Notice2023-21431
Recommencement in Reporting Requirements for the Federal Cigarette Labeling and Advertising Act (FCLAA) and Comprehensive Smokeless Tobacco Health Education Act (CSTHEA)
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 29, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
On April 27, 2020, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a notice in the Federal Register announcing an extension of the deadline for annual reporting of data submitted for cigarettes and smokeless tobacco products, respectively, under the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA). CDC announced this extension due to the public health response to the COVID-19 pandemic. CDC has since re-evaluated this extension and determined that data submissions can recommence. Required ingredient reports and nicotine analysis reports must be submitted to CDC on or before March 31, 2024.
Full Text
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<title>Federal Register, Volume 88 Issue 188 (Friday, September 29, 2023)</title>
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[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Page 67296]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21431]
[[Page 67296]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Recommencement in Reporting Requirements for the Federal
Cigarette Labeling and Advertising Act (FCLAA) and Comprehensive
Smokeless Tobacco Health Education Act (CSTHEA)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: On April 27, 2020, the Centers for Disease Control and
Prevention (CDC), located within the Department of Health and Human
Services (HHS), published a notice in the Federal Register announcing
an extension of the deadline for annual reporting of data submitted for
cigarettes and smokeless tobacco products, respectively, under the
Federal Cigarette Labeling and Advertising Act (FCLAA) and the
Comprehensive Smokeless Tobacco Health Education Act (CSTHEA). CDC
announced this extension due to the public health response to the
COVID-19 pandemic. CDC has since re-evaluated this extension and
determined that data submissions can recommence. Required ingredient
reports and nicotine analysis reports must be submitted to CDC on or
before March 31, 2024.
DATES: The deadline to submit required annual ingredient reports and
nicotine analysis reports to CDC shall be March 31, 2024. Beginning
March 31, 2024, ingredient reports for cigarette and/or smokeless
tobacco products and specifications of the quantity of nicotine
contained in smokeless tobacco products that are imported to the United
States for the first time must also be submitted at the time of
importation.
FOR FURTHER INFORMATION CONTACT: Kathy Gallagher, Office on Smoking and
Health, the Centers for Disease Control and Prevention, 4770 Buford
Highway NE, MS S107-7, Chamblee, Georgia 30341. Email:
<a href="/cdn-cgi/l/email-protection#5f313c3c3b302c37393c333e3e1f3c3b3c71383029"><span class="__cf_email__" data-cfemail="315f5252555e425957525d5050715255521f565e47">[email protected]</span></a>; Telephone: 404-639-5349.
SUPPLEMENTARY INFORMATION:
Background
In the Federal Register Notice published on April 27, 2020 (85 FR
23359), CDC announced a deadline extension for submissions required
under FCLAA (15 U.S.C. 1335a) and CSTHEA (15 U.S.C. 4403) for
cigarettes and smokeless tobacco products, respectively, due to the
public health response to the COVID-19 pandemic. CDC indicated its
inability to accept data submissions or to issue Certificates of
Compliance due to unforeseen circumstances created by the pandemic.
CDC has since re-evaluated its ability to accept data submissions
and has determined that it can recommence receiving submissions and
issuance of Certificates of Compliance. The Federal COVID-19 Public
Health Emergency (PHE) Declaration ended on May 11, 2023. As
established in prior notices, ingredient reports and nicotine analysis
reports are due annually on March 31, and upon initial importation of a
cigarette or smokeless tobacco product that is imported to the United
States for sale for the first time. For all cigarette and smokeless
tobacco products, the deadline to submit required annual ingredient
reports and nicotine analysis reports to CDC shall be March 31, 2024.
The ingredient reports and nicotine analysis reports due by this date
shall fulfill the annual submission compliance for calendar year 2023.
There is no requirement to retroactively submit ingredient reports or
nicotine analysis reports for calendar year 2020, 2021, or 2022.
Beginning March 31, 2024, ingredient reports for cigarette and/or
smokeless tobacco products and specifications of the quantity of
nicotine contained in smokeless tobacco products that are imported to
the United States for the first time must also be submitted at the time
of importation.
Information shall be submitted to CDC by mailing or faxing a
written report on the letterhead of the manufacturer, packager,
importer, respective counsel, or designated individual or entity.
However, all faxed information should be followed up with a mailed
original. CDC no longer accepts submissions transmitted on CD, 3-inch
floppy disk, and/or thumb drive. Electronic mail submissions are not
accepted at this time given the inability to ensure the confidentiality
of information submitted.
Paperwork Reduction Act
The Paperwork Reduction Act (PRA) requires that Federal agencies
obtain approval from the Office of Management and Budget (OMB) for the
standardized collection of data from 10 or more entities. CDC has
approval from OMB under Control Number 0920-0210, expiration January
31, 2026, to collect cigarette ingredient information. Pursuant to
FCLAA, each manufacturer, packager, or importer of cigarettes must
annually submit to HHS a list of ingredients added to tobacco in the
manufacture of cigarettes. HHS has delegated the responsibility of
implementing provisions under FCLAA to CDC. Submission of ingredient
reports are due to CDC every year by March 31. With respect to
cigarette products imported to the United States, the ingredient report
is due upon initial importation of cigarettes into the United States.
CDC also has approval from OMB under Control Number 0920-0338,
expiration January 31, 2026, to collect smokeless tobacco product
ingredient and nicotine content information, through ingredient reports
and nicotine analysis reports. Pursuant to the CSTHEA, each
manufacturer, packager, or importer of smokeless tobacco products must
annually submit to HHS a list of ingredients added to tobacco in the
manufacture of smokeless tobacco products and the quantity of nicotine
contained in each smokeless tobacco product. HHS has delegated the
responsibility of implementing provisions under CSTHEA to CDC.
Submission of ingredient reports and nicotine analysis reports are due
to CDC every year by March 31. With respect to smokeless tobacco
products imported to the United States, the ingredient reports and
nicotine analysis reports are due upon initial importation of smokeless
tobacco products into the United States.
Upon receipt of reports pursuant to FCLAA and CSTHEA, CDC issues
Certificates of Compliance for all submissions that meet the following
requirements: (1) the submission clearly states on whose behalf the
submission is made; and (2) the list of ingredients, including chemical
names and corresponding Chemical Abstract Service (CAS) registry
numbers, added to tobacco in the manufacture of cigarettes and/or
smokeless tobacco products is complete and without error.
This current notice published September 29, 2023 serves to provide
updates to the public regarding the recommencement of annual data
reporting requirements for cigarette and smokeless products
manufactured, packaged, or imported in calendar year 2023, for which
the next submission of data as required under FCLAA and CSTHEA must be
received by CDC on or before March 31, 2024. Beginning March 31, 2024,
ingredient reports and/or nicotine analysis reports for cigarette and/
or smokeless tobacco products newly imported to the United States must
also be submitted at the time of importation.
Tiffany Brown,
Executive Secretary,Centers for Disease Control and Prevention.
[FR Doc. 2023-21431 Filed 9-28-23; 8:45 am]
BILLING CODE 4163-18-P
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