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HHS/FDA RIN: 0910-AB27 Publication ID: Spring 2003 
Title: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 
Abstract: The Food and Drug Administration is requiring certain manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to take actions to screen and test 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 HCT/Ps regulated as drugs, medical devices, and/or biological products to incorporate the new donor eligibility 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 263a; 42 USC 264; 42 USC 271 
Legal Deadline:  None
Timetable:
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: No 
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
Email: paula.mckeever@fda.hhs.gov

 
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