[Federal Register Volume 73, Number 207 (Friday, October 24, 2008)]
[Notices]
[Pages 63489-63490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25389]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Peripheral and Central Nervous System 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 Committee: Peripheral and Central Nervous System Drugs 
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 January 7 and 8, 2009, 
from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Rockville, The Ballrooms, 1750 
Rockville Pike, Rockville, MD. The hotel telephone number is 301-468-
1100.
    Contact Person: Diem-Kieu Ngo, 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), code 301-451-2543. 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

[[Page 63490]]

site and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On January 7, 2009, the committee will discuss new drug 
application (NDA) 20-427, vigabatrin, Ovation Pharmaceuticals, Inc., 
for the proposed indication of adjunctive therapy for the treatment of 
refractory complex partial seizures in adults. January 8, 2009, the 
committee will discuss NDA 22-006, vigabatrin, Ovation Pharmaceuticals, 
Inc., for the proposed indication of treatment of infantile spasms.
    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 2009 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 
December 23, 2008. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on both days. 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 December 16, 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 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 December 17, 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 Diem-Kieu Ngo 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: October 16, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-25389 Filed 10-23-08; 8:45 am]
BILLING CODE 4160-01-S