[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Notices]
[Pages 71144-71145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33915]
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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 January 28, 1999, 9 a.m.
to 5:30 p.m. and January 29, 1999, 8:30 a.m. to 4:30 p.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 January 28, 1999, the committee will discuss new drug
application (NDA) 20-931, TikosynTM Capsules (dofetilide),
Pfizer Pharmaceuticals Production Corp., Ltd., for maintenance of
normal sinus rhythm with associated symptomatic relief in patients with
supraventricular arrhythmias, e.g., atrial flutter, atrial
fibrillation, and paroxsysmal supraventricular tachycardia; and
conversion of atrial fibrillation and flutter to normal sinus rhythm.
On January 29, 1999, the committee will discuss NDA 20-920,
Natrecor Injection (nesiritide), Scios, Inc., for short term
treatment of congestive heart failure.
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 January 18,
1999. Oral presentations from the public will be scheduled between
approximately 9 a.m. and 10 a.m. on January 28, 1999.
[[Page 71145]]
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
January 18, 1999, 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: December 16, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-33915 Filed 12-22-98; 8:45 am]
BILLING CODE 4160-01-F
