[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Notices]
[Pages 57206-57209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3065]


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the

[[Page 57207]]

Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
entitled, ``Tobacco Products; Required Warnings for Cigarette Packages 
and Advertisements.''

DATES: Either electronic or written comments on the collection of 
information must be submitted by November 18, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. eastern time at the end of November 18, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3065 for ``Tobacco Products; Required Warnings for Cigarette 
Packages and Advertisements.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

[[Page 57208]]

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.
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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 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.
    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.

                               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.


[[Page 57209]]

    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: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20196 Filed 9-16-22; 8:45 am]
BILLING CODE 4164-01-P


