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FDA Proposes Revisions to Guidance on Evaluating Safety of Antimicrobial Animal Drugs Based on Their Importance in Human Medicine

Update: March 6, 2023

In response to requests filed by stakeholders, the FDA is extending the comment period for revised draft GFI #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern” by an additional 60 days. The comment period will now close on May 19, 2023. For additional information, see: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability; Extension of Comment Period.

December 16, 2022

Today, the U.S. Food and Drug Administration issued a draft update to guidance for industry (GFI) #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003.

Updates to the guidance include revisions to the risk assessment framework, updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes, and a revised ranking of antimicrobial drug classes as critically important, highly important, or important based on the newly updated ranking criteria (Appendix A).

Other proposed changes include new text to address antimicrobial drugs that are not medically important (NMI), updates to the “Exposure” tables in collaboration with the United States Department of Agriculture’s Food Safety Inspection Service (FSIS) and Economic Research Service (ERS), and revised definitions in the “Glossary” section.

When proposing revisions to GFI #152, FDA took into account feedback from its 2020 concept paper and public meeting on a potential approach for ranking antimicrobial drugs according to their importance in human medicine.

Once FDA finalizes this revised draft GFI, the agency expects to reassess the rankings in Appendix A periodically to align with current science and clinical practices in human medicine. 

How to Comment:

The FDA is accepting public comments on draft GFI #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern” until March 20, 2023. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-1998-D-0038 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-1998-D-0038 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

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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