[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Page 51197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cardiovascular and Renal Drugs Advisory Committee; Amendment of 
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Cardiovascular and Renal 
Drugs Advisory Committee. This meeting was originally announced in the 
Federal Register of August 1, 2006 (71 FR 43487). The amendment is 
being made to reflect changes in the Agenda portion of the document. 
The word ``TRASYOL'' should read ``TRASYLOL''. In the same paragraph, 
the word ``apportioning'' should read ``aprotinin''. There are no other 
changes.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected], 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 1, 2006, 
FDA announced that the Cardiovascular and Renal Drugs Advisory 
Committee would meet on September 21, 2006, from 8 a.m. to 5 p.m., and 
the committee would discuss clinical data for aprotinin injection 
(trade name, TRASYLOL), an approved product, new drug application (NDA) 
020-304, Bayer Pharmaceuticals). On page 43487, in the third column, 
the Agenda portion of the document is amended to read as follows:
    Agenda: The committee will discuss clinical data for aprotinin 
injection (trade name, TRASYLOL), 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 
aprotinin injection (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 Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm under the heading ``Cardiovascular and Renal 
Drugs Advisory Committee'' (Click on the year 2006 and scroll down to 
the above named committee meeting.)
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-14294 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S