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HHS/FDA RIN: 0910-AI68 Publication ID: Fall 2022 
Title: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs 
Abstract:

FDA is amending its drug establishment registration and drug listing regulations via Direct Final Rule to extend the current exemption from drug establishment registration for certain manufacturers, repackers, relabelers, or salvagers of Type B or Type C medicated feeds to exempt all manufacturers, repackers, relabelers, or salvagers of Type B and C medicated feeds from drug establishment registration.  All manufacturers, repackers, relabelers, or salvagers of Type B or Type C medicated feeds are already exempt from the drug listing requirements.

 
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: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 207.1    21 CFR 207.13    21 CFR 207.17    21 CFR 207.21    21 CFR 515.10   
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. 355    21 U.S.C. 360    21 U.S.C. 360b    21 U.S.C. 371(a)    21 U.S.C. 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Direct Final Rule  10/00/2023 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Isabel W. Pocurull
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, 7519 Standish Place, , MPN-4, HFV-221,
Rockville, MD 20855
Phone:240 402-5877
Email: isabel.pocurull@fda.hhs.gov