[Federal Register Volume 73, Number 111 (Monday, June 9, 2008)]
[Pages 32588-32589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12870]



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.


    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 
    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 
    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 
    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 
    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 
    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]