Discussion of “Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern;” Notice of Public Meeting

概要

The Food and Drug Administration (FDA) is announcing the following meeting: "Discussion of Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern." The topic to be discussed is this draft guidance document that describes an approach for implementing concepts previously considered in the FDA framework document on antimicrobial resistance (64 FR 887, January 6, 1999). The draft guidance outlines a method for assessing the safety of antimicrobial new animal drugs intended for use in food- producing animals. Date and Time: The public meeting will be held on Wednesday, October 2, 2002, from 9 a.m. to 5 p.m. Interested persons, who wish their comments to be considered during the meeting, may submit written or electronic comments by September 25, 2002, to the Dockets Management Branch (see Comments and Electronic Access). Location: The meeting will be held at the DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD, 20852, 301-468-1100. Comments and Electronic Access. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers La