RFP - 2-PAM Autoinjectors for Project Bioshield (PBS)

The Biomedical Advanced Research and Development Authority (BARDA) is seeking proposals under solicitation 75A50126R00002 to develop, obtain regulatory approval for, and procure approximately two million 2-PAM (600mg) autoinjectors as a drug/device combination product for the treatment of organophosphate poisoning, including nerve agents, in both adult and pediatric populations. This effort supports the Strategic National Stockpile (SNS) and CHEMPACK Program. The contract is structured as a hybrid cost-plus-fixed-fee and firm-fixed-price instrument with an anticipated base performance period of up to 36 months and potential extension through options to a total duration of eight years. Key deliverables include late-stage clinical development, regulatory submission and approval, and large-scale manufacturing of autoinjectors, with production split across multiple CLINs totaling 2 million units. The solicitation is issued as a Statement of Objectives, requiring offerors to submit a comprehensive Statement of Work and Risk Mitigation Plan addressing program management, product development, supply chain logistics, and optional post-marketing commitments. Manufacturing and packaging must adhere to Good Manufacturing Practice regulations under 21 CFR Part 820, and all products must maintain strict temperature controls during transit, with ambient exposure logging required from the offeror’s validated facility until acceptance by the government at the ASPR/SNS location in Washington, D.C. All proposals must comply with mandatory eligibility criteria, including adherence to FAR and HHSAR clauses covering cost allowability, inspection, intellectual property, anti-kickback, and contingency fee restrictions. Offerors are required to complete SAM.gov representations and certifications, submit a detailed organizational chart identifying key personnel including a Program Director, Chief Scientific/Medical Officer, Manufacturing Lead, Regulatory Affairs Lead, and Project Manager, and demonstrate compliance with human subject protections under 45 CFR 46. Security requirements mandate layered physical controls, identification verification for personnel and visitors, and robust information and cyber security protocols encompassing access controls, intrusion detection, and encryption. Proposals must be submitted by July 30, 2026, and remain firm for 120 days. Evaluation will prioritize technical merit, past performance, and overall value over cost, with non-cost factors carrying significantly greater weight. Contract administration requires electronic invoice submissions via the Treasury IPP system to designated federal offices and strict adherence to documentation handling, packaging, and delivery protocols. The procurement is open to all qualified entities without set-aside restrictions