[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77521-77523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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 https://www.fda.gov/about-fda/visitor-information.
    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 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:
     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: 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 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:

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: https://advancingsmokingcessation.eventbrite.com. 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: https://advancingsmokingcessation.eventbrite.com. 
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: https://advancingsmokingcessation.eventbrite.com.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. 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