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HHS/FDA RIN: 0910-AH50 Publication ID: Fall 2018 
Title: Biologics License Applications and Master Files 
Abstract:

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deems 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 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.  BLAs generally may not rely on drug substance, drug substance intermediate, or drug product information contained in master files. The proposed rule would permit the contained use of DMFs for NDAs subject to the BPCI Act transition.

 
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 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 601.2   
Legal Authority: 42 U.S.C. 216    42 U.S.C. 262    42 U.S.C. 263    42 U.S.C. 263a    42 U.S.C. 264    Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2018 
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
Email: anuj.shah@fda.hhs.gov