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HHS/FDA RIN: 0910-AF26 Publication ID: 2012 
Title: Blood Initiative--Revisions To Labeling Requirements for Blood and Blood Components, Including Source Plasma 
Abstract: The Food and Drug Administration (FDA) is amending the regulations regarding container labels and instruction circulars for certain human blood and blood components, including source plasma, to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling. The rule will also consolidate most of the regulations applicable to labeling standards for blood and blood components, including source plasma. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 606    21 CFR 610    21 CFR 640   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 360d    21 USC 360h to 360j    21 USC 371    21 USC 374    21 USC 381    42 USC 216    42 USC 262 and 263    42 USC 263a    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/30/2003  68 FR 44678   
NPRM Comment Period End  10/28/2003    
Final Action  01/03/2012  77 FR 7   
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 
Related RINs: Split from 0910-AB26 
Agency Contact:
Benjamin Chacko
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852
Phone:301 827-6210