[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37231-37232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    For those unable to attend in person, the meeting will also be 
webcast and will be available at the following link: https://fda.zoomgov.com/j/1604157441?pwd=YkVzZ28vNHQrVXh3ZlhrTmlHaFVzZz09.

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: [email protected], 
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 https://www.fda.gov/AdvisoryCommittees/default.htm 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:

 MR0000020: General Loose
 MR0000021: General Dry Mint Portion Original Mini
 MR0000022: General Portion Original Large
 MR0000024: General Classic Blend Portion White Large--12 ct
 MR0000025: General Mint Portion White Large
 MR0000027: General Nordic Mint Portion White Large--12 ct
 MR0000028: General Portion White Large
 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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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