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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 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  05/25/2005  70 FR 29949 
Final Action  06/19/2007  72 FR 33667 
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 
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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