[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Notices]
[Page 55405-55406]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se05-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 Committee: Psychopharmacologic 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 October 25, 2005, from 8
a.m. to 5 p.m. and on October 26, 2005, from 8 a.m. to 3 p.m.
Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
The hotel phone number is 301-977-8900.
Contact Person: Karen Templeton-Somers, 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: somersk@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512544. Please call the
Information Line for up-to-date information on this meeting. The
background material will become available no later than the day before
[[Page 55406]]
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm under the heading
``Psychopharmacologic Drugs Advisory Committee (PDAC)'' (click on the
year 2005 and scroll down to PDAC meetings).
Agenda: On October 25, 2005, the committee will discuss issues and
questions pertinent to the need for longer-term efficacy data for
proposed drug treatments for chronic psychiatric disorders, and issues
and questions pertinent to optimal study designs for obtaining valid
information about longer-term benefits of drug treatment. On October
26, 2005, the committee will discuss the question of whether or not
dietary restrictions would be needed for the 20 milligrams (mg) dose
for proposed trade name EMSAM (selegiline transdermal system) (new drug
applications (NDAs): NDA 21-336, short-term claim, and NDA 21-708,
longer-term claim, Somerset Pharmaceuticals), for the treatment of
major depressive disorder.
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 by October 12,
2005. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on October 25, 2005, and between
approximately 11 a.m. and 11:30 a.m. on October 26, 2005. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before October 12,
2005, 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.
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 Karen Templeton-
Somers at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 8, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-18872 Filed 9-20-05; 8:45 am]
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