21 U.S.C. § 399a — Office of the Chief Scientist
submitted 88 years ago by Pub. L. 110-85 to r/title-21-FOOD-AND-DRUGS · 219 words · no verdicts yet
A translation hasn’t been published for this section yet. The official text below is complete and authoritative.
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.
The Office of the Chief Scientist shall—
oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food* and Drug* Administration;
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;
develop and advocate for a budget to support intramural research;
develop a peer review process by which intramural research can be evaluated;
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—
representatives of each of the centers and the science-based offices within the Office of the Commissioner; and
experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and
develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.
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.)
- 1938Enacted · Pub. L. 110-85 · 121 Stat. 898
- 2009Amended · Pub. L. 111-31 · 123 Stat. 1784
A history note hasn’t been published yet. The record shows enactment by Pub. L. 110-85 on 1938-06-25.
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