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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. |
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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 13771 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 |
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Timetable:
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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 |