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HHS/FDA RIN: 0910-AB28 Publication ID: Fall 2004 
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 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: Final Rule Stage 
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

Statement of Need: Donor screening and testing, although crucial, are not sufficient to prevent the transmission of disease through HCT/Ps. Each step in the manufacturing process needs to be controlled. Errors in labeling and testing records, failure to adequately clean work areas, and faulty packaging are examples of improper practices that could lead to a product capable of transmitting disease to a recipient. The agency is concerned about the spread of communicable disease through the use of such products. CGTP requirements are a fundamental component of FDA's risk-based approach to regulating HCT/Ps.

Summary of the Legal Basis: The Public Health Service Act (42 U.S.C. 264) authorizes FDA to promulgate regulations to prevent the spread of communicable diseases. HCT/Ps may transmit communicable diseases. The CGTP regulations are essential to the prevention of communicable disease transmission.

Alternatives: An alternative to the proposed approach would be to continue with the use of voluntary industry standards. Reliance on industry's voluntary standards for good tissue practice, rather than establishing regulatory requirements, would not ensure uniform or consistent compliance and would preclude the agency's ability to effectively monitor HCT/Ps to ensure public health and safety.

Anticipated Costs and Benefits: FDA has estimated that this rule would impose a total annualized cost of about $8 million for the entire industry. The primary beneficiaries of the proposed CGTP would be the patients who receive HCT/Ps. Benefits to patients would result from the reduced risk of communicable disease by avoiding product contamination through CGTP.

Risks: FDA believes that the risks posed by requiring CGTP are minimal. In contrast, failure to reduce the risk of transmission of communicable disease through the use of HCT/Ps would jeopardize the public health.

Action Date FR Cite
NPRM  01/08/2001  66 FR 1508   
NPRM Comment Period End  05/08/2001    
Final Action  12/00/2004    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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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