Document ID: FDA-2015-N-0001-0013
Agency: fda
Document Type: Notice
Title: The Tobacco Products Scientific Advisory Committee; Notice of Meeting
Posted Date: 2015-02-13T05:00Z

[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8093-8094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03000]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

The Tobacco Products Scientific Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: The Tobacco Products Scientific Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 9, 2015, from 8:30 
a.m. to 5 p.m. and April 10, 2015, from 8 a.m. to 5 p.m.
    Location: FDA White Oak, 10903 New Hampshire Ave., Building 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: 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. 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 Web site at http://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.
    Agenda: On April 9 and 10, 2015, the Committee will discuss 
modified risk tobacco product applications submitted by Swedish Match 
North America Inc. for 10 tobacco products:
     MR0000020: General Loose, smokeless tobacco, loose snus, 
1.59 oz (45g), cardboard can (SKU 4852);
     MR0000021: General Dry Mint Portion Original Mini, 
smokeless tobacco, snus portions, 0.21 oz (6g), 20 0.3g portions, 
plastic can (SKU 4800);
     MR0000022: General Portion Original Large, smokeless 
tobacco, snus portions, 0.9 oz (24g), 24 1g portions, plastic can (SKU 
4880);
     MR0000023: General Classic Blend Portion White Large, 
smokeless tobacco, snus portions, 0.48 oz (13.5g), 15 0.9g portions, 
plastic can (SKU 4877);
     MR0000024: General Classic Blend Portion White Large, 
smokeless tobacco, snus portions, 0.38 oz (10.8g), 12 0.9g portions, 
plastic can (SKU 4878);
     MR0000025: General Mint Portion White Large, smokeless 
tobacco, snus portions, 0.9 oz (24g), 24 1g portions, plastic can (SKU 
4352);
     MR0000026: General Nordic Mint Portion White Large, 
smokeless tobacco, snus portions, 0.48 oz (13.5g), 15 0.9g portions, 
plastic can (SKU 4876);
     MR0000027: General Nordic Mint Portion White Large, 
smokeless tobacco, snus portions, 0.38 oz (10.8g), 12 0.9g portions, 
plastic can (SKU 4875);
     MR0000028: General Portion White Large, smokeless tobacco, 
snus portions, 0.9 oz (24g), 24 1g portions, plastic can (SKU 4881); 
and
     MR0000029: General Wintergreen Portion White Large, 
smokeless tobacco, snus portions, 0.9 oz (24g), 24 1g portions, plastic 
can (SKU 4882).
    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 Web site 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 Web site after

[[Page 8094]]

the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate 
advisory committee meeting link.
    Procedure: On April 9, 2015, from 8:30 a.m. to 4 p.m. and on April 
10, 2015, from 8 a.m. to 5 p.m., the meeting is open to the public. 
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 March 20, 2015. Oral 
presentations from the public will be scheduled between approximately 
11 a.m. and 12 p.m. on April 10, 2015. 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 March 12, 2015. 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 March 13, 2015.
    Closed Committee Deliberations: On April 9, 2015, between 4 p.m. 
and 5 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (see 5 
U.S.C. 552b(c)(3) and (c)(4)). This portion of the meeting will be 
closed because the Committee will be discussing trade secret and/or 
confidential data provided by Swedish Match North America Inc.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Caryn Cohen at least 
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://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: February 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03000 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P