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HHS/FDA RIN: 0910-AB28 Publication ID: Spring 2002 
Title: Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
Abstract: The Food and Drug Administration (FDA) is proposing to require certain manufacturers of human cells and tissue to follow current good tissue practice (GTP), which includes proper handling, processing, and storage of human cells and tissue, recordkeeping, the maintenance of a quality program, labeling, reporting, inspections, and enforcement. 
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 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  01/08/2001  66 FR 1508 
NPRM Comment Period End  05/08/2001   
Final Action  To Be Determined   
Regulatory Flexibility Analysis Required: Yes  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
Email: paula.mckeever@fda.hhs.gov

 
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