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[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Notices]
[Pages 95221-95222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28205]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4085]

Advancing Smoking Cessation: Food and Drug Administration and 
National Institutes of Health Priorities; Public Meeting; Request for 
Comments; Reopening of Public Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; reopening of public comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) published in 
the Federal Register of September 23, 2024, a notice of public meeting 
scheduled for October 21, 2024, and solicited comments from interested 
parties. FDA requested that all electronic and written comments be 
submitted by November 21, 2024. FDA is reopening the public comment 
period until December 20, 2024, in response to feedback received from 
interested parties. This action will allow for interested parties 
additional time to review the meeting transcript and recording to 
prepare information and comments.

DATES: The comment period for the notice of public meeting published on 
September 23, 2024, (89 FR 77521) is reopened. Either electronic or 
written comments must be received on or before December 20, 2024.

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 December 20, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

[[Page 95222]]

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-2024-N-4085 for ``Advancing Smoking Cessation: Food and Drug 
Administration and National Institutes of Health Priorities.'' 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 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: Laura Chilaka, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION: On September 23, 2024, FDA published in the 
Federal Register a notice announcing a public meeting entitled 
``Advancing Smoking Cessation: Food and Drug Administration and 
National Institutes of Health Priorities.'' Jointly convened by FDA and 
the National Institutes of Health, this public meeting addressed the 
need for novel smoking cessation products to help individuals of all 
ages, including underserved and vulnerable populations, stop smoking.
    Interested persons were originally given until November 21, 2024, 
to submit comments on the public meeting.
    FDA has received requests for additional time in submitting 
comments. Due to the significant interest in the topic and to allow 
interested parties time to review the meeting transcript and recording, 
FDA has reopened the comment period until December 20, 2024.

    Dated: November 25, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28205 Filed 11-29-24; 8:45 am]
BILLING CODE 4164-01-P
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