[Federal Register: December 23, 2002 (Volume 67, Number 246)]
[Page 78235]
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 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 
    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 
    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]