[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76198-76199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0977]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless 
Tobacco To Protect Children and Adolescents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by January 12, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0312. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco To Protect Children and Adolescents--21 CFR Part 1140

OMB Control Number 0910-0312--Revision

    This information collection supports FDA regulatory requirements 
contained in part 1140 (21 CFR part 1140) authorized under Chapter IX 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 9) and 
associated Agency guidance. Regulations in part 1140 establish 
permissible forms of labeling and advertising for cigarettes or 
smokeless tobacco and include reporting requirements directing persons 
to notify FDA if they intend to use a form of advertising or labeling 
that is not addressed in the regulations. Section 1140.30(a)(2) (21 CFR 
1140.30(a)(2)) requires tobacco product manufacturers, distributors, 
and retailers to notify FDA if they intend to use advertising or 
labeling for cigarettes or smokeless tobacco in a medium that is not 
listed in the regulations. The notifications must be made 30 days prior 
to the use of such mediums.
    We allow electronic and written submission of these notifications. 
Respondents can mail notifications as prescribed in section 
1140.30(a)(2) to FDA. Instructions providing clarification on how to 
format the notification may be found in the guidance document entitled 
``Compliance with Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents'' 
(2010) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-regulations-restricting-sale-and-distribution-cigarettes-and-smokeless-tobacco-protect).
    In the Federal Register of June 27, 2022 (87 FR 38160), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited. 
Subsequent to publication of the 60-day notice, we identified the 
associated guidance as an information collection instrument.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
              21 CFR Section/Guidance Document Section                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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1140.30(a)(2)--Notification of other advertising or labeling medium              25                1               25                1               25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden hour estimates for this collection of information were 
based on submissions regarding cigarette and smokeless tobacco product 
advertising expenditures.
    FDA estimates that approximately 25 respondents will submit an 
annual notice of alternative advertising or labeling, and the Agency 
has estimated it should take 1 hour to provide such notice. Therefore, 
the total estimated

[[Page 76199]]

time required for this collection of information is 25 hours. Based on 
a review of the information collection and the number of notifications 
received since 2018, we have made no adjustments to our burden 
estimate.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27011 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P