[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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