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| HHS/FDA | RIN: 0910-AF26 | Publication ID: 2012 |
| Title: Blood Initiative--Revisions To Labeling Requirements for Blood and Blood Components, Including Source Plasma | |
| 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blood components, including source plasma, to be more consistent with current practices and to remove unnecessary or outdated requirements.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 intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling. The rule will also consolidate most of the regulations applicable to labeling standards for blood and blood components, including source plasma. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640 | |
| 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 and 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: Benjamin Chacko Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852 Phone:301 827-6210 |
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