[Federal Register Volume 63, Number 123 (Friday, June 26, 1998)]
[Notices]
[Page 34901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17211]
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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). At least one
portion of the meeting will be closed 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 July 9, 1998, 9 a.m. to
5:30 p.m., and July 10, 1998, 9 a.m. to 12 m.
Location: National Institutes of Health, Natcher Conference Center,
45 Center Dr., Bethesda, MD.
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 July 9, 1998, the committee will review new drug
application (NDA) 20-863 Pletal (cilostazol) (Otsuka America
Pharmaceutical Inc.) to be indicated for intermittent claudication. On
July 10, 1998, the committee will discuss and review trade secret and/
or confidential information.
Procedure: On July 9, 1998, from 9 a.m. to 5:30 p.m., the meeting
is open to the public. 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
July 2, 1998. Oral presentations from the public will be scheduled
between approximately 9 a.m. and 10 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 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.
Closed Committee Deliberations: On July 10, 1998, 9 a.m. to 12 m.,
the meeting will be closed to permit discussion and review of trade
secret and/or confidential information (5 U.S.C. 552b(c)(4)). This
portion of the meeting will be closed to permit discussion on pending
investigational new drug application issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17211 Filed 6-24-98; 11:16 am]
BILLING CODE 4160-01-F
