The mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB) supports one of the major missions of the NICHD to enhance maternal, pediatric, and infant pharmacology, therapeutics, and drug development. The branch promotes basic, translational, and clinical research to evaluate and improve the safety and efficacy of multiple types of therapeutics, such as (but not limited to) pharmaceutical drugs, biologics, medical devices, and regenerative tissue constructs. The branch develops and supports comprehensive national efforts to increase the knowledge base for understanding appropriate therapeutic treatment of diseases and conditions during pregnancy, the postpartum period, and lactation, and for children during infancy, childhood, and the transition from adolescence to adulthood. Branch-supported research includes expanding the genomic understanding and phenotypic characterization of drug responses and, are not limited to the following: leveraging advanced multi-omics technologies; novel clinical trial approaches, data science, and artificial intelligence methods; and pharmacometric modeling tools to inform prevention and treatment strategies. One of the major activities of the branch is the implementation and management of the Best Pharmaceuticals for Children Act (BPCA) Clinical Program. The objectives of this program include: 1. Provide support for critical infrastructure including clinical trial expertise, pharmacology expertise, and laboratory and biospecimen research including methods/assay developments in order to enhance maternal, pediatric, and adolescent therapeutics and devices. This infrastructure is called the Pediatric Trials Network (Pediatric Trials Network | PTN) which serves as the program infrastructure to conduct and oversee regulatory rigorous pediatric clinical trials that lead to drug label changes. 2. Oversee the conduct of pediatric pharmacology research and training in the US and internationally to address the global problem delays in pediatric and maternal drug development ecosystem, including therapeutics research and workforce improvements. The funding and conduct of clinical research in pediatrics and maternal health offers many challenges and requires a system/program that is flexible and responsive, and that ideally provides coordinated exposure to expertise in this ecosystem. This contract is to provide a supportive and adjunctive program and resource for regulatory rigorous clinical trials conducted within and outside of the PTN clinical infrastructure of clinical coordination.