Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration and Submission of Certain Health Information; Reopening of the Comment Period, 52495-52496 [E9-24543]

Download as PDF 52495 Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project National Program of Cancer Registries Cancer Surveillance System (OMB no. 0920–0469 exp. Date 1/31/2010)— Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In 1992, Congress passed the Cancer Registries Amendment Act, which established the National Program of Cancer Registries (NPCR). The NPCR provides support for central cancer registries (CCR) that collect, manage and analyze data about cancer cases. The NPCR-funded CCR, which are located in states, the District of Columbia, and U.S. territories, report information to CDC annually through the National Program of Cancer Registries Cancer Surveillance System (NPCR CSS) (OMB No. 0920– 0469, exp. 1/31/2010). CDC plans to request OMB approval to continue collecting this information for three years. The NPCR CSS allows CDC to collect, aggregate, evaluate and disseminate cancer incidence data at the national level, and is the primary source of information for United States Cancer Statistics (USCS), which CDC has published annually since 2002. The NPCR CSS also allows CDC to monitor cancer trends over time, describe geographic variation in cancer incidence throughout the country, and provide incidence data on minority populations and rare cancers. These activities and analyses further support CDC’s planning and evaluation efforts for State and national cancer control and prevention. In addition, datasets can be made available for secondary analysis. Each responding CCR is asked to report a cumulative file containing incidence data from the first diagnosis year for which the cancer registry collected data with the assistance of NPCR funds (e.g., 1995) through 12 months past the close of the most recent diagnosis year (e.g., 2007). Because cancer incidence data are already collected and aggregated at the State level the additional burden of reporting the information to CDC is small. Information is transmitted to CDC electronically once per year. The Revision request will include changes. First, data definitions will be updated to reflect changes in national standards for cancer diagnosis and coding. In addition, the number of respondents will decrease. Respondents will be 45 State-based CCR, the CCR of the District of Columbia, the CCR of Puerto Rico, and the CCR that aggregates information from 10 flag territories and freely associated States in the Pacific Islands. States that receive sole funding from the National Cancer Institute are not included as respondents. The adjusted number of respondents will result in a reduction in the total estimated burden hours for the NPCR CSS. The estimated burden per response will not change. There are no costs to respondents except their time. The total estimated annualized burden hours are 96. ESTIMATED ANNUALIZED BURDEN HOURS Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Central Cancer Registries in States, Territories, and the District of Columbia .......................... 48 1 2 Dated: October 5, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–24520 Filed 10–9–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration erowe on DSK5CLS3C1PROD with NOTICES [Docket No. FDA–2009–N–0406] Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration and Submission of Certain Health Information; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. VerDate Nov<24>2008 15:29 Oct 09, 2009 Jkt 220001 SUMMARY: The Food and Drug Administration (FDA) is reopening until October 26, 2009, the comment period for the notice published in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA). The agency is reopening the comment period because FDA has reevaluated the expected launch date of the electronic portal and to allow interested persons additional time to review the proposed collection of information and submit comments. DATES: Fax written comments on the collection of information by October 26, 2009. FDA is requesting approval of this emergency processing by November 2, 2009. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 ADDRESSES: To ensure that comments on the information collection are received, the Office of Management and Budget (OMB) recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–5806, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796– 3794, e-mail: Jonnalynn.Capezzuto@fda.hhs.gov. In the Federal Register of September 1, 2009 (74 FR 45219), FDA requested emergency processing of this proposed collection of information under section SUPPLEMENTARY INFORMATION: E:\FR\FM\13OCN1.SGM 13OCN1 52496 Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices 3507(j) of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3507(j) and 5 CFR 1320.13). On June 22, 2009, the President signed FSPTCA into law (Public Law 111–31). Section 101 of FSPTCA amends the Federal Food, Drug, and Cosmetic Act (the act) by adding, among other things, new sections 904 (21 U.S.C. 394) and 905 (21 U.S.C. 395). FDA originally identified its plan to collect the information submission requirements of sections 905, 904(a)(1), and 904(a)(4) through a single electronic portal. In addition to the electronic portal, FDA also plans to provide a paper based form to collect this information for those individuals who choose not to use the electronic portal. FDA originally planned to launch the electronic portal for the collection of this information on October 1, 2009. FDA now plans to launch the electronic portal for the collection of this information on November 2, 2009. If FDA were to use the normal PRA clearance procedures, the availability of the electronic portal and the submission of information by respondents could not begin with adequate time to meet the respective statutory deadlines (December 22, 2009, for section 904, and December 31, 2009, for section 905). Dated: October 6, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–24543 Filed 10–9–09; 8:45 am] BILLING CODE 4160–01–S Emphasis Panel; DMID Clinical Research Operations and Management Support. Date: November 5–6, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Roosevelt Room, Rockville, MD 20852. Contact Person: Clayton C. Huntley, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, (301) 451–2570, chuntley@niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Exploratory Investigation in Food Allergy (R21). Date: November 19–20, 2009. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Sujata Vijh, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/ NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, 301–594–0985, vijhs@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 5, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–24472 Filed 10–9–09; 8:45 am] Name of Committee: Interagency Autism Coordinating Committee (IACC). Type of meeting: Subcommittee for planning the Annual Strategic Planning Process. Date: October 15, 2009. Time: 2 p.m. to 4 p.m. Eastern Time. Agenda: To discuss the outcome of the IACC Scientific Workshop that took place on September 30 and October 1, 2009. Conference Call: Dial: 888–455–2920. Access code: 1050786. Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, Office of the Director, National Institute of Mental Health, NIH, 6001 Executive Boulevard, NSC, Room 8200, Bethesda, MD 20892–9669. Phone: 301–443–6040.E-mail: IACCPublicInquiries@mail.nih.gov. Please Note: The meeting will be open to the public through a conference call phone number. Individuals who participate using this service and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request at least 4 days prior to the meeting. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. This phone call may end prior to or later than 4 p.m., depending on the needs of the subcommittee. This meeting is being published less than 15 days prior to the meeting due to the timing limitations for the Subcommittee to review and discuss the outcomes from the IACC Workshop and to be able to present their proposals at the IACC meeting on October 23. Information about the IACC is available on the Web site: https://www.iacc.hhs.gov. BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings erowe on DSK5CLS3C1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 5, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–24473 Filed 10–9–09; 8:45 am] 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 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special VerDate Nov<24>2008 15:29 Oct 09, 2009 Jkt 220001 National Institute of Mental Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Planning Process. The purpose of the Subcommittee for Planning the Annual Strategic Planning Process is to plan the process for annually updating the IACC Strategic Plan for Autism Spectrum Disorder Research. The Subcommittee meeting will be conducted as a telephone conference call. This meeting is open to the public through a conference call phone number. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings 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 E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52495-52496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0406]


