Notice2024-09786
The Tobacco Products Scientific Advisory Committee; Notice of Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Full Text
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<title>Federal Register, Volume 89 Issue 88 (Monday, May 6, 2024)</title>
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[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37231-37232]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
The Tobacco Products Scientific Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Tobacco Products Scientific
Advisory Committee (TPSAC). The general function of the committee is to
provide advice and recommendations to the Agency on FDA's regulatory
issues. The meeting will be open to the public.
DATES: The meeting will be held on June 26, 2024, from 9 a.m. to 4:30
p.m. EST.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.
The
[[Page 37232]]
public will have the option to participate, and the advisory committee
meeting will be heard, viewed, captioned, and recorded through an
online teleconferencing and/or video conferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings,
including information regarding special accommodations due to a
disability, visitor parking, and transportation, may be accessed at:
<a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
For those unable to attend in person, the meeting will also be
webcast and will be available at the following link: <a href="https://fda.zoomgov.com/j/1604157441?pwd=YkVzZ28vNHQrVXh3ZlhrTmlHaFVzZz09">https://fda.zoomgov.com/j/1604157441?pwd=YkVzZ28vNHQrVXh3ZlhrTmlHaFVzZz09</a>.
FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products, Food and Drug Administration,
Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#500400031113103634317e3838237e373f26"><span class="__cf_email__" data-cfemail="ffabafacbebcbf999b9ed197978cd1989089">[email protected]</span></a>,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and
scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On June 26, 2024, the Center for Tobacco Product's TPSAC
will convene for one open session, during which the committee will
discuss the renewal of a risk modification order, submitted by Swedish
Match USA, Inc. for the following loose snus and portioned snus
products:
<bullet> MR0000020: General Loose
<bullet> MR0000021: General Dry Mint Portion Original Mini
<bullet> MR0000022: General Portion Original Large
<bullet> MR0000024: General Classic Blend Portion White Large--12 ct
<bullet> MR0000025: General Mint Portion White Large
<bullet> MR0000027: General Nordic Mint Portion White Large--12 ct
<bullet> MR0000028: General Portion White Large
<bullet> MR0000029: General Wintergreen Portion White Large
Additional discussion about broader Modified Risk Tobacco Products
program developments related to the conceptualization and measurement
of consumer understanding will also occur.
The meeting presentations will be heard, viewed, captioned, and
recorded through an online teleconferencing and/or video conferencing
platform.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
20, 2024. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. EST on June 26, 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, whether they would like to present online or in
person, on or before June 11, 2024, by 5 p.m. Eastern Time. 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 advisory committee meeting, FDA may conduct a lottery to
determine the speakers who will be invited to participate in person.
The contact person will notify interested persons regarding their
request to speak by June 12, 2024.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Serina Hunter-Thomas at least 7 days in advance of the meeting
(see FOR FURTHER INFORMATION CONTACT).
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform in conjunction with the physical
meeting room (see location). This waiver is in the interest of allowing
greater transparency and opportunities for public participation, in
addition to convenience for advisory committee members, speakers, and
guest speakers. The conditions for issuance of a waiver under 21 CFR
10.19 are met.
Dated: May 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09786 Filed 5-3-24; 8:45 am]
BILLING CODE 4164-01-P
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