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Parent RIN: 0910-AB26
HHS/FDA	RIN: 0910-AF00	Publication ID: Spring 2003

Title: Regulations for Human Blood and Blood Components Intended for Transfusion or For Further Manufacturing Use
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Source Plasma, and blood-derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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

Timetable:

Action	Date	FR Cite
NPRM	01/00/2004

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: