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HHS/FDA RIN: 0910-AB27 Publication ID: Spring 2002 
Title: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
Abstract: The Food and Drug Administration is requiring certain manufacturers of human cells, tissues, and cellular and tissue-based products to take actions to screen the donors of cells and tissues used in those products for evidence of, or risk factors for, relevant communicable disease. As part of this action, the agency is amending the current good manufacturing practice regulations that apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, medical devices, and/or biological products to incorporate the new donor suitability requirements into existing good manufacturing practice regulations for those products. 
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 210.1(c)    21 CFR 210.2(a)    21 CFR 210.2(b)    21 CFR 211.1(b)    21 CFR 820.1(a)(1)    21 CFR 820.1(c)    21 CFR 1271   
Legal Authority: 42 USC 216    42 USC 243    42 USC 262    42 USC 263a    42 USC 264    42 USC 271   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/30/1999  64 FR 52696   
NPRM Comment Period End  12/29/1999    
NPRM Comment Period Reopened  04/18/2000  65 FR 20774   
NPRM Comment Period Reopened End  07/17/2000    
Final Action  To Be Determined    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
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

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