Antimicrobial Resistance Project Bioshield 2
It is anticipated that an RFP may be available electronically through the FedBizOpps website in March 2019 for 60 days with proposals being due in May 2019. Once any RFP is posted we encourage all responsible sources, particularly small businesses, to submit a proposal which will be considered by the agency. It is the Offeror's responsibility to monitor this internet site (www.fbo.gov) for the release of this solicitation as well as any amendments. Potential Offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted.
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.