Centers of Excellence in Regulatory Science and Innovation (CERSI)

Background
The FDA hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science. The goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory Science and Innovation (ORSI), through collaborative interactions with FDA scientific experts and funding offices.

Grant Details
The Office of the Chief Scientist (OCS) in FDA's Office of the Commissioner (OC) is publishing this Funding Opportunity Announcement (FOA) to provide support for the Agency's Centers of Excellence in Regulatory Science and Innovation (CERSIs). The CERSIs promote innovation in regulatory science predominantly through cutting-edge scientific research that supports FDA's regulatory science needs. The program aims to harness regulatory science outcomes to modernize development and evaluation of FDA-regulated products, strengthen post-market surveillance and labeling of FDA-regulated products, and invigorate public health preparedness and response of the FDA, patients, and consumers.

The program infrastructure supports the execution of the CERSI's cooperative agreement, including coordination, management, oversight of program activities, financial transactions, reporting obligations, and interactive meetings. Cutting-edge regulatory science research is the major focus of the CERSI program. Research projects designed to address regulatory science needs at the Agency are selected and conducted in collaboration with FDA. Regulatory science information sharing opportunities are encouraged to be part of the CERSI program.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits other than institutions of higher education, for-profit organizations including small businesses, local governments, U.S. territories or possessions, Indian/Native American tribal governments (federally recognized), Indian/Native American tribal organizations (other than federally recognized tribal governments), regional organizations, independent school districts, public housing authorities/Indian housing authorities, faith-based or community-based organizations. Foreign institutions are not eligible to apply.

Period of Performance
The award will provide one year of support with future recommended support for 4 additional years contingent upon annual appropriations, availability of funding, and satisfactory recipient performance. The maximum project period is 5 years.

Grant Value
FDA/OCS/ORSI intends to make 5 awards not to exceed $10,000,000 in total costs (direct plus indirect) per award per year for fiscal year 2023 in support of this program.