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| HHS/FDA | RIN: 0910-AF98 | Publication ID: Fall 2007 |
| Title: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling | |
| Abstract: The Food and Drug Administration (FDA) is issuing a final rule, after issuing an interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule. | |
| 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 1271.55; 21 CFR 1271.80; 21 CFR 1271.90; 21 CFR 1271.290; 21 CFR 1271.370 | |
| Legal Authority: 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 | |
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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 |
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