# Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization

Canonical: https://abierto.us/opportunities/ht942524rfitjk3

- Solicitation number: HT9425-24-RFI-TJK3
- Notice type: Sources sought
- Status: Closed. Deadline was October 7, 2024 at 5:00 PM EDT
- Department: Department of Defense
- Agency: Defense Health Agency (Dha)
- Contracting office: Army Med Res Acq Activity (HT9425)
- NAICS: 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Product or service code: AN13 Health R&D Services; Health Care Services; Experimental Development
- Place of performance: Frederick, Maryland
- County: Frederick County (FIPS 24021). https://abierto.us/counties/frederick-county-md-24021
- City: Frederick. https://abierto.us/cities/frederick-md-2430325
- First posted: September 6, 2024
- Last posted: September 6, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/78632279225e4aa9844e7a978f283ffa/view

## Description

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.

## Publications

- September 6, 2024: Sources sought, due October 7, 2024 at 5:00 PM EDT. Notice 78632279225e4aa9844e7a978f283ffa. https://sam.gov/workspace/contract/opp/78632279225e4aa9844e7a978f283ffa/view

## Points of contact

- Timothy Kelly, timothy.j.kelly169.civ@health.mil, 3016197806

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/ht942524rfitjk3.