[Federal Register Volume 85, Number 55 (Friday, March 20, 2020)]
[Notices]
[Pages 16103-16104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05936]
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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; 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) is announcing the
availability of a final guidance for industry entitled ``Submission of
Plans for Cigarette Packages and Cigarette Advertisements.'' This
guidance 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.
DATES: The announcement of the guidance is published in the Federal
Register on March 20, 2020.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-D-5364 for ``Submission of Plans for Cigarette Packages and
Cigarette Advertisements.'' Received comments 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 office between 9 a.m. and 4 p.m., Monday through
Friday.
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
[[Page 16104]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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: Lauren Belcher or Annette Marthaler,
Center for Tobacco Products, Food and Drug Administration, 10903 New
Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Submission of Plans for Cigarette Packages and Cigarette
Advertisements.'' 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 (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.
FDA issued a rule entitled ``Tobacco Products; Required Warnings
for Cigarette Packages and Advertisements'' on March 18, 2020. 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.
This guidance provides recommendations related to preparing and
submitting those cigarette plans. It discusses the regulatory
requirements to submit cigarette plans as well as:
Who submits a cigarette plan;
the scope of a cigarette plan;
when to submit a cigarette plan;
what information should be submitted as part of a
cigarette plan;
where to submit a cigarette plan; and
what approval of a cigarette plan means.
FDA previously published a draft version of the guidance and sought
public comment (84 FR 71957, December 30, 2019) (announcing the
availability of the draft guidance). Among other things, comments
express some concerns, such as about printing processes, as well as the
difficulty of achieving random and equal display and distribution of
required warnings. FDA has considered the comments it received, and
included revisions in the final guidance that: (1) Discuss, per the
final rule, that manufacturers may print different required warnings on
front and rear panels of a cigarette package; (2) recognize that some
level of deviation is appropriate given the language of the FCLAA; and
(3) provide updated examples in an appendix to the guidance that
demonstrate how random and equal display and distribution may be
achieved with various printing methods, including those used by small
manufacturers.
II. Significance of Guidance
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 cigarette plans for
cigarette packages and 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.
III. Paperwork Reduction Act of 1995
This guidance refers to collections of information described in
FDA's rule on ``Tobacco Products; Required Warnings for Cigarette
Packages and Advertisements,'' which this guidance is intended to
interpret. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The information collection
provisions in the final rule have been submitted to OMB for review as
required by section 3507(d) of the Paperwork Reduction Act of 1995.
IV. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05936 Filed 3-19-20; 8:45 am]
BILLING CODE 4164-01-P