Extramural Funding Mechanisms

To expand and complement FDA’s intramural research capabilities and to spur innovation in the field of regulatory science in the extramural community, individual centers/offices as well as OCS, fund extramural research using various contract mechanisms and grants to address Agency regulatory science challenges. Depending on availability of appropriated funds, Centers and FDA may have grant and contract programs to support extramural research in very targeted areas.

OCS supports two FDA-level extramural funding mechanisms. One is a contract mechanism called FDA’s Advancing Regulatory Science Broad Agency Announcement (BAA), which enables FDA to solicit ideas and approaches to facilitate the development and evaluation of FDA-regulated products from industry, academia, and other government agencies in areas where FDA has limited expertise or capacities through this specialized contract mechanism. In the future, the BAA will incorporate the FARS to communicate the Agency’s most current regulatory science needs to solicit relevant proposals from the external scientific community.

FDA also collaborates with academic institutions to advance regulatory science through innovative research, training, and scientific exchange leveraging collaborative grants used to fund the Centers of Excellence in Regulatory Science and Innovation Program (CERSI). Through the CERSI Program, FDA offers its scientific staff a range of opportunities, including research collaborations and access to regulatory science-related training, workshops, and seminars. These opportunities support FDA staff engagement while harnessing a broader community of scientific, technical, and medical expertise within the academic communities in areas of mutual interest in regulatory science. The CERSI Program also provides training opportunities for graduate students and post-graduate fellows to learn about regulatory science, thus creating more awareness in academic institutions about FDA’s research and regulatory programs.