SCIENTIFIC AND PROGRAM SUPPORT SERVICES

科学和计划支持服务

• 批准号: 10942909
• 负责人: STACY PHILLIPSON
• 金额: $ 9万
• 依托单位: SCIENTIFIC CONSULTING GRO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-28 至 2024-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10942909
• 关键词: Acquired Immunodeficiency Syndrome; African Green Monkey; Agreement; Animals; Aotus primate; Applications Grants; Area; Assessment tool; Authorization documentation; Biomedical Research; Callithrix; Categories; Cercocebus; Cercopithecus tantalus; Classification; Communicable Diseases; Communication; Communities; Contractor; Contracts; Contracts Review; Data; Data Files; Databases; Diabetes Mellitus; Directories; Disease; Electronic Mail; Electronics; Ensure; Evaluation; Feedback; Freedom; Funding Agency; Future; Government; Graph; Individual; Institution; Interview; Investigation; Laboratories; Macaca; Macaca fascicularis; Macaca mulatta; Macaca nemestrina; Medical; Metabolic Diseases; Methods; Modeling; Monkeys; Neurosciences; Night Monkey; Notification; Online Systems; Oral; Outcome; Papio; Participant; Pharmacologic Substance; Privacy; Privacy Act; Process; Progress Reports; Property; Published Comment; Reagent; Regression Analysis; Regulation; Report (document); Reporting; Reproduction; Research; Research Project Grants; Resources; Respondent; Role; Saguinus; Saimiri; Schedule; Services; Slide; Source; Specific qualifier value; Structure; Surveys; Telephone; Testing; Time; United States Department of Agriculture; United States National Institutes of Health; Validation; Vendor; Work; Writing; authority; consumer demand; cost; data cleaning; data management; falls; follow-up; high risk; insight; instrument; instrumentation; meetings; programs; response; service providers; sex; symposium; transmission process; trend analysis; usability; virtual; web site; Acquired Immunodeficiency Syndrome; African Green Monkey; Agreement; Animals; Aotus primate; Applications Grants; Area; Assessment tool; Authorization documentation; Biomedical Research; Callithrix; Categories; Cercocebus; Cercopithecus tantalus; Classification; Communicable Diseases; Communication; Communities; Contractor; Contracts; Contracts Review; Data; Data Files; Databases; Diabetes Mellitus; Directories; Disease; Electronic Mail; Electronics; Ensure; Evaluation; Feedback; Freedom; Funding Agency; Future; Government; Graph; Individual; Institution; Interview; Investigation; Laboratories; Macaca; Macaca fascicularis; Macaca mulatta; Macaca nemestrina; Medical; Metabolic Diseases; Methods; Modeling; Monkeys; Neurosciences; Night Monkey; Notification; Online Systems; Oral; Outcome; Papio; Participant; Pharmacologic Substance; Privacy; Privacy Act; Process; Progress Reports; Property; Published Comment; Reagent; Regression Analysis; Regulation; Report (document); Reporting; Reproduction; Research; Research Project Grants; Resources; Respondent; Role; Saguinus; Saimiri; Schedule; Services; Slide; Source; Specific qualifier value; Structure; Surveys; Telephone; Testing; Time; United States Department of Agriculture; United States National Institutes of Health; Validation; Vendor; Work; Writing; authority; consumer demand; cost; data cleaning; data management; falls; follow-up; high risk; insight; instrument; instrumentation; meetings; programs; response; service providers; sex; symposium; transmission process; trend analysis; usability; virtual; web site

