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HHS/FDA RIN: 0910-AB76 Publication ID: Fall 2006 
Title: CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) 
Abstract: This rulemaking is one of a number of actions being taken to amend the biologics regulations to remove, revise, or update the regulations applicable to blood, blood components, and blood derivatives. These actions are based on FDA's comprehensive review of the biologics regulations and on reports by the U.S. House of Representatives Committee on Government Reform and Oversight's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. In this rulemaking, FDA will amend the biologics regulations to require that blood establishments prepare and follow written procedures for appropriate action when it is determined that blood and blood components pose an increased risk for transmitting hepatitis C virus (HCV) infection because they have been collected from a donor who, at a later date, tested reactive for evidence of HCV. The HIV lookback regulations will be amended for consistency. 
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   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 360c    21 USC 360d    21 USC 360h to 360j    21 USC 371    21 USC 374    42 USC 216    42 USC 262    42 USC 263 to 42 USC 263a    42 USC 264    21 USC 372    21 USC 381   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/16/2000  65 FR 69377   
NPRM Comment Period End  02/14/2001    
Final Action  02/00/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Related to 0910-AB26 
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