Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-2925
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary Medicine
In September 2018, FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in veterinary settings. This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in animals, and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases. This plan includes an action item intended “to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use.”
This guidance provides information to sponsors of certain antimicrobial animal drug products who are interested in voluntarily establishing appropriately defined durations of therapeutic administration to food-producing animals where none currently exist. The guidance also proposes timelines for stakeholders wishing to comply voluntarily with this guidance.