[Federal Register Volume 71, Number 139 (Thursday, July 20, 2006)]
[Notices]
[Page 41220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11537]


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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 September 7 and 8, 2006, 
from 8 a.m. to 5 p.m.
    Location: Hilton Hotel,The Ballrooms, 620 Perry Pkwy., 
Gaithersburg, MD 20877.
    Contact Person: Cicely Reese, 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://www.fda.gov/ohrms/dockets/ac/acmenu.htm under the heading ``Psychopharmacologic 
Drugs Advisory Committee (PDAC).'' (Click on the year 2006 and scroll 
down to PDAC meetings.)
    Agenda: On September 7, 2006, the committee will discuss new drug 
application (NDA) 21-999, paliperidone extended-release (ER) tablets, 
Janssen, L.P./Johnson & Johnson Pharmaceutical Research and 
Development, L.L.C., proposed indication for treatment of 
schizophrenia. On September 8, 2006, the committee will discuss NDA 21-
992, desvenlafaxine succinate (DVS 233), ER tablets, Wyeth 
Pharmaceuticals, proposed indication for 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 on or before 
August 23, 2006. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on both days. Time allotted for 
each presentation may be limited. 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 August 23, 2006.
    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 Cicely Reese 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: July 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11537 Filed 7-19-06; 8:45 am]
BILLING CODE 4160-01-S