Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

The Biomedical Advanced Research and Development Authority (BARDA), operating under the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is soliciting advanced research and development proposals for medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. The solicitation encompasses twelve areas of interest, including CBRN vaccines, antivirals and antitoxins, antimicrobials for drug-resistant pathogens, radiological and nuclear countermeasures, chemical medical countermeasures, burn and blast injury management, diagnostics, influenza vaccines and therapeutics, tissue chip technologies, and flexible therapeutic platforms. Proposals must meet specified Technology Readiness Level (TRL) requirements, generally ranging from TRL 4 to TRL 6 depending on the specific area of interest, and must demonstrate feasibility data with comprehensive development plans covering regulatory pathways, manufacturing, clinical strategies, and commercialization. Evaluation will be based on program relevance, scientific and technical merit, offeror capabilities and experience, cost realism, and past performance, with primary emphasis on technical merit and importance to agency programs. The solicitation operates through a three-stage process with a final proposal submission deadline of September 25, 2028, at 4:30 PM Eastern Time, with the government providing responses within 120 days of Stage 2 submissions.

This is an open solicitation with no set-aside designations, available to all responsible sources including private sector organizations, academic institutions, and government laboratories, with no incumbent contractors identified. BARDA anticipates making multiple awards of various values and contract types, including cost-reimbursement contracts, cost-sharing arrangements, firm-fixed-price contracts, grants, cooperative agreements, and Other Transactions, with award amounts dependent on program priorities, technical merit, and available funding. The government reserves the right to make awards or fund none of the proposals received and may select the instrument best suited to each individual project. All work will be performed in the United States, with preference for U.S.-based manufacturing and technologies that can be rapidly adapted to emerging threats. All submissions must be unclassified and electronically submitted through the BARDA Digital Resources Portal in searchable PDF format, with compliance required for Good Manufacturing Practice standards, export control regulations, intellectual property disclosure, and adherence to GLP, GMP, and GCP guidelines as applicable to the proposed countermeasure development.