[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