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HHS/FDA RIN: 0910-AF84 Publication ID: Fall 2007 
Title: Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma 
Abstract: FDA is issuing this rulemaking to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. Some examples of the amendments include revisions to the dating period for Platelets, Red Blood Cells Deglycerolized, and Red Blood Cells Frozen; storage temperatures for blood; and pooling and pH level of Platelets. FDA is also removing two obsolete provisions. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 606.3    21 CFR 607.65    21 CFR 610.53    21 CFR 640.4    21 CFR 640.21    21 CFR 640.22    21 CFR 640.24    21 CFR 640.25    21 CFR 640.30    21 CFR 640.32    21 CFR 640.34    21 CFR 640.64   
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 360j    21 USC 371    21 USC 372    21 USC 374    21 USC 381    21 USC 393    42 USC 216    42 USC 262    42 USC 263    42 USC 263a    42 USC 264    42 USC 271   
Legal Deadline:  None
Action Date FR Cite
NPRM--Companion to Direct Final Rule  08/16/2007  72 FR 45903   
Direct Final Rule  08/16/2007  72 FR 45883   
Comment Period End  10/30/2007    
Final Action  02/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Stephen M. Ripley
Team Leader
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17),
Rockville, MD 20852-1448
Phone:301 827-6210

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