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HHS/FDA | RIN: 0910-AI68 | Publication ID: Fall 2021 |
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, and the Nation | |
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 207 | |
Legal Authority: 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 21 U.S.C. 374 42 U.S.C. 262 ... |
Legal Deadline:
None |
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Timetable:
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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 |