Notice2023-15558
Public Meeting and Listening Session for Developing the Food and Drug Administration's Center for Tobacco Products' Strategic Plan; Request for Comments
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Published
July 24, 2023
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 140 (Monday, July 24, 2023)</title>
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[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Notices]
[Pages 47509-47511]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15558]
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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.
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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:
<a href="https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023">https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023</a>. 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: <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023">https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023</a>.
You may submit written 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 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:
<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
[[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 <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 dockets 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: May Nelson, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 877-287-1373, <a href="/cdn-cgi/l/email-protection#52110602003735273e33263b3d3c21123436337c3a3a217c353d24"><span class="__cf_email__" data-cfemail="a0e3f4f0f2c5c7d5ccc1d4c9cfced3e0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>.
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: <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023">https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023">https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023</a>.
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
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