From: Eisenstein, Edward M [Edward.Eisenstein@med.va.gov] Sent: Tuesday, March 26, 2002 1:55 PM To: 'fdadockets@oc.fda.gov' Subject: Docket 01N-0322 I strongly support the proposed FDA regulation change requiring PI's and sponsors to inform IRB Boards about any prior IRB review decisions. E.M. Eisenstein, Ph.D., M.D. Chair, IRB-B Board West Los Angeles VA Medical Center