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HHS/FDA RIN: 0910-AB26 Publication ID: Spring 2003 
Title: Blood Initiative 
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, Source Plasma, and blood-derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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, and donor suitability and testing. 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
Child RIN List:
RIN Title
0910-AE89 Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
0910-AF02 Plasma Derivatives and Similar Recombinant-Based Products; Requirements for Notification of Recalls and Withdrawals
0910-AE99 General Requirements for Blood, Blood Components, and Plasma Derivatives; Notification of Deferred Donors
0910-AE95 Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin (Human); Revision of Requirements
0910-AE98 Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents
0910-AF00 Regulations for Human Blood and Blood Components Intended for Transfusion or For Further Manufacturing Use
0910-AE96 Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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:
Paula S. McKeever
Senior Scientific Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45,
Rockville, MD 20857-0001
Phone:301 827-1520
Fax:301 443-9718

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