Antimicrobial Resistance Project BioShield: BARDA Antibiotic for AMR and Biothreat Pathogens   2

Background
The solicitation is for the Antimicrobial Resistance Project BioShield: BARDA Antibiotic for AMR and Biothreat Pathogens. The purpose of the amendment is to update various sections of the solicitation, including cutoff dates for questions, addition of FAR 52.219-14, removal of a required form in the BUSINESS proposal, removal of U.S. based manufacturing as a mandatory evaluation criterion, and addition of Attachment 19 containing responses to inquiries.

Work Details
The contract requires late-stage development, approval, and potential procurement of an antibiotic with marketing authorization for a biothreat indication (treatment and post-exposure prophylaxis) for specific pathogens. The contract includes completion of the regulatory pathway for a public health pneumonic indication and biothreat indications, as well as any efforts related to post-marketing commitments/requirements. Offerors must propose a biodefense development plan discussed with FDA, including the conduct of a Phase 3 clinical trial for a pneumonic indication if not already approved, or an alternative development/regulatory path if required by the FDA. The contract also involves providing necessary data to support an investigational or unapproved use of the product in the event of a localized outbreak or public health emergency under an appropriate FDA regulatory mechanism.

Period of Performance
The total contract period of performance (base plus option periods) will be up to 10 years. The base period includes late-stage development support for a biothreat indication. Supplementary options will be dedicated to additional late-stage development, post-marketing commitments as established by the FDA, BARDA security requirements, on-shoring commercial manufacturing activities, and shelf-life extension program activities. Firm-fixed-price options will include procurement of treatment and post-exposure prophylaxis courses of the antibiotic.