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21 U.S.C. § 399a — Office of the Chief Scientist
Federal law — U.S. Code and appendices · legal_authorities
**(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.
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Source file: Laws/federal/codes/united-states-code/title-21/section-399a-office-of-the-chief-scientist--3b34f55d79.md
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Source location: Title 21, Chapter 9, § 399a; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **New tobacco product defined** — For purposes of this section the term “new tobacco product” means—
(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
(2) **Premarket review required**
(A) *New products* — An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—
(i) the manufacturer has submitted a report under [section 387e(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j&num=0&edition=prelim); and the Secretary has issued an order that the tobacco product—
(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and
(II) is in compliance with the requirements of this chapter; or
(ii) the tobacco product is exempt from the requirements of [section 387e(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j&num=0&edition=prelim) pursuant to a regulation issued under [section 387e(j)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j/3&num=0&edition=prelim).
(B) *Application to certain post-February 15, 2007, products* — Subparagraph (A) shall not apply to a tobacco product—
(i) that was first introduced or deliv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387j
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Federal law — U.S. Code and appendices · legal_authorities
Page 709
TITLE 21—FOOD AND DRUGS
§ 399b
(e) Duration of awards
The Secretary may award grants to an indi-
vidual grant recipient under this section for pe-
riods of not more than 3 years. In the event the
Secretary conducts a program evaluation, fund-
ing in the second year or third year of the grant,
where applicable, shall be contingent on a suc-
cessful program evaluation by the Secretary
after the first year.
(f) Progress and evaluation
(1) In general
The Secretary shall measure the status and
success of each grant program authorized
under the FDA Food Safety Modernization Act
(and any amendment made by such Act), in-
cluding the grant program under this section.
A recipient of a grant described in the pre-
ceding sentence shall, at the end of each grant
year, provide the Secretary with information
on how grant funds were spent and the status
of the efforts by such recipient to enhance
food safety. To the extent practicable, the
Secretary shall take the performance of such
a grant recipient into account when deter-
mining whether to continue funding for such
recipient.
(2) No duplication
In carrying out paragraph (1), the Secretary
shall not duplicate the efforts of the Secretary
under other provisions of this chapter or the
FDA Food Safety Modernization Act that re-
quire measurement and review of the activi-
ties of grant recipients under either this chap-
ter or such Act.
(g) Supplement not supplant
Grant funds received under this section shall
be used to supplement, and not supplant, non-
Federal funds and any other Federal funds avail-
able to carry out the activities described in this
section.
(h) Authorization of appropriations
For the purpose of making grants under this
section, there are authorized to be appropriated
such sum
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 399a
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.