Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments, 77521-77523 [2024-21678]
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Rm. 6200, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug or biological product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, SYMDEKO
(tezacaftor/co-packaged with ivacaftor)
indicated for the treatment of patients
with cystic fibrosis aged 12 years and
older who are homozygous for the
F508del mutation or who have at least
one mutation in the cystic fibrosis
transmembrane conductance regulator
gene that is responsive to tezacaftor/
ivacaftor based on in vitro data and/or
clinical evidence. Subsequent to this
approval, the USPTO received patent
term restoration applications for
SYMDEKO (U.S. Patent Nos. 7,645,789;
7,776,905; 8,415,387; 8,598,181;
8,623,905; and 9,035,072) from Vertex
Pharmaceuticals Inc., and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
June 12, 2019, FDA advised the USPTO
that this human drug product had
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undergone a regulatory review period
and that the approval of SYMDEKO
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
SYMDEKO is 2,832 days. Of this time,
2,602 days occurred during the testing
phase of the regulatory review period,
while 230 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: May 15, 2010.
The applicant claims May 14, 2010, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 15, 2010,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: June 28, 2017. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
SYMDEKO (NDA 210491) was initially
submitted on June 28, 2017.
3. The date the application was
approved: February 12, 2018. FDA has
verified the applicant’s claim that NDA
210491 was approved on February 12,
2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 616 days, 864 days,
882 days, 1,001 days, 1,484 days, or
1,532 days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
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77521
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21677 Filed 9–20–24; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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 (nonFDA 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.
khammond on DSKJM1Z7X2PROD with NOTICES
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
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16:57 Sep 20, 2024
Jkt 262001
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-201509-18/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
PO 00000
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Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 877–
287–1373, TobaccoCessation@
fda.hhs.gov.
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
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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://advancing
smokingcessation.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://advancingsmoking
cessation.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
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16:57 Sep 20, 2024
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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 inperson 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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2396]
Chemistry, Manufacturing, and
Controls Development and Readiness
Pilot Program; Program
Announcement
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing year three of the Chemistry,
Manufacturing, and Controls (CMC)
Development and Readiness Pilot
(CDRP). This program facilitates the
expedited CMC development of
products under an investigational new
drug application (IND) based on the
anticipated clinical benefit of earlier
patient access to the products. FDA has
implemented this pilot program to assist
with CMC readiness for products
regulated by both the Center for
Biologics Evaluation and Research
(CBER) and the Center for Drug
Evaluation and Research (CDER) that
have accelerated clinical development
timelines. To accelerate CMC
development and facilitate CMC
readiness, the pilot features increased
communication between FDA and
sponsors and explores the use of
science- and risk-based regulatory
approaches, as applicable. This notice
outlines the eligibility criteria and
process for submitting a request to
participate in the pilot.
DATES: Starting October 1, 2024, FDA
will accept requests to participate in
year three of the CDRP program. See the
‘‘Participation’’ section of this document
for eligibility criteria, instructions on
how to submit a request to participate,
and selection criteria and process.
FOR FURTHER INFORMATION CONTACT:
Tanya Clayton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506,
Silver Spring, MD 20993–0002, 301–
796–0871; or James Myers, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
For general questions about the CDRP
Program for CBER: industry.biologics@
fda.hhs.gov.
For general questions about the CDRP
Program for CDER: cder-opq-opro-cradinquiries@fda.hhs.gov.
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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
