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

主题合同的设立是为了提供广泛的常规和专门的病理学服务，以支持国家毒理学计划(NTP)根据合同进行的研究，并对通过这些研究产生的病理标本进行补充研究。该合同还为NIEHS的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。具体地说，本合同支持以下服务：1)尸检和内部尸检协助；2)组织学(组织剪裁和处理、切片准备和染色)；3)组织病理学评估/解释；4)专门的定性和定量形态程序的应用(免疫组织化学、形态计量学、细胞增殖、细胞凋亡、电子显微镜)；5)适应、开发、改进、应用细胞和分子生物学的新技术，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，以及实时、定量和原位聚合酶链式反应，以及应用这些技术的培训；6)病理学同行评审(包括病理学数据评审[PDR]、病理标本审核[APS]、病理评估质量评估和病理学工作组协调[QA/PWG])和对这些活动的技术支持；7)病理学数据输入；8)介绍或出版病理学数据或技术，或支持这些活动；9)监督同行评审过程和编写技术/毒性报告，以及10)为实验动物医学小组提供行政支持。在过去的一年里，翻译毒理学司(DTT)和NIEHS完成了关于这份合同的以下工作：4个PWG；8个组织学项目，3个免疫毒性研究的初级病理学评估，NIEHS内部项目的10个研究的病理学评估，以及5个海报、期刊出版物或其他出版物的准备。此外，NTP和NIEHS还有许多其他项目正在进行中。 具体目标(至少250字)： 本合同的目标是为转化毒理学(DTT)司的危险识别活动提供支持，该活动旨在预防因环境暴露于化学或物理制剂而导致的疾病或不良影响。根据本病理支持合同提供的服务是DTT研究产生的病理数据评估的一个组成部分，并确保该数据的一致性和准确性。大多数研究都是毒性研究，旨在阐明化学品或制剂的致癌潜力或其他潜在毒性影响。还进行了其他类型的研究，包括免疫毒性研究和生殖和发育毒性研究。这些研究被用来评估各种化学品或物理制剂对公共卫生的影响。DTT使用这些研究中产生的病理数据来准备最终的技术和毒性报告。这些报告为公众提供了直接的好处，因为政府监管机构在作出有关使用或接触化学品或制剂的监管决定时会参考这些报告。因此，数据必须完整和准确，这突显了本合同提供的病理同行审查服务的重要性。病理学支持合同提供的服务还用于在实验室研究期间为NIEHS调查人员在不同阶段生成病理数据。这些数据经常用于编写手稿和报告，以便在同行评议的科学期刊上发表。因此，这份合同的具体目标是继续为NTP和NIEHS调查人员提供优质、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.