Draft guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern

This version of the guidance replaces the version made available October 2003. This revision
has revised criteria and an updated ranking of medically important antimicrobials, updated data
tables, and revised definitions.

Prior to approving an antimicrobial new animal drug application, FDA must determine that the
drug is safe and effective for its intended use in the animal. The Agency must also determine that
the antimicrobial drug intended for use in food-producing animals is safe with regard to human
health (21 CFR 514.1(b)(8)). FDA considers an antimicrobial new animal drug to be “safe” if it
concludes that there is reasonable certainty of no harm to human health from the proposed use of
the drug in food-producing animals. This document provides guidance for industry to evaluate
potential microbiological effects of antimicrobial new animal drugs on bacteria of human health
concern as part of the new animal drug application process.