[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Notices]
[Page 13412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7054]
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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 regulatory issues.
Date and Time: The meeting will be held on April 9, 1998, 8:30 a.m.
to 5:30 p.m., and April 10, 1998, 8:30 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 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 April 9, 1998, the committee will discuss nitric oxide.
On April 10, 1998, the committee will discuss new drug applications 20-
912 and 20-913, Aggrastat (tirofiban HCI), Merck Research
Laboratories, to be indicated: (1) In combination with heparin for
patients with unstable angina or non-Q-wave myocardial infarction to
prevent cardiac ischemic events, and (2) patients with coronary
ischemic syndromes undergoing percutaneous translumenal coronary
angioplasty or atherectomy to prevent cardiac ischemic complications
related to abrupt closure of the treated coronary artery.
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 2, 1998.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9:30 a.m. on April 9, 1998. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before April 2,
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).
Dated: March 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7054 Filed 3-18-98; 8:45 am]
BILLING CODE 4160-01-F
