This agreement provides funds forFY 2009 implementation of the Best Pharmaceuticals for Children Act (BPCA), supporting the scientific research related to pediatric therapeutics. The NIH Institutes and Centers contribute to funding studies conducted under BPCA in approximate proportion to their pediatric research portfolios and no more than 0.20/0 of the administrative costs to cover site visits and program monitoring costs. The total planned investment is $25 million. The NICHD will provide $7 million for support of the BPCA program. The remainder will be collected via the reimbursable agreement mechanism from NIH Institutes and Centers based on a proportional distribution of the FY 2008 Pediatric Research estimate across the ICs. The NICHD will continue to consult with experts in pediatrics, and colleagues at the participating ICs at NIH, as well as colleagues at FDA, to identify drugs that are utilized in pediatric care and for which studies would have public health benefit. The NICHD will continue to seek collaborative opportunities and to establish partnerships with other ICs to achieve the stated goal of the act -""""""""to improve the safety and efficacy ofpharmaceuticals for children"""""""" -by increasing knowledge of the conditions affecting children and the drugs used to treat those conditions. The NICHD shall award grants, agency agreements and contracts to support research on pediatric therapeutics. Page 1
