§ 399a. Office of the Chief Scientist

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(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. 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.)

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Cited by 2 sections

U.S. Code

§ 387j
Application for review of certain tobacco products

statutes-at-large

Public Law 110–85
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes

5 references not yet in our index

June 25, 1938, ch. 675, § 1010
Pub. L. 110–85, title VI, § 602
121 Stat. 898
Pub. L. 111–31, div. A, title I, § 101(b)(2)
123 Stat. 1784

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cites case law

§ 399a

Office of the Chief Scientist

Stat.×1

U.S.C.×1

ActJune 25, 1938, ch. 675, § 1010

Pub. L.Pub. L. 110–85, title VI, § 602

Stat.121 Stat. 898

Pub. L.Pub. L. 111–31, div. A, title I, § 101(b)(2)

Stat.123 Stat. 1784

Cites 5Cited by 2 across 2 sources