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HHS/FDA | RIN: 0910-AI54 | Publication ID: Fall 2024 |
Title: Abbreviated New Animal Drug Applications | |
Abstract:
The Generic Animal Drug and Patent Restoration Act (GADPTRA) authorized abbreviated applications for the approval of a new animal drug. This rulemaking is intended to establish the procedural requirements for the submission and approval of generic new animal drug applications.
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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: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 514 | |
Legal Authority: 21 U.S.C. 360b 21 U.S.C. 371(a) |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: No | 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: Urvi Desai Supervisory Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-101, Rockville, MD 20855 Phone:240 402-0689 Email: urvi.desai@fda.hhs.gov |