[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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]
BILLING CODE 4160-01-P