Center for Scientific Review; Amended Notice of Meeting, 58299 [E9-27216]

Download as PDF Federal Register / Vol. 74, No. 217 / Thursday, November 12, 2009 / Notices Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register with FDA by December 31 of each year. Moreover, all registrants must at the time of registration file with FDA a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution, along with certain accompanying information, including all labeling (see section 905(i)(1) of the act, as added by the Tobacco Control Act). FDA does not intend to enforce the requirement to submit registration and product listing information under section 905 of the act by December 31, 2009, provided that the submission is received by FDA on or before February 28, 2010. We recognize that the forms developed by FDA are new to industry, and so may require additional time to complete accurately. While electronic submission of registration and listing information is not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data management and submission. FDA does recognize, however, that electronic submission requires several additional steps, such as obtaining an Electronic Submissions Gateway account and becoming familiar with the eSubmitter electronic application. FDA therefore believes that this additional time for the first submission of this registration and listing information should result in submission of higher quality information. jlentini on DSKJ8SOYB1PROD with NOTICES 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 ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An 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 VerDate Nov<24>2008 16:12 Nov 10, 2009 Jkt 220001 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 6, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–27182 Filed 11–6–09; 4:15 pm] 58299 clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Experimental Therapeutics Program (NExT). Date: December 9, 2009. Time: 8:30 a.m.–4:30 p.m. Agenda: To evaluate the NCI Experimental Therapeutics Program Portfolio. Place: Bethesda Marriott—Pooks Hill, 5115 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Barbara Mroczkowski, Executive Secretary, NCI Experimental Therapeutics Program, National Cancer Institute, NIH, 31 Center Drive, Room 3A44, Bethesda, MD 20892, (301) 496–4291, mroczkowskib@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 3, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–27217 Filed 11–10–09; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2) 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 purpose of this meeting is to evaluate requests for preclinical development resources for potential new therapeutics for the treatment of cancer. The outcome of the evaluation will provide information to internal NCI committees that will decide whether NCI should support requests and make available contract resources for development of the potential therapeutic to improve the treatment of various forms of cancer. The research proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material and personal information concerning individuals associated with the proposed research projects, the disclosure of which would constitute a PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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 18, 2009, 3 p.m. to November 18, 2009, 10 p.m., Beacon Hotel and Corporate Quarters, 1615 Rhode Island Avenue, NW., Washington, DC, 20036 which was published in the Federal Register on November 3, 2009, 74 FR 56855. The starting time of the meeting on November 18, 2009 has been changed to 6 p.m. until adjournment at 10 p.m. The meeting date and location remain the same. The meeting is closed to the public. Dated: November 5, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–27216 Filed 11–10–09; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 74, Number 217 (Thursday, November 12, 2009)]
[Notices]
[Page 58299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27216]


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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 18, 2009, 3 p.m. to 
November 18, 2009, 10 p.m., Beacon Hotel and Corporate Quarters, 1615 
Rhode Island Avenue, NW., Washington, DC, 20036 which was published in 
the Federal Register on November 3, 2009, 74 FR 56855.
    The starting time of the meeting on November 18, 2009 has been 
changed to 6 p.m. until adjournment at 10 p.m. The meeting date and 
location remain the same. The meeting is closed to the public.

    Dated: November 5, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-27216 Filed 11-10-09; 8:45 am]
BILLING CODE 4140-01-P
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