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An increasingly critical shortage of human donors has limited the availability and benefit of organ and tissue transplantation. This chronic shortage, coupled with recent scientific and biotechnological advances, has been a catalyst for new therapeutic approaches directed at using animal tissues in humans. The use of xenogeneic tissues and organs for transplantation or perfusion has raised concerns about the potential of both recognized zoonotic pathogens and unknown xenogeneic agents to infect individual human recipients and then spread through human populations. Public health guidelines intended to minimize the risk for transmission of known pathogens through human-to-human transplantation exist. Similar guidelines addressing the issue of infectious agents that may be associated with xenotransplantation are being jointly developed by Public Health Service working groups at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, and the National Institutes of Health. A provisional draft of these guidelines will be published in the Federal Register in late 1995. Public comment on the proposed guidelines is invited. Critical review by members of the transplant community is particularly sought. Publication of a final version of these guidelines in CDC’s Morbidity and Mortality Weekly Report is planned for the spring of 1996.

Guidelines on the Risk for Transmission of Infectious Agents During Xenotransplants