E7-18031. Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Cardiovascular and Renal Drugs Advisory Committee. This meeting was announced in the Federal Register of August 14, 2007 (72 FR 45435). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the meeting. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Cathy A. Miller, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5630 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 14, 2007, FDA announced that a meeting of the Cardiovascular and Renal Drugs Advisory Committee would be held on October 16 and 17, 2007.

On page 45435, in the second column, the Date and Time portion of the document is amended to read as follows:

Date and Time: The meeting will be held on October 16, 2007, from 8 a.m. to 5 p.m.

On page 45435, in the third column, the Agenda portion of the document is amended to read as follows:

Agenda: On October 16, 2007, the committee will discuss regulatory considerations for extending the use of phosphate binders from the dialysis population (where they are approved) to the pre-dialysis population (where no products are approved). The committee will hear presentations on this topic from Shire Development, Genzyme Corp., and Fresenius Medical Care.

Dated: September 5, 2007.

Randall W. Lutter,

Deputy Commissioner for Policy.