Federal Register #FDA-2026-N-5829

FDA Requests Public Comment on Extralabel Drug Use Information Collection

This opportunity is a public request for comment from the Food and Drug Administration (FDA) regarding information collection for extralabel drug use in animals. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - FDA seeks public input on proposed information collection related to extralabel drug use in animals - Supports implementation of section 512 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for new animal drugs - Key Details: - Focus on reporting requirements for extralabel drug use - May involve the development of analytical methods to detect drug residues in animals - FDA estimates up to two analytical methods may be required annually - Potential respondents include sponsors of new animal drugs, state or federal agencies, academia, or individuals - No procurement of products or services is requested - No OEMs, vendors, or specific products are mentioned - The notice is solely a request for information and public comment, not a solicitation for goods or services

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to extralabel drug use in animals. This collection supports FDA implementation of section 512 of the Federal Food, Drug and Cosmetic Act, which governs new animal drugs. The FDA is soliciting comments on the reporting requirements associated with extralabel drug use in animals, including the potential need for analytical methods to detect residues. Comments are due by August 17, 2026.

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