Guidance for Industry: Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals (GFI #78); Availability; Republication

الملخص

The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Guidance for Industry: Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food- Producing Animals'' (GFI #78). After the agency considered public comments on a draft of this guidance, announced in the Federal Register of November 18, 1998, it determined that revision of the draft guidance was necessary. GFI #78 addresses how under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) FDA intends to consider the potential human health impact of the microbial effects associated with all uses of all classes of antimicrobial new animal drugs intended for use in food-producing animals when approving such drugs. For additional information regarding the subject matter dealt with in GFI #78, see the notice of availability of the document entitled ``FDA Response to Comments on a Proposed Framework for Evaluating and Assuring the Human Food Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals'' that appears elsewhere in this issue o