[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)]
[Notices]
[Pages 42299-42300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-18-0210; Docket No. CDC-2018-0069]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a continuing 
information collection project titled List of Ingredients Added to 
Tobacco in the Manufacture of Cigarette Products.

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

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0069 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> 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 (egulations.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 instruments, contact Jeffery 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: 
<a href="/cdn-cgi/l/email-protection#87e8eae5c7e4e3e4a9e0e8f1"><span class="__cf_email__" data-cfemail="3d52505f7d5e595e135a524b">[email protected]</span></a>.

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

    List of Ingredients Added to Tobacco in the Manufacture of 
Cigarette Products--Extension (OMB# 0920-0210 Exp.Date 12/31/2018)--
National Center for Chronic Disease Prevention and Health Promotion 
(NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Cigarette smoking is the leading preventable cause of premature 
death and disability in our Nation. Each year more than 480,000 deaths 
occur as the result of cigarette smoking-related diseases.
    The CDC's Office on Smoking and Health (OSH) has the primary 
responsibility for the HHS smoking and health program. Since 1986, as 
required by the Comprehensive Smoking Education Act (CSEA) of 1984, 
which amended the Federal Cigarette Labeling and Advertising Act, 15 
U.S.C. 1335a, CDC has collected information about the ingredients used 
in cigarette products. HHS has delegated responsibility for 
implementing the required information collection to CDC's OSH. 
Respondents are commercial cigarette manufacturers, packagers, or 
importers (or their representatives), who are required by the CSEA to 
submit ingredient reports to HHS on an annual basis.
    Respondents are not required to submit specific forms; however, 
they are required to submit a list of all ingredients used in their 
products. CDC requires the ingredient report to be submitted 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. The information collected is subject to strict 
confidentiality provisions.
    Ingredient reports are due annually on March 31. Information is 
submitted to CDC by mailing or faxing a written report on the 
respondent's letterhead. All faxed lists should be followed up with a 
mailed original. Data may also be submitted to CDC by CD, three-inch 
floppy disk, or thumb drive. Electronic mail submissions are not 
accepted. Mail Annual Ingredient Submissions 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 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. There are no costs to respondents other

[[Page 42300]]

than their time. The total estimated annualized burden hours are 358. 
OMB approval is requested for three years.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Business Entities.............  N/A.............              55               1             6.5             358
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             358
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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. 2018-17978 Filed 8-20-18; 8:45 am]
BILLING CODE 4163-18-P


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