Public Meeting and Listening Session for Developing the Food and Drug Administration's Center for Tobacco Products' Strategic Plan; Request for Comments, 47509-47511 [2023-15558]
Download as PDF
47509
Federal Register / Vol. 88, No. 140 / Monday, July 24, 2023 / Notices
URM PROVIDER AGENCIES
Instrument
Total number
of respondents
Total number
of responses
per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
ORR–3 URM Placement Report ..........................................
ORR–4 URM Outcomes Report ..........................................
24
24
270
162
0.50
1.0
3,240
3,888
1,080
1,296
Estimated Total Annual Burden Hours (URM Provider Agencies): 2,376.
YOUTH PARTICIPANTS
Instrument
Total number
of respondents
Total number
of responses
per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
ORR–4 URM Outcomes Report ..........................................
1032
3
0.50
1,548
516
Estimated Total Annual Burden Hours (Youth Participants): 516.
Total Estimated Annual Burden
Hours: 4,137.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522(d).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–15556 Filed 7–21–23; 8:45 am]
BILLING CODE 4184–89–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2873]
lotter on DSK11XQN23PROD with NOTICES1
Public Meeting and Listening Session
for Developing the Food and Drug
Administration’s Center for Tobacco
Products’ Strategic Plan; Request for
Comments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notification of public meeting;
request for comments.
AGENCY:
The Food and Drug
Administration (FDA, the Agency, or
SUMMARY:
VerDate Sep<11>2014
16:56 Jul 21, 2023
Jkt 259001
we) is announcing the following virtual
listening session entitled ‘‘Public
Meeting and Listening Session for
Developing FDA’s Center for Tobacco
Products’ Strategic Plan.’’ The purpose
of the listening session is to obtain
feedback on the proposed strategic goals
that are being used to develop FDA’s
Center for Tobacco Products’ (CTP)
comprehensive Strategic Plan. FDA will
provide information on the proposed
goals and provide the public an
opportunity to provide open public
comment.
DATES: The virtual listening session will
be held on August 22, 2023, beginning
at 10 a.m. Eastern Time. Additional
details, such as the time of the listening
session and registration information, is
available at: https://www.fda.gov/
tobacco-products/ctp-newsroom/
listening-session-developing-fdascenter-tobacco-products-strategic-plan08222023. All requests to make open
public comment must be received by
August 14, 2023, at 11:59 p.m. Eastern
Time. Either electronic or written
comments on this listening session must
be submitted to the docket by August
29, 2023. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The listening session will
be held virtually and more information
will be posted here: https://
www.fda.gov/tobacco-products/ctpnewsroom/listening-session-developingfdas-center-tobacco-products-strategicplan-08222023.
You may submit written 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 August 29, 2023.
Comments received by mail/hand
PO 00000
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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
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Federal Register / Vol. 88, No. 140 / Monday, July 24, 2023 / Notices
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–
2023–N–2873. 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 dockets 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: May
Nelson, Center for Tobacco Products,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 877–287–1373,
CTPRegulations@fda.hhs.gov.
VerDate Sep<11>2014
16:56 Jul 21, 2023
Jkt 259001
SUPPLEMENTARY INFORMATION:
I. Background
In September 2022, per the request of
the FDA Commissioner, Dr. Robert
Califf, an independent expert panel
facilitated by the Reagan-Udall
Foundation began an operational
evaluation of CTP. The evaluation’s goal
was to help ensure that CTP has the
tools to address today’s challenges as it
works to prevent tobacco use among
youth and to reduce tobacco-attributable
death and disease. The final report was
issued on December 19, 2022, and
included 15 recommendations across a
number of areas.
One recommendation stated: ‘‘To
address today’s challenges and position
itself for the future, CTP must pivot
from a reactive mode to a proactive
mode. CTP must invest the time, now,
with staff and public input, to create
and implement a strategic plan that
identifies CTP’s strategic objectives and
plots an operational roadmap of the
steps CTP will take over the next five
years to achieve those objectives.’’
In response, CTP has initiated the
development of a 5-year Strategic Plan
to advance its mission. As part of an
iterative, Center-wide process, CTP has
developed five proposed goal areas that
have been shaped by staff and leaders
across the Center. These goal areas are
intended to be interconnected with four
proposed cross-cutting themes: health
equity, science, transparency, and
stakeholder engagement. The Center
intends to publish its Strategic Plan by
the end of 2023.
