0910-AH51 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements

FDA is amending its postmarketing safety reporting regulations for approved new animal drugs to remove requirements that certain adverse drug experience and product/manufacturing defect reports be submitted to us in a paper format and replace it with an electronic format. 

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Fully or Partially Exempt 21 CFR 514.80 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 360b 21 U.S.C. 371 No NPRM 02/14/2018 83 FR 6480 NPRM Comment Period End 04/30/2018 Final Action 02/00/2019 No Businesses Federal No No No No Linda Walter-Grimm Deputy Division Director 0910 Food and Drug Administration FDA 240 402-5762 linda.walter-grimm@fda.hhs.gov Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Room 2666, HFV 241, Rockville MD 20855