Comprehensive Toxicological Assessments for the National Toxicology Program

该项目的主要目标是为国家毒理学计划(NTP)的危险评估活动提供支持，旨在预防因环境暴露于化学和物理制剂而导致的疾病或不良影响。 该项目专门支持美国国家卫生研究院(NIH)的国家环境健康科学研究所(NlEHS)和美国食品和药物管理局(FDA)之间的跨部门协议。 国家毒理学计划(NTP)是一个跨部门计划，总部设在NIEHS，由卫生与公众服务部部长设立，目的是向监管和研究机构以及公众提供有关潜在有毒化学物质的信息，协调毒理学研究和测试活动，并加强毒理学的科学基础。 这一滞后解决了FDA需要获得受FDA监管的化学和物理制剂的全面毒理学数据的需求，这些化学品和物理制剂存在安全性问题，但FDA没有法律权力要求受监管社区提供此类数据，或者没有必要的测试赞助商。这些病原体可能引发的潜在疾病包括癌症、生殖和发育影响、心血管疾病、神经疾病以及对免疫系统的影响。 使用这一IAG进行评估的药物包括内分泌活性药物、艾滋病治疗药物、膳食补充剂、补充和替代药物、儿科药物中使用的麻醉药，以及可在共同暴露于紫外线下激活的药物。

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.