View Rule

Statement of Need: Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the FD&C Act to require that the sponsor of each new animal drug product that contains an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA, the Agency) on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This legislation was enacted to assist FDA in its continuing analysis of the interactions (including drug resistance), efficacy, and safety of antibiotics approved for use in both humans and food-producing animals (H. Rpt. 110-804). This proposed rulemaking is to codify these requirements. In addition, FDA is exploring the establishment of other reporting requirements to provide for the collection of additional drug distribution data, including reporting sales and distribution data by species.

Summary of the Legal Basis: Section 105 of ADUFA (110 Pub. L. 316; 122 Stat. 3509) amended section 512 of the FD&C Act (21 U.S.C. 360b) to require that sponsors of applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. FDA is also issuing this rule under its authority under section 512(l) of the FD&C Act to collect information relating to approved new animal drugs.

Alternatives: This rulemaking codifies the Congressional mandate of ADUFA section 105. The annual reporting required under ADUFA is necessary to address potential problems concerning the safety and effectiveness of antimicrobial new animal drugs. Less frequent data collection would hinder this purpose.

Anticipated Costs and Benefits: Sponsors of antimicrobial drugs sold for use in food-producing animals currently report sales and distribution data to the Agency under section 105 of ADUFA; this rulemaking will codify a current statutory requirement. There may be a minimal additional labor cost if any other reporting requirement is proposed. Additional data beyond the reporting requirements specified in ADUFA section 105 will help the Agency better understand how the use of medically important antimicrobial drugs in food-producing animals may relate to antimicrobial resistance.

Risks: Section 105 of ADUFA was enacted to address the problem of antimicrobial resistance, and to help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. 154 Cong. Rec. H7534.