To gain additional perspectives as
CTP develops its Strategic Plan, the
Center seeks public comments on these
proposed goal areas or on any other
areas that CTP should consider that
might not be encapsulated by these
proposed goal areas. CTP asks that
comments be forward-looking,
constructive, and concise in addressing
the following questions:
1. What key features, activities, or
initiatives would you like CTP to
consider as related to any of these
proposed goal areas? For example, in
the area of regulations and guidance
documents, we would be interested in
your feedback on specific regulations
and guidance documents FDA should
pursue and how they should be
prioritized.
2. What are measurable short- and
long-term outcomes for the proposed
goal areas over the next 2 to 5 years?
3. What are three specific actions CTP
could take in the next 5 years that
would have the most impact in
significantly reducing tobacco-related
death and disease?
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
4. Are there any important features,
activities, or initiatives not encapsulated
by these proposed goal areas that you
believe CTP should consider as part of
its Strategic Plan?
Proposed goal areas are as follows:
1. Develop, Advance, and
Communicate Comprehensive and
Impactful Tobacco Regulations and
Guidance. This goal includes activities
related to the development and
implementation of CTP’s regulatory and
policy agenda; the articulation and
publication of clear and comprehensive
public policy statements; and efforts to
advance health equity.
2. Ensure Timely, Clear, and
Consistent Product Application Review
to Protect Public Health. This goal
includes activities related to work
processes such as optimizing the
efficiency, consistency, and
effectiveness of the product application
review process; enhancing public
understanding of regulatory
requirements through transparency and
stakeholder engagement efforts; and
ensuring that the review process is
supported by a strong regulatory science
program.
3. Ensure Compliance of Regulated
Industry and Tobacco Products Utilizing
All Available Tools, Including Robust
Enforcement Actions. This goal includes
pursuing enforcement actions to reduce
violations; enhancing collaborations
with federal and state agencies on
tobacco enforcement efforts; and
prioritizing agile market intelligence
and surveillance to facilitate awareness
of and effective responses to the
evolving tobacco landscape.
4. Improve Public Health by
Enhancing Knowledge and
Understanding of CTP Tobacco Product
Regulation and the Risks Associated
with Tobacco Product Use. This goal
includes timely, clear, and accessible
health communications and education
to diverse public audiences, including
those to discourage youth initiation,
encourage cessation, and to inform
adults who smoke about the relative
risks of tobacco products.
5. Advance Operational Excellence.
This goal includes prioritization of
workforce growth, engagement, and
retention and CTP’s commitment to
diversity, equity, inclusion, and
accessibility; modernizing business
processes to enhance information
management and programmatic efficacy;
and seeking and applying needed
resources to support CTP’s full portfolio
of regulatory activities.
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Federal Register / Vol. 88, No. 140 / Monday, July 24, 2023 / Notices
II. Topics for Discussion at the
Listening Session
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The listening session will provide the
public an opportunity to provide open
public comment on the proposed goal
areas and help inform development of
the final Strategic Plan. After
introductions, FDA will begin the
listening session with an overview of
the development of CTP’s Strategic Plan
and subsequent proposed goal areas.
Then, the registered speakers will have
approximately 4 minutes each to share
their comments on any topics related to
the proposed goal areas.
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript and recording will also be
available on the internet at https://
www.fda.gov/tobacco-products/ctpnewsroom/listening-session-developingfdas-center-tobacco-products-strategicplan-08222023.
Dated: July 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15558 Filed 7–21–23; 8:45 am]
BILLING CODE 4164–01–P
III. Participating in the Listening
Session
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Registration: To register to attend the
free listening session, please visit the
following website: https://www.fda.gov/
tobacco-products/ctp-newsroom/
listening-session-developing-fdascenter-tobacco-products-strategic-plan08222023. Registration information will
be posted soon.
Live closed captioning will be
provided during the listening session.
Additional information on requests for
special accommodations due to a
disability will be provided during
registration.
Requests to Provide Open Public
Comment: During online registration
you may indicate if you wish to make
open public comments during the
listening session. All requests to make
open public comment must be received
by August 14, 2023, at 11:59 p.m.
Eastern Time. We will do our best to
accommodate requests to make public
comments. We are seeking to have a
broad representation of ideas and
perspectives presented at the meeting.
During the listening session, FDA is
especially interested to hear from those
individuals or communities who may be
less likely or less able to provide written
comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
comments and request time for a joint
presentation. FDA will allow registered
speakers 4 minutes to provide their
open public comments and will notify
all registrants of their approximate time
ahead of the listening session if they are
selected to make public comment. FDA
will not accept presentation materials
for the listening session. Instead, any
materials can be submitted to the
respective docket noted in the ‘‘Docket’’
section of this document before the end
of the comment period.
