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HHS/FDA RIN: 0910-AG87 Publication ID: Spring 2015 
Title: Blood Initiative--Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 
Abstract:

FDA is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements, more consistent with current practices in the blood industry to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. These actions are intended to help ensure the continued safety of the Nation's blood supply and to help protect donor health.

 
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: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 606    21 CFR 610    21 CFR 630    21 CFR 640    21 CFR 660    21 CFR 820   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360c to 360e    21 U.S.C. 360h to 360j    21 U.S.C. 360l    21 U.S.C. 371    21 U.S.C. 372    21 U.S.C. 374    21 U.S.C. 381    21 U.S.C. 383    42 U.S.C. 216    42 U.S.C. 262    42 U.S.C. 263    42 U.S.C. 263a    42 U.S.C. 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/08/2007  72 FR 63416   
NPRM Comment Period Extended  01/11/2008  73 FR 1983   
NPRM Comment Period End  02/06/2008    
NPRM Comment Period Extended End  08/04/2008    
Final Action  05/00/2015 
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 
Agency Contact:
Valerie A. Butler
Team Leader
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71,
Silver Spring, MD 20903-0002
Phone:240 402-7911
Fax:301 595-1310