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
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 April 18, 2007, 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 A. 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, FAX: 301-827-6776, e-mail: Cathy.Groupe@fda.hhs.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 application (sNDA) 20-758/S-037, AVALIDE (irbesartan plus hydrochlorothiazide), Bristol-Myers Squibb Co. The sponsor is seeking approval for first-line use in hypertensive patients unlikely to achieve blood pressure goals on one drug. The committee will be asked to consider what constitutes adequate data to support such a claim and how the information can be most usefully displayed in labeling.
FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link.
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 on or before April 3, 2007. Oral presentations from the public will be scheduled between approximately 8:30 a.m. to 9:30 a.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of Start Printed Page 9766proposed participants and an indication of the approximate time requested to make their presentation on or before March 26, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 27, 2007.
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 Cathy Groupe 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: February 26, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-3721 Filed 3-2-07; 8:45 am]
BILLING CODE 4160-01-S