[Federal Register: June 28, 2002 (Volume 67, Number 125)]
[Notices]
[Page 43634-43635]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn02-79]
-----------------------------------------------------------------------
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 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
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
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
outlets.
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]
BILLING CODE 4160-01-S