[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Notices]
[Pages 29124-29125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2066]


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

[[Page 29125]]

forthcoming public advisory committee meeting of the Tobacco Products 
Scientific Advisory 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 September 13, 2018, from 8:30 a.m. 
to 5 p.m. and on September 14, 2018, from 8 a.m. to 3 p.m.

ADDRESSES: FDA White Oak Conference Center, 10903 New Hampshire Ave., 
Bldg. 31 Conference Center, the Great Room (Rm. 1503), 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.

FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993-0002, 1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#faaeaaa9bbb9ba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="b7e3e7e4f6f4f7d1d3d699dfdfc499d0d8c1">[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 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 September 13 and 14, 2018, the Committee will discuss 
modified risk tobacco product applications, submitted by R.J. Reynolds 
Tobacco Company for six products:

<bullet> MR0000068: Camel Snus Frost
<bullet> MR0000069: Camel Snus Frost Large
<bullet> MR0000070: Camel Snus Mellow
<bullet> MR0000071: Camel Snus Mint
<bullet> MR0000072: Camel Snus Robust
<bullet> MR0000073: Camel Snus Winterchill

    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 
August 29, 2018. Oral presentations from the public will be scheduled 
between approximately 8 a.m. and 9 a.m. on September 14, 2018. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
August 16, 2018. 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 August 17, 2018.
    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 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. app. 2).

    Dated: June 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13405 Filed 6-21-18; 8:45 am]
BILLING CODE 4164-01-P


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