Comprehensive Toxicological Assessments for the National Toxicology Program

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The primary goal of this project is to provide support of National Toxicology Program (NTP) hazard assessment activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical and physical agents. This project specifically supports an interagency agreement between the National Institute of Environmental Health Sciences (NlEHS) of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) The National Toxicology Program (NTP) is an interagency program headquarted at NIEHS and was established by the Secretary of Health and Human Services to provide information about potentially toxic chemicals to regulatory and research agencies and the public, coordinate toxicology research and testing activities and strengthen the science base in toxicology. This lAG addresses a need by the FDA to obtain comprehensive toxicological data on chemical and physical agents regulated by the FDA for which questions about safety existed, but where the FDA either had no legal authority to require the regulated community to provide such data or there was no sponsor for the needed testing. Potential diseases of concern that may be induced by these agents include cancer, reproductive and developmental effects, cardiovascular disease, neurological disease and effects on the immune system. Agents under evaluation using this IAG include endocrine active agents, AIDS therapeutics, dietary supplements, complementary and alternative medicines, anesthetics used in pediatric medicine, and agents that can be activated on co-exposure to UV light.