Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization
ID: HT9425-24-RFI-TJK3Type: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT (AN13)

Original Source

https://sam.gov/opp/78632279225e4aa9844e7a978f283ffa/view
Timeline
    Description

    The Department of Defense, through the Army Medical Research Acquisition Activity, is seeking manufacturers for the procurement of intramuscular injectable generic analgesic ketamine intended for use under an FDA-approved Emergency Use Authorization (EUA) for battlefield injuries. The primary objective is to identify suppliers capable of providing ready-to-inject ketamine that meets specific criteria, including being an FDA-approved generic drug available in multidose vials and ready for immediate purchase, without any combination products. This initiative is crucial for enhancing pain management strategies within the military healthcare system, particularly for acute severe pain associated with battlefield injuries. Interested parties must submit a capabilities statement by October 7, 2024, addressing various topics such as FDA status and manufacturing capacity, with all submissions becoming government property. For further inquiries, contact Timothy Kelly at timothy.j.kelly169.civ@health.mil or call 301-619-7806.

    Point(s) of Contact
    Timothy Kelly
    (301) 619-7806
    timothy.j.kelly169.civ@health.mil
    Files
    Title
    Posted
    HT9425-24-RFI-TJK3 RFI.docx
    The U.S. Army Medical Materiel Development Activity (USAMMDA) has issued a Request for Information (RFI) to explore the procurement of intramuscular injectable generic analgesic ketamine for use in Emergency Use Authorization (EUA) related to battlefield injuries. This RFI seeks to identify potential manufacturers capable of delivering ready-to-inject ketamine, which must meet specific criteria, including being an FDA-approved generic drug, available in multidose vials, and ready for immediate purchase. The RFI emphasizes that the ketamine should not involve combination products and is vital for establishing an EUA to enhance analgesic treatment within the military healthcare system. Respondents must submit a capabilities statement addressing various topics, including FDA status, manufacturing capacity, and costs. The submission instructions detail that all information will become government property, with a strict limit on page numbers and a submission deadline set for October 7, 2024. This initiative underscores the government's intention to enhance pain management strategies in military settings while streamlining the procurement process of critical medical supplies.
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