Proposed Rule2022-13209
Establishment of Tobacco Product Standards for Menthol in Cigarettes and Characterizing Flavors in Cigars; Extension of Comment Period
Primary source
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Published
June 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for two proposed rules that appeared in the Federal Register of May 4, 2022, which are a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes ("Tobacco Product Standard for Menthol in Cigarettes"; Docket No. FDA-2021-N-1349) and a tobacco product standard that would prohibit characterizing flavors (other than tobacco) in all cigars ("Tobacco Product Standard for Characterizing Flavors in Cigars"; Docket No. FDA-2021-N-1309). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 87 Issue 118 (Tuesday, June 21, 2022)</title>
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[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Proposed Rules]
[Pages 36786-36787]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1162 and 1166
[Docket Nos. FDA-2021-N-1349 and FDA-2021-N-1309]
RIN 0910-AI60 and 0910-AI28
Establishment of Tobacco Product Standards for Menthol in
Cigarettes and Characterizing Flavors in Cigars; Extension of Comment
Period
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Proposed rules; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
extending the comment period for two proposed rules that appeared in
the Federal Register of May 4, 2022, which are a tobacco product
standard that would prohibit menthol as a characterizing flavor in
cigarettes (``Tobacco Product Standard for Menthol in Cigarettes'';
Docket No. FDA-2021-N-1349) and a tobacco product standard that would
prohibit characterizing flavors (other than tobacco) in all cigars
(``Tobacco Product Standard for Characterizing Flavors in Cigars'';
Docket No. FDA-2021-N-1309). The Agency is taking this action in
response to requests for an extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment period on the proposed rules
published in the Federal Register on May 4, 2022 (87 FR 26454 and 87 FR
26396). Submit either electronic or written comments by August 2, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 2, 2022. 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:
<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-2021-N-1349 for ``Tobacco Product Standard for Menthol in
Cigarettes'' and/or Docket No. FDA-2021-N-1309 for ``Tobacco Product
Standard for Characterizing Flavors in Cigars.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential
[[Page 36787]]
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.
FOR FURTHER INFORMATION CONTACT: Beth Buckler or Nate Mease, Center for
Tobacco Products, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002, 877-287-1373,
<a href="/cdn-cgi/l/email-protection#10534440427577657c7164797f7e63507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="7b382f2b291e1c0e171a0f121415083b1d1f1a55131308551c140d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 4, 2022 (87
FR 26454 and 87 FR 26396), FDA published two proposed rules: (1) a
tobacco product standard that would prohibit menthol as a
characterizing flavor in cigarettes (``Tobacco Product Standard for
Menthol in Cigarettes''; Docket No. FDA-2021-N-1349) and (2) a tobacco
product standard that would prohibit characterizing flavors (other than
tobacco) in all cigars (``Tobacco Product Standard for Characterizing
Flavors in Cigars''; Docket No. FDA-2021-N-1309). Both proposed rules
published with a 60-day comment period. Comments on the proposed rules
will inform FDA's rulemakings to establish tobacco product standards
for menthol in cigarettes and characterizing flavors in cigars.
Interested persons were originally given until July 5, 2022, to
comment on the proposed rules. We have received a number of requests
for a 60-day extension of the comment period for both proposed rules,
which conveyed concern that the current 60-day comment period does not
allow sufficient time to develop a meaningful response to the proposed
rules. Several organizations have requested that FDA close the comment
period after 60 days, conveying that 60 days is enough time to receive
meaningful responses and stressed a public health urgency with both
product standards.
FDA has considered the requests and is extending the comment period
for the proposed rules by an additional 30 days, until August 2, 2022.
We believe that a 90-day comment period is appropriate as it allows
adequate time for interested persons to fully consider the proposed
rules, including specific requests for comments, and develop and submit
comments without significantly lengthening the rulemaking proceedings.
Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13209 Filed 6-17-22; 8:45 am]
BILLING CODE 4164-01-P
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