[Federal Register Volume 64, Number 165 (Thursday, August 26, 1999)]
[Notices]
[Page 46687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 October 7, 1999, from 8:30
a.m. to 5 p.m., and October 8, 1999 from 8 a.m. to 4:30 p.m.
Location: Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Sandra L. Titus, 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, or by e-mail at tituss@cder.fda.gov'', or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area) code 12544. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On October 7, 1999, the committee will consider the safety
and efficacy of new drug application (NDA) supplement 20-592/S-009,
Zyprexa (olanzapine, Lilly), proposed to treat psychosis
associated with dementia. On October 8, 1999, the committee will
consider the safety and efficacy of NDA supplement 19-839/S-026,
Zoloft (sertraline hydrochloride, Pfizer Pharmaceuticals)
proposed to treat posttraumatic stress disorder.
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 by October 1,
1999. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 1, 1999,
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 18, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-22099 Filed 8-25-99; 8:45 am]
BILLING CODE 4160-01-F
