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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 (PATH) 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), Suicide Prevention National Research Action Plan (NRAP) 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 (NRAP) to develop biomarkers, define the pathophysiology, and develop 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 National Institute of Neurological Disorders and Stroke (NINDS), with both Institutes working closely with VA and DoD. The NRAP was published in 2013. Prior investments integrating the molecular, genomic, and brain 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. This 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. The agencies meet weekly and produce quarterly progress reports.
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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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Preclinical Assessment of Phage Therapy for Pathogen Decolonization
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Research Initiative
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FDA
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NIAID
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This project addresses key regulatory considerations relevant to using bacteriophages for decolonization of the drug-resistant nosocomial pathogens, vancomycin-resistant enterococci (VRE) and methicillin-resistant staphylococcus aureus (MRSA). These include characterizing pathogen resistance to phage, defining phage mixtures ("cocktails") to circumvent resistance, optimizing mouse models to evaluate pathogen decolonization and identifying endpoints that support claims for clinical benefit (e.g., reduced risk of disease transmission).
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PregSource Management Team
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Committee, Work group, Advisory group, or Task Force
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CDC, CMS, HRSA
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NICHD, NCCIH, NHLBI, NIDCR, NIEHS, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH
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In consultation with the PregSource Partners, the PregSource Management Team:
•Finalizes selection of topics for inquiry
•Works closely with PregSource contractor to develop site
•Assures compliance with applicable NIH policies and procedures, including IRB approval
•Develops content for online and app-based versions
•Oversees outreach efforts to bolster participation
•Monitors overall function and usage of PregSource
•Participates in analysis and interpretation of data
•Reports results in publications and presentations
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Preparing for the Next Outbreak of Ebola Virus Infection: Working Group Meeting
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Meeting/ Workshop
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CDC, FDA, OS
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NIAID
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The goal of this workshop was to plan the next iteration of a medical countermeasures research protocol against Ebola virus infection.
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President''s Commission on the Study of Bioethical Issues
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Committee, Work group, Advisory group, or Task Force
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OS
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CC
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The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. The Commission undertakes study of issues presented to them by the President and the Secretary of Health and Human Services.
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President''s Task Force on Environmental Health Risks and Safety Risks to Children
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Committee, Work group, Advisory group, or Task Force
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FDA, OSG
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NIEHS, NCI, NHLBI, NIAID, NICHD
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The Secretary of the Department of Health and Human Services and the Administrator of the Environmental Protection Agency co-chair the Task Force, which is focused on coordinating Federal actions in this area, and which comprises representatives of 17 federal departments and White House offices. The Task Force currently focuses on priority areas including climate change, asthma disparities, healthy homes, chemical exposures, and lead. NIEHS staff co-chair the climate change, chemical exposures, and lead subcommittees. The Task Force released an inventory of federal activities to reduce children''s lead exposure in October 2016: https://ptfceh.niehs.nih.gov/features/assets/files/key_federal_programs…
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