SUPPLEMENTARY INFORMATION:

I. Background

In 2003, FDA issued GFI #152, entitled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.” GFI #152 outlines a qualitative risk assessment methodology as a process for evaluating foodborne antimicrobial resistance concerns related to the use of antimicrobial drugs in food-producing animals. GFI #152 also contains an appendix, commonly referred to as “Appendix A,” in which FDA ranks antimicrobial drugs according to their relative importance to human medicine: “critically important,” “highly important,” or “important.” As stated in the guidance, the drug/drug class rankings provided in the Appendix are intended specifically to inform one component of the described qualitative risk assessment methodology, and they are not intended to be used as a standalone guide for antimicrobial use in veterinary practice or otherwise to serve as a standalone risk management tool.

The list, as published in 2003, of medically important antimicrobial drugs ( printed page 50861) in Appendix A reflects FDA's thinking at the time of publication. It was envisioned at the time of publication of GFI #152 that the Agency would reassess the rankings provided in Appendix A periodically to confirm that the rankings are consistent with contemporary practices and needs. As noted in GFI #152, the development of new antimicrobial drugs for human therapy, the emergence or re-emergence of diseases in humans, and changes in prescribing practices, are some factors that may cause the human medical importance rankings to change over time.

Given the considerable advances in science that have taken place since 2003, new relevant information has become available. In light of those advances and the new information now available, FDA published a document in the Federal Register of October 13, 2020 (85 FR 64481), announcing a public meeting and requesting comments on a concept paper entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” FDA received more than 60 comment submissions from pharmaceutical companies, academia, organizations, and private citizens on this concept paper. In the Federal Register of December 19, 2022 (87 FR 77619), FDA announced the availability of draft revised GFI #152 entitled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.” Interested parties were originally given until March 20, 2023, to comment on the guidance. In the Federal Register of March 7, 2023 (88 FR 14170), FDA extended the comment period for the guidance to May 19, 2023.

FDA received over 9,200 comments on the draft guidance that appear to have been the result of 2 write-in campaigns. These campaigns asked FDA to “quit delaying efforts to stop the overuse of antibiotics in meat production,” “stop allowing the meat industry to use antibiotics to counter unhealthy conditions in livestock facilities,” “treat all drugs used in human medicine as medically important. . .,” and said that “FDA must make a plan for updating [the list of medically important drugs in Appendix A] more frequently.” With the exception of the comment that FDA should treat all drugs used in human medicine as medically important, these comments expressed broad policy views and did not address specific recommendations in the draft guidance.

Twenty-two comments outside of the write-in campaigns were submitted by animal pharmaceutical companies, food animal producers, veterinarians, consumer and public health interest groups, a State agriculture department, and other organizations and individuals. These comments offered feedback and suggestions addressing specific recommendations in the draft guidance.

FDA considered all comments as we finalized the guidance. In the final guidance, we made several changes, including: providing a more detailed description of hazard characterization; combining sections of the guidance discussing Application of Risk Management Strategies and Risk Management; clarifying why the ranking of medically important drugs in Appendix A should not be used alone to dictate risk management decisions, but instead be used to inform one component of the risk assessment process as described in the guidance; and addressing why FDA excludes topicals in our ranking of medically important antimicrobials. In addition, we made editorial changes to improve clarity.

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

FDA considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds this action to be neither regulatory nor deregulatory under this E.O.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.

III. Electronic Access

Persons with access to the internet may obtain the guidance at www.fda.gov/​animal-veterinary/​guidance-regulations/​guidance-industry,www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or www.regulations.gov.

91 FR 50860