[Federal Register Volume 73, Number 111 (Monday, June 9, 2008)]
[Notices]
[Pages 32588-32589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12870]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Peripheral and Central Nervous System Drugs
Advisory Committee and the Psychopharmacologic Drugs 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). The meeting will
be open to the public.
Name of Committees: Peripheral and Central Nervous System Drugs
Advisory Committee and the Psychopharmacologic Drugs Advisory
Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 10, 2008, from 8
a.m. to 5 p.m.
Location: Sheraton College Park Hotel, The Ballroom, 4095 Powder
Mill Rd., Beltsville, MD, 301-937-4422.
Contact Person: Yvette Waples, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: [email protected], or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), codes 3014512543 and 3014512544. 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: The Peripheral and Central Nervous System Drugs Advisory
Committee, the Psychopharmacologic Drugs Advisory Committee,
representatives from the Pediatric Advisory Committee, and the Drug
Safety and Risk Management Advisory Committee will consider the results
of FDA's analysis of suicidality (both suicidal ideation and behavior)
from placebo-controlled clinical studies of 11 drugs. The following
drugs will be considered: (1) Carbamazepine (marketed as CARBATROL,
Shire Pharmaceuticals, EQUETRO, Validus Pharmaceuticals, Inc.,
TEGRETOL, Tegretol XR, Novartis Pharmaceuticals Corp.); (2) felbamate
(marketed as FELBATOL, Meda Pharmaceuticals, Inc.); (3) gabapentin
(marketed as NEURONTIN, Pfizer, Inc.); (4) lamotrigine (marketed as
LAMICTAL, GlaxoSmithKline); (5) levetiracetam (marketed as KEPPRA, UCB,
Inc.); (6) oxcarbazepine (marketed as TRILEPTAL, Novartis
Pharmaceuticals Corp.); (7) pregabalin (marketed as LYRICA, Pfizer
Inc.); (8) tiagabine (marketed as GABITRIL, Cephalon, Inc.); (9)
topiramate (marketed as TOPAMAX, Ortho-McNeil-Janssen Pharmaceuticals,
Inc.,); (10) valproate (marketed as DEPAKOTE, DEPAKOTE ER, DEPAKENE,
DEPACON, Abbott Laboratories); and (11) zonisamide (marketed as
ZONEGRAN, Dainippon). FDA will discuss with the committee actions taken
in light of the results and whether any additional actions are
necessary.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
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 June
25, 2008. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 3 p.m. Those desiring to make 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 17, 2008. 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
[[Page 32589]]
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 18, 2008.
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 Yvette Waples 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/oc/advisory/default.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 2, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-12870 Filed 6-6-08; 8:45 am]
BILLING CODE 4160-01-S