Agency Emergency Processing Under Office of Management and Budget 
Review; Tobacco Product Establishment Registration and Submission of 
Certain Health Information; Reopening of the Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is reopening until 
October 26, 2009, the comment period for the notice published in the 
Federal Register of September 1, 2009 (74 FR 45219). The document 
announced the proposed collection of information concerning the 
submission of tobacco product establishment registration and submission 
of certain health information, including ingredient listing and health 
related documents, as required by The Family Smoking Prevention and 
Tobacco Control Act (FSPTCA). The agency is reopening the comment 
period because FDA has reevaluated the expected launch date of the 
electronic portal and to allow interested persons additional time to 
review the proposed collection of information and submit comments.

DATES:  Fax written comments on the collection of information by 
October 26, 2009. FDA is requesting approval of this emergency 
processing by November 2, 2009.

ADDRESSES:  To ensure that comments on the information collection are 
received, the Office of Management and Budget (OMB) recommends that 
written comments be faxed to the Office of Information and Regulatory 
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-5806, or e-mailed to 
oira_submission@omb.eop.gov. All comments should be identified with 
the OMB control number 0910-NEW. Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794, e-mail: 
Jonnalynn.Capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 1, 2009 
(74 FR 45219), FDA requested emergency processing of this proposed 
collection of information under section

[[Page 52496]]

3507(j) of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3507(j) 
and 5 CFR 1320.13). On June 22, 2009, the President signed FSPTCA into 
law (Public Law 111-31). Section 101 of FSPTCA amends the Federal Food, 
Drug, and Cosmetic Act (the act) by adding, among other things, new 
sections 904 (21 U.S.C. 394) and 905 (21 U.S.C. 395).
    FDA originally identified its plan to collect the information 
submission requirements of sections 905, 904(a)(1), and 904(a)(4) 
through a single electronic portal. In addition to the electronic 
portal, FDA also plans to provide a paper based form to collect this 
information for those individuals who choose not to use the electronic 
portal. FDA originally planned to launch the electronic portal for the 
collection of this information on October 1, 2009. FDA now plans to 
launch the electronic portal for the collection of this information on 
November 2, 2009. If FDA were to use the normal PRA clearance 
procedures, the availability of the electronic portal and the 
submission of information by respondents could not begin with adequate 
time to meet the respective statutory deadlines (December 22, 2009, for 
section 904, and December 31, 2009, for section 905).

    Dated: October 6, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24543 Filed 10-9-09; 8:45 am]
BILLING CODE 4160-01-S

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