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HHS/FDA RIN: 0910-AC57 Publication ID: Spring 2003 
Title: ●Revision of the Requirements for Spore-Forming Microorganisms 
Abstract: The Food and Drug Administration (FDA) is issuing a direct final rule and a companion proposed rule to amend the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore-forming microorganisms. FDA is taking this action due to advances in facility, system and equipment design, and sterilization technologies, that would allow work with spore-forming microorganisms to be performed in multi-product manufacturing areas. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
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 600.10(c); 21 CFR 600.11(e) 
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM-Companion to Direct Final Rule  01/00/2004   
Direct Final Rule  01/00/2004   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: 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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