International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals; Request for Comments

See attached file(s) The American Chemistry Council (ACC) appreciates the opportunity to provide written comments on the Food and Drug Administration's (FDA) consideration of "Proposed change to rodent carcinogenicity testing of pharmaceuticals" - the International Conference on Harmonization (ICH) S1 guidance on rodent carcinogenicity testing. It's our view that the FDA's proposal to implement the requirement for submission of carcinogenicity assessment documents, in lieu of performing a two-year rat carcinogenicity study, is a sound approach that should be pursued. Richard A. Becker, Ph.D. DABT