LOGISTICS CONTRACT IN SUPPORT OF OBSTETRIC AND PEDIATRIC PHARMACOLOGY AND THERAPEUTICS

支持产科和儿科药理学和治疗的物流合同

• 批准号: 10844271
• 负责人: DOREEN ALBERTSON
• 金额: $ 3.5万
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-29 至 2023-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10844271
• 关键词: Address; Area; Authorization documentation; Award; Basic Science; Best Pharmaceuticals for Children Act; Books; Child; Childhood; Clinical Research; Clinical Trials; Complex; Conduct Clinical Trials; Consultations; Contractor; Contracts; Data; Discipline of obstetrics; Educational workshop; Electronics; Ensure; Europe; Exhibits; Expenditure; Funding Mechanisms; Funding Opportunities; General Population; Goals; Government; Government Officials; Human Resources; Incentives; International; Label; Legal patent; Logistics; Methods; Mission; National Institute of Child Health and Human Development; Nature; Newsletter; Obstetric pharmacology; Online Systems; Participant; Pediatric Research; Pharmaceutical Preparations; Pharmacologic Substance; Price; Public Health; Recommendation; Records; Reporting; Research; Research Personnel; Services; Staff Development; Statutes and Laws; System; Therapeutic; Training; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; Update; Work; Writing; authority; drug development; improved; interest; meetings; outreach; pediatric pharmacology; programs; service delivery; symposium; training opportunity; webinar; working group

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.

2004年，尤尼斯·肯尼迪·施莱佛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分支（OPPTB）。 该分支的目标是集中基础、临床和转化研究，包括临床试验和儿科和产科药理学研究和培训的其他药物开发活动。 OPPTB中的一个项目与国会授权的《儿童最佳药物法案》（BPCA）有关。 BPCA最初于2002年获得授权，允许美国食品和药物管理局（FDA）通过使用激励措施（如专利延长排他性）强制制药公司进行儿童药物研究。 BPCA还指示HHS秘书，通过美国国立卫生研究院（NIH）院长，与FDA专员和儿科研究专家协商，开展重大工作，以改善儿童药物使用的可用信息，特别是与药物标签变更有关的信息（BPCA立法第409 I节）。 NICHD，特别是OPPTB，监督BPCA在NIH的实施。 为支持《巴塞尔公约》，需要国家排雷中心： · 制定并优先考虑需要进行儿科研究的治疗领域和药物清单。 · 制定资助机制，为研究人员提供机会，在这些优先领域提交建议，以解决儿科标签的差距。 · 通过临床试验、基础和转化研究以及培训来改善儿科治疗。 · 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，让美国和欧洲的高级政府官员，研究人员，学者和科学专家与NICHD合作，以完成以下任务：召集专家审查数据，以帮助确定公共卫生和儿科和产科治疗的整体差距;确定和共享可能导致优先药物的信息，以进行进一步研究;提供建议，可以帮助确定进行临床试验的必要性/可行性;并确定儿科和产科药理学的科学差距。 此外，OPPTB有兴趣让公众了解可能支持产科和儿科活动的资助机会和培训机会。 由于它的授权活动（如BPCA）和在分支的许多其他领域的广泛推广，后勤支助是OPPTB实现其研究议程的目标所必需的。 重要的计划、跟踪、审查和报告与OPPTB物流活动的管理相关。 2017年9月，NICHD授予了一份为期3年的固定价格合同，HHSN 275201800294 U。 该项目是一项性质复杂的服务的延续，国家排雷中心寻求启动一项后续合同，为支持OPPTB提供各种后勤和行政服务。OPPTB预计，在此要求的过程中所需的活动和工作水平将在每个财政年度增加约5%。