Title 21, Food and DrugsRelease 119-110

§399a Office of the Chief Scientist

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

Last updated Sep 22, 2026|Official source

Summary

The Secretary must set up an Office of the Chief Scientist inside the Office of the Commissioner and must appoint a Chief Scientist to run it. That Office must oversee and coordinate the FDA’s internal (intramural) research, keep its quality and regulatory focus, track and coordinate research awards across centers and science-based offices so work is not duplicated with the Reagan-Udall Foundation, create and push for a research budget and a peer-review process, seek proposals using an advisory board made of center reps and experts in areas like trial design, epidemiology, demographics, drug-safety monitoring, basic science, and public health, and develop postmarket safety measures as measurable and rigorous as existing premarket measures.

Full Legal Text

Title 21, §399a

Food and Drugs, Source: USLM XML via OLRC

(a)Establishment; appointment

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)Duties of the Office

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

Sep 22, 2026

Release point: 119-110