[Federal Register: December 28, 2001 (Volume 66, Number 249)]
[Notices]
[Page 67268]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de01-102]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs 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's regulatory issues.
Date and Time: The meeting will be held on January 17 and 18, 2002,
from 8:30 a.m. to 4:30 p.m.
Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver
Spring, MD.
Contact: Jaime Henriquez, 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 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 January 17, 2002, the committee will discuss new drug
application (NDA) 20-757/S-021, AVAPRO (irbesartan), Sanofi-Synthelabo
(c/o Bristol-Myers Squibb), for the treatment of hypertensive patients
with type 2 diabetic renal disease. On January 18, 2002, the committee
will discuss NDA 21-387, pravastatin/aspirin, Bristol-Myers Squibb, co-
package, for long-term management to reduce the risk of death, nonfatal
myocardial infarction, myocardial revascularization procedures, and
ischemic stroke in patients with clinically evident coronary heart
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 January 7,
2002. Oral presentations from the public will be scheduled each day
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 January 7, 2002,
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: December 14, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-31879 Filed 12-27-01; 8:45 am]
BILLING CODE 4160-01-S