[Federal Register Volume 65, Number 71 (Wednesday, April 12, 2000)]
[Notices]
[Pages 19781-19782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9003]


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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

[[Page 19782]]

(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 May 1, 2000, from 8:30 
a.m. to 5:30 p.m., and on May 2, 2000, from 9 a.m. to 5:30 p.m.
    Location: National Institutes of Health, 9000 Rockville Pike, Bldg. 
10, Clinical Center, Jack Masur Auditorium, Bethesda, MD.
    Contact Person: Joan C. Standaert, Center for Drug Evaluation and 
Research (HFD-110), Food and Drug Administration, Woodmont II Bldg., 
1451 Rockville Pike, Rockville, MD 20752, 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 May 1, 2000, the committee will discuss new drug 
applications (NDA) 21-188, Vanlev (omapatrilat) Bristol Myers 
Squibb to be indicated for hypertension, and NDA 19-901, 
Altace (ramipril) Capsules, King Pharmaceuticals, Inc., to be 
indicated for significant reduction of mortality, myocardial 
infarction, stroke, revascularization procedures, and heart failure in 
high risk patients. On May 2, 2000, the committee will discuss NDA 20-
807/S-004, Refludan [lepirudin(-DNA) for injection] Aventis 
Pharmaceuticals, Inc., to be indicated for anticoagulation in adult 
patients with acute coronary syndromes (unstable angina and acute 
myocardial infarction without ST segment elevations on 
electrocardiogram (EKG).
    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 24, 
2000. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. on May 1, 2000. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before April 24, 2000, 
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: April 4, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-9003 Filed 4-11-00; 8:45 am]
BILLING CODE 4160-01-F