[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