Transcript: Please be advised that as
soon as the transcript of the listening
session is available, it will be accessible
at https://www.regulations.gov. It may
Health Resources and Services
Administration
VerDate Sep<11>2014
16:56 Jul 21, 2023
Jkt 259001
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Evaluation of Programs
Supporting the Mental Health of the
Health Professions Workforce, OMB
No. 0915–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than August 23, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 594–
4394.
DATES:
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Fmt 4703
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47511
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evaluation of Programs Supporting the
Mental Health of the Health Professions
Workforce, OMB No. 0915–xxxx–New.
Abstract: The Public Health Service
Act and the American Rescue Plan Act
of 2021 authorized three programs
administered by HRSA: (1) the Health
and Public Safety Workforce Resiliency
Training Program (the Training
Program); (2) the Promoting Resilience
and Mental Health among Health
Professional Workforce Program (the
Workforce Program); and (3) the Health
and Public Safety Workforce Resiliency
Technical Assistance Center (the
Technical Assistance Center). The
Training Program funds resilience
training activities for the health
workforce in rural and underserved
communities. The Workforce Program
supports organizations’ programs or
protocols that foster resilience and
wellness among the health workforce in
these communities. The Technical
Assistance Center provides tailored
training and technical assistance to
Training Program and Workforce
Program awardees. The purpose of the
planned evaluation is to assess the three
programs with respect to their goals of
promoting resiliency and mental health
in the health workforce. Data collection
efforts will inform HRSA leadership
about the progress, costs and benefits,
and impact of these efforts to support
the delivery of health care in the United
States.
Methods of Collection
Quantitative and qualitative deidentified data will be collected from
awardees and their health care
workforce. Each instrument will be
administered twice over the 4-year
evaluation period; once mid-way
through the project period and once at
the end of the project period. There will
also be a one-time comparison group
survey. To achieve the evaluation, the
study will use the following quantitative
data collection instruments:
The Healthcare Workforce Survey is a
web-based survey intended to collect
data on the impact and implementation
of the Training Program and the
Workforce Program from individuals in
both programs’ target populations.
Respondents will only be asked
questions that are relevant to their
experience. The Survey includes
questions about before and after
program participation to assess selfreported change.
The Fielding Tracker is an Excelbased tool that Workforce Program and
Training Program awardees will help
populate with information on how they
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Agencies
[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Notices]
[Pages 47509-47511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15558]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2873]
Public Meeting and Listening Session for Developing the Food and
Drug Administration's Center for Tobacco Products' Strategic Plan;
Request for Comments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual listening session entitled ``Public
Meeting and Listening Session for Developing FDA's Center for Tobacco
Products' Strategic Plan.'' The purpose of the listening session is to
obtain feedback on the proposed strategic goals that are being used to
develop FDA's Center for Tobacco Products' (CTP) comprehensive
Strategic Plan. FDA will provide information on the proposed goals and
provide the public an opportunity to provide open public comment.
DATES: The virtual listening session will be held on August 22, 2023,
beginning at 10 a.m. Eastern Time. Additional details, such as the time
of the listening session and registration information, is available at:
https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023. All
requests to make open public comment must be received by August 14,
2023, at 11:59 p.m. Eastern Time. Either electronic or written comments
on this listening session must be submitted to the docket by August 29,
2023. See the SUPPLEMENTARY INFORMATION section for registration date
and information.
ADDRESSES: The listening session will be held virtually and more
information will be posted here: https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023.
You may submit written 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 August 29, 2023. 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
[[Page 47510]]
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-2023-N-2873. 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 dockets 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: May Nelson, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In September 2022, per the request of the FDA Commissioner, Dr.
Robert Califf, an independent expert panel facilitated by the Reagan-
Udall Foundation began an operational evaluation of CTP. The
evaluation's goal was to help ensure that CTP has the tools to address
today's challenges as it works to prevent tobacco use among youth and
to reduce tobacco-attributable death and disease. The final report was
issued on December 19, 2022, and included 15 recommendations across a
number of areas.
One recommendation stated: ``To address today's challenges and
position itself for the future, CTP must pivot from a reactive mode to
a proactive mode. CTP must invest the time, now, with staff and public
input, to create and implement a strategic plan that identifies CTP's
strategic objectives and plots an operational roadmap of the steps CTP
will take over the next five years to achieve those objectives.''
