Late-stage development, FDA marketing authorization, procurement, and stockpile of antibiotics for the treatment of drug-resistant secondary bacterial infections and/or the treatment or PEP of infections caused by biothreat pathogens.

BARDA seeks to identify qualified vendors capable of advancing the development of antibiotics for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI), as well as post-exposure prophylaxis (PEP) and/or treatment of biothreat pathogens. In direct support of BARDAs preparedness and response posture, the antibiotics will be positioned for potential procurement. Capable vendors must furnish all necessary services, qualified professional, technical and administrative personnel, materials, equipment, and facilities to perform the required tasks. The target product description and mandatory source requirements are antibiotic programs that 1) already have or expect to hold their end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by May 1, 2025, with an intended indication for the treatment of HABP/VABP; 2) or already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of BSI; 3) or already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of HABP/VABP or BSI that could also be developed for a biothreat indication; 4) or antibiotics that are approved for HABP/VABP and/or BSI that have sufficient data to warrant development for a biothreat indication. This project is for investing in late-stage development, procurement, and stockpiling of antibiotics to treat HABP/VABP and/or BSI caused by drug-resistant bacterial and/or biothreat pathogens, and actively seeks vendors with existing domestic manufacturing capabilities or at minimum a timeline and summarized approach to onshore drug substance manufacturing and fill/finish of drug product. The total period of performance will be no more than 120 months; the period of performance for the Base and Option periods may overlap; the duration of each period will be dependent on the work proposed. Contract(s) expected to be executed September 30, 2025-September 30, 2026. The work will be performed at the responders facilities or subcontracted out to commercial laboratories, contract research organizations, and/or contract manufacturing organizations. Unique requirements include domestic drug substance and fill/finish drug product manufacturing, implemented or a timeline and summary of the approach to onshore manufacturing. Federal Supply Schedules and Government Wide Acquisition contracts are not available to purchase this service. Currently, there are no identified related requirements that will affect this service and conversely, this service will not affect other requirements. Pre-Solicitation Notice Objective: This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Updates to the details provided could arise based on information and insight gained in the interim. Furthermore, BARDA is not at this time seeking proposals, and will not accept unsolicited proposals. Any contract(s) awarded from the RFP solicitation will have both cost-plus-fixed-fee and firm-fixed- price line items and may be awarded in or around September 2025. The anticipated period of performance for any resultant contract(s) will be up to 120 months. Additional details and requirements will be described in the solicitation. Furthermore, all respondents must be registered in the System for Award Management (SAM): https://www.sam.gov.