Attachment 1-Ketamine Autoinjector Request For Information SOW_Final.docx

+REQUEST FOR INFORMATION

REQUEST FOR INFORMATION (RFI) NO.: HT9425-25-RFI-50mg KETAMINE AUTOINJECTOR

1.0 RFI TITLE: 50 mg Ketamine Autoinjector

2.0 AGENCY: Program Executive Office Operational Medical Systems (PEO OPMED)

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

4.0 LOCATION: Fort Detrick, MD

5.0 SUBJECT: The purpose of this RFI is to address the PEO OPMED WPAC PMO’s requirement for a 50 mg ketamine autoinjector for battlefield analgesia. The WPAC PMO of PEO OPMED is conducting market research to determine the feasibility of securing and partnering with a manufacturer(s) for the procurement of a 50 mg ketamine autoinjector for intramuscular injection (IM). For this RFI, “currently” refers to as of the date of publication of this RFI. Partners who meet any of the following conditions are encouraged to reply (1) are currently developing a 50 mg ketamine autoinjector using an autoinjector platform approved by the FDA (2) have a currently FDA approved and marketed autoinjector (for any drug); (3) have Food and Drug Administration (FDA) inspected ketamine manufacturing capabilities.

6.0 DISCLAIMER: 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 Research and Development (DHA R&D), or collaborative Department of Defense (DoD) activities. 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.

7.0 DESCRIPTION: WPAC has a requirement for a partner to work with WPAC to develop a 50 mg ketamine autoinjector and achieve FDA approval for it. WPAC believes that the 50 mg ketamine autoinjector should have the following desired characteristics:

(1) The autoinjector is currently approved and marketed, for any drug, and does not need to be engineered de novo.

(2) The autoinjector can contain 50 mg of liquid, FDA approved ketamine

8.0 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: HT9425-25-RFI-50mg KETAMINE AUTOINJECTOR. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Electronic files shall not exceed 20MB. All submissions become Government property and will not be returned. Submission should include the following information:

8.1 CAPABILITIES STATEMENT: The Capabilities Statement should clearly address the following topics:

a. Please provide information about one or more candidates that has the desired characteristics (the 2 characteristics identified in Section 7.0).

b. For each candidate, please provide information about the (a) status and ownership of intellectual property; (b) autoinjector manufacturing capabilities; (c) past history in developing/fielding FDA approved autoinjectors; (d) experience in handling, transporting, and fielding controlled substance drugs; (e) favorable history in FDA approved combination products; (f) ketamine manufacturing facilities that have passed FDA inspection and are producing commercially available FDA approved ketamine; (g) Estimated monthly production capacity for a 50 mg ketamine autoinjector; (h) any past or present contracts or agreements with U.S. government organizations, programs, or personnel; and; (i) any other information that may be relevant in a business sense to the product.

c. Please discuss the ability to, or potential ability to, have the desired characteristics (the 2 characteristics identified in Section 7.0). If a desired characteristic is thought to be unattainable or irrelevant to intended use, please explain why.

d. Please present a rough order of magnitude (ROM) for the per unit cost of the ketamine autoinjector and the approximate anticipated monthly manufacturing capacity.

8.2 CONTACT INFORMATION:

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Peter Mitchell at Peter.d.Mitchell8.civ@health.mil no later than the close of business 13 June 2025. Telephonic communication will not be considered as submission nor receive response.

Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis. Telephonic communication will not be considered as submission nor receive response.

Responses shall be limited to thirty (30) pages. Please address all topics described in Section 8. All submissions become Government property and will not be returned.

10.0 REQUIRED INFORMATION: Fill in the below table 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

DUNS Number

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

REQUEST FOR INFORMATION (RFI)_TEMPLATE_6 MARCH 2020 |