Notice2024-21678
Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments
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Published
September 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Advancing Smoking Cessation: FDA and NIH Priorities." Jointly convened by FDA and the National Institutes of Health (NIH), this public meeting will address the need for novel smoking cessation products to help individuals of all ages, including underserved and vulnerable populations, stop smoking. The overall goal of the meeting is to stimulate novel product development to reduce rates of smoking and related chronic illnesses. The meeting format will include presentations and panel discussions.
Full Text
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<title>Federal Register, Volume 89 Issue 184 (Monday, September 23, 2024)</title>
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77521-77523]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21678]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Advancing Smoking
Cessation: FDA and NIH Priorities.'' Jointly convened by FDA and the
National Institutes of Health (NIH), this public meeting will address
the need for novel smoking cessation products to help individuals of
all ages, including underserved and vulnerable populations, stop
smoking. The overall goal of the meeting is to stimulate novel product
development to reduce rates of smoking and related chronic illnesses.
The meeting format will include presentations and panel discussions.
DATES: The public meeting will be held in person with an option for
virtual attendance on October 21, 2024, from 9 a.m. to 4:30 p.m.
Eastern Time. Submit requests to make oral presentations at the public
meeting by 5 p.m. Eastern Time, October 1, 2024. Either electronic or
written comments on this public meeting must be submitted by November
21, 2024. See the
[[Page 77522]]
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held in the White Oak Great Room
at the Food and Drug Administration, White Oak Campus, 10903 New
Hampshire Ave., Silver Spring, MD 20993. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
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 November 21, 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.
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-2024-N-4085 for ``Advancing Smoking Cessation: FDA and NIH
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 <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 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: Laura Chilaka, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 877-287-1373, <a href="/cdn-cgi/l/email-protection#31655e535052525e725442425045585e5f715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="9fcbf0fdfefcfcf0dcfaececfeebf6f0f1dff9fbfeb1f7f7ecb1f8f0e9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting is intended to bring together key people in
supporting research on and development of new smoking cessation
products in order to stimulate novel product development to reduce the
burden of smoking and related chronic illnesses. Participants will hear
updates on NIH research and FDA operations.
II. Topics for Discussion at the Public Meeting
Session 1. NIH-supported smoking cessation research and areas of
opportunity. This session will provide a brief overview of NIH areas of
support and identification of gap areas including focus on underserved
and vulnerable populations.
Session 2. Update from FDA. This session will provide a brief
overview of relevant FDA operations including focus on underserved and
vulnerable populations. The session will discuss the regulatory
framework for developing smoking cessation drugs, medical devices and
their role in smoking cessation, and tobacco pathways.
Session 3. Clinical and community perspectives. This session will
offer a concise introduction to smoking cessation treatment
considerations from the clinical viewpoint, with a special emphasis on
underserved and diverse communities along with potential access and
uptake challenges, through the lens of real-world experiences and
diversity considerations.
Session 4. Promising targets for development. This session will
highlight selected new and emerging areas for intervention development
including pharmacologic agents, brain stimulation, and digital
therapeutics. In addition, we will discuss the potential endpoints for
use in randomized trials of new interventions.
Session 5. Regulatory paths forward. This session will discuss
endpoints for smoking cessation drug development programs, evidence
necessary to support their role in drug development, clinical outcome
assessments, and innovative clinical trial designs and conduct,
including trials integrated in clinical practice and clustering in
trial design to increase participation from underserved communities.
Session 6. Public comment. Interested persons may present data,
information, or views, orally or in writing, on issues
[[Page 77523]]
related to cessation and should address the following questions:
1. How can researchers increase enrollment for traditionally
underrepresented populations in clinical trials (e.g., racial and
ethnic minority populations, LGBTQ+ populations, rural populations)?
2. Would there be interest in an externally led Patient Focused
Drug Development (PFDD) meeting to better understand the challenges and
barriers to smoking cessation from individuals trying to quit and what
additional endpoints can be evaluated in smoking cessation clinical
trials?
3. What are some novel targets that could facilitate cigarette
cessation product development?
4. What challenges are researchers and/or drug developers facing in
their efforts to identify novel targets for smoking cessation
therapies?
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website to register: <a href="https://advancingsmokingcessation.eventbrite.com">https://advancingsmokingcessation.eventbrite.com</a>. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone number.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting in person must register by October 15, 2024, 11:59 p.m. Eastern
Time. Persons interested in attending this public meeting virtually
must register by October 21, 2024, 9 a.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted.
For special accommodations due to a disability, please visit the
registration website: <a href="https://advancingsmokingcessation.eventbrite.com">https://advancingsmokingcessation.eventbrite.com</a>.
Please submit special accommodation requests no later than October 7,
2024.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the public comment session. We
will do our best to accommodate requests to make public comments.
Oral presentations from the public will be scheduled between
approximately 3:15 p.m. and 4:15 p.m. Eastern Time on October 21, 2024.
Those individuals interested in making formal oral presentations should
notify the contact person (see FOR FURTHER INFORMATION CONTACT) and
submit a brief statement describing the general nature of the evidence
or arguments they wish to present and the names and email addresses of
proposed participants, on or before October 1, 2024, by 5 p.m. Eastern
Time. Topics should address the questions listed in II., Section 6.
Individuals making formal oral presentations will not have the capacity
to present slides during the public comment session. Individuals may
submit presentation materials to the docket on or before November 21,
2024.
Time allotted for each presentation may be limited. If the number
of registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. Similarly, room for interested persons to
participate in person may be limited. If the number of registrants
requesting to speak in person during the open public hearing is greater
than can be reasonably accommodated in the venue for the in-person
portion of the meeting, FDA may conduct a lottery to determine the
speakers who will be invited to participate in person. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin
and will select and notify participants as soon as possible to provide
speakers with adequate time to prepare. No commercial or promotional
material will be permitted to be presented or distributed at the public
meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Please visit the following website for more
information: <a href="https://advancingsmokingcessation.eventbrite.com">https://advancingsmokingcessation.eventbrite.com</a>.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES).
(Notice of this meeting is given pursuant to 21 CFR 10.65.)
Dated: September 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21678 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
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