[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 [www.gpo.gov]
[FR Doc No: 2022-13209]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 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 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, 
[email protected].

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


