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HHS/FDA RIN: 0910-AF26 Publication ID: Fall 2005 
Title: Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; and Technical Amendment 
Abstract: The Food and Drug Administration (FDA) is amending the regulations regarding container labels and instruction circulars for certain blood, blood components, including Source Plasma to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. This action is intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
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; 21 CFR 610; 21 CFR 640 
Legal Authority: 21 USC 321; 21 USC 360j; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa to 25; 21 USC 331; 21 USC 310 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/30/2003  68 FR 44678 
NPRM Comment Period End  10/28/2003   
Final Action  06/00/2006   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Split from 0910-AB26 
Agency Contact:
Brenda Friend
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
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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