[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53305-53306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0338; Docket No. CDC-2021-0101]


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 proposed 
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. This 
Extension permits CDC to collect 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. CDC's Office of 
Smoking and Health (OSH) has been delegated with the responsibility for 
implementing the required information collection by HHS.

DATES: CDC must receive written comments on or before November 26, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0101 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 H21-8, 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 instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, 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,

[[Page 53306]]

including the validity of the methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    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; and
    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. (OMB Control No. 0920-0338, Exp. 4/30/2022)--
Extension--National Center for Chronic Disease and Public 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) is the lead federal 
agency for comprehensive tobacco prevention and control. 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, and to report on the 
quantity of nicotine contained in each smokeless tobacco product as 
specified in previous Federal Register Notices. Respondents may submit 
the required information to CDC through a designated representative. 
The information collection is subject to strict confidentiality 
provisions.
    Ingredient and nicotine analysis 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. 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.
    Following receipt 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.
    There are no costs to respondents other than their time. The total 
estimated annualized burden hours are 18,843. 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 Ingredient                11               1             6.5            71.5
 Manufacturers, Packagers, and   Report.
 Importers.
Smokeless Tobacco               SLT Nicotine                  11               1         1,706.5        18,771.5
 Manufacturers, Packagers, and   Data Reporting.
 Importers.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          18,843
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-20845 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P