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HHS/FDA RIN: 0910-AH55 Publication ID: Fall 2021 
Title: Post Approval Changes to Approved Applications 
Abstract:

The proposed rule would update the existing regulations governing supplements and other changes to approved new drug applications (NDAs) abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports.

 
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 314.70    21 CFR 314.81    21 CFR 601.12    21 CFR 601.70   
Legal Authority: 21 U.S.C. 355    42 U.S.C. 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ashley Boam
Health Science Administrator
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6341
Email: ashley.boam@fda.hhs.gov