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HHS/FDA RIN: 0910-AF25 Publication ID: Spring 2008 
Title: Blood Initiative--Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 
Abstract: The Food and Drug Administration (FDA) is proposing to amend the biologics regulations, particularly those related to blood donor eligibility, by removing, revising, or updating specific regulations applicable to blood, blood components, source plasma, and source leukocytes to be more consistent with current practices and to remove unnecessary or outdated requirements.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 responsive to reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the Government Accountability Office (previously, the General Accounting Office), and the Institute of Medicine, and to public comments. These actions are intended to help ensure the continued safety of the Nation's blood supply. 
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 606    21 CFR 610    21 CFR 630    21 CFR 640    21 CFR 660    21 CFR 820    21 CFR 1270   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 360c to 360e    21 USC 360h to 360j    21 USC 360l    21 USC 371    21 USC 372    21 USC 374    21 USC 381    21 USC 383    42 USC 216    42 USC 243    42 USC 262    42 USC 263    42 USC 263a    42 USC 264    42 USC 271   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/08/2007  72 FR 63416   
NPRM Comment Period End  02/06/2008    
NPRM Comment Period Extended  01/11/2008  73 FR 1983   
NPRM Comment Period End  08/04/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: 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