[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Page 67296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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