80 FR 8093 - The Tobacco Products Scientific Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 30 (February 13, 2015)

Page Range		8093-8094
FR Document		2015-03000

Federal Register, Volume 80 Issue 30 (Friday, February 13, 2015)

[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8093-8094]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-03000]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8093

related to the approval process for these Freedom of Information request. Written 287–1373, email: TPSAC@fda.hhs.gov.
products that can be accomplished requests are to be sent to the Division A notice in the Federal Register about
under the Agency’s existing statutory of Freedom of Information (ELEM– last minute modifications that impact a
authority. FDA will consider comments 1029), Food and Drug Administration, previously announced advisory
received at this meeting as it moves 12420 Parklawn Dr., Element Bldg., committee meeting cannot always be
forward with this process. Rockville, MD 20857. Additionally, published quickly enough to provide
FDA has already opened public FDA will be recording the meeting via timely notice. Therefore, you should
docket FDA Docket No. FDA–2014–N– Adobe Connect on March 16, 2015. always check the Agency’s Web site at
1050 to receive comments on the issue Once the recording has been made 508 http://www.fda.gov/
(79 FR 53431, September 9, 2014). compliant, it will be accessible at FDA’s AdvisoryCommittees/default.htm and
Although you can comment on this CVM Web site at http://www.fda.gov/ scroll down to the appropriate advisory
document at any time, to ensure that the ForIndustry/UserFees/ committee meeting link, or call the
Agency considers your comment before AnimalDrugUserFeeActADUFA/ advisory committee information line to
finalizing work on the exploration ucm042891.htm. learn about possible modifications
process described in this document, before coming to the meeting.
Dated: February 10, 2015.
submit either electronic or written Agenda: On April 9 and 10, 2015, the
comments by March 31, 2016. Leslie Kux,
Committee will discuss modified risk
Associate Commissioner for Policy.
II. Participation in a Public Meeting tobacco product applications submitted
[FR Doc. 2015–03002 Filed 2–12–15; 8:45 am] by Swedish Match North America Inc.
While oral presentations from specific BILLING CODE 4164–01–P for 10 tobacco products:
individuals and organizations may be • MR0000020: General Loose,
limited due to time constraints during smokeless tobacco, loose snus, 1.59 oz
the public meeting, stakeholders may DEPARTMENT OF HEALTH AND (45g), cardboard can (SKU 4852);
submit electronic or written comments HUMAN SERVICES • MR0000021: General Dry Mint
discussing any issues of concern to the Portion Original Mini, smokeless
administration record (the docket). All Food and Drug Administration
tobacco, snus portions, 0.21 oz (6g), 20
relevant data and documentation should [Docket No. FDA–2015–N–0001] 0.3g portions, plastic can (SKU 4800);
be submitted with the comments to • MR0000022: General Portion
Docket No. FDA–2014–N–1050. Submit The Tobacco Products Scientific Original Large, smokeless tobacco, snus
electronic comments to http:// Advisory Committee; Notice of Meeting portions, 0.9 oz (24g), 24 1g portions,
www.regulations.gov. Submit written plastic can (SKU 4880);
comments to the Division of Dockets AGENCY: Food and Drug Administration, • MR0000023: General Classic Blend
Management (HFA–305), Food and Drug HHS. Portion White Large, smokeless tobacco,
Administration, 5630 Fishers Lane, Rm. ACTION: Notice. snus portions, 0.48 oz (13.5g), 15 0.9g
1061, Rockville, MD 20852. It is only portions, plastic can (SKU 4877);
necessary to send one set of comments. This notice announces a forthcoming • MR0000024: General Classic Blend
Identify comments with the docket meeting of a public advisory committee Portion White Large, smokeless tobacco,
number FDA–2014–N–1050. Received of the Food and Drug Administration snus portions, 0.38 oz (10.8g), 12 0.9g
comments may be seen in the Division (FDA). At least one portion of the portions, plastic can (SKU 4878);
of Dockets Management between 9 a.m. meeting will be closed to the public. • MR0000025: General Mint Portion
and 4 p.m., Monday through Friday, and Name of Committee: The Tobacco White Large, smokeless tobacco, snus
will be posted to the docket at http:// Products Scientific Advisory portions, 0.9 oz (24g), 24 1g portions,
www.regulations.gov. Committee. plastic can (SKU 4352);
III. Comments, Transcripts, and
General Function of the Committee: • MR0000026: General Nordic Mint
To provide advice and Portion White Large, smokeless tobacco,
Recorded Video recommendations to the Agency on snus portions, 0.48 oz (13.5g), 15 0.9g
Information and data submitted FDA’s regulatory issues. portions, plastic can (SKU 4876);
voluntarily to FDA during the public Date and Time: The meeting will be • MR0000027: General Nordic Mint
meeting will become part of the held on April 9, 2015, from 8:30 a.m. to Portion White Large, smokeless tobacco,
administrative record and will be 5 p.m. and April 10, 2015, from 8 a.m. snus portions, 0.38 oz (10.8g), 12 0.9g
accessible to the public at http:// to 5 p.m. portions, plastic can (SKU 4875);
www.regulations.gov. The transcript of Location: FDA White Oak, 10903 New • MR0000028: General Portion White
the proceedings from the public meeting Hampshire Ave., Building 31 Large, smokeless tobacco, snus portions,
will become part of the administrative Conference Center, the Great Room (Rm. 0.9 oz (24g), 24 1g portions, plastic can
record. Please be advised that as soon as 1503), Silver Spring, MD 20993–0002. (SKU 4881); and
a transcript is available, it will be Answers to commonly asked questions • MR0000029: General Wintergreen
accessible at http:// including information regarding special Portion White Large, smokeless tobacco,
www.regulations.gov, Docket No. FDA– accommodations due to a disability, snus portions, 0.9 oz (24g), 24 1g
2014–N–1050, and at FDA’s CVM Web visitor parking, and transportation may portions, plastic can (SKU 4882).
site at: http://www.fda.gov/ForIndustry/ be accessed at: http://www.fda.gov/ FDA intends to make background
UserFees/ AdvisoryCommittees/ material available to the public no later
AnimalDrugUserFeeActADUFA/ AboutAdvisoryCommittees/ than 2 business days before the meeting.
tkelley on DSK3SPTVN1PROD with NOTICES

ucm042891.htm. It may also be viewed ucm408555.htm. If FDA is unable to post the background
at the Division of Dockets Management Contact Person: Caryn Cohen, Office material on its Web site prior to the
(HFA–305), Food and Drug of Science, Center for Tobacco Products, meeting, the background material will
Administration, 5630 Fishers Lane, Rm. Food and Drug Administration, be made publicly available at the
1061, Rockville, MD 20852. A transcript Document Control Center, Bldg. 71, Rm. location of the advisory committee
will also be available in either hardcopy G335, 10903 New Hampshire Ave., meeting, and the background material
or on CD–ROM, after submission of a Silver Spring, MD 20993–0002, 1–877– will be posted on FDA’s Web site after

VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1

Document Created: 2015-12-18 13:18:23
Document Modified: 2015-12-18 13:18:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
FR Citation		80 FR 8093

80 FR 8093 - The Tobacco Products Scientific Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 30 (February 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration