[Federal Register: September 15, 2005 (Volume 70, Number 178)]
[Page 54559]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee; Notice of 

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 
    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 November 16, 2005, from 
8 a.m. to 5 p.m.
    Location: Food and Drug Administration, CDER Advisory Committee 
Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Cathy Groupe, 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, e-mail: GroupeC@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-
628, proposed trade name CERTICAN (everolimus) Tablets (0.25 milligrams 
(mg), 0.50 mg, 0.75 mg, and 1.0 mg), Novartis Pharmaceuticals 
Corporation, for the proposed indication of prophylaxis of rejection in 
heart transplantation. The background material will become available no 
later than the day before the meeting and will be posted on FDA's Web 
site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the 

year 2005 and scroll down to the heading Cardiovascular and Renal Drugs 
Advisory Committee.)
    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 November 8, 
2005. 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 November 8, 2005, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Beverly O'Neil at 
301-827-7001, 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: September 6, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-18365 Filed 9-14-05; 8:45 am]