FDA proposes framework for collecting antimicrobial use data

Updated September 21, 2023

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is seeking public comment on a report outlining a potential framework for establishing a public-private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food-producing animals.

Prepared by the Reagan-Udall Foundation, the report describes a potential PPP structure that includes a data repository coordinator, external data partners, and a steering committee. The document touches on information about AMU standardization and protection of data confidentiality, and also summarizes stakeholder input and public comments about potential PPP objectives, membership, organizational structure, and financing.

People wearing blue protective gear walking through large room of chickens
The Food and Drug Administration’s Center for Veterinary Medicine’s goal in developing a national antimicrobial use data framework is to help foster antimicrobial stewardship and slow the development of antimicrobial resistance by providing insights into what drugs are being used, how much of the drugs are being used, and how they’re being used.

The FDA CVM is accepting public comments on the report through October 31. Although the agency is interested in receiving comment on all aspects of the report, it is specifically requesting additional information on the following:

  • Cost estimates for external data partners to develop and sustain the collection of AMU data in animals, recognizing the diversity of data sources across animal sectors.
  • Cost estimates for the setup and maintenance of the AMU data repository under the PPP framework described in the report.
  • Descriptions or suggestions on the type of organizations most appropriate to coordinate a national AMU data repository.
  • Descriptions or suggestions on how the steering committee should be structured and membership roles and responsibilities long-term.

The report is preliminary and intended to further discussion about collecting and analyzing food animal AMU data, according to the FDA CVM. The agency expects to make additional announcements on the framework’s progress within the next year; any future iterations of the framework will be shared for public comment before being finalized.

The FDA CVM lacks the authority to require reporting AMU data. However, because these data would be vital in helping to guide stewardship efforts, the FDA CVM has been exploring, with the Reagan-Udall Foundation’s assistance, whether a PPP could balance the need for public health information with concerns of the veterinary professionals and producers who would voluntarily contribute to the data repository.

To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2022-N-0824 in the search box. To submit comments to the docket by mail, use the following address: Dockets Management Staff; HFA-305; Food and Drug Administration; 5630 Fishers Lane, Room 1061; Rockville, MD 20852. Comments should be sure to include docket number FDA-2022-N-0824 on each page of the written comments.