§ 399a. Office of the Chief Scientist

• (a) 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) 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.