[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Notices]
[Pages 50917-50918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25360]
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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 October 22, 1998, 9 a.m.
to 5:30 p.m., and October 23, 1998, 9 a.m. to 3 p.m.
Location: National Institutes of Health, Clinical Center, Bldg. 10,
Jack Masur Auditorium, 9000 Rockville Pike, Bethesda, MD. Parking in
the Clinical Center is reserved for Clinical Center patients and their
visitors.
Contact Person: Joan C. Standaert, Center for Drug Evaluation and
Research (HFD-110), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 419-259-6211, or John M. Treacy (HFD-21), 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 October 22, 1998, the committee will discuss guidelines
for the study of congestive heart failure. On October 23, 1998, the
committee will discuss new drug application (NDA) 20-873, Hirulog
(bivalirudin, The Medicine's Co.), injection for anticoagulation in
patients undergoing percutaneous transluminal angioplasty.
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 14,
1998. Oral presentations from the public will be scheduled between
approximately 9 a.m. and 10 a.m. on October 23, 1998. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 14, 1998,
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).
[[Page 50918]]
Dated: September 16, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-25360 Filed 9-22-98; 8:45 am]
BILLING CODE 4160-01-F