IV. REPORTING REQUIREMENTS AND DELIVERABLES All information and materials developed pursuant to this contract are the property of the U.S. Government and fall within the purview of the Freedom of Information Act. The contractor is enjoined against unauthorized release of the facts, findings, and written materials from this contract without the expressed, written authorization of the Contract Officer Representative (COR). All contractors working on this requirement must sign and abide by a nondisclosure agreement. 1. Meetings to Discuss Progress, Technical and Financial Issues: The contractor shall be available for meetings and conference calls with the DCM-PS for: • Project Initiation Meeting: to review contract requirements and to establish roles, responsibilities, and lines of communications. • Monthly Project and Financial Status Meetings: DCM-PS may request a meeting to review the monthly status report. This meeting would also serve as an exchange to discuss progress, technical issues and questions. • Other Meetings as needed: as requested by DCM-PS or the Contractor. 2. Monthly Reports: With the monthly invoice, the Contractor shall submit a short narrative email progress report and estimated financial statement for the previous month. The narrative report shall briefly summarize: • A description, by task, of the Contractor's activities, services provided and accomplishments • Scheduled activities and tasks to be completed for the upcoming period • Anticipated deadlines • Any problems during the past month, or anticipated during the upcoming month, and proposed solutions. This report and estimated financial statement will be delivered to the COR. The Contractor also may be required to give timely and accurate reports on the status of any specific Task at any point in each month at the request of the COR or DCM-PS. 3. Data Files: The contractor will provide the government with raw data /analyzable data file(s) for each Task under this project. Where appropriate, after discussion with DCM-PS, the data file provided to the government may have personal identifiers stripped to protect the confidentiality of the respondents. However, if personal identifies are removed, the contractor shall retain a category field to represent the source of the response (e.g., commercial vendor, academic institution, pharmaceutical company, etc.). 4. Interim and Other Reports: The contractor will provide the government with interim reports for each task as described in the sections below. The Contractor shall also provide other reports, as requested by the COR or DCM-PS. V. TASKS Task 1: Identify/characterize major U.S. NHP service providers The Contractor shall identify and assess the services provided by vendors, suppliers, and other sources of NHPs to the biomedical research community. Categories of services include providing NHPs as well as specialized laboratory space, instrumentation or specialized labor/expertise. The Contractor shall create a draft assessment/categorization plan, obtain and incorporate feedback from DCM-PS and others as needed to finalize the plan. The Contractor will compile the results in the form of a searchable directory to include information on the services provided by the identified sources (e.g., searchable PDF or Excel spreadsheet). Task 2: Five-year NHP usage trend analysis The Contractor shall perform a 5-year trend analysis of NHP usage in biomedical research using appropriate databases as identified by DCM-PS and Contractor Staff. Database sources used in this analysis might include ones maintained by the NSF, USDA, CDC, NIH, or DoD and others as identified appropriate and accessible. The Contractor will work with DCM-PS to formulate a query method. DCM-PS will use this query to provide data files for this task. At a minimum, the species of NHPs to be included in the analysis are: rhesus macaque (Macaca mulatta), cynomolgus macaque (Macaca fascicularis), pigtailed macaque (Macaca nemestrina), other macaques (Macaca spp.), baboon (Papio spp.), marmoset (Callithrix spp.), squirrel monkey (Saimiri spp.), African green monkey (Chlorocebus sabaeus), vervet monkey (Chloricebus pygerythrus), mangabeys (Cercocebus spp.), owl monkey (Aotus spp.), and tamarin monkeys (Saguinus spp.). Databases will be mined for the NHP species used in biomedical research. Data to be collected from identified projects include total number of projects which used each identified NHP species; number of animals used in each project; sex of the animals used; funding agency/source for each project; cost of the project; and classification of the research project in terms