Attachment 1-Ketamine Non-Clinical RFI Final v2.docx

REQUEST FOR INFORMATION (RFI)

for

HT9425-25-RFI-KETAMINE NON-CLINICAL INTRAMASCULAR

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 After a review of the responses received, a synopsis and/or solicitation may or may NOT be published at a future date and time.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 NON-CLINICAL INTRAMASCULAR

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

3. RFI Issue Date: 5/14/2025

4. RFI Title: Good Laboratory Practice (GLP) Compliant Investigational New Drug (IND) Enabling Non-Clinical Ketamine Studies

5. Agency: Program Executive Office Operational Medical Systems (OPMED)

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

7. Location: Fort Detrick. MD

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 Defense Health Agency Research & Development Medical Research and Development Command (DHA RDMRDC), USAMRAA, OPMED 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: OPMED WPAC PMO is looking for Prolonged Field Care solutions for battlefield pain management.

10. Objective and Scope: WPAC has a requirement for a CRO to perform the full suite of GLP compliant, IND enabling, non-clinical safety studies on intramuscular (IM) injectable ketamine products, as determined by WPAC, to support a new clinical indication for ketamine as an analgesic. The partner for the non-clinical safety studies shall have the following characteristics:

(1) GLP capabilities and compliance with 21 CFR Part 58 as certified by recent FDA inspection

(2) Capabilities for multiple different large and small animal models including but not limited to rats, mice, rabbits, mini-pigs, and ferrets

(3) The experience and capability to test, handle, and store controlled substances

(4) Experience testing controlled and/or uncontrolled analgesics, preferably ketamine

(4) Successful FDA IND enabling data submissions

(5) A quality management plan

(6) Ability to generate, compile, and package data in compliance with FDA IND submission requirements (CDISC Standard for Exchange of Nonclinical Data (SEND) format)

(7) Complaint with 21 CFR Part 11

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

12. Response Due Date: Interested parties shall submit the RFI response electronically by 1600 Eastern on 13 June 2025 via e-mail to:

Peter Mitchell at Peter.d.Mitchell8.civ@health.mil

Email subject/title: "RFI response for HT9425-25-RFI-KETAMINE NON-CLINICAL INTRAMASCULAR”

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: GLP Compliant IND Enabling Non-Clinical Ketamine Studies. 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 characteristics identified in Section 10.0).

b. For each candidate, please provide information about the (a) animal facilities and testing competencies; (b) board certified pathologist qualifications; (c) any past or present connections to U.S. government organizations, programs, or personnel; (d) quality and data management plan; (e) any quality management or laboratory testing accreditations/registrations, include certificate number as applicable; (f) development of non-clinical testing protocols; (g) statistician qualifications; (f) The country in which the studies will be conducted if not in the United States; (g) The date of the last regulatory inspection and the results of the inspection (e.g. FDA, GLP certification, etc.) and (h) any other information that may be relevant in a business sense to the testing.

c. Please discuss the ability to, or potential ability to, have the desired characteristics (the characteristics identified in Section 10.0). Please address each of the characteristics. If a desired characteristic is thought to be unattainable or irrelevant to intended use, please explain why.

d. The study must be performed in accordance with the U.S. Department of Health and Human Services, Food and Drug Administration, United States Code of Federal Regulations, Title 21, Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies and as accepted by Regulatory Authorities throughout the European Union (OECD Principles of Good Laboratory Practice), Japan (MHLW), and other countries that are signatories to the OECD Mutual Acceptance of Data Agreement. Please present a rough order of magnitude (ROM) for the cost of the full suite of GLP compliant (21 CFR Part 58), IND enabling non-clinical studies in following the FDA’s Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals for intramuscular administration of ketamine with the following requirements for the animal study portion:

(1) Two different ketamine compounds, as determined by WPAC

(2) Median Lethal Dose 50%, Maximum Tolerated Dose, and No Observable Adverse Effect Level using rats

(3) Three non-primate non-rodent mammalian animal models (e.g. ferrets, rabbits, and mini-pigs) for the repeat dose studies

(4) Three repeat dosing protocols for each animal model (e.g. variation in dosing intervals)

(5) Seven (7)-day pathology reversal time point

(6) Two (2) additional brain pathology slices than required by the FDA, brain slices specifically must include at least the cingulate and retrosplenial cortex as part of the pathology analysis

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)