2020-08797. Notice of Change 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:

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces that it is extending the March 31, 2020 deadline for submissions required under the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) for cigarette and smokeless tobacco products, respectively. CDC also announces that it is extending the deadline for ingredient reports for new products that are due at the time of first importation. Previous notices announced that ingredient reports are due annually on March 31, and/or upon initial importation of cigarettes and/or smokeless tobacco products. Due to the current public health response to COVID-19, CDC is not able to accept any ingredient submissions and will not be issuing Certificates of Compliance at this time. CDC is communicating this information to state government entities and will re-evaluate this approach as necessary.

FOR FURTHER INFORMATION CONTACT:

Kathy Gallagher, Associate Director for Policy, the Office on Smoking and Health, the Centers for Disease Control and Prevention, 4770 Buford Highway NE, Chamblee, Georgia 30341; [e-mail] or at 404-639-5349.

SUPPLEMENTARY INFORMATION:

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, which expires April 30, 2022, 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. CDC has been delegated by HHS with the responsibility of implementing provisions under FCLAA. Submissions of reports are due to CDC every year by March 31, and/or upon initial importation of tobacco products into the United States.

CDC also has approval from OMB under Control Number 0920-0338, which expires April 30, 2022, to collect smokeless tobacco product ingredient and nicotine content information. 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. CDC has been delegated by HHS with the responsibility of implementing provisions under CSTHEA. Submissions of reports are due to CDC every year by March 31, and/or upon initial importation of smokeless tobacco products.

Upon receipt of reports pursuant to FCLAA and CSTHEA, CDC issued Certificates of Compliance for all submissions that met 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.

Due to the current COVID-19 public health crisis, CDC is indefinitely extending the March 31, 2020 deadline. CDC is neither processing any previously received reports nor issuing Certificates of Compliance at this time. CDC will provide updates to the public through subsequent notices published in the Federal Register.

Dated: April 21, 2020.

Sandra Cashman,

Executive Secretary, Centers for Disease Control and Prevention.