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Summary: Antimicrobial Animal Drug Sales and Distribution Reporting (Proposed Rule)

Summary: Antimicrobial Animal Drug Sales and Distribution Reporting (Proposed Rule)

The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the FDA on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. It also includes an additional reporting provision intended to enhance FDA's understanding of antimicrobial animal drug sales intended for use in specific food-producing animal species.

Regulatory Impact Analysis

Antimicrobial Animal Drug Sales and Distribution Reporting ; Proposed Rule (PDF - 103KB)

Federal Register: 80 FR 28863, May 20, 2015

Docket: FDA-2012-N-0447; 0910-AG45