
[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6903-6904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe09-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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 March 18, 2009, from 8
a.m. to 5 p.m.

[[Page 6904]]

    Location: Marriott Conference Centers, UMUC Inn and Conference
Center, 3501 University Blvd. East, Adelphi, MD. The hotel telephone
number is 301-985-7385.
    Contact Person: Elaine Ferguson, 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:
elaine.ferguson@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. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 22-
425, dronedarone 400 milligrams oral tablets, Sanofi Aventis, for the
proposed indication in patients with a history of, or current atrial
fibrillation or atrial flutter, for the reduction of the risk of
cardiovascular hospitalization or death. FDA intends to make background
material available to the public no later than 2 business days 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 2008 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
March 4, 2009. Oral presentations from the public will be scheduled
approximately between 1 p.m. to 2 p.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 proposed participants, and an
indication of the approximate time requested to make their presentation
on or before February 24, 2009. 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 February
25, 2009.
    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 Elaine Ferguson at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 4, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-2862 Filed 2-10-09; 8:45 am]

BILLING CODE 4160-01-S
