Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), as amended by section 105 of Animal Drug User Fee Amendments of 2008 (ADUFA 105) (Title I of Pub. L. 110–316), to submit to us an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. We are also required by ADUFA 105 to publish annual summary reports of the data we receive from animal drug sponsors. In accordance with the law, sponsors of the affected antimicrobial new animal drug products began submitting their sales and distribution data to us on an annual basis, and we have published summaries of such data for each calendar year beginning with 2009.

In the Federal Register of May 11, 2016 (81 FR 29129), we published a final rule entitled “Antimicrobial Animal Drug Sales and Distribution Reporting” that amended our existing records and reports regulation in part 514 (21 CFR part 514) to incorporate the sales and distribution data reporting requirements specific to antimicrobial new animal drugs that were added to the FD&C Act by ADUFA 105. The rule also added an additional reporting provision intended to improve our understanding of antimicrobial animal drug sales intended for use in specific food-producing animal species. In accordance with the new rule, the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient must submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. The final rule, which is codified at 21 CFR 514.80 and 514.87, became effective July 11, 2016. This Small Entity Compliance Guide is intended to help small businesses understand and comply with our amended reporting regulations.

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