Notice2025-17259
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 9, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 continuing information collection, 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. This activity is designed to allow 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.
Full Text
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<title>Federal Register, Volume 90 Issue 172 (Tuesday, September 9, 2025)</title>
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[Federal Register Volume 90, Number 172 (Tuesday, September 9, 2025)]
[Notices]
[Pages 43449-43450]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17259]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0338; Docket No. CDC-2025-0420]
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 continuing information
collection, 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. This activity is designed to allow 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.
DATES: CDC must receive written comments on or before November 10,
2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0420 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#17787a755774737439707861"><span class="__cf_email__" data-cfemail="81eeece3c1e2e5e2afe6eef7">[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
[[Page 43450]]
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;
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. 1/31/2026)--
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.
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. 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. 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.
The total estimated annualized burden hours are 18,843. OMB
approval is requested for three years. There are no costs to
respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response burden (in
respondent (in hours) hours)
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Smokeless Tobacco Manufacturers, SLT Ingredient 11 1 6.5 71.5
Packagers, and Importers. Report.
Smokeless Tobacco Manufacturers, SLT Nicotine Data 11 1 1,706.5 18,771.5
Packagers, and Importers. Reporting.
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Total......................... .................... ............ .............. ........... 18,843
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-17259 Filed 9-8-25; 8:45 am]
BILLING CODE 4163-18-P
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