[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Pages 40362-40363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16643]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-12-0338]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and 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) 639-7570 or send an email to 
[email protected]. 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

    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--
National Center for Chronic Disease Prevention and Health Promotion 
(NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), Office on 
Smoking and Health (OSH) has the 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 
use through programs of information, education and research.
    Since 1994, as required by the Comprehensive Smokeless Tobacco 
Education Act of 1986 (CSTHEA, 15 U.S.C. 4401 et seq., Pub. L. 99-252), 
CDC has collected information about the ingredients used in smokeless 
tobacco products and their nicotine content. Respondents are commercial 
smokeless tobacco product manufacturers, packagers, or importers (or 
their designated representatives), who are required by the CSTHEA to 
submit ingredient reports to HHS on an annual basis. The legislation 
also authorizes HHS to undertake research, and to report to Congress, 
as deemed appropriate, about the health effects of these ingredients.
    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 currently 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.
    Ingredient reports for new 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. 
The information collection is subject to strict confidentiality 
provisions and 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.
    OMB approval is requested for three years. There are no changes to 
information collection procedures or the estimated burden per response. 
Due to an increase in the estimated number of respondents (from 11 to 
13), there is an increase in the total estimated annualized burden 
hours (from 18,843 to 22,269). There are no costs to respondents other 
than their time.

[[Page 40363]]



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


Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-16643 Filed 7-6-12; 8:45 am]
BILLING CODE 4163-18-P