2 PAM Autoinjectors

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeks proposals for the late-stage clinical development and regulatory approval of 2-PAM autoinjectors as a drug-device combination product for treating organophosphate poisoning in adult and pediatric populations. Additionally, it seeks to procure 2-PAM autoinjectors for the Strategic National Stockpile CHEMPACK Program upon approval. Proposals are due by August 15, 2022 and must address clinical development, regulatory, manufacturing, and supply objectives. Questions regarding the solicitation were due by July 21, 2022. Evaluation will consider an offeror's ability to meet the clinical development, regulatory approval, and initial and future procurement requirements.

There is no set-aside designation. The place of performance is Washington, D.C. Key dates include questions due by July 21, 2022 and proposals due by August 15, 2022. The base period is up to three years for development activities and an initial procurement. Optional periods provide for additional procurements, post-market commitments, and late-stage development work. Manufacturers must demonstrate the ability to meet stated production quantities and timelines for procuring up to 600,000 autoinjectors over five years but final commercial facilities are not required by the August 15th proposal deadline.