Animal & Veterinary
Framework Document Available
December 9, 1998
This CVM Update was edited on April 23, 2009 to indicate that Guidance #78 was replaced by Guidance #152.
A document entitled "A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" is available for review and comment. This document sets out a risk-based framework for evaluating the microbial safety of antimicrobial drugs intended for use in food-producing animals.
This document is the second step in the Agency's consideration of issues related to use of antimicrobial drugs in food-producing animals. The first step was a draft guidance document entitled, "Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" (Guidance for Industry #78), (63 FR 64094) which FDA made available to the public in November.
The Proposed Framework document will be discussed at the next meeting of the Food and Drug Administration's (FDA's) Veterinary Medicine Advisory Committee (VMAC), which is expected to be held in early 1999.
Copies of "A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" may be obtained from CVM's Internet Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Send one self-addressed adhesive label to assist in processing your requests.
Written comments on the document should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the document and the Docket Number 98D-1146.