2016 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter X - Miscellaneous
Sec. 399a - Office of the Chief Scientist
| 21 U.S.C. § 399a (2016) |
| §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 OfficeThe 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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(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.) |
| United States Code, 2012 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER X - MISCELLANEOUS Sec. 399a - Office of the Chief Scientist |
| section 399a |
| 2016 |
| January 6, 2017 |
| No |
| standard |
| 121 Stat. 898 123 Stat. 1784 |
| Public Law 110-85, Public Law 111-31 |
