The Best Pharmaceuticals for Children Act (BPCA) mandates the establishment of a pediatric drug development program for studying on- and off-patent drugs in children set forth under Part B, Title IV, section 409I (a) and (b) of the Public Health Service Act (PHS Act). The original BPCA of 2002 directed the Secretary of the Department of Health and Human Services (DHHS), acting through the Director of the National Institutes of Health (NIH), and delegated to the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the authority and responsibility for establishment and conduct of the research program. The BPCA legislation authorizes NICHD, in consultation with the Food and Drug Administration (FDA) and with experts in pediatric research, to identify therapeutic gaps in pediatric diseases, disorders or conditions in which more complete knowledge of treatment strategies, including drugs and biologics, may be beneficial to the pediatric population. The legislation has been reauthorized in 2007, 2012, 2017, and 2022. NICHD, specifically the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), administers the research program (hence forth termed the “BPCA Program”) and works cooperatively with other NIH Institutes and Centers (ICs) with significant pediatric research portfolios in order to fulfill the mandate to improve pediatric therapeutics. NICHD develops a priority list of drugs needing further study in pediatric practice and sponsors the clinical trials of those prioritized therapeutics (see BPCA website for more information at (https://www.nichd.nih.gov/research/supported/bpca). NICHD has awarded more than 35 individual projects for the purpose of gathering information to improve labeling of drugs that are used in children. The BPCA Structure NICHD currently maintains an infrastructure of contracts to provide support for the various clinical activities in the BPCA program. This infrastructure requires a high level of interaction with the NICHD and the other responsible parties. This structure, henceforth termed “the Consortium”, work together to construct, implement, monitor and audit pre-clinical and clinical activities in order to improve the knowledge and labeling of drugs, biologics and devices used in children. Below are the responsible parties, hence forth termed Contractors, within the Consortium that support BPCA initiatives and projects: • The BPCA Data Coordinating Center (DCC) (this contract) manages and houses all of the data generated by the Pediatric Trials Network and the previous data from the legacy studies under the BPCA 2002. All completed trials are then submitted to the NICHD Data and Specimen Hub (DASH) Repository. The BPCA DCC also provides leadership in statistics and in the preparation and tracking of all FDA regulatory documents generated under prospective BPCA clinical trials. • The BPCA Pediatric Trials Network (PTN) serves as the master Cont...