View Rule

This final rule would require that the sponsor of each approved or conditionally approved antimicrobial new animal drug product submit an annual report to the Food and Drug Administration (FDA or 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 any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data.

Statement of Need:

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that the sponsor of each approved or conditionally appoved new animal drug product that contains an antimicrobial active ingredient submit an annual report to FDA 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 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 (Pub. L. 110-316; 122 Stat. 3509) amended section 512 of the FD&C Act (21 U.S.C. 360b) 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 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 section 105 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 in FDA's regulations a current statutory requirement. There may be a minimal additional labor cost if any other reporting requirement is included.  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 Congressional Record H7534.