[Federal Register Volume 74, Number 41 (Wednesday, March 4, 2009)]
[Notices]
[Pages 9406-9407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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.

[[Page 9407]]

    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 April 7 and 8, 2009, 
from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd, Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Yvette Waples, 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. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hotline/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On April 7, 2009, the committee will discuss safety and 
efficacy issues of new drug application (NDA) 20-644, sertindole 
(Serdolect) tablets, Lundbeck USA, proposed for the treatment of 
schizophrenia. On April 8, 2009, the committee will discuss safety and 
efficacy issues of supplemental new drug applications (sNDAs) 22-047/S-
010/S-011/S-012, quetiapine b6 maleate (Seroquel XR), Astra Zeneca 
Pharmaceuticals LP, proposed for the treatment of major depressive 
disorder and 22-047/S-014/S-015, Seroquel XR (quetiapine maleate), 
Astra Zeneca Pharmaceuticals LP, proposed for the treatment of 
generalized anxiety disorder. Particular safety issues for discussion 
on April 8, 2009, regarding the Seroquel XR applications are concerns 
regarding exposing a greatly expanded population to a drug with known 
metabolic side effects and a possible risk of tardive dyskinesia.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2009 and scroll down to the appropriate advisory committee 
link.
    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 
March 27, 2009. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on both days. 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 March 18, 2009. 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 March 23, 2009.
    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 John Lauttman at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 26, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-4523 Filed 3-3-09; 8:45 am]
BILLING CODE 4160-01-S