[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Page 16976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8500]
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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 April 29, 1999, from 9
a.m. to 5:30 p.m., and on April 30, 1999, from 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.
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 Lauren W. Parcover (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 April 29, 1999, the committee will discuss new drug
application (NDA) 19-865/S-007, Betapace (sotalol), Berlex
Laboratories, Inc., for prevention of the recurrence of chronic or
paroxysmal symptomatic atrial fibrillation/atrial flutter. On April 30,
1999, the committee will discuss the interpretation of antiarrhythmic
trials in patients with implanted ventricular defibrillators.
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 21,
1999. 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 April 21, 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: March 26, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-8500 Filed 4-6-99; 8:45 am]
BILLING CODE 4160-01-F
