PhenX Tobacco Regulatory Research (TRR) Working Groups
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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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The FDA and the NIH Tobacco Regulatory Science Program (TRSP) are seeking to expand the depth and breadth of tobacco-related measures that can enhance cross-study analysis in large-scale research. Use of the selected consensus measures will facilitate the comparison of results from different studies and the combination of studies to create larger sample sizes, increasing statistical power and the ability to detect more subtle and complex associations. The measures will be housed within the PhenX Toolkit (https://www.phenxtoolkit.org/). PhenX is a repository for measures identified as central in a field, developed with funding from the NHGR
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Pillbox
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Resource Development
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FDA
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NLM
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The National Library of Medicine and the Food and Drug Administration have established a collaborative relationship to enhance patient safety through the linking of digital images of prescription solid dosage form medications to the Structured Product Labeling (SPL) files and the substance information of those pharmaceuticals.
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Pink Ribbon Red Ribbon
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Meeting/ Workshop
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CDC
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NCI
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Pink Ribbon Red Ribbon (PRRR) is a partnership to leverage public and private sector investments to address breast and cervical cancers in developing countries. It is being implemented in several countries in sub-Saharan Africa. The National Cancer Institute and Centers for Disease Control and Prevention provide technical assistance in implementation strategies to the PRRR countries. This assistance involves drafting guidelines for monitoring and evaluation of prevention and treatment services as well as developing communication strategies.
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Planning and Design for Post-Acute Care Assessment Instruments and Data Elements
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Resource Development
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CMS
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NLM
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The ultimate goal of this work is to improve quality of care and interoperability of computerized data in acute hospitals and post-acute care (PAC) settings through use of health informatics and real-time transfer of patient information. The National Library of Medicine (NLM) and Centers for Medicare & Medicaid Services (CMS) collaborate on planning and design for the Continuity Assessment Record & Evaluation (CARE) instrument and its data elements, and those of other CMS post-acute care assessment tools; develop logical data model and software applications that promote compliance and compatibility with Federal Health Architecture consolidated health informatics (CHI) standards; adopt Federal government-wide health information interoperability standards associated with Meaningful Use; and improve data and messaging for the Medicare program. This collaboration benefits from NLM''s role as central U.S. Department of Health and Human Services (HHS) coordinating body for clinical terminology standards, and provides NLM specific and usage-based feedback on the utility of such standards in this environment.
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Polyhalogenated Aromatic Hydrocarbons (PHAH) and Thyroid Cancer
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Research Initiative
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CDC
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NCI
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Polyhalogenated aromatic hydrocarbons are being measured in banked serum/plasma samples from cohort studies to evaluate the association with thyroid cancer incidence.
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Population Assessment of Tobacco and Health Study
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Health Survey
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FDA
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NIDA
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The Population Assessment of Tobacco and Health (PATH) Study is the first large-scale National Institutes of Health (NIH)/U.S. Food and Drug Administration (FDA) collaboration since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009. The PATH Study is a national longitudinal cohort study that will follow an estimated 59,000 U.S. household residents ages 12 years and older for at least three years. Objectives are to assess initiation and use patterns; to study trends in tobacco-product use cessation and relapse; to monitor behavioral and health impacts, including in risk perceptions and other tobacco-related attitudes; and to assess differences in tobacco-related attitudes, behaviors, and health outcomes among racial/ethnic, gender, and age subgroups. The PATH Study will also collect biospecimens from adults to analyze biomarkers of tobacco use and related health outcomes. By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use in the U.S., the PATH Study will provide an empirical evidence base to help inform FDA’s decisions about changes in tobacco products in meeting the objectives of the 2009 FSPTCA.
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Post-traumatic Stress Disorder (PTSD)/Trauma Brain Injury (TBI) Workgroup
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Committee, Work group, Advisory group, or Task Force
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OS
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NIMH, NIAAA, NIDA, NINDS
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A 2012 White House Executive Order, emphasizing support of service members, veterans, and their families as a “top priority,” called for an urgent increase in the Departments of Health and Human Services (HHS), Defense (DOD), and Veterans Affairs (VA) research coordination to address the problems of PTSD, TBI, and suicide. Section 5 of this Executive Order requested a National Research Action Plan to develop biomarkers, define the pathophysiology, and create new treatments for PTSD. HHS charged the National Institute of Mental Health (NIMH) to lead this effort along with a parallel effort for TBI led by the National Institute of Neurological Diseases and Stroke (NINDS), with both Institutes working closely with the VA and DOD. In 2013, the National Research Action Plan, a multi-year multi-agency research action plan, was released in response to the Executive Order. Fortunately, prior investments interrogating the molecular, genomic, and circuitry changes that give rise to PTSD in the context of environmental factors provide the requisite foundation to respond to this White House request for biomarkers for risk prediction, as well as new targets for medications and other therapies to treat PTSD. Such an investment has the potential to revolutionize the care for individuals at high risk for PTSD, and prevent the development of chronic complex treatment resistant PTSD. In 2014, the agencies continued joint and coordinated efforts to fulfill the Executive Order expectations concerning research to address the problems of PTSD, TBI, and suicide.
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Poverty Reduction and the Developing Brain: A Pilot Study
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Research Initiative
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OS
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NICHD
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The primary aim of this one-year pilot study is to examine the feasibility of its components in order to develop an effective large-scale income intervention. We will examine the feasibility of participant recruitment, group assignment, payment disbursement, retention, and research participation in order to plan protocols and adjust methods in planning for the scaling the intervention up to a larger randomized study.
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Practical Oral Care for People with Developmental Disabilities
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Public Education Campaign
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CDC
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NIDCR, NICHD
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A series of publications designed to equip dental professionals in the community with the information they need to deliver quality oral health care to people with special needs.
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Practice-Based Research and Implementation: Developing a Framework for Collaboration to Reduce Mental Health Disparities
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Meeting/ Workshop
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SAMHSA
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NIMH
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In September 2014, NIMH and SAMSHA convened a webinar to enhance understanding of the development of behavioral health services collaborative approaches. Such approaches will accelerate the dissemination of research-based material and treatment information into communities. NIMH and SAMSHA brought together ten leaders in the field as primary discussants and 15 participants to engage in an exchange of ideas. The conversations set the stage for identifying ways to align ongoing efforts to address disparities in mental health outcomes across diverse populations. The discussant information will be used to develop an action plan and help to enhance the partnership between NIMH and SAMSHA.
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