E6-19248. 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 December 13, 2006, from 8 a.m. to 5 p.m.

Addresses: Electronic comments should be submitted to http://www.fda.gov/​dockets/​ecomments. Select “2006N-0414 Suicidality data from Adult Antidepressant Trials” and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on December 1, 2006. All comments received will be posted without change, including any personal information provided. Comments received on or before December 1, 2006, will be provided to the committee before the meeting.

Location: Hilton Washington DC/Silver Spring, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-5200.

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.

Agenda: The committee will discuss the results of the FDA ongoing meta-analysis of suicidality data from adult antidepressant trials. 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 year 2006 and scroll down to PDAC meetings).

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 November 21, 2006. Oral presentations from the public will be scheduled between approximately 10 a.m. and 12 noon. 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 November 21, 2006. 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 November 27, 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: November 1, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.