[Federal Register: November 18, 2003 (Volume 68, Number 222)]
[Notices]               
[Page 65075]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no03-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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 December 8, 2003, from 
8:30 a.m. to 5 p.m. and on December 9, 2003, from 8 a.m. to 4:30 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Dornette Spell-LeSane, Center for Drug Evaluation 
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: spelllesaned@cder.fda.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572) in the Washington, DC area), code 12533. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: On December 8, 2003, the committee will discuss whether 
aspirin should be recommended for primary prevention of myocardial 
infarction. Professional labeling for aspirin currently recommends its 
use for prevention of a second myocardial infarction. On December 9, 
2003, the committee will discuss new drug application (NDA) 21-526, 
proposed trade name Ranexa (ranolazine) 375 milligrams (mg) and 500 mg 
Tablets, CV Therapeutics Inc., for the proposed indication of treatment 
of chronic stable angina.
    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 by December 2, 
2003. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before December 2, 2003, 
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.
    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 Dornette Spell-
LeSane at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 10, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-28686 Filed 11-17-03; 8:45 am]

BILLING CODE 4160-01-S