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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #273 entitled “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals.” This guidance document provides recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on the medicated feed of food-producing animals that are currently approved with one or more indications that lack a defined duration of use. Establishing defined durations of use within the approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) is intended to mitigate development of antimicrobial resistance for these antimicrobial drugs, which are important to human medicine. It also proposes timelines for sponsors to voluntarily align their affected applications with this guidance.
The announcement of the guidance is published in the Federal Register on February 13, 2026.
You may submit either electronic or written comments on Agency guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2023-D-2925 for “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food- ( printed page 6856) Producing Animals.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Policy and Regulations Staff, U.S. Food and Drug Administration, Center for Veterinary Medicine, CPK1, 5001 Campus Drive, College Park, MD 20740-3835. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
In the Federal Register of September 26, 2023 (88 FR 66009), FDA published the notice of availability for a draft guidance entitled “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals” giving interested persons until December 26, 2023, to comment on the draft guidance. In response to a request for an extension, the comment period was extended to January 5, 2024 (88 FR 82384, November 24, 2023).
FDA received 4,511 comments on the draft guidance from a variety of interested parties; 4,495 comments were campaign letters and from individuals, and 16 comments were from consumer advocacy groups, industry associations, pharmaceutical companies, academia, and veterinary organizations. The comments received from the campaign letters, consumer advocacy groups, and individuals primarily requested that FDA limit all durations of use to no more than 21 days and requested that drug sponsors provide data demonstrating that the established durations do not lead to increased antimicrobial resistance. The comments from industry associations, pharmaceutical companies, academia, and veterinary organizations expressed concerns regarding the timelines proposed in the draft guidance, sought assurance the antimicrobial resistance mitigation statements be clearly worded and consistently included on labeling, sought assurance that data and information used to justify newly-defined durations of use be of high quality and transparent, and expressed concerns that veterinarians may authorize the maximum labeled duration in practice if only a maximum duration is established. All comments were considered as the guidance was finalized.
Changes were made to the final guidance to (1) revise the anticipated submissions and overall project timelines, (2) clarify the discussion regarding mitigation statements with the inclusion of examples of such statements for illustrative purposes, (3) request that sponsors propose and justify a typical duration range, in addition to the maximum permitted duration, that encompasses durations that veterinarians would authorize in most circumstances, and (4) include criteria that should be followed to ensure that the justification of the typical duration range and maximum permitted duration is comprehensive, focused, balanced, and limits bias. The recommended directions for use statements in this guidance were revised accordingly and now describe the typical duration range as well as the maximum permitted duration. Other editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated September 23, 2023.
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 defining durations of use for approved medically important antimicrobial drugs fed to food-producing animals. 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.
While this guidance contains no new 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; the collections of information in section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-0669.
Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov/.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-02934 Filed 2-12-26; 8:45 am]
BILLING CODE 4164-01-P