FDA proposes draft update to guidance for industry (GFI) #152
The scope and purpose of updated GFI #152 remain the same as the first version of the guidance that was issued in 2003
The FDA 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.” This guidance is a tool to assess the risk of antimicrobial resistance in humans which could result from the use of medically important antimicrobial drugs in food-producing animals.1
Revisions to the risk assessment framework,1 ranking criterion 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), are among those included in the guidance revisions.
Other changes that were proposed include updates to the “Exposure” table in partnership with the United States Department of Agriculture’s Food Safety Inspection Service and Economic Research Service, revised “Glossary” section definitions, and text addressing antimicrobial drugs that are not medically important.1
Since 2003,2 GFI #152 has been referenced nearly exclusively as a template for sponsors that are preparing a microbial food safety risk assessment for review all original and supplements approval of antimicrobial new animal drugs by the Agency. These new animal drugs were approved under the condition that they will only be available if they are ordered by a licensed veterinarian for use in limited quantity of animals for control treatment, and sometimes prevention of major diseases in food. However, none are approved for broad production in large numbers of animals for long periods of time.
The FDA will accept public comments on the draft up until March 20, 2023. Anyone that wishes to comment on the docket can visit www.regulations.gov and type FDA-1998-D-0038 in the search box. Anyone that wishes to submit a comment by mail, they should mail to the following address and include docket number FDA-1998-D-0038 on every written page:
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
- FDA Proposes Revisions to Guidance on Evaluating Safety of Antimicrobial Animal Drugs Based on Their Importance in Human Medicine. News release. U.S. Food and Drug Administration. December 16, 2022. Accessed December 16, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-proposes-revisions-guidance-evaluating-safety-antimicrobial-animal-drugs-based-their-importance
- Q&A on Draft Revised GFI #152: Explaining the major changes since 2003. U.S. Food and Drug Administration. Accessed December 16, 2022. https://www.fda.gov/animal-veterinary/antimicrobial-resistance/questions-answers-draft-revised-gfi-152