E6-14294. Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [phone], e-mail: [e-mail], 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.