[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Notices]
[Page 9765-9766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr07-55]
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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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
[[Page 9766]]
proposed 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).
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