E6-11537. 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 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: [phone], e-mail: [e-mail], 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.