ASPR/BARDA Antimicrobial Resistance Project Bioshield

The purpose of this Other Than Small Business Sources Sought Notice is to use responses for planning potential future acquisitions.BARDA seeks pertinent marketplace data on availabilities and capabilities for procuring, stockpiling, and investing in the late stage development of antibiotic products for commercial use for treatment of multiple biodefense indications. BARDA seeks information on availabilities, capabilities, and other pertinent marketplace data to strengthen BARDA's understanding of the current and future marketplace enhance its ability to obtain quality services economically, and to efficiently and lawfully establish potential vendor source files and listings. BARDA will not award any contracts under this notice. The Government seeks an FDA-approved antibiotic(s) for a biothreat indication (Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) for delivery to the Office of the Assistant Secretary for Preparedness and Response (ASPR)/Strategic National Stockpile (SNS). The antibiotic(s) must be FDA-approved or in Phase 3 clinical development and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. If the antibiotic is not FDA approved for a pneumonic indication, the Offeror must seek development and FDA approval for a pneumonic indication that could support approval of a biothreat indication. The oral or parenteral antibiotic(s) must have demonstrated efficacy against drug resistant pathogen(s) to include demonstrated in vitro efficacy against one or more of the aforementioned biothreat pathogens. In addition, the manufacturing process for active pharmaceutical ingredient (API) and drug product must be developed and established, meeting and/or development data indicating acceptable product quality attributes during product shelf life. CMC Registration/Primary batches must be ongoing with plans for full process validation established or full process validation is complete. In consideration of the biothreat approval and inclusion in the SNS, extended stability of the antibiotic(s) must be considered to include an ongoing stability program agreed by FDA for bulk drug substance (BDS) and final drug product (FDP) process validation, registration batches and annual commercial manufacturing programs. In addition, the Offeror shall provide required FDA regulatory documentation (i.e. investigator brochure, regulatory binder, etc.) that will be used to support use under EUA and/or approval for a biodefense indication. Also, the Offeror shall provide documentation and/or plans to comply with Post-Marketing Commitments and/or Requirements (PMCR) as specified by the FDA. This effort will also support the necessary late-stage development to achieve approval of the alternative formulation of the product(s) being procured. Procurement of the antibiotic(s) will include a pre-determined number of therapeutic treatment courses as FDP, which will depend upon program requirements for the number of treatment courses to be purchased, and the expected duration of stability for the antibiotic(s). The R&D development work and phase IV post marketing commitments will include late-stage development activities to support approval of the drug.