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HHS/FDA RIN: 0910-AC47 Publication ID: Spring 2003 
Title: Bioavailability and Bioequivalence Requirements 
Abstract: The final rule revises and clarifies certain sections of parts 314 and 320 and eliminates duplication and inconsistencies. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 320   
Legal Authority: 21 USC 321    21 USC 351    21 USC 352    21 USC 355    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/19/1998  63 FR 64222   
NPRM Comment Period End  02/02/1999    
Final Rule  12/19/2002  67 FR 77668   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Previously reported as 0910-AA51 
Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: christine.rogers@fda.hhs.gov