[Federal Register Volume 66, Number 185 (Monday, September 24, 2001)]
[Notices]
[Pages 48884-48885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23749]


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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 October 11, 2001, from 9 
a.m. to 5 p.m.
    Location: National Institutes of Health, Bldg. 10, Jack Masur 
Auditorium, 9000 Rockville Pike, 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 Treacy or 
Jayne E. Peterson , 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: The committee will discuss new drug applications (NDA) 20-
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[[Page 48885]]

(capsules) and NDA 21-283 (tablets) Diovan (valsartan), 
Novartis Pharmaceuticals Corp., for the treatment of patients with 
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 October 5, 
2001. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 a.m. on October 11, 2001. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before October 5, 2001, 
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: September 18, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-23749 Filed 9-21-01; 8:45 am]
BILLING CODE 4160-01-S