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HHS/FDA RIN: 0910-AF85 Publication ID: Fall 2007 
Title: Revision of the Requirements for Live Vaccine Processing 
Abstract: This rulemaking is being issued to provide options to the existing requirement for processing live vaccines. FDA is amending the regulations due to advances in facility, system, and equipment design, and in sterilization technologies that will allow live vaccine processing to be performed in multiproduct manufacturing areas. We are amending this regulation to permit manufacturers greater flexibility in the use of their buildings and equipment for processing live vaccines when appropriate controls exist and have been demonstrated to be effective in preventing cross contamination of other products and areas. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 600.11 
Legal Authority: 21 USC 321; 21 USC 351 to 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  12/00/2007   
Direct Final Rule  12/00/2007   
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:
Nathaniel L. Geary
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852-1448
Phone:301 827-6210
Fax:301 827-9434
Email: nathaniel.geary@fda.hhs.gov

 
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