[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: 99-22101]


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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
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 Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.

    Date and Time: The meeting will be held November 3, 1999, 8 a.m. to 
4:30 p.m.

    Location: Hilton, Salons A, B, and C, 620 Perry Pkwy., 
Gaithersburg, 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 e-mail [email protected], 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 November 3, 1999, the committee will consider the safety 
and efficacy of new drug application (NDA) supplement 18-936/SE1-058, 
Prozac (fluoxetine hydrochloride, Lilly), proposed to treat 
premenstrual dysphoric 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 27, 
1999. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 27, 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. 99-22101 Filed 8-25-99; 8:45 am]
BILLING CODE 4160-01-F