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HHS/FDA RIN: 0910-AI14 Publication ID: Fall 2023 
Title: Biologics Regulation Modernization 

FDA’s biologics regulations will be updated to clarify existing requirements and procedures related to Biologic License Applications and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 601   
Legal Authority: 42 U.S.C. 262    21 U.S.C. 301, et seq.   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/00/2024 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Sandra Benton
Senior Policy Coordinator
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 22, Room 1132,
Silver Spring, MD 20993
Phone:301 796-1042