FY27 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

The U.S. Food and Drug Administration (FDA) Office of Acquisition and Grant Services is soliciting Stage One submittal packages under FY27 Broad Agency Announcement FDABAA-27-00123 for basic and applied regulatory science research and development, due January 22, 2027 at 5:00 p.m. Eastern Standard Time. No set-aside is used, and the BAA is open to all responsible sources. Amendment 001 moved the due date up from February 1, 2027.

Eligible applicants include private sector organizations, Federally Funded Research and Development Centers (FFRDCs), and academic institutions, and small businesses are strongly encouraged to respond. Awards will be procurement contracts only, not grants, and cost-reimbursement contracts are authorized under Executive Order 14402. Proposals span 22 research areas aligned with FDA's four public health pillars, with priorities including real-world evidence, new approach methodologies, decentralized clinical trials, onshoring manufacturing, medical countermeasures, cybersecurity, and rare diseases. Proposals are not limited to PSC AJ11.

Stage One packages require a completed checklist, a freestanding concept paper, and a freestanding full proposal with a statement of work consistent with the FAR 35.001 R&D definition. Early submission is highly encouraged. Packages received after the deadline will be accepted but may not be considered for FY27 award, and incomplete or nonconforming submissions will be rejected at FDA's discretion. Evaluation follows a two-tiered process assessing scientific and technical merit, program relevance, capabilities and experience, past performance, and cost realism. Multiple awards are anticipated, with funding levels dependent on proposal quality and fund availability. The BAA remains continuously open throughout FY27 on SAM.gov under keyword "FDABAA-27-00123."