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26 August 2009. Three notices.
[Federal Register: August 26, 2009 (Volume 74, Number 164)][Rules and Regulations] [Page 43042-43043] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26au09-4] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: erik.mettler@fda.hhs.gov. 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]] 0 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] BILLING CODE 4160-01-S
[Federal Register: August 26, 2009 (Volume 74, Number 164)] [Notices] [Page 43140-43141] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26au09-62] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0383] Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Tobacco Products Scientific Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Tobacco Products Scientific Advisory Committee notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents announcing the establishment of the committee and the request for nomination of the Tobacco Products Scientific Advisory Committee. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating the interest to FDA by September 25, 2009, for vacancies listed in the notice. Concurrently, nomination material for [[Page 43141]] prospective candidates should be sent to FDA by September 25, 2009. ADDRESSES: All nominations for membership should be sent electronically to cv@oc.fda.gov, or by mail to Advisory Committee Oversight & Management Staff, 5600 Fishers Lane (HF-4), rm. 14C03, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Erik P. Mettler, Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4324, Silver Spring, MD 20993, 301-796- 4711, FAX: 301-847-3541, e-mail: erik.mettler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The agency requests nominations for nonvoting industry representatives on the Tobacco Products Scientific Advisory Committee. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents announcing the establishment of the committee and the request for nomination of the Tobacco Products Scientific Advisory Committee. I. Center for Tobacco Tobacco Products Scientific Advisory Committee The Tobacco Products Scientific Advisory 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 of Food and Drugs. 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. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document. Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the Tobacco Products Scientific Advisory Committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner of Food and Drugs will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person within the 30 days. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages, nominations for appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: August 19, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9-20483 Filed 8-25-09; 8:45 am] BILLING CODE 4160-01-S
[Federal Register: August 26, 2009 (Volume 74, Number 164)] [Notices] [Page 43147-43148] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26au09-68] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0394] Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (the committee) in the Office of Science, Center for Tobacco Products. Elsewhere in this issue of the Federal Register, FDA is publishing a document announcing the establishment of this committee. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups. DATES: Nominations received on or before October 13, 2009, will be given first consideration for membership on the Tobacco Products Scientific Advisory Committee. Nominations received after October 13, 2009, will be considered for nomination to the Tobacco Products Scientific Advisory Committee should nominees still be needed. ADDRESSES: All letters of interest and nominations should be submitted in writing to Erik P. Mettler (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Erik P. Mettler, Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., WO1, rm. 4324, Silver Spring, MD 20993, 301-796-4711, FAX: 301-847-3541, e-mail: erik.mettler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the Tobacco Products Scientific Advisory Committee. Elsewhere in this issue of the Federal Register, FDA is publishing a Request for Notification from Industry Organizations interested in participating in the selection process for nonvoting industry representatives on the Tobacco Products Scientific Advisory Committee. I. Function of the Tobacco Products Scientific Advisory Committee The Tobacco Products Scientific Advisory Committee advises the Commissioner of Food and Drugs (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. II. Criteria for Voting Members 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. 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 [[Page 43148]] different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the committee. Elsewhere in this issue of the Federal Register, FDA is publishing a Request for Notification from Industry Organizations interested in participating in the selection process for nonvoting industry representatives on the Tobacco Products Scientific Advisory Committee. The Commissioner or designee shall designate one of the voting members of the committee to serve as chairperson. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current resume or curriculum vitae of each nominee, including current business address and/or home address, telephone number, and e-mail address if available. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask the potential candidates to provide detailed information concerning matters related to financial holdings, employment, and research grants and/or contracts. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: August 19, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9-20487 Filed 8-25-09; 8:45 am] BILLING CODE 4160-01-S