[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: CTPRegulations@fda.hhs.gov.

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


