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HHS/FDA RIN: 0910-AI68 Publication ID: Spring 2025 
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 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 
EO 14192 Designation: Deregulatory 
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  12/00/2025 
NPRM - Companion to Direct Final Rule  12/00/2025 
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, 7500 Standish Place , MPN-2, HFV-221,
Rockville, MD 20855
Phone:240 402-5877
Email: isabel.pocurull@fda.hhs.gov