[Federal Register: February 23, 2006 (Volume 71, Number 36)]
[Page 9357-9358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee; Notice of 

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 
    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-

[[Page 9358]]

21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-
7001, 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: 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 
    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.
[FR Doc. E6-2542 Filed 2-22-06; 8:45 am]