[Federal Register Volume 71, Number 220 (Wednesday, November 15, 2006)]
[Notices]
[Pages 66545-66546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0414]


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 December 13, 2006, from 
8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted tohttp://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: 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.
    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

[[Page 66546]]

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.
[FR Doc. E6-19248 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S