[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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