[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35894-35895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-2030]


Tobacco Products Scientific Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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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 Committee). 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 October 7, 2025, from 9:00 a.m. to 
4:30 p.m. Eastern Time.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. The public will have the option to participate, and the advisory 
committee meeting and meeting presentations 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 links:
    Live Link: https://youtube.com/live/MNXGH9aki4I?feature=share.
    Caption Link: http://upload.youtube.com/closedcaption?cid=jfzr-97fr-a9ax-sxcz-c31k.

FOR FURTHER INFORMATION CONTACT: Rachel Jang, PharmD, DFO, Center for 
Tobacco Products, Food and Drug Administration, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 1-877-287-1373, [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 FDA'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 October 7, 2025, the Center for Tobacco Product's TPSAC 
will convene for one open session, during which the Committee will 
discuss the renewal of modified risk granted orders issued to Philip 
Morris Products S.A. for the following products:
 MR0000059: Marlboro Amber HeatSticks
 MR0000060: Marlboro Green Menthol HeatSticks
 MR0000061: Marlboro Blue Menthol HeatSticks
 MR0000133: IQOS 2.4 System Holder and Charger
 MR0000192: IQOS 3.0 System Holder and Charger
    Discussion will focus on whether the statutory standards continue 
to be met.
    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 be posted on the FDA's website after 
the meeting. Background material and the link to the online 
teleconference and/or video conference meeting will be available at 
https://

[[Page 35895]]

www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 submitted to the contact person on or before 
September 25, 2025. Oral presentations from the public will be 
scheduled between 1:00 p.m. and 2:00 p.m. ET on October 7, 2025. 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, the names and email addresses of 
proposed participants, and whether they would like to present online or 
in-person, on or before September 11, 2025. 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 September 
15, 2025.
    Persons attending FDA's advisory committee meetings are advised 
that FDA 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 Rachel Jang, PharmD, DFO (see FOR FURTHER INFORMATION CONTACT) 
at least 7 days in advance of the meeting.
    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.
    For press inquiries, please contact the HHS Press Room at 
www.hhs.gov/press-room/index.html or 202-690-6343.
    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. No participant will be prejudiced by this waiver, and 
that the ends of justice will be served by allowing for this 
modification to FDA's advisory committee meeting procedures.

    Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14347 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P