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HHS/FDA RIN: 0910-AG16 Publication ID: 2012 
Title: Amendments to Sterility Testing Requirements for Biological Products 
Abstract: The Food and Drug Administration (FDA) is issuing a rule to amend the sterility testing requirements for biological products. This rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art methodologies to ensure the safety of biological products. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 600; 21 CFR 610; 21 CFR 680 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/21/2011  76 FR 36019 
NPRM Comment Period End  09/19/2011   
Final Action  05/03/2012  77 FR 26167 
Final Action Effective  06/04/2012   
Additional Information: Includes Retrospective Review under E.O.13563.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paul E. Levine
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210

 
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