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B-24 Project
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Research Initiative
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CDC, FDA
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NICHD
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NICHD has played a lead role in the evolution of the process to include infants/children from birth to 24 months and pregnant women in future (2020 and beyond) iterations of the Dietary Guidelines for Americans; the "B-24 Project." An offshoot of that project was the effort to develop guidelines for nutritional care of preterm infants (the "Pre-B Project"). Both projects have included members of the CDC and FDA on working groups constituted to develop the initial reports that will serve as the basis for the subsequent systematic review and guideline development process.
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Behavioral Aspects of Prep Counseling HIV Prevention Trials Network (HPTN) Protocol #067: The ADAPT Study (Y01-MH-0315)
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Research Initiative
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CDC
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NIMH, NIAID
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This behavioral research study is evaluating whether non-daily medication regimens for HIV Pre-Exposure Prophylaxis (PrEP) may be more acceptable and foster better adherence to treatment. PrEP represents a novel biomedical approach to HIV prevention in which individuals at-risk for HIV take antiretroviral medications to help prevent HIV infection. The HPTN 067 study is conducted through the HIV Prevention Trials Network led by the National Institute of Allergy and Infectious Diseases (NIAID). An interagency agreement between the National Institute of Mental Health (NIMH) and the Centers for Disease Control and Prevention (CDC) supports the implementation of this international study at a clinical research site in Bangkok, Thailand.
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Best Pharmaceuticals for Children Act (BPCA) Data Monitoring Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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The Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) is responsible for managing all aspects of BPCA clinical trials including developing trial design, collecting and analyzing trial data, monitoring data quality, conducting site monitoring, collecting and preparing safety reports, organizing and submitting documentation to the FDA, and managing the Data Monitoring Committee.
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Best Pharmaceuticals for Children Act Working Group (BPCA)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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This working group supports the goals of the Best Pharmaceuticals for Children Act (BPCA). The BPCA seeks to improve the level of information—in scientific publications and on the label—about pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations and publish a list of drugs/needs in pediatric therapeutics.
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Big Data to Knowledge (BD2K)
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Research Initiative
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AHRQ, CMS, FDA, OS
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OD/DPCPSI, CC, CIT, CSR, FIC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/OAR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODP, OD/DPCPSI/ORIP, OD/DPCPSI/ORWH, 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. BD2K had held discussions with other HHS agencies who have shared interests in Big Data. In FY16, BD2K participated in a joint funding opportunity with the National Science Foundation (NSF) to support collaborations between biomedical researchers and data scientists on Quantiative Approaches to Biomedical Big Data (QuBBD).
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Biological Select Agents and Toxins Interagency Policy Committee (BSAT IPC)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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OD/OSP, NIAID
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Coordinating group with senior level leadership from CDC, FDA, and NIH that discusses appropriate oversight of Select Agents and Toxins.
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Biological Select Agents and Toxins sub-Interagency Policy Committee (BSAT Sub-IPC)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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OD/OSP, NIAID
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Coordinating sub-group of FDA, CDC, and NIH staff that discuss the appropriate oversight of Select Agents and Toxins. This is a Subcomitte of the Biological Select Agents and Toxins Interagency Policy Committee (BSAT IPC)
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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 FDA and NIH 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 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 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, and 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 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 HHS Assistant Secretary for Health serves as the Council Chair, and the OASH Senior Advisor for Blood and Tissue Policy serves as the BOTSEC Executive Director.
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