[Federal Register Volume 75, Number 223 (Friday, November 19, 2010)]
[Notices]
[Page 70933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Cardiovascular and Renal Drugs 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 December 8, 2010, from 8
a.m. to 3:30 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: [sol][sol]www.fda.gov[sol]AdvisoryCommittees[sol]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 have a valid driver's license or other picture ID, and
must enter through Building 1.
Contact Person: Elaine Ferguson, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 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), 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: On December 8, 2010, from 8 a.m. to 11:30 a.m., the
committee will discuss and provide general advice on the appropriate
clinical study design for thromboxane receptor antagonists for
prevention of cardiovascular events (such as heart attacks) in patients
with aspirin intolerance due to immunologically-based adverse reactions
(adverse events related to immune system function), specifically in the
setting of coronary artery bypass grafting (also referred to as ``heart
bypass surgery'').
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:[sol][sol]www.fda.gov[sol]AdvisoryCommittees[sol]Calendar[sol]defau
lt.htm. Scroll down to the appropriate advisory committee link.
Procedure: On December 8, 2010, from 8 a.m. to 11:30 a.m., the
meeting is open to the public. 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 December 6, 2010. Oral presentations from the public will be
scheduled between approximately 10 a.m. and 11 a.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 November 29, 2010.
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 November 30, 2010.
Closed Presentation of Data: On December 8, 2010, from 12:30 p.m.
to 3:30 p.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential commercial information (5
U.S.C. 552b(c)(4)).
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:[sol][sol]www.fda.gov[sol]AdvisoryCommittees[sol]AboutAdvisoryCommi
ttees[sol]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: November 15, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-29278 Filed 11-18-10; 8:45 am]
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