Notice2023-08280
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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.
Full Text
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<title>Federal Register, Volume 88 Issue 75 (Wednesday, April 19, 2023)</title>
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[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24191-24193]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08280]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3065]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Products;
Required Warnings for Cigarette Packages and Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 May 19, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0877. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#f9a9abb8aa8d989f9fb99f9d98d791918ad79e968f"><span class="__cf_email__" data-cfemail="e4b4b6a5b790858282a4828085ca8c8c97ca838b92">[email protected]</span></a>.
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.
[[Page 24192]]
Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements--21 CFR Part 1141
OMB Control Number 0910-0877--Extension
This information collection supports FDA regulations and guidance.
Tobacco products are generally governed by chapter IX of the Federal
Food, Drug, and Cosmetic Act (sections 900 through 920) (21 U.S.C. 387
through 21 U.S.C. 387t).
On March 18, 2020, FDA issued a final rule establishing new
cigarette health warnings for cigarette packages and advertisements
entitled ``Tobacco Products; Required Warnings for Cigarette Packages
and Advertisements'' (85 FR 15638; <a href="https://www.federalregister.gov/d/2020-05223">https://www.federalregister.gov/d/2020-05223</a>). The final rule implements a provision of the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub.
L. 111-31) that requires FDA to issue regulations requiring color
graphics depicting the negative health consequences of smoking to
accompany new textual warning label statements. The Tobacco Control Act
amends the Federal Cigarette Labeling and Advertising Act of 1965
(FCLAA) (15 U.S.C. 1333) to require each cigarette package and
advertisement to bear one of the new required warnings. The final rule
specifies the 11 new textual warning label statements and accompanying
color graphics.
Section 1141.10(g) (21 CFR 1141.10(g) and section 4(c) of the FCLAA
sets forth the specific marketing requirements relating to the random
and equal display and distribution of required warnings on cigarette
packaging and quarterly rotation of required warnings in alternating
sequence in cigarette advertising and requires the submission of plans
outlining how the cigarette packaging and advertising will comply with
such requirements. FDA must review and approve cigarette plans in
advance of any person displaying or distributing cigarette packages or
advertisements for products that are required to carry the required
warnings, and a record of the FDA-approved plan must be established and
maintained by the tobacco product manufacturer.
To implement these statutory and regulatory requirements, cigarette
plans will be reviewed by FDA upon submission by respondents. FDA
published a guidance document on July 9, 2021, entitled ``Submission of
Plans for Cigarette Packages and Cigarette Advertisements'' which
describes cigarette plans information, format and submission (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-plans-cigarette-packages-and-cigarette-advertisements-revised">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-plans-cigarette-packages-and-cigarette-advertisements-revised</a>).
Pursuant to section 201(b) of the Tobacco Control Act, FDA
finalized the ``Required Warnings for Cigarette Packages and
Advertisements'' rule with an effective date of June 18, 2021, 15
months after the date of publication. On April 3, 2020, the final rule
was challenged in the U.S. District Court for the Eastern District of
Texas.\1\ The effective date of the final rule has been delayed in
accordance with orders issued by the U.S. District Court for the
Eastern District of Texas. Visit FDA's website at <a href="https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements">https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements</a> for updates
regarding the effective date of the rule and related timelines,
including the recommended date for submitting cigarette plans for FDA
review.
In the Federal Register of September 19, 2022 (87 FR 57206), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Part 1141 and activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Original Submission (Initial 59 1 59 150 8,850
Plan)..........................
Supplement...................... 30 1 30 75 2,250
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Total....................... .............. .............. .............. .............. 11,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates are based on FDA's experience with information
collections for other tobacco product plans (i.e., smokeless, OMB
control number 0910-0671 and cigars, OMB control number 0910-0768) and
2017 Treasury Alcohol and Tobacco Tax and Trade Bureau data.
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\1\ R.J. Reynolds Tobacco Co. et al. v. United States Food and
Drug Administration et al., No. 6:20-cv-00176 (E.D. Tex. filed April
3, 2020).
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FDA estimates 59 entities are affected. We estimate these 59
entities will submit initial plans, and it will take an average of 150
hours per respondent to prepare and submit a plan for packaging and
advertising for a total of 8,850 hours. We estimate that about half of
respondents will submit a supplement. If a supplement to an approved
plan is submitted, FDA estimates it will take half the time per
response. We estimate receiving 30 supplements at 75 hours per response
for a total of 2,250 hours. FDA estimates that the total hours for
submitting initial plans and supplements will be 11,100.
Section 1141.10(g)(4) establishes that each tobacco product
manufacturer required to randomly and equally display and distribute
warnings on cigarette packages or quarterly rotate warnings in
cigarette advertisements in accordance with an FDA-approved plan under
section 4 of the FCLAA and part 1141 must maintain a copy of the FDA-
approved plan (approved under Sec. 1141.10(g)(3)). This copy of such
FDA-approved plan must be available for inspection and copying by
officers or employees of FDA. This subsection requires that the FDA-
approved plan must be retained while in effect and for a period of not
less than 4 years from the date it was last in effect.
[[Page 24193]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Part 1141 and activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Original Submission (Initial 59 1.5 89 3 267
Plan) Records.................
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Total...................... .............. .............. .............. ............... 267
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that 59 recordkeepers will keep a total of about 89
records at 3 hours per record for a total of 267 hours. As stated
previously, these estimates are based on FDA's experience with
information collections for other tobacco product plans (i.e.,
smokeless, OMB control number 0910-0671 and cigars, OMB control number
0910-0768). Based on our estimates for the submission of one-time,
initial plans and supplements (i.e., that all respondents will submit
one-time, initial plans and about half of respondents will submit
supplements to FDA-approved plans), we estimate that each recordkeeper
will keep an average of 1.5 records.
FDA concludes that the required warnings for cigarette packages and
cigarette advertisements in Sec. 1141.10 are not subject to review by
OMB because they do not constitute a ``collection of information''
under the PRA (44 U.S.C. 3501-3521). Rather, these labeling statements
are a ``public disclosure'' of information originally supplied by the
Federal Government to the recipient for the purpose of ``disclosure to
the public'' (5 CFR 1320.3(c)(2)).
Since our last request for OMB approval, we have made no
adjustments to our burden estimate.
Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08280 Filed 4-18-23; 8:45 am]
BILLING CODE 4164-01-P
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