[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