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HHS/FDA RIN: 0910-AH50 Publication ID: Fall 2023 
Title: Biologics License Applications and Master Files 

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020. Some of the affected former NDAs were approved using drug master files (DMFs). A DMF, or other master file, allows an applicant to incorporate proprietary information from another manufacturer into its application by reference to the master file. FDA’s longstanding policy is that BLAs generally may not rely on drug substance, drug substance intermediate, or drug product information contained in master files.

The final rule will codify that a biological product that was originally approved as an NDA under the FD&C Act can continue to reference a DMF for drug substance, drug substance intermediate, or drug product information after the application is deemed to be a license under the PHS Act. The final rule also codifies FDA’s existing practice that a BLA may not otherwise rely on a master file for information concerning a drug substance, a drug substance intermediate, or a drug product except in the investigational phase of the application under an investigational new drug application. The final rule also clarifies that the non-biological constituent part(s) of a combination product in a BLA may rely on any information in a master file.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 601.2   
Legal Authority: 42 U.S.C. 262    42 U.S.C. 321 et seq.    Pub. L. 111–148, title VII sec. 7002(e), Mar. 23, 2010, 124 Stat. 817   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/28/2019  84 FR 30968   
NPRM Comment Period End  08/27/2019 
Final Rule  04/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Anuj Shah
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 6224,
Silver Spring, MD 20993
Phone:301 796-2246