Center for Scientific Review; Amended Notice of Meeting, 62796-62797 [E9-28734]

Download as PDF 62796 Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices mstockstill on DSKH9S0YB1PROD with NOTICES I. Background In the Federal Register of November 3, 2009 (74 FR 56842), FDA announced the availability of a draft guidance document entitled ‘‘Listing of Ingredients in Tobacco Products.’’ The agency considered received comments as it finalized this guidance. This guidance document is designed to assist tobacco product manufacturers and importers with making tobacco product ingredient submissions to FDA. Under section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, each tobacco product manufacturer or importer, or agent thereof, is required to submit ‘‘a listing of all ingredients, including tobacco, substances, compounds, and additives that are * * * added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.’’ For tobacco products on the market as of June 22, 2009, information must be submitted to FDA by December 22, 2009, and include the ingredients added as of the date of submission. FDA does not, however, intend to enforce the statutory deadline of this subsection provided the ingredient list is submitted on or before June 22, 2010. For tobacco products not on the market as of June 22, 2009, section 904(c)(1) requires that the list of ingredients be submitted at least 90 days prior to delivery for introduction into interstate commerce. Section 904(c) of the act also requires submission of information whenever additives, or the quantities of additives, are changed. FDA does not, however, intend to enforce the statutory deadlines for ingredient reporting under section 904(c) of the act for additive changes or the initial introduction of products into interstate commerce occurring between June 22, 2009, and 90 days after the section 904(a)(1) ingredient list is submitted, provided that these report(s) are submitted at the time of the section 904(a)(1) submission and the report(s) include the date, or planned date, of making the change to the additive or introducing the product into interstate commerce. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on ‘‘Listing of Ingredients in Tobacco Products.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An VerDate Nov<24>2008 20:14 Nov 30, 2009 Jkt 220001 alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information in this guidance was approved under OMB control number 0910–0650. V. Electronic Access An electronic version of the guidance document is available on the Internet at https://www.regulations.gov and https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. Dated: November 25, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–28747 Filed 11–27–09; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Drug Targeting. Date: December 15, 2009. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Hungyi Shau, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, 301–435– 1720, shauhung@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, OBT Review Panel Member Applications. Date: January 7–8, 2010. Time: 9 a.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nywana Sizemore, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6204, MSC 7804, Bethesda, MD 20892, 301–435– 1718, sizemoren@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 24, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–28732 Filed 11–30–09; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Center For Scientific Review; Notice of Closed Meetings National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which Center for Scientific Review; Amended Notice of Meeting PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, November 24, 2009, 3 p.m. to November 24, 2009, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on November 18, 2009, 74 FR 59569. The meeting will be held December 9, 2009, from 12 p.m. to 2 p.m. The meeting location remains the same. The meeting is closed to the public. E:\FR\FM\01DEN1.SGM 01DEN1 Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices Dated: November 23, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–28734 Filed 11–30–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 7, 2009, 1 p.m. to December 7, 2009, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on November 10, 2009, 74 FR 58027. The meeting will be held December 16, 2009, from 10:30 a.m. to 12:30 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: November 23, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–28736 Filed 11–30–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special, Emphasis Panel. Date: January 20, 2010. Time: 12 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ruixia Zhou, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Suite 957, Bethesda, MD 20892, 301–496–4773, zhour@mail.nih.gov. Dated: November 23, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–28724 Filed 11–30–09; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSKH9S0YB1PROD with NOTICES Center for Scientific Review; Amended Notice of Meeting BILLING CODE 4140–01–P Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 16, 2009, 1 p.m. to December 18, 2009, 3 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on November 2, 2009, 74 FR 56652–56653. The meeting will be two days only December 16, 2009 to December 17, 2009, from 1 p.m. to 11 p.m. The meeting location remains the same. The meeting is closed to the public. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 24, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–28730 Filed 11–30–09; 8:45 am] BILLING CODE 4140–01–P VerDate Nov<24>2008 20:14 Nov 30, 2009 Jkt 220001 National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NICHD. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 62797 The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the Eunice Kennedy Shriver National Institute of Child Health & Human Development, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, NICHD. Date: December 4, 2009. Open: 8 a.m. to 11:30 a.m. Agenda: A report by the Scientific Director, NICHD, on the status of the NICHD Division of Intramural Research. Place: National Institutes of Health, Building 31, 9000 Rockville Pike, Room 2A48, Bethesda, MD 20892. Closed: 11:30 a.m. to 4 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Building 31, 9000 Rockville Pike, Room 2A48, Bethesda, MD 20892. Contact Person: Constantine A. Stratakis, MD, Acting Scientific Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 9000 Rockville Pike, Building 31, Room 2A50, Bethesda, MD 20892, 301–496–2133, stratakc@cc1.nichd.nih.gov. This notice is being published less than 15 days prior to the meeting due to the urgent need to meet timing limitations imposed by the intramural research review cycle. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/bsd/htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 74, Number 229 (Tuesday, December 1, 2009)]
[Notices]
[Pages 62796-62797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Center for 
Scientific Review Special Emphasis Panel, November 24, 2009, 3 p.m. to 
November 24, 2009, 5 p.m., National Institutes of Health, 6701 
Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal 
Register on November 18, 2009, 74 FR 59569.
    The meeting will be held December 9, 2009, from 12 p.m. to 2 p.m. 
The meeting location remains the same. The meeting is closed to the 
public.


[[Page 62797]]


    Dated: November 23, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-28734 Filed 11-30-09; 8:45 am]
BILLING CODE 4140-01-P
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