[Federal Register Volume 62, Number 181 (Thursday, September 18, 1997)]
[Notices]
[Pages 49015-49016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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: Cardiovascular and Renal Drugs Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on October 23, 1997, 8:30 
a.m. to 5:30 p.m., and October 24, 1997, 9 a.m. to 4 p.m.
    Location: National Institutes of Health, Clinical Center, Bldg. 10, 
Jack Masur Auditorium, 9000 Rockville Pike, Bethesda, MD.
    Parking in the Clinical Center visitor area is reserved for 
Clinical Center patients and their visitors. If you must drive, please 
use an outlying lot such as Lot 41B. Free shuttle bus service is 
provided from Lot 41B to the Clinical Center every 8 minutes during 
rush hour and every 15 minutes at other times.
    Contact Person: Joan C. Standaert, Center for Drug Evaluation and 
Research (HFD-110), 419-259-6211, or Danyiel D'Antonio (HFD-21), 301-
443-5455, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), code 12533. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On October 23, 1997, the committee will discuss basic 
statistical considerations for the evaluation of active control 
clinical trials, and new drug application (NDA) 20-845, inhaled nitric 
oxide (Ohmeda Pharmaceutical Products Division, Inc.), for treatment of 
primary pulmonary hypertension of the newborn. On October 24, 1997, the 
committee will discuss NDA 20-839, Plavix<SUP>TM</SUP> (clopidogrel 
bisulfate, Sanofi

[[Page 49016]]

Pharmaceuticals, Inc.), for prevention of vascular ischemic events in 
patients with a history of symptomatic atherosclerotic disease.
    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 9, 
1997. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. on October 23, 1997. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 9, 1997, 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: September 10, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-24848 Filed 9-17-97; 8:45 am]
BILLING CODE 4160-01-F