[Federal Register Volume 66, Number 138 (Wednesday, July 18, 2001)]
[Notices]
[Page 37481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17921]


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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 August 9, 2001, from 
8:30 a.m. to 5 p.m., and on August 10, 2001, from 8:30 a.m. to 3 p.m.
    Location: National Institutes of Health, Jack Masur Auditorium, 
Bldg. 10, 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 Jaime Henriquez, 
301-827-6803, 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 August 9, 2001, in the morning, the committee will 
discuss new drug application (NDA) 21-272, Remodulin 
(treprostinil sodium injection), United Therapeutics Corp., for the 
treatment of pulmonary hypertension. On August 9, 2001, in the 
afternoon, the committee will discuss NDA 21-321, Extraneal 
(7.5 percent icodextrin) peritoneal dialysis solution, Baxter 
Healthcare Corp. On August 10, 2001, in the morning, the committee will 
discuss NDA 21-290, Tracleer (bosentan tablets), Actelion, 
Ltd., for the treatment of pulmonary hypertension.
    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 August 2, 
2001. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9 a.m. on each day. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 2, 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: July 12, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-17921 Filed 7-17-01; 8:45 am]
BILLING CODE 4160-01-S