PATHOLOGY PEER REVIEW AND PATHOLOGY SUPPORT FOR THE DNTP AND DIR AT NIEHS" CHARLES RIVER LABORATORIES (CRL)

建立受试者合同是为了提供广泛的常规和专业病理学服务，以支持国家毒理学计划（NTP）根据合同开展的研究，并对这些研究生成的病理学标本进行补充研究。该合同还为NIEHS内部研究人员进行的研究和其他NIEHS合同研究提供关键病理学（包括分子病理学）支持。具体而言，本合同支持以下服务：1）尸检和内部尸检协助; 2）组织学（组织修剪和处理、载玻片制备和染色）; 3）组织病理学评价/解释; 4）应用专门的定性和定量形态学程序（免疫组织化学、形态计量学、细胞增殖、凋亡、电子显微镜）; 5）适应，发展，完善，应用细胞和分子生物学新技术，包括（但不限于）基因分型、DNA测序、原位杂交、DNA和RNA分离和扩增、以及真实的实时定量和原位PCR，以及这些技术应用的培训; 6）病理学同行评议（包括病理学数据审查[PDR]、病理学标本稽查[APS]、病理学评价的质量评估和病理学工作组协调[QA/PWG]）以及这些活动的技术支持; 7）病理学数据录入; 8）病理学数据或技术的介绍或出版，或对这些活动的支持; 9）同行评审过程的监督和技术/毒性报告的编写，以及10）对实验室动物医学组的行政支持。在过去一年中，转化毒理学部（DTT）和NIEHS根据该合同完成了以下工作：4个PWG; 8个组织学项目，3项免疫毒性研究的初步病理学评价，内部NIEHS项目的10项研究的病理学评价，以及5份海报、期刊出版物或其他出版物的编写。此外，还有许多其他的NTP和NIEHS项目正在进行中。 目标（至少250字）： 本合同的目的是为转化毒理学（DTT）部门的危害识别活动提供支持，这些活动旨在预防因环境暴露于化学或物理制剂而引起的疾病或不良影响。根据本病理支持合同提供的服务是DTT研究生成的病理数据评估的组成部分，并确保该数据的一致性和准确性。大多数研究是毒性研究，旨在阐明化学品或制剂的致癌潜力或其他潜在毒性作用。还进行了其他类型的研究，包括免疫毒性研究以及生殖和发育毒性研究。这些研究用于评估各种化学品或物理制剂对公众健康的影响。DTT使用这些研究中生成的病理学数据编制最终技术和毒性报告。这些报告直接有益于公众，因为政府管理机构在作出关于化学品或制剂的使用或接触的管理决定时参考了这些报告。因此，数据必须完整和准确，这突出了本合同提供的病理学同行评审服务的重要性。病理学支持合同提供的服务还用于在实验室研究的各个阶段为NIEHS研究人员生成病理学数据。这些数据经常用于编写手稿和报告，供同行评审的科学期刊发表。因此，本合同的具体目标是继续为NTP和NIEHS研究人员提供优质、专业的病理学、组织学、尸检和分子生物学/病理学服务。

The subject contract was established to provide a broad range of routine and specialized pathology services in support of studies conducted under contract by the National Toxicology Program (NTP) and for supplemental studies on pathology specimens generated through these studies. The contract also provides critical pathology (including molecular pathology) support for studies conducted by in-house investigators at NIEHS and other NIEHS contract studies. Specifically, the following services are supported by this contract: 1) necropsy and in-house necropsy assistance; 2) histology (tissue trimming and processing, slide preparation, and staining); 3) histopathological evaluation/interpretation; 4) application of specialized qualitative and quantitative morphological procedures (immunohistochemistry, morphometrics, cell proliferation, apoptosis, electron microscopy); 5) adaptation, development, refinement, application of new techniques in cellular and molecular biology including (but not limited to) genotyping, DNA sequencing, in situ hybridization, DNA and RNA isolation and amplification, and real time, quantitative, and in situ PCR, as well as training in the application of these techniques; 6) Pathology Peer Review (including Pathology Data Review [PDR], Audit of Pathology Specimens [APS], Quality Assessment of pathology evaluations and Pathology Working Group Coordination [QA/PWG]) and technical support for these activities; 7) pathology data entry; 8) presentation or publication of pathology data or techniques, or support for these activities; 9) oversight of the peer review process and preparation of the technical/toxicity reports, and 10) administrative support for the laboratory animal medicine group. The following work was completed for the Division of Translational Toxicology (DTT) and the NIEHS on this contract in the past year: four PWGs; 8 histology projects, primary pathology evaluations for 3 immunotoxicity studies, pathological evaluation of 10 studies for in-house NIEHS projects, and preparation of 5 posters, journal publications, or other publications. In addition, there are many other projects for the NTP and NIEHS that are in progress. Specific Aims (at least 250 words): The goal of this contract is to provide support to Division of Translational Toxicology (DTT) hazard identification activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical or physical agents. The services provided under this pathology support contract are an integral component of the evaluation of pathology data generated by DTT studies and in ensuring the consistency and accuracy of that data. The majority of the studies are toxicity studies aimed at elucidating the cancer-causing potential or other potential toxic effects of chemicals or agents. Other types of studies are also conducted, including immunotoxicity studies and reproductive and developmental toxicity studies. These studies are used to evaluate the effects of various chemicals or physical agents of public health concern. Pathology data generated in these studies are used by the DTT to prepare final technical and toxicity reports. These reports provide a direct benefit to the public inasmuch as government regulatory agencies consult these reports when making regulatory decisions concerning the use of or exposure to chemicals or agents. Therefore, it is imperative that the data be complete and accurate, which underscores the importance of the pathology peer review services provided by this contract. The services provided by the Pathology Support Contract are also utilized to generate pathology data for NIEHS investigators at various stages during the conduct of laboratory-based research studies. This data is often used in the preparation of manuscripts and reports for publication in peer-reviewed scientific journals. Therefore, the specific aim of this contract is to continue to provide quality, professional pathology, histology, necropsy, and molecular biology/pathology services to the NTP and to NIEHS investigators.