RFP - 2-PAM Autoinjectors for Project Bioshield (PBS)
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response awarded contract 75A50126C00010 to KALEO, INC. on September 28, 2026, for late-stage clinical development, regulatory approval, and procurement of 2-PAM autoinjectors to treat organophosphate poisoning in adult and pediatric populations under Project Bioshield.
The award funds development and regulatory approval of 2-PAM autoinjectors as a drug/device combination product, along with procurement for the Strategic National Stockpile CHEMPACK Program. The award was made under unrestricted competition with no set-aside applied.
75A50126C00010 Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response
9/30/26, 11:37 AM 2-PAM Autoinjectors Project Bioshield
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR/BARDA) intends to solicit late-stage clinical development, regulatory approval, and procurement of 2-PAM autoinjectors as a drug/device combination product to treat organophosphate poisoning, including nerve agents, in adult and pediatric populations for the SNS/CHEMPACK Program, with responses due by June 16, 2026. No set-aside is anticipated. Work falls under biotechnology research and development (NAICS 541714). The procurement encompasses clinical development through regulatory approval and subsequent device procurement, suggesting a phased approach spanning clinical validation and stockpile acquisition for the Strategic National Stockpile.
75A50126R00002 Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response
6/2/26, 12:31 PM RFP - 2-PAM Autoinjectors for Project Bioshield (PBS)
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (BARDA) seeks late-stage clinical development, FDA regulatory approval, and procurement of 2-PAM (Pralidoxime) autoinjectors as a drug/device combination product to treat organophosphate poisoning and nerve agents in adult and pediatric populations, with proposals due July 30, 2026.
Place of performance is Washington, DC. The procurement is unclassified and carries no set-aside. The base period is 36 months (2026–2029) with optional periods extending through 2034 for a total contract value up to 96 months. The base contract combines one Cost-Plus-Fixed-Fee (CPFF) CLIN (0001) for development activities and one Firm-Fixed-Price (FFP) CLIN (0002) for procurement of 500,000 adult-dose autoinjectors. Option periods include additional CPFF CLINs (0003, 0005) for post-market commitments and FFP CLINs (0004, 0006, 0007) for procurement of 1,500,000 additional autoinjectors, targeting approximately 2,000,000 total units for the SNS/CHEMPACK Program.
The product must achieve FDA approval or Emergency Use Authorization with minimum three-year stability and demonstrate 99.999% reliability per FDA guidance. Offerors must be registered in SAM and provide facility security plans for procurement-related subcontractors. The Final Security Plan is due 90 days post-award; the Quality Management System Plan is due 30 days post-award. Past performance may include non-government contracts deemed relevant to the effort. Long lead-time items such as glass cartridges and active pharmaceutical ingredients should include risk mitigation strategies. Small business subcontracting plans are required for offerors that are not small businesses. The Contracting Officer is Erin Greninger (erin.greninger@hhs.gov; 771-210-7767). NAICS 541714; PSC AB12. All questions must be submitted by July 15, 2026.
75A50126R00002 Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response
6/16/26, 4:46 PM