FDA's Plans to Monitor Progress
FDA intends to keep the public apprised of progress in the following ways:
- FDA is making public on its website a listing of all antimicrobial products affected by the guidance.
- FDA intends to publish summary information following the 3-month notification period indicated in GFI #213, to provide an indicator of the level of engagement of affected drug sponsors in the voluntary process.
- FDA will notify the public of completed changes to affected products through publication of approval of supplemental new animal drug applications.
In addition to tracking completion of the recommended changes, FDA recognizes that it is important to identify ways to assess the effect of GFI #209 and GFI #213 over time. FDA currently collects data on the sale and distribution of antimicrobial drugs intended for use in food-producing animals, as well as data on antimicrobial resistance among foodborne pathogens as part of the National Antimicrobial Resistance Monitoring System. FDA is currently working in collaboration with other agencies, including United States Department of Agriculture and the Centers for Disease Control, to explore approaches for enhancing current data collection efforts in order to measure the effectiveness of the strategy. FDA anticipates seeking additional public input as it develops these enhancements.