of research field/disease category (e.g., neuroscience, infectious disease, AIDS, reproduction, diabetes, metabolic disease, etc.) The Contractor will review the quality and completeness of data defining any limitations (e.g., data not included in initial file or grant application), process and clean the data, ensure that privacy and confidentiality is protected, and prepare the data for NIH review in a format specified by DCM-PS. The Contractor shall develop an analysis plan in conjunction with the DCM-PS. After performing the necessary analyses, the Contractor shall present the results in writing and orally to DCM-PS. A report of the results should include summary tables and graphs. The Contractor shall also provide copies/files of mined raw data to DCM-PS. DCM and OAR will disseminate data to the research community on the use of NHPs in biomedical research and may use the information obtained to make programmatic adjustments as needed. Task 3: Obtain and assess independent forecasts for NHP use The Contractor shall identify and engage research suppliers of NHPs in structured interviews (e.g., telephone, zoom or other virtual meeting format) to obtain independent forecasts. The Contractor, with input from DCM-PS, shall define the structure of the interview with a set of key questions and include follow up questions, as needed. Reports will be developed summarizing analyzed findings in a format agreed to by DCM-PS. Information collected will be subject to compliance with all Federal rules and regulations, the Privacy Act and other confidentiality and privacy rules. To encourage greater vendor participation, the study approach should consider confidentiality of provided information, in order to protect proprietary information of respondents and potential information that might be easily misinterpreted and become damaging to the organization. These data will be compared to data collected from Task 2, to aid in validation of data from all sources and identify potential outliers. These results should also identify potential high-risk challenges that DCM or OAR may want to consider or may want to avoid. Task 4: Characterize Consumer Demand The Contractor shall conduct broad anonymous surveys throughout the NHP user community to answer basic questions of usage. Questions may cover topics such as descriptions of the consumers, future needs, problems encountered, current supplier, factors influencing species choice, disease/research area, as well as others as deemed necessary for this research project. The Contractor shall, with input from DCM-PS, develop all assessment instruments for this task. Assessment instruments (e.g., surveys) are to be compliant with all applicable rules and regulations, presented in an audience-appropriate manner, and be operable 99% of the time during survey administration. Instruments and data management shall be tested for usability and validated by the contractor prior to use. When a Web-based survey instrument is to be used, the contractor shall develop and implement a plan to invite selected individuals to complete the survey (e.g., notify participants via mail or e-mail, describe the purpose of the survey, how they were chosen to participate, how to access the survey online and report problems, etc.). In administrating each survey instrument, the contractor shall develop and implement a set of strategies to ensure adequate response rates (e.g., e-mail reminders). The contractor shall provide the COR and DCM-PS with survey progress reports (e.g., number of expected respondents, survey completion rate to-date, actions performed to increase response rates). Surveys should not only provide a broad view of the types and amounts of products and services used by consumers but will also describe the different users and their preferred products within the research community. Task 5: Interim Study Report on future demand and supply Tasks 1-4 will be summarized in a cohesively written report. Presentations of findings will include preliminary and