The ?Best Pharmaceuticals for Children/Pediatric Devices? act was signed into law by the President on September 27th, 2007 (P.L. 110-85). The legislation was reauthorized as part of the Food and Drug Administration Amendments Act of 2007 (P.L. 110-85), extending patent exclusivity and making improvements to the research program led by the NICHD in partnership with other NIH Institutes and Centers and the Foundation of the NIH (FNIH). The steps that NIH has taken to implement the new legislation include;redirecting prioritization to focus on needs in pediatric therapeutics, identification of gaps in testing drugs and biologics, identification of diseases and conditions bringing children into contact with the health care system and therapeutic approaches utilized in treating those diseases and conditions. This agreement provides funds for FY 2011 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. The total planned investment is $24.8 million. The NICHD will provide approximately $7 million for support of the BPCA program. The remainder will be collected via the reimbursable agreement mechanism from select NIH Institutes and Centers based on a proportional distribution of the FY 2010 Pediatric Research estimate across the ICs.