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