[Federal Register: January 24, 2005 (Volume 70, Number 14)]
[Notices]               
[Page 3374-3375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja05-47]                         

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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 (CRDAC).
    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 February 24, 2005, from 
8 a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers 
Lane, Rockville, MD.
    Contact Person: Cathy Groupe, 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, e-mail: groupec@cder.fda.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512533. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss supplemental new drug 
applications (sNDAs) S-022, S-024, and S-025 to approved new drug 
application (NDA) 20-838, ATACAND (candesartan cilexetil) Tablets (4 
milligrams (mg), 8 mg, 16 mg, and 32 mg), AstraZeneca LP, for the use 
in the treatment of patients with congestive heart failure, 
specifically in the following ways: (1) S-022, reducing the risk of 
cardiovascular mortality or heart failure hospitalization when added to 
an angiotensin-converting enzyme inhibitor-containing regimen in 
congestive heart failure patients with left ventricular systolic 
dysfunction; (2) S-024, reducing the risk of cardiovascular mortality 
or heart failure hospitalization in congestive heart failure patients 
with left ventricular systolic dysfunction, as a primary renin-
angiotensin-aldosterone system modulating treatment; and (3) S-025, 
reducing the frequency of hospitalizations for heart failure in 
congestive heart failure patients with preserved left ventricular 
systolic dysfunction. ATACAND is currently approved for use in the 
treatment of hypertension. The background material will become 
available no later than the day before the meeting and will be posted 
on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm 

under the heading

[[Page 3375]]

``Cardiovascular and Renal Drugs Advisory Committee.'' (Click on the 
year 2005 and scroll down to CRDAC meetings.)
    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 February 16, 
2005. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before February 16, 2005, 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 Beverly O'Neil at 
301-827-7001 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: January 12, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1182 Filed 1-21-05; 8:45 am]

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