due Date: Interested parties shall submit the RFI response electronically by 1600 local time on 12 January 2026 via email to:

Jeanette Collins, jeanette.m.collins4.civ@health.mil Shannon Lertora, shannon.p.lertora.civ@health.mil

Email Subject/Title: RFI Response: HT9427-26-RFI-701 Analgesic Ketamine for Battlefield Use

11.0 CONFIDENTIALITY: All 'Proprietary', 'Classified', 'Confidential', or 'Sensitive' information shall be marked as such and will be treated accordingly. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

(End of RFI)