[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, PlavixTM (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
