[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42503-42505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0338; Docket No. CDC-2018-0076]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS)

ACTION: Notice with comment period

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed work 
and/or continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a continuing 
information collection project titled Annual Submission of the 
Ingredients Added to, and the Quantity of Nicotine Contained in, 
Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S.

DATES: CDC must receive written comments on or before October 22, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0076 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:  To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and

[[Page 42504]]

instruments, contact Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. In addition, the PRA also requires Federal agencies 
to provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each new proposed 
collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

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

Background and Brief Description

    Smokeless tobacco products (SLT) are associated with many health 
problems. Using smokeless tobacco: Can lead to nicotine addiction; 
causes cancer of the mouth, esophagus, and pancreas; is associated with 
diseases of the mouth; can increase risks for early delivery and 
stillbirth when used during pregnancy; can cause nicotine poisoning in 
children; and, may increase the risk for death from heart disease and 
stroke.
    The CDC's Office on Smoking and Health (OSH) has the primary 
responsibility for the HHS smoking and health program. As required by 
the Comprehensive Smokeless Tobacco Health Education Act of 1986 
(CSTHEA, 15 U.S.C. 4401 et seq., Pub. L. 99-252), CDC collects a list 
of ingredients added to tobacco in the manufacture of smokeless tobacco 
products and a specification of the quantity of nicotine contained in 
each product. HHS has delegated responsibility for implementing the 
required information collection to CDC's OSH. Respondents are 
manufacturers, packagers, or importers (or their representatives) of 
smokeless tobacco products. 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 CDC 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. Annual submission 
reports are mailed to Attention: FCLAA Program Manager, Office on 
Smoking and Health, National Center for Chronic Disease Prevention and 
Health Promotion, Centers for Disease Control and Prevention, 4770 
Buford Highway NE, MS S107-7, Atlanta, GA 30341-3717.
    Upon receipt and verification of the annual nicotine and ingredient 
report, CDC issues a Certificate of Compliance to the respondent. As 
deemed appropriate by the Secretary of HHS, HHS is authorized to use 
the information to report to Congress the health effects of 
ingredients, research activities related to the health effects of 
ingredients, and other information that the Secretary determines to be 
of public interest. The estimated annual Burden Hours are 18,843. There 
are no costs to respondents other than their time. 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               SLT Nicotine and              11               1           1,713          18,843
 Manufacturers, Packagers, and   Ingredient and
 Importers.                      Report.
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[[Page 42505]]

Jeffrey M. Zirger,
Acting 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. 2018-18053 Filed 8-21-18; 8:45 am]
 BILLING CODE 4163-18-P