Document ID: FDA-2018-N-4162-0001
Agency: fda
Document Type: Notice
Title: The Tobacco Products Scientific Advisory Committee; Notice of Meeting
Posted Date: 2018-12-11T05:00Z

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63658-63659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26721]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4162]

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 (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 February 6, 2019, from 8:30 a.m. to 
5 p.m. and on February 7, 2019 from 8 a.m. to 1 p.m.

ADDRESSES: FDA White Oak Conference Center, Bldg. 31, Rm. 1503 (the 
Great Room), 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. 
Answers to commonly asked questions 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.

[[Page 63659]]

FOR FURTHER INFORMATION CONTACT: Caryn Cohen, 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: TPSAC@fda.hhs.gov, 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 February 6-7, 2019, the Committee will convene for two 
sessions. The first session will convene on February 6, 2019, during 
which the Committee will discuss an amendment to the modified risk 
tobacco product applications (MRTPAs), submitted by Swedish Match North 
America for the following snus smokeless tobacco products:
     MR0000020: General Loose;
     MR0000021: General Dry Mint Portion Original Mini;
     MR0000022: General Portion Original Large;
     MR0000024: General Classic Blend Portion White Large-12ct;
     MR0000025: General Mint Portion White Large;
     MR0000027: General Nordic Mint Portion White Large-12ct;
     MR0000028: General Portion White Large; and
     MR0000029: General Wintergreen Portion White Large.
    The second session will convene, after the first session has 
concluded, on February 6, 2019, and continue on February 7, 2019. 
During the second session the Committee will discuss the MRTPA, 
submitted by Altria Client Services LLC on behalf of U.S. Smokeless 
Tobacco Company LLC for the following smokeless tobacco product:
     MR0000108: Copenhagen Snuff Fine Cut.
    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.
    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 
January 22, 2019. Oral presentations from the public for the first 
session will be scheduled between approximately 10 a.m. and 10:30 a.m. 
on February 6, 2019, and for the second session between approximately 8 
a.m. and 8:30 a.m. on February 7, 2019. Those individuals interested in 
making formal oral presentations should notify the contact person 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 the session during which they would like to 
speak, on or before January 14, 2019. 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. 
The contact person will notify interested persons regarding their 
request to speak by January 15, 2019.
    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 Caryn Cohen (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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26721 Filed 12-10-18; 8:45 am]
 BILLING CODE 4164-01-P