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Parent RIN:   0910-AB26
HHS/FDA RIN: 0910-AE98 Publication ID: Fall 2003 
Title: Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents 
Abstract: In multiple rulemakings, the Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and blood-derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. The remaining subjects intended to be addressed in the rulemakings include: labeling of blood and blood components and donor eligibility requirements. 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: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 600    21 CFR 601    21 CFR 606    21 CFR 607    21 CFR 610    21 CFR 630    21 CFR 640    21 CFR 660    21 CFR 680   
Legal Authority: 21 USC 321    21 USC 331    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   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/19/1999  64 FR 45340   
Final Action  06/11/2001  66 FR 31146   
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 
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