[Federal Register Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Rules and Regulations]
[Pages 43042-43043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2009-N-0381]


Advisory Committee; Tobacco Products Scientific Advisory 
Committee; Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
Establishment of the Tobacco Products Scientific Advisory Committee. 
These actions are needed to implement the Federal Food, Drug, and 
Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco 
Control Act. Elsewhere in this issue of the Federal Register, FDA is 
publishing two separate documents requesting nominations for voting and 
non-voting membership on this committee. This document also amends the 
agency's regulations to add the Tobacco Products Scientific Advisory 
Committee (the committee) to the agency's list of standing advisory 
committees.

DATES: This rule is effective August 26, 2009. The committee is being 
established and this charter will remain in effect until amended or 
terminated by the Commissioner of Food and Drugs (the Commissioner).

FOR FURTHER INFORMATION CONTACT: Erik P. Mettler, Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
4324, Silver Spring, MD 20993-0002, 301-796-4711, FAX: 301-847-3541, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The committee was established under 21 
U.S.C. 387q, as added by section 917 of the Family Smoking Prevention 
and Tobacco Control Act (Public Law 111-31). The committee is also 
governed by part 14 (21 CFR part 14), Public Law 92-463 (5 U.S.C. 
app.), and the Federal Advisory Committee Act, which sets forth 
standards for the formation and use of advisory committees. The 
committee advises the Commissioner or designee in discharging 
responsibilities as they relate to the regulation of tobacco products.
    The committee reviews and evaluates safety, dependence, and health 
issues relating to tobacco products and provides appropriate advice, 
information, and recommendations to the Commissioner.
    Specifically, the committee will submit reports and recommendations 
on tobacco-related topics, including the following:
     The impact of the use of menthol in cigarettes on the 
public health, including such use among children, African Americans, 
Hispanics and other racial and ethnic minorities;
     The nature and impact of the use of dissolvable tobacco 
products on the public health, including such use on children;
     The effects of the alteration of nicotine yields from 
tobacco products and whether there is a threshold level below which 
nicotine yields do not product dependence on the tobacco product 
involved; and
     Any application submitted by a manufacturer for a modified 
risk tobacco product.
    The committee may provide recommendations to the Secretary of 
Health and Human Services regarding any regulations to be issued under 
the Federal Food, Drug, and Cosmetic Act and may review any 
applications for new tobacco products or petitions for exemption under 
section 906(e) of the Family Smoking Prevention and Tobacco Control 
Act. The committee may consider and provide recommendations on any 
other matter as provided in the Family Smoking Prevention and Tobacco 
Control Act.
     The committee shall consist of 12 members including the Chair. 
Members and the Chair are selected by the Commissioner or designee from 
among individuals knowledgeable in the fields of medicine, medical 
ethics, science, or technology involving the manufacture, evaluation, 
or use of tobacco products. Members will be invited to serve for 
overlapping terms of up to 4 years. Almost all non-Federal members of 
this committee serve as Special Government Employees. The committee 
shall include nine technically qualified voting members, selected by 
the Commissioner or designee. The nine voting members shall be 
physicians, dentists, scientists, or health care professionals 
practicing in the area of oncology, pulmonology, cardiology, 
toxicology, pharmacology, addiction, or any other relevant specialty. 
One member shall be an officer or employee of a State or local 
government or of the Federal Government. The final voting member shall 
be a representative of the general public. In addition to the voting 
members, the committee shall include three nonvoting members who are 
identified with industry interests. These members shall include one 
representative of the tobacco manufacturing industry, one 
representative of the interests of tobacco growers, and one 
representative of the interests of the small business tobacco 
manufacturing industry. This final position can 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 committee.
    The Commissioner or designee shall designate one of the voting 
members of the committee to serve as chairperson.
    As added by section 917 of the Family Smoking Prevention and 
Tobacco Control Act, 21 U.S.C. 387q(d)(3) provides that section 14 of 
the Federal Advisory Committee Act does not apply to this committee.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule. 
Notice and public comment and a delayed effective date are unnecessary 
and are not in the public interest as this final rule merely amends the 
information in Sec.  14.100 to reflect the establishment of the 
committee.
    Therefore the agency is amending Sec.  14.100(a) as set forth in 
the regulatory text of this document.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended to read as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority:  5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.

[[Page 43043]]


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2. In Sec.  14.100, add paragraph (a)(5) to read as follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (a) * * *
    (5) Tobacco Products Scientific Advisory Committee.
    (i) Date Established: August 12, 2009.
    (ii) Function: The committee reviews and evaluates safety, 
dependence, and health issues relating to tobacco products and provides 
appropriate advice, information, and recommendations to the 
Commissioner of Food and Drugs. Specifically, the committee will submit 
reports and recommendations on tobacco-related topics, including: The 
impact of the use of menthol in cigarettes on the public health, 
including such use among children, African Americans, Hispanics and 
other racial and ethnic minorities; the nature and impact of the use of 
dissolvable tobacco products on the public health, including such use 
on children; the effects of the alteration of nicotine yields from 
tobacco products and whether there is a threshold level below which 
nicotine yields do not produce dependence on the tobacco product 
involved; and any application submitted by a manufacturer for a 
modified risk tobacco product. The committee may provide 
recommendations to the Secretary of Health and Human Services regarding 
any regulations to be issued under the Federal Food, Drug, and Cosmetic 
Act and may review any applications for new tobacco products or 
petitions for exemption under section 906(e) of the Family Smoking 
Prevention and Tobacco Control Act. The committee may consider and 
provide recommendations on any other matter as provided in the Family 
Smoking Prevention and Tobacco Control Act.
* * * * *

    Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20485 Filed 8-26-09; 8:45 am]
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