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Diagnostic Integrated Program Team (IPT) under Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE)
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Committee, Work group, Advisory group, or Task Force
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BARDA, CDC, FDA
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NIAID
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Integrated Program Teams (IPT) are established by the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). This IPT is focused on diagnostics related to medical countermeasures requirements and development.
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Diet-Induced Hypomethylation in Preneoplastic Liver
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Research Initiative
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FDA
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NCI
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The Food and Drug Administration (FDA), the National Center for Toxicological Research, and the National Cancer Institute (NCI) Division of Cancer Prevention, Nutritional Sciences Research Group are collaborating on an Interagency Agreement in which NCI will provide funds to examine the role of epigenetic mechanisms as factors that determine susceptibility to the development of hepatocellular carcinoma and to examine epigenetic alterations which may be used as markers of susceptibility to disease development, and whether correction of those epigenetic abnormalities during hepatocarcinogenesis may be a crucial decisive factor in cancer prevention strategies.
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Dietary Guidelines Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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OS
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OD/DPCPSI/ODP, NCI
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The 2020 Dietary Guidelines Advisory Committee worked on developing the 2020-2025 Dietary Guidelines for Americans in 2019. Public comments on all aspects of the Committee’s work were solicited throughout 2019. The United States Department of Agriculture (USDA) and HHS plan for the release of the 2020-2025 Dietary Guidelines for Americans by the end of 2020. The report summarizes the scientific evidence on physical activity and health and is used by the government to develop the Physical Activity Guidelines for Americans. The Department of Health and Human Services (HHS) Office of Disease Prevention and Health Promotion (ODPHP) coordinates the overall effort for this activity and oversees the Federal Advisory Committee Act (FACA). The National Institutes of Health (NIH) Office of Disease Prevention (ODP) coordinates NIH input on this effort.
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Dietary Supplements Clinical Research Roundtable
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Meeting/ Workshop
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FDA
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NCCIH, NIEHS, OD/DPCPSI/ODS
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This roundtable will bring together individuals involved in dietary supplement research from the National Institutes of Health (NIH), Food and Drug Administration (FDA), academia, and industry. The following goals will be addressed during the roundtable: clarify the regulatory requirements that must be addressed to conduct clinical trials with dietary supplement structure function claims as primary outcomes; compare and contrast the regulatory requirements for clinical trials to test drug claims vs. dietary supplement claims; provide examples of clinical trials of natural products that have been conducted to support dietary supplement claim or support a New Drug Application for a specific indication; and dispel myths about the implications of obtaining an Investigational New Drug Application for a clinical trial of a natural product.
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Digital Quantitation of Plasma Cells in Marrow Biopsies
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Research Initiative
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FDA
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CC
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This project is a collaboration between the National Institutes of Health (NIH )Clinical Center and the Food and Drug Administration (FDA)that consists of developing software and establishing validations for the automated determination of marrow cellularity and enumeration of plasma cells identified by immunohistochemistry (IHC) using a CD138 antibody. This initial effort should serve as proof of principle for a broader plan to utilize IHC-based automated quantitation of different types of cells in bone marrow core biopsies for diagnosis, prognosis, and therapy monitoring of marrow disorders.
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Dominantly Inherited Alzheimer''s Network (DIAN): International Network for the Identification, Evaluation, and Follow up of Families with Early Onset of Dominantly Inherited Alzheimer''s Disease
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Research Initiative
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FDA
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NIA
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This collaboration aims to set up an international network consisting of a consortium of scientific investigators that will have the responsibility to identify, recruit, evaluate, and follow-up individuals from families with early onset dominantly inherited Alzheimer’s Disease [i.e., families with the amyloid precursor protein (APP), presenilin 1 (PS1), and presenilin 2 (PS2) mutations or duplications or others still to be discovered].
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Drug Development Interest Group
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Committee, Work group, Advisory group, or Task Force
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BARDA, CDC
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NIAID, FIC, NCI, NHLBI
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Share information about state of the art and challenges in drug development for infectious diseases
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Drug Induced Liver Injury Network (DILIN)
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Resource Development
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FDA
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NIDDK
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Both a prospective and retrospective database containing cases of drug-induced liver disease, the Drug-Induced Liver Injury Network (DILIN) is funded by a cooperative agreement and includes eight clinical centers and a central data coordinating center. One of the goals of the DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. The DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Three employees of the Food and Drug Administration (FDA) serve as ad hoc members on the committee overseeing the network activities.
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E-Cigarette or Vaping Product Use-Associated Lung Injury (EVALI): Developing a Research Agenda
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Meeting/ Workshop
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CDC, FDA
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NHLBI, NCI, NIDA
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The purpose of this workshop was to develop a research agenda to understand the causes, biology, and long-term health effects of EVALI. National Heart, Lung, and Blood Institute (NHLBI) led the workshop, and National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), National Institutes of Health (NIH) Office of the Director (OD), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA).
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Early Hearing Detection and Intervention
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Meeting/ Workshop
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CDC, HRSA
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NIDCD
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This is Federal collaboration program involving the National Institute on Deafness and Other Communication Disorders (NIDCD), the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA). NIDCD collaborates on early identification and diagnosis of hearing loss and intervention services for newborns and infants. HRSA funds awards to states and healthcare providers to screen newborns and young children for hearing loss. CDC funds states to develop data systems to track hearing loss. NIDCD also funds research grants to scientists throughout the US to study early hearing detection and intervention services.
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