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HHS/FDA RIN: 0910-AH57 Publication ID: Fall 2019 
Title: Definition of the Term "Biological Product" 

The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (42 U.S.C. 262(j)) adopted in the Biologics Price Competition and Innovation Act of 2009.

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 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 600.3   
Legal Authority: 21 U.S.C. 371    42 U.S.C. 262    Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/12/2018  83 FR 63817   
NPRM Comment Period End  02/25/2019 
Final Rule  01/00/2020 
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 Gottlieb
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6210,
Silver Spring, MD 20993
Phone:301 796-6650