[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Page 16977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8501]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Peripheral and Central Nervous System 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 is 
open to the public.
    Name of Committee: Peripheral and Central Nervous System 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 April 28 and 29, 1999, 
8:30 a.m. to 5 p.m.
    Location: Holiday Inn Gaithersburg, The Ballrooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Sandra Titus or Tony Slater, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-21), 5600 
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12543. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On April 28, 1999, the committee will discuss the safety 
and efficacy of new drug application (NDA) 20-884, 
AggrenoxTM (dipyridamole/aspirin capsules, Boehringer 
Ingelheim Pharmaceuticals, Inc.), proposed to reduce the combined risk 
of death and nonfatal stroke in patients who have had transient 
ischemia of the brain or completed ischemic stroke.
     On April 29, 1999, the committee will discuss the safety and 
efficacy of NDA 20-399, Freedox (tirilazad mesylate 
injection, Pharmacia and Upjohn, Inc.), proposed for the treatment of 
aneurysmal subarachnoid hemorrhage to improve survival and functional 
outcome in patients with poor neurologic function following the initial 
hemorrhage.
    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 April 21, 
1999. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on April 28 and 29, 1999. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before April 21, 
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: March 26, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-8501 Filed 4-6-99; 8:45 am]
BILLING CODE 4160-01-F