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

Closed Solicitation Posted

This opportunity was awarded. See the award notice from .

Solicitation number
75A50126R00002
Agency
Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
541714 Research and Development in Biotechnology (except Nanobiotechnology)
PSC
AB12 Community And Regional Development R&D Services; Community Development; Applied Research
Place of performance
Washington, District of Columbia 20024, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

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.

Notice text

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.

Attachments

Files attached to this notice, newest first
File Type Posted
75A50126R00002 Amend 0001.pdf PDF
75A50126R00002 Amendment 0001.pdf PDF
06 RFP_PBS_2PAM_2026_Final.pdf PDF

Notice history

Notices posted for this opportunity, newest first
Notice Type Posted
RFP - 2-PAM Autoinjectors for Project Bioshield (PBS) Award Award Notice
RFP - 2-PAM Autoinjectors for Project Bioshield (PBS) This notice · Latest solicitation Solicitation
2-PAM Autoinjectors Project Bioshield Original Pre-Solicitation

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