[Federal Register: August 10, 2004 (Volume 69, Number 153)]
[Notices]               
[Page 48509-48510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au04-95]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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 September 10, 2004, from 
8:30 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, 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 
3014512533. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: The committee will discuss new drug application (NDA) 21-
686 proposed trade name EXANTA (ximelagatran) 24-milligram (mg) and

[[Page 48510]]

36-mg tablets, AstraZeneca, for the proposed indication of the 
prevention of venous thromboembolism (VTE) in patients undergoing knee 
replacement surgery, the prevention of stroke, and other thromboembolic 
complications associated with atrial fibrillation and the long term 
secondary prevention of VTE after standard treatment of an episode of 
acute VTE.
    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 September 2, 
2004. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before September 2, 2004, 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: August 1, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-18166 Filed 8-9-04; 8:45 am]

BILLING CODE 4160-01-S