Food and Drug Administration, HHS.
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: firstname.lastname@example.org, 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://www.fda.gov/ohrms/dockets/ac/acmenu.htm under the heading Start Printed 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).Start Signature
Dated: January 12, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1182 Filed 1-21-05; 8:45 am]
BILLING CODE 4160-01-S