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HHS/FDA RIN: 0910-AH50 Publication ID: Spring 2017 
Title: ●Biologics License Applications and Master Files 

The Biologics Price Competition and Innovation Act of 2009 created a new category of approved products Biosimilars to encourage competition and reduced drug prices in the biologics drug market.  The legislation deemed certain biologics approved under the drug provisions (NDAs) of the FD&C Act as biologics (BLAs) after March 23, 2020.  These drugs were approved under the NDA provisions based on drug master files (DMF) which provide additional information about the drug substance not included in the application and with right of reference from a sponsor other drug applications can refer to these DMFs which reduces the data and work applicants may have to gather and include in the marketing application. To ensure that such right of reference can still occur after the statutorily required transition, FDA has to change its regulations to permit this continued use of DMFs and ensure no unnecessary delays or disruption to the consideration of these biosimilar products.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
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    42 U.S.C. 300aa-25    Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2017 
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:
Daniel Orr
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Building 51, Room 5199, 10993 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-0979