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View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

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
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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