HT9425-24-RFI-TJK3 RFI.docx

REQUEST FOR INFORMATION

REQUEST FOR INFORMATION (RFI) NO. : HT9425-24-RFI-TJK3

1.0 RFI TITLE: Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization

2.0 AGENCY: U.S. Army Medical Materiel Development Activity (USAMMDA)

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

4.0 LOCATION: Fort Detrick, MD

5.0 SUBJECT: The purpose of this RFI is to address the USAMMDA WPAC requirement for the development of analgesics for acute severe pain associated with battlefield injuries. The WPAC PMO of USAMMDA is conducting market research to determine the feasibility of securing a manufacturer for the procurement of generic ready-to-inject ketamine for intramuscular injection (IM) for analgesia. No other route of ketamine administration or combination product(s), including autoinjectors, will be considered. In addition, the injectable ketamine must be available for immediate purchase from the open market. The generic ketamine will be used to gain an FDA approved Emergency Use Authorization (EUA) for analgesic ketamine with a subsequent proposed label indication for acute pain via the 505(b)(2) pathway. The sponsor for the EUA will be the Department of Defense (DoD). The analgesic ketamine EUA will allow the DoD to formulate policies on analgesic ketamine use which is expected to result in a large demand for ketamine throughout the Joint Service Military Health System.

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 USAMRDC, 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 the immediate purchase of intramuscular injectable generic analgesic ketamine that can be used to treat severe pain for an FDA approved EUA. WPAC believes that the ketamine should have the following desired characteristics:

(1) It is able to treat severe pain.

(2) It is currently an FDA approved generic drug.

(3) It is not part of a combination product (e.g. autoinjector).

(4) It is ready to inject and does not require reconstitution.

(5) It is available in a 50 mg/mL multidose vial.

(6) It is available for immediate purchase from the open market.

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: Generic Analgesic Ketamine for Acute Pain. 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 address the following topics:

a. Please provide information about one or more candidates that has the desired characteristics (the 6 characteristics identified in Section 7.0).

b. For each candidate, please provide information about the (a) status and ownership of intellectual property; (b) FDA regulatory status; (c) manufacturing; (d) ability to meet the additional product demand for the EUA; (e) any company experience with EUAs (f) any past or present connections to U.S. government organizations, programs, or personnel; and (g) 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 6 characteristics identified in Section 7.0). Please address each of the 6 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 and the monthly supply that can be provided.

8.2 CONTACT INFORMATION:

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Timothy J. Kelly at timothy.j.kelly169.civ@health.mil no later than the close of business 7 October 2024. 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 |