[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Notices]
[Pages 55405-55406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18872]


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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: [email protected], 
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 
the meeting and will be posted on FDA's Web site at http://

[[Page 55406]]

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]
BILLING CODE 4160-01-S