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SAMDAILY.US - ISSUE OF SEPTEMBER 08, 2024 SAM #8321
SOURCES SOUGHT

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

Notice Date
9/6/2024 10:33:30 AM
 
Notice Type
Sources Sought
 
NAICS
541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
 
Contracting Office
ARMY MED RES ACQ ACTIVITY FORT DETRICK MD 21702 USA
 
ZIP Code
21702
 
Solicitation Number
HT9425-24-RFI-TJK3
 
Response Due
10/7/2024 2:00:00 PM
 
Archive Date
10/22/2024
 
Point of Contact
Timothy Kelly, Phone: 3016197806
 
E-Mail Address
timothy.j.kelly169.civ@health.mil
(timothy.j.kelly169.civ@health.mil)
 
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.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/78632279225e4aa9844e7a978f283ffa/view)
 
Place of Performance
Address: Frederick, MD 21702, USA
Zip Code: 21702
Country: USA
 
Record
SN07202256-F 20240908/240906230121 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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