[Federal Register Volume 66, Number 82 (Friday, April 27, 2001)]
[Notices]
[Pages 21159-21160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10450]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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 May 24, 2001, from 8:30 
a.m. to 5 p.m., and on May 25, 2001, from at 9 a.m. to 3:30 p.m.
    Location: National Institutes of Health (NIH), 9000 Rockville Pike, 
Bldg. 10, Clinical Center, Jack Masur Auditorium, Bethesda, MD.
    Contact: 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, 
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.

[[Page 21160]]

    Agenda: On May 24, 2001, the committee will discuss: (1) Published 
interim analyses of ALLHAT (antihypertensive and lipid lowering 
treatment to prevent heart attack trial) sponsored by the National 
Heart, Lung, and Blood Institute, NIH, and (2) response to the 
citizen's petition of Lawrence D. Bernhardt and Arnold Liebman, 
regarding new drug application (NDA) 19-668, Cardura 
(doxazosin), Pfizer, Inc. On May 25, 2001, the committee will discuss 
NDA 20-920 Natrecor (nesiritide), Scios, Inc., for treatment 
of acute 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 May 18, 2001. 
Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 18, 2001, and 
submit a brief statement on 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 11, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-10450 Filed 4-26-01; 8:45 am]
BILLING CODE 4160-01-S