The Food and Drug Administration (FDA), part of the Department of Health and Human Services (HHS), has announced the FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science (FDABAA-25-00123). This funding opportunity is aimed at advancing regulatory science and fostering innovation in FDA-regulated products, including drugs, biologics, medical devices, tobacco products, and food. The FDA seeks to collaborate with industry, academia, and federally funded research institutions to support scientific advancements that will improve the safety, effectiveness, and quality of medical and consumer products.

The purpose of this BAA is to solicit proposals that address specific research areas aligned with FDA’s mission. These include modernizing the development and evaluation of regulated products, strengthening post-market surveillance and labeling, and enhancing public health preparedness and response. The FDA is particularly interested in proposals related to alternative methods of evaluation, advanced manufacturing, computational modeling, clinical outcome assessments, real-world data utilization, and public health risk mitigation strategies.

The funding will be distributed through procurement contracts, rather than traditional grants. The total program funding is determined based on the quality and scope of proposals received, with multiple awards anticipated. The FDA reserves the right to fund projects in phases or select partial proposals for funding. Cost reimbursement contracts are preferred over fixed-price models due to the inherent uncertainties of scientific research.

Eligibility for this BAA is broad and includes private sector organizations, federally funded research and development centers (FFRDCs), and academic institutions. While non-U.S. organizations may participate, they must comply with U.S. laws, regulations, and disclosure agreements. Proposals from FFRDCs and government entities must demonstrate that their work is not otherwise available from the private sector and include documentation from their sponsoring organization.

The application process consists of two stages. Stage 1 requires the submission of a Concept Paper and a Full Proposal by March 4, 2025. Optional early Concept Papers may be submitted by November 8, 2024, to receive preliminary feedback, though this is not required for consideration. Stage 2 is applicable only if revisions to the Full Proposal are requested, with a 14-day window for resubmission. The FDA will notify applicants of their proposal status via email, and selected applicants may be asked for further administrative information.

Evaluation criteria include scientific and technical merit, alignment with FDA priorities, feasibility, and potential impact on regulatory science. Proposals must include a detailed research plan, expected deliverables, and a cost proposal. Specific attention will be given to applications that leverage artificial intelligence, machine learning, big data, and innovative methodologies to enhance regulatory decision-making.

The FDA will host virtual events to support applicants, including an FDA Broad Agency Announcement Day on November 14, 2024, and a Q&A Session on January 16, 2025. The funding opportunity remains continuously open, but applications received after March 4, 2025, may be considered for future funding cycles.

For further inquiries, applicants can contact the FDA at FDABAA@fda.hhs.gov.