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Food and Drug Administration, HHS.
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://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 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@example.com, 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://www.fda.gov/AdvisoryCommittees/Calendar/default.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://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).Start Signature
Dated: November 15, 2010.
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-29278 Filed 11-18-10; 8:45 am]
BILLING CODE 4160-01-P