In response, CTP has initiated the development of a 5-year
Strategic Plan to advance its mission. As part of an iterative, Center-
wide process, CTP has developed five proposed goal areas that have been
shaped by staff and leaders across the Center. These goal areas are
intended to be interconnected with four proposed cross-cutting themes:
health equity, science, transparency, and stakeholder engagement. The
Center intends to publish its Strategic Plan by the end of 2023.
To gain additional perspectives as CTP develops its Strategic Plan,
the Center seeks public comments on these proposed goal areas or on any
other areas that CTP should consider that might not be encapsulated by
these proposed goal areas. CTP asks that comments be forward-looking,
constructive, and concise in addressing the following questions:
1. What key features, activities, or initiatives would you like CTP
to consider as related to any of these proposed goal areas? For
example, in the area of regulations and guidance documents, we would be
interested in your feedback on specific regulations and guidance
documents FDA should pursue and how they should be prioritized.
2. What are measurable short- and long-term outcomes for the
proposed goal areas over the next 2 to 5 years?
3. What are three specific actions CTP could take in the next 5
years that would have the most impact in significantly reducing
tobacco-related death and disease?
4. Are there any important features, activities, or initiatives not
encapsulated by these proposed goal areas that you believe CTP should
consider as part of its Strategic Plan?
Proposed goal areas are as follows:
1. Develop, Advance, and Communicate Comprehensive and Impactful
Tobacco Regulations and Guidance. This goal includes activities related
to the development and implementation of CTP's regulatory and policy
agenda; the articulation and publication of clear and comprehensive
public policy statements; and efforts to advance health equity.
2. Ensure Timely, Clear, and Consistent Product Application Review
to Protect Public Health. This goal includes activities related to work
processes such as optimizing the efficiency, consistency, and
effectiveness of the product application review process; enhancing
public understanding of regulatory requirements through transparency
and stakeholder engagement efforts; and ensuring that the review
process is supported by a strong regulatory science program.
3. Ensure Compliance of Regulated Industry and Tobacco Products
Utilizing All Available Tools, Including Robust Enforcement Actions.
This goal includes pursuing enforcement actions to reduce violations;
enhancing collaborations with federal and state agencies on tobacco
enforcement efforts; and prioritizing agile market intelligence and
surveillance to facilitate awareness of and effective responses to the
evolving tobacco landscape.
4. Improve Public Health by Enhancing Knowledge and Understanding
of CTP Tobacco Product Regulation and the Risks Associated with Tobacco
Product Use. This goal includes timely, clear, and accessible health
communications and education to diverse public audiences, including
those to discourage youth initiation, encourage cessation, and to
inform adults who smoke about the relative risks of tobacco products.
5. Advance Operational Excellence. This goal includes
prioritization of workforce growth, engagement, and retention and CTP's
commitment to diversity, equity, inclusion, and accessibility;
modernizing business processes to enhance information management and
programmatic efficacy; and seeking and applying needed resources to
support CTP's full portfolio of regulatory activities.
[[Page 47511]]
II. Topics for Discussion at the Listening Session
The listening session will provide the public an opportunity to
provide open public comment on the proposed goal areas and help inform
development of the final Strategic Plan. After introductions, FDA will
begin the listening session with an overview of the development of
CTP's Strategic Plan and subsequent proposed goal areas. Then, the
registered speakers will have approximately 4 minutes each to share
their comments on any topics related to the proposed goal areas.
III. Participating in the Listening Session
Registration: To register to attend the free listening session,
please visit the following website: https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023. Registration information will be
posted soon.
Live closed captioning will be provided during the listening
session. Additional information on requests for special accommodations
due to a disability will be provided during registration.
Requests to Provide Open Public Comment: During online registration
you may indicate if you wish to make open public comments during the
listening session. All requests to make open public comment must be
received by August 14, 2023, at 11:59 p.m. Eastern Time. We will do our
best to accommodate requests to make public comments. We are seeking to
have a broad representation of ideas and perspectives presented at the
meeting. During the listening session, FDA is especially interested to
hear from those individuals or communities who may be less likely or
less able to provide written comments. Individuals and organizations
with common interests are urged to consolidate or coordinate their
comments and request time for a joint presentation. FDA will allow
registered speakers 4 minutes to provide their open public comments and
will notify all registrants of their approximate time ahead of the
listening session if they are selected to make public comment. FDA will
not accept presentation materials for the listening session. Instead,
any materials can be submitted to the respective docket noted in the
``Docket'' section of this document before the end of the comment
period.
Transcript: Please be advised that as soon as the transcript of the
listening session is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript and recording will also be
available on the internet at https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023.
Dated: July 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15558 Filed 7-21-23; 8:45 am]
BILLING CODE 4164-01-P