§387q — Title 21 Food and Drugs | U.S. Code

Summary

Within 6 months after June 22, 2009, the Secretary must set up a 12-member group called the Tobacco Products Scientific Advisory Committee. The group will include 7 clinicians or scientists who work in areas like cancer, lung or heart disease, toxicology, pharmacology, or addiction; 1 government officer or employee; 1 person from the general public; 1 tobacco industry representative; 1 small tobacco manufacturer representative (this seat can rotate among different small manufacturers); and 1 tobacco grower representative. The last three are nonvoting consultants. Except for those three, members must not have taken pay, grants, or support from companies that make, sell, or market cigarettes or other tobacco products during their service or in the 18 months before joining. Regular full-time FDA employees cannot be appointed, though federal officials may join as ex officio members. The Secretary must pick a chair from among the clinicians, the government member, or the public member. The committee must give the Secretary advice and recommendations about the law, about changing nicotine yields, about whether a nicotine threshold for dependence exists, and about other safety or health issues the Secretary asks about. Nonfederal members may be paid up to the daily equivalent of the rate under the Senior Executive Schedule (section 5382 of title 5) and get travel expenses under section 5703 of title 5. The Secretary must provide staff help. The committee must keep transcripts of meetings and remove any information protected under section 552(b) of title 5. Section 1013 of title 5 does not apply.

Title 21, §387q

Food and Drugs — Source: USLM XML via OLRC

(a)Not later than 6 months after June 22, 2009, the Secretary shall establish a 12-member advisory committee, to be known as the Tobacco Products Scientific Advisory Committee (in this section referred to as the “Advisory Committee”).

(b)(1)(A)The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of—

(i)7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;

(ii)1 individual who is an officer or employee of a State or local government or of the Federal Government;

(iii)1 individual as a representative of the general public;

(iv)1 individual as a representative of the interests of the tobacco manufacturing industry;

(v)1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee; and

(vi)1 individual as a representative of the interests of the tobacco growers.

(B)The members of the committee appointed under clauses (iv), (v), and (vi) of subparagraph (A) shall serve as consultants to those described in clauses (i) through (iii) of subparagraph (A) and shall be nonvoting representatives.

(C)No members of the committee, other than members appointed pursuant to clauses (iv), (v), and (vi) of subparagraph (A) shall, during the member’s tenure on the committee or for the 18-month period prior to becoming such a member, receive any salary, grants, or other payments or support from any business that manufactures, distributes, markets, or sells cigarettes or other tobacco products.

(2)The Secretary may not appoint to the Advisory Committee any individual who is in the regular full-time employ of the Food and Drug Administration or any agency responsible for the enforcement of this chapter. The Secretary may appoint Federal officials as ex officio members.

(3)The Secretary shall designate 1 of the members appointed under clauses (i), (ii), and (iii) of paragraph (1)(A) to serve as chairperson.

(c)The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to the Secretary—

(1)as provided in this subchapter;

(2)on the effects of the alteration of the nicotine yields from tobacco products;

(3)on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and

(4)on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary.

(d)(1)Members of the Advisory Committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which may not exceed the daily equivalent of the rate in effect under the Senior Executive Schedule under section 5382 of title 5, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently.

(2)The Secretary shall furnish the Advisory Committee clerical and other assistance.

(3)Section 1013 of title 5 does not apply to the Advisory Committee.

(e)The Advisory Committee shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made under this subsection information which is exempt from disclosure under section 552(b) of title 5.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Subsec. (d). Pub. L. 117–286, § 4(a)(160)(A), substituted “chapter 10 of title 5” for “FACA” in heading. Subsec. (d)(3). Pub. L. 117–286, § 4(a)(160)(B), substituted “chapter 10 of title 5” for “FACA” in heading and “Section 1013 of title 5” for “section 14 of the Federal Advisory Committee Act” in text.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial ActionWith respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

§387q Tobacco Products Scientific Advisory Committee