[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4468-4469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02496]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-0338]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request 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. to the Office of 
Management and Budget (OMB) for review and approval. CDC previously 
published a ``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on August 22, 2018 to obtain comments from the 
public and affected agencies. CDC received two comments related to the 
previous notice. This notice serves to allow an additional 30 days for 
public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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 submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

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. 12/31/2018)--Reinstatement 
without Change--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

[[Page 4469]]

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 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
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Smokeless Tobacco Manufacturers,        SLT Nicotine and                      11               1           1,713
 Packagers, and Importers.               Ingredient and Report.
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-02496 Filed 2-14-19; 8:45 am]
 BILLING CODE 4163-18-P