August 4, 2023
The U.S. Food and Drug Administration (FDA) has opened a docket to seek 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. The report was prepared for the FDA by the Reagan-Udall Foundation (the Foundation) and summarizes the work completed over a multi-year cooperative agreement funded by the FDA. Under the agreement, the Foundation convened a working group to evaluate the feasibility of developing and maintaining a system to collect and report AMU data in the United States.
The report includes information about AMU standardization and protection of data confidentiality. It also summarizes stakeholder input and public comments about potential PPP objectives, membership, organizational structure, and financing. The report describes a potential PPP structure, supported in part by public and private resources, that includes a Data Repository Coordinator, External Data Partners, and a Steering Committee.
"Antimicrobial use data can help foster antimicrobial stewardship and slow the development of antimicrobial resistance because it provides insight into what drugs are being used, how much of the drugs are being used, and how they’re being used," FDA said.
While FDA does not currently have the authority to require end users to report AMU data, it said these data would be vital in helping to guide stewardship efforts. As such, the agency has been exploring, with the Foundation’s assistance, whether a PPP could balance the need for public health information with practical concerns of the veterinary professionals and producers who would voluntarily contribute to the data repository.
The FDA is accepting public comments on the latest report through October 31, 2023. Although the FDA is interested in receiving comment on all aspects of the report, the agency said it is specifically requesting additional information on:
Cost estimates for External Data Partners to develop and sustain the collection of AMU data in animals, recognizing diversity of data sources across animal sectors.
Cost estimates for the setup and maintenance of the AMU data repository under the PPP framework that is 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.
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. Please be sure to include docket number FDA-2022-N-0824 on each page of your written comments.
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
The report is preliminary and intended to advance a public discussion about collecting and analyzing food animal AMU data, FDA said. "This comment period is an opportunity for the public and affected stakeholders to share their opinions on a potential framework and provide concrete information and suggestions for how to put the framework into practice."
The FDA expects to make more future announcements on this framework’s progress within the next calendar year and any future iterations of the framework will be shared for public comment before being finalized.
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