[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20927-20928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08069]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
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 April 30, 2013, from
8:30 a.m. to 5:30 p.m.
Location: 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 5), email: [email protected], 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 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: Modified risk tobacco products (MRTPs) are tobacco products
that are sold or distributed for use to reduce harm or the risk of
tobacco-related disease associated with commercially marketed tobacco
products. Before an MRTP can be introduced or delivered for
introduction into interstate commerce, an order from
[[Page 20928]]
FDA under section 911(g) (21 U.S.C. 387k(g)) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) must be in effect with respect to the
tobacco product. 21 U.S.C. 387k(a). Any person may submit an
application seeking an order under section 911(g) of the FD&C Act.
Section 911(f) of the FD&C Act (21 U.S.C. 387k(f)) requires FDA to
refer modified risk tobacco product applications to the Tobacco
Products Scientific Advisory Committee (TPSAC) for its recommendations.
TPSAC is required to report its recommendations on an application to
FDA no later than 60 days after the date the application is referred to
them. 21 U.S.C. 387k(f)(2). On April 30, 2013, FDA will present
information to the committee on the process it will use to refer
individual modified risk tobacco product applications to TPSAC.
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 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 30, 2013, from 8:30 a.m. to 3 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 April 23, 2013. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 noon on April 30, 2013.
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
April 15, 2013. 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 April 16, 2013.
Closed Committee Deliberations: On April 30, 2013 from 3:30 p.m. to
5:30 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)).
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: April 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08069 Filed 4-5-13; 8:45 am]
BILLING CODE 4160-01-P