Nonclinical Studies Subcommittee of the

Advisory Committee for Pharmaceutical Science

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

November 13, 2001

Backgrounder Contents

Agenda

Federal Register Notice

NCSS Background Information

Slides Presentation from the July 19, 2001 Pharmaceutical Science Advisory Committee

NCSS Vasculitis Working Group Progress, William D. Kerns, DVM, MS, DACVP

NCSS Cardiotoxicity Working Group Progress, Gordon Holt, Ph.D.

Helen Winkle, FDA, NCSS Subcommittee Next Steps