[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Proposed Rules]
[Pages 60966-60968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24511]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1141
[Docket No. FDA-2019-N-3065]
RIN 0910-AI39
Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements; Additional Materials; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; additional materials; reopening of the comment
period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the proposed rule that appeared in the
Federal Register of August 16, 2019. The Agency is providing additional
information in the docket and reopening the public comment period for
15 days to afford the public an opportunity to comment on this
additional information.
DATES: FDA is reopening the comment period on the proposed rule
published August 16, 2019 (84 FR 42754). Submit either electronic or
written comments by November 27, 2019. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 27, 2019. The https://www.regulations.gov electronic filing system will accept comments until
[[Page 60967]]
11:59 p.m. Eastern Time at the end of November 27, 2019.
ADDRESSES: You may submit comments as follows. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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.
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.gpo.gov/fdsys/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.
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,
email: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2019
(84 FR 42754), FDA published a proposed rule that will, once finalized,
implement a provision of the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) that requires FDA to issue
regulations requiring color graphics depicting the negative health
consequences of smoking to accompany new textual warning statements.
The Tobacco Control Act amends the Federal Cigarette Labeling and
Advertising Act of 1965 to require each cigarette package and
advertisement to bear one of the new required warnings. This proposed
rule, once finalized, will specify the color graphics that must
accompany the new textual warning statements. The proposed new textual
warnings include some that are specified in the Tobacco Control Act and
some new textual warning statements that FDA is proposing to promote
greater public understanding of the negative health consequences of
cigarette smoking. FDA's proposed cigarette warning rule was issued
pursuant to a court-ordered schedule (see Am. Acad. Pediatrics v. FDA,
No. 16-cv-11985, 2019 U.S. Dist. LEXIS 34946 (D. Mass. Mar. 5, 2019)),
which, among other things, requires FDA to submit the proposed rule for
publication by August 15, 2019, and to submit the final rule by March
15, 2020.
As described in FDA's proposed rule, in developing the new
cigarette health warnings, FDA undertook a science-based, iterative
research process. The proposed rule was informed by two quantitative
consumer research studies, ``Experimental Study on Warning Statements
for Cigarette Graphic Health Warnings'' (Office of Management and
Budget (OMB) control number 0910-0848) and ``Experimental Study of
Cigarette Warnings'' (OMB control number 0910-0866), that assessed the
extent to which FDA's proposed warnings increase understanding of the
negative health consequences of cigarette smoking. As part of
developing and informing its research, FDA conducted various
qualitative focus groups and interviews (``qualitative studies'') to
test and refine image concepts and obtain feedback on which textual
statements should be selected for further study. Qualitative studies
are based on small samples, have exploratory aims and objectives,
should not be viewed as nationally representative, and do not yield
data that can be generalized. FDA did not originally include the
qualitative study reports in the docket as FDA did not rely on these
studies as part of the rulemaking. However, because the qualitative
studies were used to inform further research, namely, the quantitative
consumer research studies, FDA is making these additional materials
available as well.
FDA is placing additional materials in the docket and reopening the
comment period for the proposed rule for 15 days to allow comment on
the additional materials. The Agency believes that a 15-day reopening
allows adequate time
[[Page 60968]]
for interested persons to submit comments on this additional
information without significantly delaying rulemaking.
FDA is adding the following materials to the docket for the
proposed rule:
``Qualitative Study on Cigarettes and Smoking: Knowledge,
Beliefs, and Misperceptions'' (July 2015) (OMB control number 0910-
0674, ``Qualitative Study on Cigarettes and Smoking: Knowledge,
Beliefs, and Misperceptions'')
``Memorandum of Findings from Cognitive Testing of Spanish
Warning Labels'' (March 2016)
``FDA Graphic Health Warning Image Concept Testing'' (June
2016) (OMB control number 0910-0796, ``Qualitative Study of Perceptions
and Knowledge of Visually Depicted Health Conditions'')
``Qualitative Study on Consumer Perceptions of Cigarettes
Health Warning Images'' (April 2018) (OMB control number 0910-0796,
``Qualitative Study on Consumer Perceptions of Cigarettes Health
Warning Images'')
Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24511 Filed 11-8-19; 8:45 am]
BILLING CODE 4164-01-P