SAM #75A50126R00002

BARDA Solicitation for 2-PAM Autoinjectors: Development, Approval, and Procurement for National Stockpile

BARDA, part of the Department of Health and Human Services, is seeking proposals for the advanced development, regulatory approval, and large-scale procurement of 2-PAM (600 mg) autoinjectors for the Strategic National Stockpile and CHEMPACK Program. - Government Buyer: - Department of Health and Human Services (HHS) - Administration for Strategic Preparedness and Response (ASPR) - Biomedical Advanced Research and Development Authority (BARDA) - Products/Services Requested: - Up to 2,000,000 FDA-approved or EUA-authorized 2-PAM (600 mg) autoinjectors for organophosphate poisoning (including nerve agents) - Initial procurement: 500,000 units - Three option periods: 500,000 units each (totaling 1,500,000 additional units) - Devices must be suitable for both adult and pediatric use - Must meet FDA reliability standards and be approved or authorized by FDA - Includes labeling, packaging, and delivery to the Strategic National Stockpile/CHEMPACK - Program management and late-stage clinical development services - Includes manufacturing validation, human factors studies, and regulatory activities - Post-market license commitments and additional late-stage development as required by FDA - Unique/Notable Requirements: - Drug/device combination product must achieve FDA reliability requirements - Delivery in increments of 500,000 units per phase - Contract includes both product supply and regulatory/clinical development services - No specific OEMs or vendors are named; open to qualified manufacturers of 2-PAM autoinjectors - OEMs: - No specific OEMs are named, but the opportunity is open to manufacturers of 2-PAM autoinjectors

Description

BARDA seeks late-stage clinical development, regulatory approval for 2-PAM autoinjectors (as a drug/device combination product) to treat organophosphate (OP) poisoning, including nerve agents, in adult and pediatric populations, and procurement of 2-PAM autoinjectors for the SNS/CHEMPACK Program.

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