21 U.S.C. § 399a
Verified against govinfo.gov as of June 20, 2026View official text on govinfo.gov ↗
- (a)The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.
- (b)The Office of the Chief Scientist shall—
- (1)oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;
- (2)track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;
- (3)develop and advocate for a budget to support intramural research;
- (4)develop a peer review process by which intramural research can be evaluated;
- (5)identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—
- (6)develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.