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HHS/FDA | RIN: 0910-AF25 | Publication ID: Fall 2008 |
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source plasma, and source leukocytes to be more consistent with current practices and to remove unnecessary or outdated requirements.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 responsive to 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, and to 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: Long-Term Actions |
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 and 263 42 USC 263a 42 USC 264 42 USC 271 |
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 | |
RIN Data Printed in the FR: No | |
Related RINs: Split from 0910-AB26 | |
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 |