[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