January 8, 2021

The U.S. Food and Drug Administration has published a concept paper to obtain early input from the public on a potential framework for how animal drug sponsors could voluntarily make changes to the approved conditions of use for certain medically important antimicrobial drugs to establish a defined duration of use for those indications that currently lack a defined duration of use. FDA also published a notice in the Federal Register that invites the public to comment on specific questions regarding the concept paper. FDA is accepting public comments on the concept paper until April 12, 2021. 

The concept paper focuses on medically important antimicrobial drugs administered through the medicated feed of food-producing animals. These products can only be used with the order of a licensed veterinarian. A limited number of medically important antimicrobials administered through animal feed include approved uses that lack a defined duration of use. This means the labeling for the identified product indication includes no information regarding the duration of administration or otherwise does not provide an appropriately targeted duration of use. The concept paper is limited to feed-use drugs because FDA has determined that all of the approved uses of medically important antimicrobial drugs in dosage forms other than feed already have appropriately defined durations of use. 

Today, there are 89 approved animal drug applications for medically important antimicrobials that have one or more indications without a defined duration of use. These make up approximately 28 percent of all medically important antimicrobials approved for administration through animal feed. The affected products included in each of these 89 applications have already undergone label changes as recommended in FDA’s Guidance for Industry #213 and are only available for use in animals under the oversight of a licensed veterinarian through the use of a veterinary feed directive. Defining durations of use for those uses of medically important antimicrobials in medicated feed that currently lack them will allow for the effective use of these products while minimizing the extent of antimicrobial drug exposure. 

In the potential approach described in the concept paper, the process for voluntarily revising the conditions of use (e.g., dosage regimen, instructions for use, etc.) would involve sponsors working with FDA to make changes to the approved labeling for affected products to establish appropriately defined durations of use. If the potential framework outlined in the concept paper were later issued as final agency guidance, implementation of that guidance would help ensure that all medically important antimicrobial animal drugs are administered consistent with ongoing efforts by FDA to slow the development of antimicrobial resistance by ensuring the judicious use of medically important antimicrobial drugs in animals. This important work helps to preserve the effectiveness of these antimicrobials in both veterinary and human medicine and is one of the actions highlighted in CVM’s five-year plan for supporting antimicrobial stewardship in veterinary settings.

The concept paper is intended to facilitate public comment on a potential voluntary approach to defining durations of use and does not contain any recommendations or guidance. FDA intends to consider all information and comments received on the concept paper before issuing draft guidance for additional public comment. 

How to Comment:

FDA is accepting public comments on “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper” until April 12, 2021. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2016-D-2635 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2016-D-2635 on each page of your written comments. 

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Additional Information

• Concept Paper: Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed 
• Federal Register Notice: Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper; Request For Comments 
• List of Approved Medically Important Antimicrobial Drugs Administered in the Feed of Food-Producing Animals that Lack a Defined Duration of Use
• FDA - Judicious Use of Antimicrobials
• Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for FY 2019 - FY 2023
• FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings