2 PAM Autoinjectors

The Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response seeks proposals to support late-stage clinical development and regulatory approval of 2-PAM autoinjectors as a drug-device combination product to treat organophosphate poisoning. Upon FDA approval by the end of 2024, the selected offeror must be capable of manufacturing and delivering 2 million 600 mg 2-PAM autoinjectors to the Strategic National Stockpile by September 2029. Responses to the anticipated request for proposals will be evaluated based on the offeror's ability to meet these mandatory criteria. The contracting office plans to award one or more cost-plus-fixed-fee and firm-fixed-price contracts by September 2022 for a base period of up to three years and total period of performance up to seven years.

There is no set-aside designation specified. Upon approval, the selected contractor must deliver 2 million autoinjectors to the Strategic National Stockpile by September 2029. Evaluation criteria include the offeror's ability to complete clinical development, gain FDA approval by the end of 2024, and manufacture and deliver the required quantity of autoinjectors by the specified deadline.