LOGISTICS CONTRACT IN SUPPORT OF OBSTETRIC AND PEDIATRIC PHARMACOLOGY AND THERAPEUTICS

2004年，尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD)创建了产科和儿科药理学和治疗学分会(OPPTB)。该处的目标是为儿科和产科药理学研究和培训集中基础、临床和转化性研究，包括临床试验和其他药物开发活动。OPPTB内的一个项目与国会的一项授权有关，该授权被称为儿童最佳药品法案(BPCA)。BPCA最初于2002年获得授权，允许食品和药物管理局(FDA)通过使用激励措施，如专利延长排他性，强制制药公司对儿童药物进行研究。BPCA还指示卫生和卫生局秘书通过国家卫生研究院(NIH)主任，与FDA专员和儿科研究专家协商，作出重大努力，改进可供儿童使用药物的信息，特别是与药品标签变化有关的信息(BPCA立法第409I条)。NICHD，特别是OPPTB，监督BPCA在NIH的实施。 为支持BPCA所做的努力要求NICHD： ·制定一份需要进行儿科研究的治疗领域和药物清单，并确定其优先顺序。 ·建立资助机制，使研究人员有机会在这些优先领域内提交建议，以解决儿科标签方面的差距。 ·通过临床试验、基础研究和转化性研究以及培训改进儿科治疗。 ·向研究人员和公众传播研究结果。 为了支持所有这些努力，OPPTB建立了各种方法来动员美国和欧洲的政府高级官员、研究人员、院士和科学专家与NICHD合作，以完成以下工作：召集专家审查数据，以帮助确定公共卫生以及儿科和产科治疗学总体上的差距；确定和分享可能导致优先进行进一步研究的药物的信息；提供有助于确定进行临床试验的必要性/可行性的建议；以及确定儿科和产科药理学方面的科学差距。此外，OPPTB有兴趣让公众随时了解可能支持产科和儿科活动的资金机会和培训机会。 由于其授权的活动(如BPCA)和在该处许多其他领域的广泛外联，OPPTB必须提供后勤支助，才能实现其研究议程的目标和目的。重要的规划、跟踪、审查和报告与OPPTB这项后勤活动的管理有关。 2017年9月，NICHD授予了一份为期3年的固定价格合同，HHSN275201800294U。这一项目是一系列性质复杂的服务的延续，排雷中心试图启动一项后续合同，为禁毒办提供各种后勤和行政服务。OPPTB预计，在这一要求过程中所需的活动和努力程度将在每个财政年度增加约5%。

In 2004, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) created the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB). The objectives of the Branch are to centralize basic, clinical and translational research, including clinical trials and other drug development activities for pediatric and obstetric pharmacology research and training. One of the programs within the OPPTB is related to a congressional mandate called the Best Pharmaceuticals for Children Act (BPCA). BPCA was originally authorized in 2002 and allows the Food and Drug Administration (FDA) to mandate the study of medications in children by pharmaceutical companies through the use of incentives, such as patent extensions for exclusivity. The BPCA also directs the Secretary of HHS, acting through the Director of the National Institutes of Health (NIH), in consultation with the Commissioner of the FDA and experts in pediatric research, to carry out major efforts to improve the information available for the use of medications in children, particularly related to drug label changes (section 409I of the BPCA legislation). The NICHD, specifically the OPPTB, oversees the implementation of the BPCA at the NIH. Efforts in support of BPCA require NICHD to: • Develop and prioritize a list of therapeutic areas and drugs for which pediatric studies are needed. • Develop funding mechanisms that provide researchers with opportunities to submit proposals within these prioritized areas to address gaps in pediatric labeling. • Improve pediatric therapeutics through clinical trials, basic and translational research, and training. • Disseminate study findings to researchers and the general public. To support all of these efforts, the OPPTB established various methods to engage senior government officials, researchers, academicians, and scientific experts throughout the U.S. and Europe to work with the NICHD to accomplish the following: convene experts to review data to help identify gaps in public health and in pediatric and obstetrics therapeutics overall; identify and share information that may lead to prioritizing drugs for further study; provide recommendations that can help determine the need/feasibility for conducting clinical trials; and identify scientific gaps in pediatric and obstetric pharmacology. Additionally, the OPPTB is interested in keeping the general public apprised of funding opportunities and training opportunities that may support both obstetric and pediatric activities. Because of its mandated activities (like BPCA) and broad outreach in many other areas of the branch, logistics support is necessary for OPPTB to achieve the goal and objectives of its research agenda. Significant planning, tracking, review, and reporting are associated with the management of this OPPTB logistics activity. In September 2017NICHD awarded a 3-year Firm Fixed Price Contract, HHSN275201800294U. This project is a continuance of services which are complex in nature and NICHD seeks to initiate a follow-on contract to provide a wide variety of logistical and administrative services in support of the OPPTB. The OPPTB anticipates the activities and level of effort required during the course of this requirement will increase by approximately five percent during each fiscal year.