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| HHS/FDA | RIN: 0910-AF26 | Publication ID: Spring 2008 |
| Title: Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; and Technical Amendment | |
| Abstract: The Food and Drug Administration (FDA) is amending the regulations regarding container labels and instruction circulars for certain human blood and blood components, including Source Plasma, to be more consistent with current practices and to remove unnecessary or outdated requirements.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 Subcommittee on House Resources and Intergovernmental Relations, the Government Accountability Office (previously, the General Accounting Office), and the Institute of Medicine, as well as on public comments. This action is intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling. | |
| 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: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: No | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
| Related RINs: Split from 0910-AB26 | |
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Agency Contact: Brenda Friend Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone:301 827-6210 Fax:301 827-9434 |
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