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| Parent RIN: 0910-AB26 | ||
| HHS/FDA | RIN: 0910-AE93 | Publication ID: Fall 2000 |
| Title: Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; Notification of Deferred Donors | |
| 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components, and blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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 | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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Agency Contact: |
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