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HHS/FDA RIN: 0910-AH57 Publication ID: Fall 2018 
Title: Definition of the Term "Biological Product" 
Abstract:

The Food and Drug Administration (FDA) proposes to amend its regulation that defines biological product to conform to the statutory definition (21 U.S.C. 262) 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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 600.3   
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
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:
Janice L. Weiner
Principal Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270,
Silver Spring, MD 20993-0002
Phone:301 796-3475
Fax:301 847-8440
Email: janice.weiner@fda.hhs.gov