[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]
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