[Federal Register: May 2, 2003 (Volume 68, Number 85)]
[Page 23467-23468]
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). At least one 
portion of the meeting will be closed 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 May 29, 2003, from 8 
a.m. to 5 p.m. and on May 30, 2003, from 8 a.m. to 12 noon.
    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: www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the 
year 2003 and scroll down to Cardiovascular and Renal Drugs Advisory 
Committee meetings.)
    Agenda: On May 29, 2003, the committee will discuss QT prolongation 
issues associated with two new drug applications (NDAs): (1) NDA 21-
287, (alfuzosin HCl), Sanofi-Synthelabo Inc., for the proposed 
indication of treatment of the signs and symptoms of benign prostatic 
hyperplasia; and (2) NDA 21-400, Levitra (vardenafil HCl), Bayer Corp., 
proposed for the indication of treatment of erectile dysfunction. The 
discussion will focus on: (1) Clinical trial designs for assessment of 
QT prolongation; (2) approaches to the correction of QT interval for 
drugs that affect the heart rate; and (3) risks of cardiac arrythmias 
associated with different degrees of QT prolongation. Premarketing 
clinical safety data from these applications and postmarketing safety 
data relevant to cardiac QT prolongation from drugs in the same two 
drug classes (i.e., alpha adrenergic blockers and phosphodiesterase 
type 5 inhibitors) will be considered.
    On May 30, 2003, the meeting will be closed to permit discussion 
and review of trade secret and/or confidential information.
    Procedure: On May 29, 2003, the meeting is open to the public. 
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 May 21, 2003. Oral presentations 
from the public will be scheduled between approximately 1 p.m. and 2 
p.m. on May 29, 2003. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before May 21, 2003, 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.
    Closed Presentation of Data: On May 30, 2003, the meeting will be 
closed to permit discussion and review of trade secret and/or 
confidential information (5 U.S.C. 552b(c)(4)).
    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

[[Page 23468]]

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: April 24, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-10805 Filed 5-1-03; 8:45 am]