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HHS/FDA RIN: 0910-AH51 Publication ID: Spring 2018 
Title: Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements 
Abstract:

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. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 14192 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 514.80   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  02/14/2018  83 FR 6480   
NPRM Comment Period End  04/30/2018 
Final Action  02/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Linda Walter-Grimm
Deputy Division Director
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Room 2666, HFV 241,
Rockville, MD 20855
Phone:240 402-5762
Email: linda.walter-grimm@fda.hhs.gov