Document ID: FDA-2019-N-3065-0884
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
Posted Date: 2023-04-19T04:00Z

[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Notices]
[Pages 24191-24193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0877. 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, 
[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.

[[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; https://www.federalregister.gov/d/2020-05223). 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 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-plans-cigarette-packages-and-cigarette-advertisements-revised).
    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 https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements 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