[Federal Register: December 23, 2002 (Volume 67, Number 246)]
[Notices]
[Page 78235]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de02-53]
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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 January 6, 2003, from
8:30 a.m. to 5 p.m.; and on January 7, 2003, from 8 a.m. to 4:30 p.m.
Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver
Spring, MD.
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. When available, background materials for
this meeting will be posted 1-business day prior to the meeting on the
FDA Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the
year 2003 and scroll down to Cardiovascular and Renal Drugs Advisory
Committee.)
Agenda: On January 6, 2003, beginning at 8:30 a.m., the committee
will discuss supplemental new drug application (SNDA) 20-386/S-032,
COZAAR (losartan potassium) Tablets, Merck and Co., for the proposed
indication of reduction in the risk of cardiovascular morbidity and
mortality as measured by the combined incidence of cardiovascular
death, stroke, and myocardial infarction in hypertensive patients with
left ventricular hypertrophy. On January 7, 2003, beginning at 8 a.m.,
the committee will discuss SNDA 20-297/S-009, COREG (carvedilol),
GlaxoSmithKline, for the proposed indication to reduce mortality and
the risk of infarction in clinically stable patients who have survived
the acute phase of a myocardial infarction and have a left ventricular
ejection fraction <=40 percent.
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 December 23,
2002. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on January 6 and 7, 2003. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before December 23,
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: December 16, 2002.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 02-32159 Filed 12-20-02; 8:45 am]
BILLING CODE 4160-01-S