[Federal Register: February 23, 2006 (Volume 71, Number 36)]
[Notices]
[Page 9357-9358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23fe06-65]
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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.
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
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.
[FR Doc. E6-2542 Filed 2-22-06; 8:45 am]
BILLING CODE 4160-01-S