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Parent RIN:   0910-AB26
HHS/FDA RIN: 0910-AE94 Publication ID: Fall 2000 
Title: Reqs. for Testing Human Blood Donors for Evid. of Infection Due to Communicable Disease Agents 
Abstract: In multiple rulemakings, the Food and Drug Administration is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on a comprehensive review of the regulations that has been performed by FDA. 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; the Institute of Medicine; as well as public comments. Some of the subjects intended to be addressed in the rulemakings include: "Lookback" requirements for hepatitis C virus; notification of consignees and end users of product safety information for plasma derivative products; notification of deferred donors; requirements for donor suitability and testing and infectious agent clearance. 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: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 600    21 CFR 601    21 CFR 606    21 CFR 607    21 CFR 610    21 CFR 640    21 CFR 660    21 CFR 680   
Legal Authority: 21 USC 321    42 USC 216    42 USC 262    42 USC 263    42 USC 263a    42 USC 264    42 USC 300aa-25    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 371    21 USC 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/19/1999  64 FR 45340   
Final Action  03/00/2001    
Additional Information: See RIN 0910-AB76.
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-AB76 
Agency Contact: