The Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR), has released a Request for Proposals (RFP) for 2-PAM Autoinjectors for Project BioShield. The RFP supports late-stage clinical development, regulatory approval, procurement, and delivery of pralidoxime, also known as 2-PAM, autoinjectors for the treatment of organophosphate (OP) poisoning, including nerve agent exposure.
The goal of the acquisition is to replace 2-PAM autoinjectors currently held in legacy MARK-1™ kits within the Strategic National Stockpile’s (SNS) CHEMPACK Program with modern, 600 mg, single dose 2-PAM autoinjectors. BARDA is seeking products that can support treatment in adult and pediatric populations and improve flexibility for emergency response in a diverse civilian population.
Organophosphate and nerve agent poisoning can cause symptoms within minutes, making rapid administration of medical countermeasures critical. While modern FDA-approved atropine autoinjectors are available, BARDA notes that there are currently no 2-PAM autoinjectors aside from those found in legacy MARK-1™ kits. This RFP is intended to address that gap by supporting the development, approval, and procurement of standalone 2-PAM autoinjectors for SNS/CHEMPACK readiness.
Technical Focus and Key Requirements
BARDA is seeking offerors with products already in late-stage development that can achieve FDA approval by the end of 2028. Proposed autoinjectors must be at Phase III clinical development or higher and supported by prior FDA engagement regarding the proposed regulatory pathway.
Key requirements include:
- Manufacturing 600 mg 2-PAM autoinjectors for treatment of OP poisoning, including nerve agents, in adults and pediatric populations (ages 12 and older)
- Demonstrating compliance with FDA emergency-use autoinjector reliability standards, including a target reliability of 99.999%
- Supporting NDA or ANDA submission and FDA approval as a drug-device combination product
- Conducting any required clinical studies and regulatory activities to support approval
- Completing remaining CMC, manufacturing validation, quality control, stability, and cGMP activities
- Establishing a minimum three-year shelf life at intended storage conditions
- Demonstrating usability in emergency situations through human factors validation
- Providing security plans covering manufacturing, storage, inventory, and supply chain operations
In addition to development activities, BARDA intends to procure and maintain approximately 2 million 2-PAM autoinjectors for the SNS CHEMPACK Program.
Key Dates
- RFP Issued: June 16, 2026
- Initial Questions Due: June 23, 2026, at 12:00 PM Eastern Time
- Proposal Responses Due: July 30, 2026, at 5:00 PM Eastern Time
Award Structure
BARDA anticipates awarding up to two hybrid contracts that combine cost-plus-fixed-fee (CPFF) and firm-fixed-price (FFP) components. The three-year base period includes late-stage development, regulatory activities, manufacturing validation, human factors studies, and an initial procurement of 500,000 adult-dose Autoinjectors.
The total period of performance may extend to eight years through option periods that support post-marketing commitments and additional procurement. BARDA ultimately intends to acquire approximately 2 million 2-PAM autoinjectors for the SNS CHEMPACK Program, with all deliveries completed by May 31, 2034.
Additional Information
Technical evaluation criteria include technical manufacturing capabilities, regulatory strategy and processes, and project management capabilities. Each technical evaluation criterion is of equal importance. BARDA notes that all non-cost factors combined are significantly more important than cost or price in the overall evaluation.
Offerors must demonstrate adequate manufacturing capacity, the ability to achieve FDA approval by the end of 2028, and a credible plan for meeting reliability, production, and delivery requirements. BARDA may make multiple awards under this solicitation.
For organizations with expertise in medical countermeasures, drug device combination products, autoinjector development, regulatory affairs, and large-scale pharmaceutical manufacturing, this opportunity represents a significant pathway to support national health security and chemical threat preparedness.
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