E9-20485. Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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: [phone], e-mail: [e-mail].

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 § 14.100 to reflect the establishment of the committee.

Therefore the agency is amending § 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

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

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.

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

§ 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.