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| HHS/FDA | RIN: 0910-AB76 | Publication ID: Fall 2007 |
| Title: CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) | |
| Abstract: This rulemaking is one of a number of actions being taken to amend the biologics regulations to remove, revise, or update the regulations applicable to blood, blood components, and blood derivatives. These actions are based on FDA's comprehensive review of the biologics regulations and 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. In this rulemaking, FDA will amend the biologics regulations to require that blood establishments prepare and follow written procedures for appropriate action when it is determined that blood and blood components pose an increased risk for transmitting hepatitis C virus (HCV) infection because they have been collected from a donor who, at a later date, tested reactive for evidence of HCV. The HIV lookback regulations will be amended for consistency. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
| Major: Yes | Unfunded Mandates: No |
| CFR Citation: 21 CFR 606; 21 CFR 610 (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 360c; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263 to 263a; 42 USC 264; 21 USC 372; 21 USC 381 | |
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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 | |
| RIN Data Printed in the FR: No | |
| Related RINs: Related to 0910-AB26 | |
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Agency Contact: Stephen M. Ripley Team Leader Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), 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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