FDA Broad Agency Announcement (BAA) — Advancing Regulatory Science

FDA BAA Regulatory Science

Funds regulatory science work that strengthens product evaluation and post-market health monitoring.

The FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science is a competitive procurement contracting mechanism, not a grant, administered by the FDA's Office of Regulatory and Emerging Science (ORES) since 2012. It funds extramural research across three regulatory science framework areas: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. In FY2023, FDA awarded $273 million in total federal assistance across all programs; BAA-specific totals have trended downward, from a peak of $142.5 million across 45 awards in FY2022 to $16.7 million across 15 awards in FY2025.

The FY2026 required submission deadline was February 24, 2026; applications submitted after that date are held for FY2027 consideration through September 21, 2026. The optional Early Concept Paper stage was removed for FY2026, meaning applicants now submit a combined Concept Paper and Full Proposal as a single freestanding package. The FY2025 acceptance rate was approximately 4.9% (15 awards from 308 applications), making this among the most selective federal R&D vehicles. Eligible organizations include US-registered for-profit companies, non-profits, universities, and research institutions; individuals may not apply. The solicitation is published on SAM.gov, not Grants.gov, and pre-submission contact via FDABAA@fda.hhs.gov is recommended.

Because BAA awards are procurement contracts under the Federal Acquisition Regulation, the federal government typically retains rights to resulting intellectual property — negotiating data rights at proposal stage is essential. Applicants competing for FY2027 consideration should note the sharply declining award pool and structure proposals that directly map to one of the three framework areas with clear relevance to FDA's product-regulatory mission. The SAM.gov solicitation should be consulted for current evaluation criteria and any scope updates.