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21 USC § 399a - Office of the Chief Scientist

---
identifier: "/us/usc/t21/s399a"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 399a - Office of the Chief Scientist"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "399a"
section_name: "Office of the Chief Scientist"
chapter_number: 9
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
subchapter_number: "X"
subchapter_name: "MISCELLANEOUS"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)"
---

# § 399a. Office of the Chief Scientist

**(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.

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**Source Credit**: (June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)