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Best Pharmaceuticals for Children Act
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Research Initiative
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FDA, HRSA
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NICHD, NHLBI, NIMH
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The Best Pharmaceuticals for Children Act (BPCA) Program is a major activity for the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB) at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). OPPTB is responsible for developing and supporting a comprehensive national research and training effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, and childhood using pharmaceuticals that are appropriately tested within their target populations. NICHD activities related to BPCA are intended to improve pediatric drug therapeutics through preclinical and clinical testing that lead to drug labeling changes. We are performing pediatric clinical trials in order to submit data to FDA for labeling changes. BPCA is a partnership with FDA, to a degree.
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Best Pharmaceuticals for Children Act Activities
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIMH, NHLBI, NICHD
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NIH, FDA, and non-Federal experts in pediatric pharmacology meet several times a year to identify important unmet needs for conducting research on the efficacy and safety of medications in children.
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Big Data to Knowledge
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Meeting/ Workshop
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AHRQ, CMS, FDA, OS
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OD/DPCPSI, OD/DPCPSI/OSC
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The Big Data to Knowledge (BD2K) program aims to facilitate broad use of biomedical big data, develop and disseminate analysis methods and software, enhance training for disciplines relevant for large-scale data analysis, and establish centers of excellence for biomedical big data. In FY 2013, BD2K held a series of workshops on topics of interest in the area of Big Data, including community-based standards, facilitating use of clinical data, and training in big data. Workshop participants included OS, FDA, CMS, and AHRQ.
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Biomarkers of Nutrition for Development (BOND) Meetings
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Meeting/ Workshop
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CDC, FDA, HRSA, OS
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NICHD, FIC, NCI, NHLBI, NIDDK, OD/DPCPSI/ODP
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The National Institute of Child Health and Human Development had meetings concerning an initiative entitled Biomarkers of Nutrition for Development (BOND). The goal of the BOND initiative is to provide information and service to support the entire nutrition research and global health enterprise and to include core elements of discovery, development and delivery/implementation. The Centers for Disease Control and Prevention (CDC) is a member of the Steering Committee and has membership in individual Expert Panels.
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BioMedical Informatics Coordinating Committee Common Data Elements (CDE) Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIDA
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This working group conducts initiatives to improve the communication and coordination of efforts to identify, develop, and promote the use of Common Data Elements (CDEs) across NIH and beyond.
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Bioresource Development, Validation Tools, and Integrating High-Throughput Screening Technology Standards in Complementary and Alternative Medicine (CAM) Product Use in Children
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Research Initiative
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CDC, HRSA, SAMHSA
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NCCAM, NICHD
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Collaborative efforts between the FDA/CBER and the NIH/NCCAM for substantiating health benefit claims for probiotics under Investigational New Drug Applications (INDs) were placed in the framework of U01 Cooperative Agreements that began in 2008. The successful evaluation of the initiative has recently developed into an invitation to develop a Memorandum of Understanding (MoU) to promote resource sharing and exchange of research expertise; development of demonstration project(s); and the initiation of trans-agency research initiatives focused on the integration of advanced molecular technologies that lead to harmonization standards and improved diagnostics for safety and substantiation of the health benefits of probiotic interventions. In 2011, a collaboration with FDA/CFSAN was initiated to expand the validation tool. In 2012, a Materials Transfer Agreement [MTA] was approved and the FDA/CFSAN received the entire data collection to undergo testing employing their novel microarray multi-loci sequence testing system [MLST].
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Board of Scientific Counselors, CDC''s National Center for Injury Prevention and Control
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Committee, Work group, Advisory group, or Task Force
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CDC
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NIA
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A member of the NIA staff serves on the Board of Scientific Counselor''s for the Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention and Control. NIA''s staffer brings expertise in research on older adults.
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Body Mass and Mortality Relationships
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Research Initiative
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CDC
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NCI
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A study of the relationships between categories of body mass and mortality in the U.S. population.
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Brain Attack Coalition
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Committee, Work group, Advisory group, or Task Force
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CDC
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NINDS
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The Brain Attack Coalition (BAC) is a group of public and private entities representing medical, scientific, advocacy, and government professionals from across the stroke continuum. The BAC is dedicated to setting direction, advancing knowledge, and communicating best practices to improve our ability to prevent and combat stroke.
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Breastfeeding and Human Lactation Research Scientific Interest Group (BALSIG) Special Interest Group
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Committee, Work group, Advisory group, or Task Force
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FDA, OSG
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NICHD, NCI, NIDDK, OD/DPCPSI/ORWH
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In August 2012, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) formed a trans-U.S. Department of Health and Human Services (HHS) scientific interest group, Breastfeeding and Human Lactation Research Scientific Interest Group (BALSIG), to provide an intellectual platform for the scientists from HHS agencies interested in breastfeeding and human lactation research activities.
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