[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Pages 20965-20966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10451]



Food and Drug Administration

[Docket No. FDA-2009-N-0197]

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 June 9, 2009 from 8 a.m. 
to 6 p.m. and June 10, 2009, from 8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://www.regulations.gov. Enter ``FDA-2009-N-0197 Use of Antipsychotics for 
Schizophrenia and Bipolar Disorder in Pediatric and Adolescent 
Patients'' 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. All comments received will be posted without 
change, including any personal information provided. Comments received 
on or before May 26, 2009, will be provided to the committee before the 
    Location: Marriott Conference Centers, UMUC Inn and Conference 
Center, 3501 University Blvd. East, Adelphi, MD. The hotel telephone 
number is 301-985-7385.
    Contact Person: Diem-Kieu Ngo, 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 hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On both days, the committee will discuss safety and 
efficacy issues for the following new drug applications (NDAs): (1) NDA 
20-639/S-045 and S-046: SEROQUEL (quetiapine fumarate) Tablets, 
AstraZeneca Pharmaceuticals LP, for the acute treatment of 
schizophrenia in adolescents from 13 to 17 years of age, and the acute 
treatment of bipolar mania in children from 10 to 12 years of age and 
adolescents from 13 to 17 years of age; (2) NDA 20-825/S-032: GEODON 
(ziprasidone hydrochloride) Capsules, Pfizer Inc., for the acute 
treatment of manic or mixed episodes associated with bipolar disorder, 
with or without psychotic features in children and adolescents ages 
from 10 to 17 years of age; and (3) NDA 20-592/S-040 and S-041: ZYPREXA 
(olanzapine) Tablets, Eli Lilly and Co., for the acute treatment of 
manic or mixed episodes associated with bipolar I disorder and the 
acute treatment of schizophrenia in adolescents. The committee will be 
asked to vote on whether or not these products have been shown to be 
effective and acceptably safe for these pediatric indications.
    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 
    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 May 
26, 2009. Oral presentations from the public will be scheduled between 
approximately 4 p.m. and 6 p.m. on June 9, 2009. 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 May 22, 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 May 26, 2009.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Diem-Kieu Ngo 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 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

[[Page 20966]]

    Dated: April 28, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-10451 Filed 5-5-09; 8:45 am]