0910-AG45 201504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals

This proposed 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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 514.80 21 U.S.C. 360b(l) 21 U.S.C. 371 Yes ANPRM 07/27/2012 77 FR 44177 ANPRM Comment Period End 09/25/2012 ANPRM Comment Period Extended 09/26/2012 77 FR 59156 ANPRM Comment Period End 11/26/2012 NPRM 05/00/2015 Undetermined Businesses None No No No Sujaya Dessai Supervisory Veterinary Medical Officer 0910 Food and Drug Administration FDA 240 402-5761 sujaya.dessai@fda.hhs.gov Center for Veterinary Medicine, Room 2620, HFV–212, 7519 Standish Place, Rockville MD 20855