Written comments may be submitted until December 11, 2000. 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Registration is required. There is no registration fee for the meeting.
Limited space is available, and early registration is encouraged.
This document discussed several risk management approaches to the regulatory management of antimicrobial drug resistance associated with food-producing animal use of antimicrobials. The Framework Document discussed the concept of two thresholds, the resistance threshold and the monitoring threshold, that would be established prior to the approval of an antimicrobial new animal drug for use in food-producing animals to ensure that food products derived from treated animals are safe for consumers. The resistance threshold would be established in humans to represent the upper limit of resistant bacteria that can be transferred from animals to consumers. The Framework Document discussed the possibility of establishing resistance thresholds based on human data, animal data, or both. Monitoring thresholds would also be established to guide the postapproval monitoring of resistance development in animals.