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HHS/FDA RIN: 0910-AG16 Publication ID: Spring 2009 
Title: ●Amendments to Sterility Testing Requirements for Biological Products 
Abstract: The Food and Drug Administration (FDA) is issuing a proposed rule to amend the sterility testing requirements for biological products. This proposed 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: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 610.12   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 360c    21 USC 360d    21 USC 360h    21 USC 360i    21 USC 371    21 USC 372    21 USC 374    21 USC 381    42 USC 216    42 USC 262    42 USC 263    42 USC 263a    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2009    
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:
Laura Rich
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Email: ctpregulations@fda.hhs.gov