Cigar Reference Products Program

项目概要/摘要：自1968年以来，肯塔基州大学提供了 烟草制造商将烟草产品作为非临床研究目的的标准， 合同和政府实验室以及学术机构。该项目将生产和 表征机器制造的薄片包装雪茄烟草参考产品， 大雪茄（加工过的叶填料，非优质），小雪茄（棕色香烟）和小雪茄 （cigarillos）.这些新的认证参考产品将在一次生产运行中生产 确保产品的一致性，并将具有经过认证的物理和化学特性， 允许能力验证、仪器校准、员工/学生培训，以及方法 验证和研究目的。设计、分析和批准的过程是 包括以确保利益相关者的投入，新的雪茄参考烟草产品 达到指定的目标。定义了质量控制和样品检测参数， 将进行大量的化学分析，以便对产品特性进行认证 和成分水平。 CTRP将努力与利益攸关方合作和协调研究，包括 烟草监管科学中心，商业产品测试实验室，烟草产品 制造商和学术研究人员。该提案概述了重大改进， 在产品设计和认证方面， 分销、产品储存、规划新的参考烟草产品、建立研究 提高烟草研究能力，提供新的服务，使烟草研究界受益。一张网- - 用于订购参考烟草产品和用于安全传输的基于接口，以及 协作数据的存储正在开发中，并将得到增强，以包括雪茄 参考产品。CTRP基于Web的解决方案和数据库将迁移到云 环境来扩展资源以满足未来需求，同时降低运营成本， 提高IT流程和人员的效率。作为一个学术机构，我们 该提案将为整个烟草研究界提供服务， 目前协调和管理实验室间烟草比较研究的努力 参考产品和机制，以提供各种雪茄烟草参考产品。的 开发高质量的雪茄烟草参考产品，并通过 CTRP将加强FDA发展烟草监管科学的努力，并提供一个 烟草产品研究和监管急需的基本资源。

Project Summary/Abstract: Since 1968 the University of Kentucky has provided reference tobacco products as standards for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. This project will produce and characterize machine made, sheet-wrapped cigar tobacco reference products representative of large cigars (processed leaf filler, non-premium), little cigars (brown cigarettes) and small cigars (cigarillos). These new certified reference products will be manufactured in one manufacturing run each, to ensure product uniformity, and will have certified physical and chemical characteristics to allow for proficiency testing, instrument calibration, employee/student training, and for method validation and investigational purposes. A process for the design, analysis, and approval is included to ensure input from stakeholders and that the new cigar reference tobacco products meet the specified goals. Quality control and sample testing parameters are defined and substantial chemical analyses will be conducted to allow for certification of product characteristics and constituent levels. The CTRP will advance efforts to collaborate and coordinate studies with stakeholders, including Tobacco Centers for Regulatory Science, commercial product testing laboratories, tobacco product manufacturers, and academic researchers. This proposal outlines significant improvements to current cigar tobacco reference products in terms of product design and certification, product distribution, product storage, planning for new reference tobacco products, establishing research capability and providing new services that will benefit the tobacco research community. A web- based interface for ordering reference tobacco products and for the secure transmission and storage of collaborative data is under development and will be enhanced to include the cigar reference products. The CTRP web-based solution and database will be migrated to a Cloud environment to scale resources to meet future demand, while reducing operational costs and increasing the effectiveness of IT processes and personnel. As an academic institution, our proposal will be a service to the entire tobacco research community and is an improvement over current efforts to coordinate and administer inter-laboratory comparison studies on tobacco reference products and mechanisms to provide various cigar tobacco reference products. The development of high-quality cigar tobacco reference products and providing those through the CTRP will strengthen the FDA’s effort to develop the science of tobacco regulation and provide a much needed basic resource for tobacco product research and regulation.