[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Page 43487-43488]
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 September 21, 2006, 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, FAX: 301-827-6778, e-mail: Cathy.Groupe@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.
    Agenda: The committee will discuss clinical data for aprotinin 
injection (trade name, TRASYOL), an approved product, new drug 
application (NDA) 020-304, Bayer Pharmaceuticals) with the indication 
for prophylactic use to reduce perioperative blood loss and the need 
for blood transfusion in patients undergoing cardiopulmonary bypass in 
the course of coronary artery bypass graft surgery. This discussion 
follows a February 8, 2006, FDA Public Health Advisory for the use of 
apportioning injection (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/drug/advisory/aprotinin.htm). 

The background material for this meeting will be posted 1 business day 
before the meeting on FDA's Website 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
 under the heading ``Cardiovascular and Renal 

Drugs Advisory Committee.'' (Click on the

[[Page 43488]]

year 2006 and scroll down to the above named committee meeting.)
    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 
September 13, 2006. 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 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 September 13, 2006.
    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 John Lauttman 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: July 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-12269 Filed 7-31-06; 8:45 am]