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| HHS/FDA | RIN: 0910-AF26 | Publication ID: Fall 2004 |
| Title: Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma | |
| Abstract: The Food and Drug Administration (FDA) is amending the labeling requirements for blood, blood components, and Source Plasma to be more consistent with current practices and to remove unnecessary or outdated requirements.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 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 and storage temperatures. | |
| 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 606; 21 CFR 640 | |
| Legal Authority: 21 USC 321; 21 USC 360j; 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; 42 USC 300aa to 25; 21 USC 331; 21 USC 310 | |
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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: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| Related RINs: Split from 0910-AB26 | |
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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 Email: paula.mckeever@fda.hhs.gov |
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