§ 399a. Office of the Chief Scientist

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Amendments Act of 2007

   Pub. L. 110–85 title VI § 602 · 121 Stat. 823

   Enacted · 21 U.S.C. § 399a

   June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898

   Source evidence

   Code 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

   Enacted provision · exact public law section
   SEC. 602. OFFICE OF THE CHIEF SCIENTIST.   Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following: “SEC. 910. 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.” .

1 of 1 references resolved to an enrolled provision