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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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NCCIH, NICHD
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Collaborative efforts between the Food and Drug Administration (FDA) and National Institutes of Health (NIH) for substantiating health benefit claims for probiotics under Investigational New Drug Applications (IND) 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 was initiated to expand the validation tool. In 2012, a Materials Transfer Agreement [MTA] was approved and the FDA received the entire data collection to undergo testing employing their novel microarray multi-loci sequence testing system [MLST].
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Blood Products Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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CC, NHLBI
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The Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The committee also advises the Commissioner of Food and Drugs of its findings.
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Blood, Organ, and Tissue Safety Committee (BOTSEC)
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Committee, Work group, Advisory group, or Task Force
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CDC, CMS, FDA, OS
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CC, NHLBI
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The Blood, Organ, and Tissue Senior Executive Council (BOTSEC) is an advisory forum for senior leadership from the Department of Health and Human Services (HHS) organizational components, as well as liaison representatives from Department of Defense and Veterans’ Health Administration, that are involved in blood, organ, and tissue safety and availability. The Department of Health and Human Services (HHS) Assistant Secretary for Health serves as the Council Chair, and the Office of the Assistant Secretary of Health (OASH) Senior Advisor for Blood and Tissue Policy serves as the BOTSEC Executive Director.
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Board of Scientific Counselors (BSC) of the CDC''s National Center of Injury Prevention and Control
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Committee, Work group, Advisory group, or Task Force
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ACF, ACL, AHRQ, CDC, HRSA, IHS, SAMHSA
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NICHD, NIA, NIDA, NIMH
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The BSC advises the Secretary, Department of Health and Human Services; the Director, Centers for Disease Control and Prevention (CDC); and the Director, National Center for Injury Prevention and Control (NCIPC) regarding surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury and violence. The Board makes recommendations regarding policies, strategies, objectives, projects, and priorities, and reviews progress toward injury and violence prevention.
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Botulism Guidelines Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC
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CC
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The National Institutes of Health (NIH) Clinical Center is participating in a working group with the Centers for Disease Control and Prevention (CDC) to develop clinical guidelines for treatment of botulism and use of botulism antitoxin.
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BPCA Initiative to Advance Pediatric Therapeutics (IAPT)
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Training Initiative
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FDA
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NICHD
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There is a major need to integrate clinical pharmacology and disease-specific therapeutic issues—identification of similarities and differences in the etiology, diagnosis, pathophysiology, prognosis, and natural response to therapy—of diseases or conditions affecting children and adults. The National Institute of Child Health and Human Development (NICHD) and the Best Pharmaceuticals for Children Act (BPCA) partly address this need through the IAPT. The Initiative focuses on identifying similarities and differences in diseases or conditions expressed in children and adults by studying etiology, diagnosis, biomarkers, pathophysiology, and outcomes, among other subjects.
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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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Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative
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Research Initiative
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FDA
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NINDS, NCCIH, NEI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIMH, OD/DPCPSI/OBSSR
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The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is part of a new Presidential focus aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a revolutionary new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. Long desired by researchers seeking new ways to treat, cure, and even prevent brain disorders, this picture will fill major gaps in our current knowledge and provide unprecedented opportunities for exploring exactly how the brain enables the human body to record, process, utilize, store, and retrieve vast quantities of information, all at the speed of thought.
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C-PATH Global Pediatric Trials Consortium
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Research Initiative
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FDA, OS
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NICHD
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The Pediatric Trials Consortium of the Critical Path Institute (C-PATH) is committed to enabling the creation of a sustainable solution that assures the timely and efficient evaluation of innovative drugs, biologics, and devices for children by delivering the regulatory-quality data needed for product labeling.
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Cancer and Women''s Health Interagency Agreement
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Research Initiative
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FDA
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NCI
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This formal agreement establishes the framework and procedures to enhance collaborations and exchange of information between the Food and Drug Administration (FDA) Office of Women’s Health (OWH) and the National Cancer Institute (NCI) Center to Reduce Cancer Health Disparities (CRCHD). Working together, FDA and NCI seek to increase scientific knowledge and understanding of cancer in women through targeted basic, clinical, bio-behavioral, translational, and community-based participatory research approaches/efforts. FDA and NCI both recognize the need for a unified approach to advancing scientific knowledge related to cancer and women’s health. This harmonized approach will aid in advancing the public health of all women through innovation in cancer research and medical therapies.
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