[Federal Register: June 28, 2002 (Volume 67, Number 125)]
[Page 43634-43635]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee; Notice of 

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 
    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 July 18, 2002, from 8 
a.m. to 5 p.m. and on July 19, 2002, from 8 a.m. to 3 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD, 301-652-2000.
    Contact Person: Jayne E. Peterson, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, petersonj@cder.fda.gov, 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 July 18, 2002, beginning at 8 a.m., the committee will 
discuss supplemental new drug application (SNDA) 20-838/S-015, ATACAND 
(candesartan cilexetil) Tablets, AstraZeneca LP, for a proposed claim 
of comparative efficacy of candesartan cilexetil and losartan in 
hypertension. Beginning at 1 p.m., the committee will discuss new drug 
application (NDA) 21-387, PRAVIGARD PAC (pravastatin sodium/aspirin co-
packaged product), Bristol-Myers Squibb Co., proposed for long-term 
management to reduce the risk of cardiovascular events (death, nonfatal 
myocardial infarction, myocardial revascularization procedures, and 
ischemic stroke) in patients with clinically evident coronary heart 
disease. On July 19, 2002, the committee will discuss NDA

[[Page 43635]]

21-188, VANLEV (omapatrilat) Bristol-Myers Squibb Co., proposed for the 
treatment of hypertension. The background material for this meeting 
will be posted 1 working day before the meeting on the FDA Web site at 
    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 July 11, 2002. 
Oral presentations from the public will be scheduled between 
approximately 10:15 a.m. and 10:45 a.m. and 3:15 p.m. and 3:45 p.m. on 
July 18, 2002, and between approximately 10:15 a.m. and 10:45 a.m. on 
July 19, 2002.
    Time allotted for each presentation may be limited. Those desiring 
to make formal oral presentations should notify the contact person 
before July 11, 2002, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Jayne E. Peterson at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 21, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-16351 Filed 6-27-02; 8:45 am]