[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Pages 12595-12596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-12-0338]


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 Kimberly Lane, CDC Reports Clearance Officer, 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. 9/30/2012)--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 Health and Human Services (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

[[Page 12596]]

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, by CD, three-inch floppy disk, or thumb 
drive. Electronic mail submissions are not accepted. Upon receipt and 
verification of the annual nicotine and ingredient report, OSH issues a 
Certificate of Compliance to the respondent.
    There are no changes to information collection procedures or the 
estimated burden per response. There is an increase in total estimated 
burden due to an increase in the estimated number of respondents, from 
11 to 13. There are no costs to respondents other than their time.

                                                            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 and                 13                1            1,713           22,269
 Importers.                                        Report.
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Kimberly S. Lane,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2012-4950 Filed 2-29-12; 8:45 am]
BILLING CODE 4163-18-P