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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

in plain englishAI-generated · not legal advice

The Secretary must create an Office of the Chief Scientist inside the FDA, led by an appointed Chief Scientist. This office oversees FDA research, tracks research funding, and prevents duplicate research. It also creates ways to measure drug safety after products reach the market.

(a) Establishment; appointment
The Secretary must set up an office inside the Office of the Commissioner, called the Office of the Chief Scientist. The Secretary must appoint someone to lead it as Chief Scientist.

(b) Duties of the Office
This Office must oversee and coordinate the FDA's own in-house ("intramural") research, making sure it stays high-quality and focused on regulation. It must track the research money each FDA center or science office awards, and coordinate that spending so it does not duplicate research already funded by the Reagan-Udall Foundation for the Food and Drug Administration.

The Office must build and push for a budget to support this in-house research. It must create a peer-review process to judge that research's quality.

The Office must also seek out and gather research ideas from across the FDA. It does this through an advisory board made up of FDA employees. That board must include representatives from every center and science-based office in the Commissioner's office, plus experts in trial design, epidemiology, population data, drug-safety monitoring, basic science, and public health.

Finally, the Office must develop ways to measure drug safety after a product goes on the market. These measures must be just as precise and rigorous as the ones already used before a product goes on the market.

the actual law source: uscode.house.gov ↗public domain
(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.

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.)

history & why it existsrecord from the source credit
  • 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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