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| HHS/FDA | RIN: 0910-AF25 | Publication ID: Fall 2005 |
| Title: Blood Initiative--Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | |
| Abstract: The Food and Drug Administration (FDA) is proposing to amend the biologics regulations, particularly those related to blood donor eligibility, by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and Source Leukocytes to be more consistent with current practices and to remove unnecessary or outdated requirements.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, and on public comments. 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: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 820; 21 CFR 1270 | |
| Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360e; 21 USC 360h to 360j; 21 USC 360l; 21 USC 371 ; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 383; 42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271 | |
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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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