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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 399a Office of the Chief Scientist us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 399a 21 U.S.C. § 399a current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s399a data/legal/raw/us/code/title-21/usc21.xml e5e51acdbee12cfe508bd79042a18425e0f3017d6c7675c854b466516d7b710f 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 59218da3a6db851c1db473fd833c1316d2f9aa131ca47bb55ea93a8f0f760d2c 2026-07-04 official
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21 U.S.C. § 399a - Office of the Chief Scientist

Text

(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.

(June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 11085, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 11131, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)