A. 02 Ketamine EUA RFI SAM.docx

RFI Number: HT9425-25-RFI-Ketamine-EUA

REQUEST FOR INFORMATION (RFI)

for

HT9425-25-RFI-KETAMINE-EUA

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 After a review of the responses received, a synopsis and/or solicitation may or may NOT be published at a future date and time.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. RFI Number: HT9425-25-RFI-Ketamine-EUA

2. RFI Issuing Office: United States Army Medical Research Acquisition Activity (USAMRAA)

3. RFI Issue Date: 20 November 2024

4. RFI Title: Intramuscular Injectable Generic Ketamine for use in an FDA Approved Emergency Use Authorization (EUA)

5. Agency: United States Army Medical Materiel Development Activity (USAMMDA)

6. Office: Warfighter Protection and Acute Care Project Management Office (WPAC PMO)

7. Location: Fort Detrick. Maryland

8. 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 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.

9. Background: USAMMDA WPAC PMO is looking for Prolonged Field Care solutions for battlefield injuries.

10. Objective and Scope: 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.

11. North American Industry Classification System (NAICS) Code: 325412

12. Response Due Date: Interested parties shall submit the RFI response electronically by 1600 local time on 20 December 2024 via e-mail to:

Katherine Ramsburg, katherine.j.ramsburg.civ@health.mil Shannon Lertora, shannon.p.lertora.civ@health.mil

Email subject/title: "RFI Response for HT9425-RFI-25-KETAMINE-EUA”

13. 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 for HT9425-RFI-25-KETAMINE-EUA.” 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 shall include the following information:

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

a. Please provide information about one or more candidates that has the desired characteristics (the 7 characteristics identified in Section 10.0).

b. For each candidate, please provide information about the (a) status and ownership of intellectual property; (b) manufacturing; (c) ability to meet the additional product demand for the EUA; (d) any company experience with EUAs (e) any past or present connections to U.S. government organizations, programs, or personnel; (f) length of time the drug is stable at room temperature; and (g) 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 7 characteristics identified in Section 10.0). Please address each of the 7 characteristics. 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 vial cost of the generic ketamine, the monthly supply that can be provided, and lead time.

13.2 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

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?

14.0 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)