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HHS/FDA RIN: 0910-AB28 Publication ID: Spring 2005 
Title: Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement 
Abstract: The Food and Drug Administration (FDA) is requiring certain human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, recordkeeping, and the establishment of a quality program. FDA is also issuing regulations pertaining to 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: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 16; 21 CFR 1270; 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  11/24/2004  69 FR 68612 
Regulatory Flexibility Analysis Required: Yes  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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