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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.