Notice2021-20845
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 27, 2021
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 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.
Full Text
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<title>Federal Register, Volume 86 Issue 184 (Monday, September 27, 2021)</title>
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[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53305-53306]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">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://Regulations.gov">Regulations.gov</a>.
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:
<a href="/cdn-cgi/l/email-protection#1e71737c5e7d7a7d30797168"><span class="__cf_email__" data-cfemail="5d32303f1d3e393e733a322b">[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,
[[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.
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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
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