[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22889-22890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08214]



[[Page 22889]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-0338]


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 September 27, 2021, to obtain comments from 
the public and affected entities. CDC did not receive comments related 
to the FRN. This notice serves to allow an additional 30 days for 
public and affected entities' 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 Control No. 0920-0338, Exp. 04/30/2022)--
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 Office of Smoking and Health 
(OSH). Respondents are the 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 and nicotine 
reports. Ingredient reports must be submitted 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 and nicotine reports for new SLT products are due at the 
time of first importation. Thereafter, ingredient and nicotine reports 
are due annually on March 31. Information is submitted to CDC by 
mailing a written report on the respondent's letterhead. 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.
    OMB approval is requested for three years. CDC requests OMB 
approval for an estimated 18,843 annual burden hours. There are no 
costs to respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Smokeless Tobacco Manufacturers,        SLT Ingredient Report...              11               1             6.5
 Packagers, and Importers.

[[Page 22890]]

 
Smokeless Tobacco Manufacturers,        SLT Nicotine Report.....              11               1         1,706.5
 Packagers, and Importers.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-08214 Filed 4-15-22; 8:45 am]
BILLING CODE 4163-18-P