67296 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

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. 

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: nccdoshfclaa@cdc.gov; 

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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