Document ID: FDA-2010-N-0001-0059
Agency: fda
Document Type: Notice
Title: Meetings: Cardiovascular and Renal Drugs Advisory Committee
Posted Date: 2010-06-02T04:00Z

[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Notices]               
[Page 30839]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn10-85]                         

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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). The meeting will 
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 28, 2010, from 8 
a.m. to 5 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College, 3501 University Blvd. East, Adelphi, MD. 
The conference center telephone number is 301-985-7300.
    Contact Person: Elaine Ferguson, c/o Christine Shipe, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2419, Silver 
Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8532, e-mail: 
elaine.ferguson@fda.hhs.gov, 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 July 28, 2010, the committee will discuss new drug 
application (NDA) 22-433, ticagrelor tablets, 90 milligrams, 
manufactured by AstraZeneca LP, for the proposed indication for use in 
acute coronary syndrome (including heart attacks and any of a group of 
signs and symptoms, such as chest pain or shortness of breath, that are 
consistent with blockages in the blood vessels that supply 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 committee. 
Written submissions may be made to the contact person on or before July 
14, 2010. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Those desiring to make 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 July 6, 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 July 7, 
2010.
    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).

    Dated: May 27, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-13141 Filed 6-1-10; 8:45 am]
BILLING CODE 4160-01-S