[Federal Register Volume 65, Number 27 (Wednesday, February 9, 2000)]
[Notices]
[Page 6377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2861]



[[Page 6377]]

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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.
    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.

ACTION: Notice.

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    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 March 9, 2000, 8 a.m. to 
4:30 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Sandra L. Titus or LaNise S. Giles, 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 e-mail: <a href="/cdn-cgi/l/email-protection#1d497469686e6e5d7e79786f337b797c337a726b"><span class="__cf_email__" data-cfemail="f3a79a87868080b390979681dd959792dd949c85">[email protected]</span></a>, 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: The committee will discuss the best way to develop drugs 
for the treatment of the various psychiatric and behavioral 
disturbances that are frequently associated with Alzheimer's disease 
and other dementias. In particular, the presentations and discussions 
will focus on the problem of how to identify, define, and name the 
clinical entities that fall under this broad category of disorders. 
This is a major regulatory issue because the failure to adequately 
define specific disorders in this area could lead to misleading 
labeling. As background information for this meeting, FDA has provided 
an issues paper at http://www.fda.gov/ohrms/dockets/dockets/00n-0088/00n-0088.htm) that describes in detail the regulatory issues and 
concerns and proposes how this question might be addressed. This paper 
is intended to serve as a stimulus for others in the community of 
clinicians, academicians, and pharmaceutical sponsors to articulate and 
submit alternative positions in response to this question. Interested 
persons may submit written statements by February 17, 2000. Written 
statements submitted by the above date will be made available on FDA's 
website identified above. In addition to submitting written statements, 
interested persons are invited to make presentations of up to 10 
minutes in an expanded open public session at the March 9, 2000, 
meeting. Those persons interested in making a presentation should 
follow the procedures given in the ``Procedure'' section below.
    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 Dockets Management Branch, Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. These submissions should contain Docket No. 00N-0088, and should 
be received by February 17, 2000. Oral presentations from the public 
will be scheduled between approximately 10 a.m. and 12:30 p.m. 
Additional time may be allocated for oral presentations. Time allotted 
for each presentation may be limited to 10 minutes. Those desiring to 
make formal oral presentations should notify the contact person before 
February 17, 2000, 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: January 28, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-2861 Filed 2-8-00; 8:45 am]
BILLING CODE 4160-01-F


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