[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32219-32220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13779]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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: 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 July 21, 2011, from 9 
a.m. to 5 p.m., and on July 22, 2011, from 8 a.m. to 5 p.m.
    Location: Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-
1373.
    Contact Person: Caryn Cohen, Center for Tobacco Products, Food and 
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-
287-1373 (choose option 4), e-mail: [email protected], or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), and follow the prompts to the desired center or 
product area. Please call the Information Line for up-to-date 
information on this meeting. 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On the morning of July 21, 2011, the committee will discuss 
changes proposed by committee members to the Tobacco Products 
Scientific Advisory Committee (TPSAC) Menthol Report submitted to the 
Agency on March 18, 2011. The committee will consider additional oral 
and written comments from the public on the Menthol Report and the 
proposed changes to the report, as submitted according to the 
instructions in the Procedure portion of this document. The committee 
will consider and deliberate on proposed changes to the report and 
adopt amendments that constitute the advice of the committee. Redacted 
versions of the document, reflecting the changes to the report proposed 
by the committee members, will be made available on the FDA Web site at 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm237359.htm, no later than 
June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011, 
the TPSAC will initiate discussions on the issue of the nature and 
impact of the use of dissolvable tobacco products on the

[[Page 32220]]

public health. These discussions will begin the process for the TPSAC's 
required report to the Secretary of Health and Human Services regarding 
the issue of the nature and impact of the use of dissolvable tobacco 
products on the public health, including such use among children. The 
final report should take into consideration the following: (1) The 
risks and benefits to the population as a whole, including users and 
nonusers of tobacco products; (2) the increased or decreased likelihood 
that existing users of tobacco products will stop using such products; 
and (3) the increased or decreased likelihood that those who do not use 
tobacco products will start using such products.
    FDA intends to make redacted 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 the meeting. Background material 
is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: On July 21, 2011, from 9 a.m. to 5 p.m., and on July 22, 
from 8 a.m. to 12 noon, 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 July 5, 2011. Oral presentations 
from the public will be scheduled between approximately 10 a.m. and 11 
a.m. on both July 21, 2011, and July 22, 2011. 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 June 27, 2011. 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 June 28, 2011.
    Closed Committee Deliberations: On July 22, 2011, from 1 p.m. to 5 
p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). This portion of the meeting must be closed because the 
Committee will be discussing trade secret and/or confidential data 
regarding dissolvable tobacco products provided by the tobacco 
companies.
    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: May 25, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-13779 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P