final evaluation outcomes. The report’s format and audience will be finalized through collaborative discussion with DCM-PS and will include trend analysis/regression analysis overall and by species data tables, and graphs or pie charts. Additional PowerPoint slides may be necessary for clear communication of the results. VI. PROJECT DELIVERABLES List of Deliverables: 1. Supplier Analysis Report and Directory (Task 1) 2. Interim Utilization Report (Task 2) 3. Analysis of Independent Forecasts (Task 3) 4. Analysis of Consumer Demand (Task 4) 5. Interim Study Report (Task 5) 6. Final Study Report The format/s for each of the deliverables is dependent on the outcomes of each task and should best convey the results. Decisions on format should be obtained through collaborative discussion with DCM-PS. Where relevant it is expected that copies of raw mined data files will also be included. Deliverables will be transmitted to DCM-PS electronically (e.g., email) or other PC-compatible electronic file in Microsoft Office format unless another format is specified (i.e., all data files in both SAS and SPSS formats).

iv。报告要求和可交付成果 根据本合同开发的所有信息和材料都是美国政府的财产，属于《信息自由法》的权限。承包商无需未经授权的事实，调查结果和书面材料即可订婚，而没有明确的合同官员代表（COR）的书面授权。所有从事此要求的承包商都必须签署并遵守不公开协议。 1。讨论进度，技术和财务问题的会议：承包商应与DCM-PS的会议和电话会议： •项目启动会议：审查合同要求并建立角色，职责和沟通线。 •每月项目和财务状况会议：DCM-PS可能会要求会议审查每月状态报告。这次会议还将作为讨论进度，技术问题和问题的交流。 •根据需要的其他会议：根据DCM-PS或承包商的要求。 2。每月报告：通过每月发票，承包商应提交简短的叙述性电子邮件进度报告，并为上个月提交估计的财务报表。叙述报告应简要摘要： •按任务描述承包商的活动，提供的服务和成就 •即将到来的期间完成的活动和任务 •预期的截止日期 •在过去一个月中或在接下来的一个月中预期的任何问题以及拟议的解决方案。该报告和估计的财务报表将交付给COR。 应承包商应COR或DCM-PS的要求，在每个月的任何时刻对任何特定任务的状态进行及时，准确的报告。 3.数据文件：承包商将为该项目下的每个任务提供政府提供原始数据 /可分析数据文件。在适当的情况下，在与DCM-PS进行了讨论之后，提供给政府的数据文件可能会剥离个人标识符，以保护受访者的机密性。但是，如果删除了个人身份，承包商应保留一个类别字段，以代表响应的来源（例如，商业供应商，学术机构，制药公司等）。 4。临时和其他报告：承包商将为政府提供以下各节所述的每个任务的临时报告。承包商还应按照COR或DCM-PS的要求提供其他报告。 V.任务 任务1：识别/表征美国主要NHP服务提供商 承包商应确定并评估NHP的供应商，供应商和其他来源提供的服务。服务类别包括提供NHP以及专业实验室空间，仪器或专业实验室/专业知识。承包商应制定评估/分类计划草案，根据需要获得DCM-PS和其他人的反馈，以最终确定计划。承包商将以可搜索目录的形式编译结果，以包括有关确定来源提供的服务的信息（例如，可搜索的PDF或Excel电子表格）。 任务2：五年NHP使用趋势分析 承包商应使用DCM-PS和承包商人员确定的适当数据库对生物医学研究中的NHP使用趋势分析。此分析中使用的数据库源可能包括NSF，USDA，CDC，NIH或DOD以及其他确定且易于访问的数据库源。承包商将与DCM-PS合作以制定查询方法。 DCM-PS将使用此查询为此任务提供数据文件。 至少，分析中包括的NHP物种是：鼠尾草（Macaca Mulatta），cynomolgus猕猴（Macaca fascicularis），笨拙的猕猴（Macaca nemestrina），其他猕猴，其他猕猴（Macaca spp。 （Saimiri spp。），非洲绿色猴子（氯糖珠），Vervet Monkey（Choricebus pygerythrus），Mangabeys（Cercocebus spp。），Owl Monkey（Aotus spp。）和Tamarin Monkeys（Saguinus spp。）。将针对生物医学研究中使用的NHP物种开采数据库。从确定的项目中收集的数据包括使用每个已识别NHP物种的项目总数；每个项目中使用的动物数量；使用的动物的性别；每个项目的资助代理/来源；项目成本；研究项目的分类在研究领域/疾病类别方面（例如神经科学，传染病，艾滋病，繁殖，糖尿病，代谢疾病等） 承包商将审查定义任何限制（例如，在初始文件或授予应用程序中未包含的数据），处理和清洁数据，确保保护隐私和信心的数据的质量和完整性，并以DCM-PS规定的格式来准备NIH审核的数据。执行必要的分析后，承包商应以书面形式和口服DCM-PS介绍结果。结果的报告应包括摘要表和图。承包商还应向DCM-PS提供挖掘原始数据的副本/文件。 DCM和OAR将向研究社区传播NHP在生物医学研究中的使用，并可能使用获得的信息根据需要进行程序化调整。 任务3：获得并评估NHP使用的独立预测 承包商应在结构化访谈（例如电话，Zoom或其他虚拟会议格式）中确定并聘请NHP的研究供应商，以获得独立的预测。承包商通过DCM-PS的意见，应用一组关键问题定义访谈的结构，并根据需要包括后续问题。将开发报告，以DCM-PS同意的格式进行分析的调查结果。收集的信息将遵守所有联邦规则和法规，《隐私法》以及其他机密性和隐私规则。为了鼓励更大的供应商参与，研究方法应考虑提供的信息的机密性，以保护受访者的专有信息和潜在的信息，这些信息可能很容易被解释并对组织造成损害。 这些数据将与任务2收集的数据进行比较，以帮助验证来自所有来源的数据并确定潜在的异常值。这些结果还应确定DCM或OAR可能想要考虑或可能避免的潜在高风险挑战。 任务4：表征消费者需求 承包商应在整个NHP用户社区进行广泛的匿名调查，以回答使用的基本问题。问题可能涵盖诸如对消费者的描述，未来需求，遇到的问题，当前的供应商，因素影响物种选择，疾病/研究领域以及该研究项目所必需的其他问题。承包商应在DCM-PS的意见下为此任务开发所有评估工具。 评估工具（例如，调查）应符合所有适用的规则和法规，以适合受众的方式呈现，并在调查管理期间的99％的时间运行。工具和数据管理应进行可用性测试，并在使用前由承包商验证。当要使用基于网络的调查工具时，承包商应制定并实施一项计划，邀请选定的个人完成调查（例如，通过邮件或电子邮件通知参与者，描述调查的目的，如何选择参加，如何在线访问调查并报告问题等）。在管理每个调查工具中，承包商应制定并实施一组策略，以确保足够的回复率（例如，电子邮件提醒）。承包商应为COR和DCM-PS提供调查进度报告（例如，预期响应的数量，迄今为止的调查完成率，采取的措施提高响应率）。 调查不仅应该对消费者使用的产品和服务的类型和数量进行广泛的了解，而且还将描述研究社区中不同用户及其首选产品。 任务5：关于未来需求和供应的临时研究报告 任务1-4将在凝聚力的书面报告中总结。调查结果的演示将包括初步和最终评估结果。该报告的格式和受众将通过与DCM-PS的协作讨论来最终确定，并将包括趋势分析/回归分析整体和物种数据表以及图形或饼图。对于清晰的结果，可能需要其他PowerPoint幻灯片。 vi。项目可交付成果 可交付成果清单： 1。供应商分析报告和目录（任务1） 2。临时利用率报告（任务2） 3。独立预测的分析（任务3） 4。消费者需求分析（任务4） 5。临时研究报告（任务5） 6。最终研究报告 每个可交付成果的格式都取决于每个任务的结果，应最好地传达结果。格式的决定应通过与DCM-PS的协作讨论获得。在相关的情况下，预计还将包括原始数据文件的副本。除非指定其他格式（即，SAS和SPSS格式的所有数据文件，否则，以电子方式（例如，电子邮件）或其他PC兼容电子文件将传输到DCM-PS（例如，电子邮件）或其他PC兼容电子文件。