[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19374-19375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8284]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Joint Meeting of the Cardiovascular and Renal Drugs Advisory
Committee and the Drug Safety and Risk Management 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
[[Page 19375]]
of the Food and Drug Administration (FDA). The meeting will be open to
the public.
Name of Committees: Cardiovascular and Renal Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 2, 2011, from 8 a.m.
to 4 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center, rm. 1503, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Information regarding special accommodations due
to a disability, visitor parking and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings''.
Please note that visitors to the White Oak Campus must enter through
Building 1.
Contact Person: Nicole Vesely, Pharm.D., Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Avenue,
WO31-2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-
8533, e-mail: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product area.
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: On May 2, 2011, the committees will discuss safety
considerations of ultrasound contrast agents (materials intended to
improve the clarity of ultrasound imaging), particularly related to new
information and developments since the prior Advisory Committee meeting
on the same topic on June 24, 2008. The discussion will include the
results of required postmarketing safety studies and data from
postmarketing surveillance. Specific drugs to be discussed include: (1)
New drug application (NDA) 21-064, perflutren lipid microsphere
injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899,
perflutren protein-type A microspheres injectable suspension, GE
Healthcare; and (3) the investigational new drug (IND) application for
sulfur hexafluoride microbubble injection, Bracco Diagnostics, Inc.
Perflutren lipid microsphere injectable suspension and perflutren
protein-type A microspheres injectable suspension are indicated for use
in patients with suboptimal echocardiograms to opacify the left
ventricular chamber and to improve the delineation of the left
ventricular endocardial border (improve the clarity of imaging of
specific areas of the left lower side of the heart).
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/AdvisoryCommittees/Calendar/default.htm. 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 committees.
Written submissions may be made to the contact person on or before
April 18, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making 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 April 8, 2011. 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 April 11, 2011.
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 Nicole Vesely 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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 March 22, 2011.
Leslie Kux,
Acting Associate Commissioner for Policy.
[FR Doc. 2011-8284 Filed 4-6-11; 8:45 am]
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