FDA -- Centers of Excellence in Regulatory Science and Innovation (CERSI) (U01) Clinical Trials Optional

Funding Agency:
National Institutes of Health

The FDA hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science, and 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.

This funding opportunity will provide support, depending on availability of FDA funding, for collaborative research with FDA and regulatory science information sharing opportunities.

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed. Institutions interested in involving multiple offices/departments (within their institution) should internally coordinate and choose one (1) entity to apply. Interested applicants from within Duke should contact fundopps@duke.edu as early as possible.


  • Letter of Intent Due Date(s): October 31, 2022

  • Application Due Date(s): December 22, 2022

RFA-FD-23-004 Expiration Date December 23, 2022

Agency Website

Amount Description

Application budgets need to reflect the actual needs of the proposed program annually (including FDA-CERSI collaborative research projects proposed to be funded at initial CERSI award and those proposed for possible funding post-award) and should not exceed the following in total costs (direct and indirect):

YR 01: $10,000,000

YR 02: $10,000,000

YR 03: $10,000,000

YR 04: $10,000,000

YR 05: $10,000,000

Funding Type





Medical - Basic Science
Medical - Clinical Science
Medical - Translational
Social Sciences

External Deadline

December 22, 2022