Notice2021-14674
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for Industry; Availability
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Published
July 12, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled "Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)." This is a revision to the third edition of this final guidance, which issued in February 2021, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 21, 2021, court order that postponed the effective date of the final rule entitled "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements" to July 13, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by the recommended submission date, which is currently September 13, 2021.
Full Text
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<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
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[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36560-36562]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5364]
Submission of Plans for Cigarette Packages and Cigarette
Advertisements (Revised); Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised final guidance for industry entitled
``Submission of Plans for Cigarette Packages and Cigarette
Advertisements (Revised).'' This is a revision to the third edition of
this final guidance, which issued in February 2021, and is intended to
assist those required to submit cigarette plans for cigarette packages
and cigarette advertisements by providing content, timing, and other
recommendations related to those submissions. FDA is revising this
guidance to reflect the May 21, 2021, court order that postponed the
effective date of the final rule entitled ``Tobacco Products; Required
Warnings for Cigarette Packages and Advertisements'' to July 13, 2022.
Pursuant to the court order, this revised guidance strongly encourages
entities to submit cigarette plans to FDA as soon as possible after
publication of the final rule, and in any event, by the recommended
submission date, which is currently September 13, 2021.
[[Page 36561]]
DATES: The announcement of the revised final guidance is published in
the Federal Register on July 12, 2021.
ADDRESSES: You may submit electronic or written comments on Agency
guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-D-5364 for ``Submission of Plans for Cigarette Packages and
Cigarette Advertisements (Revised).'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidance may be sent. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Courtney Smith, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#a1e0d2cae2f5f1f3c4c6d4cdc0d5c8cecfd2e1c7c5c08fc9c9d28fc6ced7"><span class="__cf_email__" data-cfemail="f6b7859db5a2a6a49391839a97829f999885b6909297d89e9e85d8919980">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised final guidance for
industry entitled ``Submission of Plans for Cigarette Packages and
Cigarette Advertisements (Revised).'' The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) was enacted
on June 22, 2009, and granted FDA important new authority to regulate
the manufacture, marketing, and distribution of tobacco products. The
Tobacco Control Act also amended section 4 of the Federal Cigarette
Labeling and Advertising Act of 1965 (Pub. L. 89-92) (FCLAA) to direct
FDA to issue regulations requiring each cigarette package and
advertisement to bear a new textual warning label statement accompanied
by color graphics depicting the negative health consequences of smoking
(section 201 of the Tobacco Control Act). In enacting this legislation,
Congress also provided that FDA may adjust the required warnings if FDA
found that such a change would promote greater public understanding of
the risks associated with the use of tobacco products (section 202 of
the Tobacco Control Act). The Tobacco Control Act also modified the
requirements of the FCLAA regarding the submission of cigarette plans
for the random and equal display and distribution of required warnings
on cigarette packages and quarterly rotation of required warnings in
cigarette advertisements. It also requires that such cigarette plans be
submitted to FDA for review and approval, rather than to the Federal
Trade Commission.
In the Federal Register of March 18, 2020, FDA issued a final rule
entitled ``Tobacco Products; Required Warnings for Cigarette Packages
and Advertisements'' (85 FR 15638). The rule specifies the color
graphics that must accompany the new textual warning label statements
and establishes marketing requirements for cigarette packages and
advertisements. The marketing requirements include, among other things,
submission of a cigarette plan that provides for the random and equal
display and distribution of the required warnings on cigarette packages
and quarterly rotation of the required warnings in cigarette
advertisements, as described under section 4 of FCLAA.
On April 3, 2020, the final rule was challenged in the U.S.
District Court for
[[Page 36562]]
the Eastern District of Texas.\1\ On May 8, 2020, the Court granted a
joint motion to govern proceedings in that case and postpone the
effective date of the final rule by 120 days.\2\ On December 2, 2020,
the same Court granted a new motion by Plaintiffs in the same case to
postpone the effective date of the final rule by an additional 90
days.\3\ On March 2, 2021, the same Court granted a new motion by
Plaintiffs in the same case to postpone the effective date of the final
rule by an additional 90 days.\4\ On May 21, 2021, the same Court
granted a new motion by Plaintiffs in the same case to postpone the
effective date of the final rule by an additional 90 days.\5\ The new
effective date of the final rule is July 13, 2022. Pursuant to the
court order, any obligation to comply with a deadline tied to the
effective date of the final rule is similarly postponed, and those
obligations and deadlines are now tied to the postponed effective date.
As such, this revised guidance strongly encourages entities to submit
cigarette plans to FDA as soon as possible after publication of the
final rule, and in any event, by September 13, 2021.
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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).
\2\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D.
Tex. May 8, 2020) (order granting joint motion and establishing
schedule), Doc. No. 33.
\3\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D.
Tex. December 2, 2020) (order granting Plaintiffs' motion and
postponing effective date), Doc. No. 80.
\4\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D.
Tex. March 2, 2021) (order granting Plaintiffs' motion and
postponing effective date), Doc. No. 89.
\5\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D.
Tex. May 21, 2021) (order granting Plaintiffs' motion and postponing
effective date), Doc. No. 91.
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FDA is issuing this guidance consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA regarding the submission of plans for cigarette
packages and cigarette advertisements. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 1141.10 have been approved under 0910-0877.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidance at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance">https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance</a>, and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14674 Filed 7-9-21; 8:45 am]
BILLING CODE 4164-01-P
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