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HHS/FDA RIN: 0910-AB28 Publication ID: Fall 2001 
Title: Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products 
Abstract: As part of implementing the proposed regulatory approach to human cells, tissues, and cellular and tissue-based products, the Food and Drug Administration (FDA) is proposing to require 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, and the maintenance of a quality program. FDA is also proposing to amend the current good manufacturing practice regulations that apply to medical device products and human drug products in order to incorporate the new GTP requirements into existing good manufacturing practice regulations. 
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  01/00/2003    
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