E6-2542. Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

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). 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 25 and 26, 2006, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD, 301-977-8900.

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: [e-mail], 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: On April 25, 2006, the committee will meet between 8 a.m. to 5 p.m., to discuss new drug application (NDA) 21-359 CELLEGESIC (nitroglycerin [NTG] ointment), 0.4% intra-anal, Cellegy Pharmaceuticals, Inc., for the proposed indication of relief of pain associated with anal fissures. On April 26, 2006, the committee will meet between 8 a.m. to 12 noon, to discuss the agency's draft recommendations for relabeling of antihypertensive drugs for outcome claims, as a followup to the committee's meeting on June 15, 2005, where the committee discussed class labeling of antihypertensive drugs based on the proximity of their data to outcome trials. Following this, from approximately 1 p.m. to 5 p.m., the committee will discuss the “Placebo in Hypertension Adverse Reaction Meta-Analysis” Study, a meta-analysis of more than 80,000 patients in placebo-controlled trials of antihypertensive medications, which evaluated the risk of irreversible harm in conducting placebo-controlled trials in patients with 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/​orhms/​dockets/​ac/​acmenu.htm under the heading “Cardiovascular and Renal Drugs Advisory Committee.” (Click on the year 2006 and scroll down to the above named committee).

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 April 14, 2006. On April 25, 2006, oral presentations from the public will be scheduled between approximately 8:15 a.m. to 8:45 a.m. On April 26, 2006, oral presentations from the public will be scheduled between approximately 8:15 a.m. to 8:45 a.m. and 1 p.m. to 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 14, 2006, 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 John Lauttman at least 7 days in advance of the meeting at 301-827-7001.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: February 15, 2006.

Jason Brodsky,

Acting Associate Commissioner for External Relations.