Federal Register #FDA-2026-N-1303

FDA Seeks Public Comment on Animal Drug Adverse Event Reporting Requirements

This opportunity involves a regulatory information collection by the Food and Drug Administration (FDA) regarding adverse event and defect reporting for approved new animal drugs. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Collection of information on adverse experiences and product/manufacturing defects related to approved new animal drugs - Applies to applicants with approved New Animal Drug Applications (NADAs and ANADAs) - Requirements: - Establishment and maintenance of records - Submission of reports on drug use and safety as required by law - Compliance with statutory and regulatory frameworks for animal drug safety reporting - OEMs and Vendors: - No specific OEMs or vendors are mentioned, as this is not a procurement for products or services - Notable Details: - FDA is seeking public comment on the proposed information collection - No products or services are being purchased; this is a regulatory compliance activity

Description

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection supports statutory and regulatory requirements governing reporting associated with certain animal drug products, specifically adverse events and product/manufacturing defects related to approved new animal drugs. Applicants with approved new animal drug applications are required to establish and maintain records and reports of data relating to experience with such drugs to facilitate regulatory determinations. The FDA is requesting public comments on this information collection by June 22, 2026.

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