Title 21 — Food and DrugsRelease 119-73

§399a Office of the Chief Scientist

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER X— - MISCELLANEOUS › § 399a

Last updated Apr 6, 2026|Official source

Summary

The Secretary must set up an Office of the Chief Scientist inside the Commissioner's Office and hire a Chief Scientist to lead it. The office must run and coordinate the FDA’s in-house research, check quality and regulatory focus, and track awards from each center so work is not duplicated with the Reagan‑Udall Foundation. It must also push for a research budget, create a peer review system, seek research ideas through an employee advisory board that includes center and science-office reps and experts in trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health, and build measurable postmarket safety performance measures like those used for premarket review.

Full Legal Text

Title 21, §399a

Food and Drugs — Source: USLM XML via OLRC

(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—

(A)representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B)experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and

(6)develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

Reference

Citations & Metadata

Citation

21 U.S.C. § 399a

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73