[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65323-65324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0338)


Agency Forms Undergoing Paperwork Reduction Act Review

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to CDC, LeRoy Richardson, 1600 Clifton Road, MS D-74, 
Atlanta, GA 30333 or send an email to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Annual Submission of the Ingredients Added to, and the Quantity of 
Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or 
Packaged in the U.S. (OMB No. 0920-0338, exp. 02/28/2014)--Extension--
Office on Smoking and Health, National Center for Chronic Disease 
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    The oral use of smokeless tobacco (SLT) products represents a 
significant health risk. Smokeless tobacco products contain carcinogens 
which can cause cancer and a number of non-cancerous oral conditions, 
as well as leading to nicotine addiction and dependence. Furthermore, 
SLT use is not a safe substitute for cigarette smoking. Adolescents who 
use smokeless tobacco are more likely to become cigarette smokers.
    The Centers for Disease Control and Prevention (CDC), Office on 
Smoking and Health (OSH), has primary responsibility for the Department 
of Health and Human Services (HHS) smoking and health program. HHS's 
overall goal is to reduce death and disability resulting from the use 
of smokeless tobacco products and other forms of tobacco through 
programs of information, education and research.
    The Comprehensive Smokeless Tobacco Health Education Act of 1986 
(CSTHEA, 15 U.S.C. 4401 et seq., Pub. L. 99-252) requires each person 
who manufactures, packages, or imports smokeless tobacco products to 
provide the Secretary of HHS with a list of ingredients added to 
tobacco in the manufacture of smokeless tobacco products. CSTHEA 
further requires submission of the quantity of nicotine contained in 
each smokeless tobacco product. Finally, the legislation authorizes HHS 
to undertake research, and to report to Congress (as deemed 
appropriate) discussing the health effects of these ingredients.
    HHS has delegated responsibility for implementing the required 
information collection to CDC's Office on Smoking and Health. 
Respondents are not required to submit specific forms; however, they 
are required to meet reporting guidelines and to submit the ingredient 
report by chemical name and Chemical Abstract Service (CAS) 
Registration Number, consistent with accepted reporting practices for 
other companies that are required to report ingredients added to other 
consumer products. Typically, respondents submit a summary report to 
CDC with the ingredient information for multiple products, or a 
statement that there are no changes to their previously submitted 
ingredient report. Respondents may submit the required information to 
CDC through a designated representative. The information collection is 
subject to strict confidentiality provisions.
    Ingredient reports for new SLT products are due at the time of 
first importation. Thereafter, ingredient reports are due annually on 
March 31. Information is submitted to OSH by mailing a written report 
on the respondent's letterhead, which may be accompanied by a Compact 
Disc (CD), three-inch floppy disk, or thumb drive. Electronic mail 
submissions are not accepted. Annual submission reports are mailed to: 
Office on Smoking and Health, Attention: FCLAA Program Manager, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS 
F-79, Atlanta, GA 30341-3717. Upon receipt and verification of the 
annual nicotine and ingredient report, OSH issues a Certificate of 
Compliance to the respondent.
    There are no costs to respondents other than their time. Office of 
Management and Budget (OMB) approval is requested for three years.

                                                            Estimated Annualized Burden Hours
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                                                                                                          Number of     Average  burden
               Type of respondents                             Form name                 Number of      responses per    per  response     Total burden
                                                                                        respondents       respondent       (in hours)       (in hours)
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Smokeless Tobacco Manufacturers, Packagers, and   SLT Nicotine and Ingredient Report              13                1            1,713           22,269
 Importers.
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[[Page 65324]]

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2013-25860 Filed 10-30-13; 8:45 am]
BILLING CODE 4163-18-P