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HHS/FDA | RIN: 0910-AI67 | Publication ID: Fall 2021 |
Title: ●Revision of Requirements for the Establishment and Maintenance of Records Related to Medicated Animal Feed and Veterinary Feed Directive Drugs | |
Abstract:
FDA is amending the Center for Veterinary Medicine’s (CVM) medicated animal feed and veterinary feed directive drug regulations via Direct Final Rule to exempt certain records, including records related to medicated animal feed and veterinary feed directive drugs, from the requirements that apply to the creation, modification, maintenance, archiving, retrieval, or transmission of records and signatures to FDA in electronic formats as opposed to paper records and handwritten signatures. |
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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: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 11 21 CFR 225 21 CFR 510.301 21 CFR 558.6 | |
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. 353 21 U.S.C. 354 21 U.S.C. 360b 21 U.S.C. 360ccc 21 U.S.C. 360ccc-1 21 U.S.C. 371 21 U.S.C. 379e ... |
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: April Hunt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, 7500 Standish Place, MPN2, HFV-200, Rockville, MD 20855 Phone:202 597-4661 Email: april.hunt@fda.hhs.gov |