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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 the 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 US 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. The National Cancer Institute (NCI) investigators are leading nested case-control studies of thyroid cancer in three cohorts to examine associations between pre-diagnostic concentrations of polychlorinated biphenyls (PCB), polybrominated diethyl ethers (PBDE), and organochlorine insecticides and thyroid cancer risk.
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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)/ and the US 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 US 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 United States, 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 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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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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Pregnancy and Birth to 24 Months (P/B-24) Project''s Federal Expert Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, HRSA, OS
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NICHD, NCI, NHLBI, NIDDK
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In 2012, the US Department of Agriculture (USDA) and Department of Health and Human Services (HHS) initiated a project informally called the “B-24 project.” This multi-phase project was originally intended to conclude in 2018 with information that could help the Departments develop dietary recommendations for infants and toddlers for release separate from the Dietary Guidelines. The first phase was completed in 2012-2013.
In February 2014, Congress passed the Agricultural Act of 2014, also known as the Farm Bill, mandating that the Dietary Guidelines expand to include dietary guidance for infants and toddlers (from birth to age 24 months), as well as women who are pregnant, beginning with the 2020-2025 edition. Thus, USDA and HHS adjusted the purpose, timeline, and scope of the project. Now called the “Pregnancy and Birth to 24 Months project” or “P/B-24 project” to reflect the addition of pregnant women, this project is a joint initiative led by USDA and HHS in collaboration with programmatic and scientific experts. Rather than concluding in 2018 with dietary recommendations, the goal of the current project is to begin examining topics of public health importance for women who are pregnant and infants and toddlers from birth to 24 months of age. The findings from this work will be made publicly available at the completion of the project.
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PregSource® Management Team
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Public Education Campaign
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CDC, CMS, HRSA
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NICHD, NCCIH, NHLBI, NIEHS, NIMHD, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH
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PregSource is a crowdsourcing research project that aims to learn about the pregnancy experience. Getting information directly from pregnant women about what they feel, think, do, and experience during pregnancy and after giving birth can teach us more about pregnancy and how to improve care.
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President''s Emergency Plan for AIDS Relief (PEPFAR) Cervical Cancer Prevention Expert Task Force
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Committee, Work group, Advisory group, or Task Force
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CDC
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NCI, NIAID
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Experts from the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH) National Cancer Institute (NCI) Division of Cancer Prevention and National Institute of Allergy and Infectious Diseases (NIAID) and other US government agencies (Department of Defense (DOD), United States Agency for International Development (USAID), Department of State, Peace Corps) participated on an expert task force to inform development and oversight of cervical cancer prevention programs within the US President''s Emergency Plan for AIDS Relief (PEPFAR) initiative in eight sub-Saharan African countries
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Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB)
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Committee, Work group, Advisory group, or Task Force
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BARDA
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NIAID
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In March 2015, HHS announced the establishment of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This Federal Advisory Committee (FACA) includes public voting members, non-voting liaison representatives from organizations and/or interest groups, and non-voting federal ex-officio members. PACCARB provides advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for CARB and the National Action Plan for CARB. PACCARB has been reauthorized until Jan 18, 2019 (based on its charter), through Executive Order 13811 on Sept. 29, 2017.
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President’s Emergency Plan for AIDS Relief (PEPFAR) Implementation Science/Combination Prevention
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Research Initiative
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CDC
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NIAID, FIC, NCI, NIAAA, NIDA, NIMH, OD/DPCPSI/OAR
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This President’s Emergency Plan for AIDS Relief (PEPFAR) activity focuses on testing treatment as prevention on the population level in South Africa and Zambia. This activity was initiated through the HIV Prevention Trials Network (HPTN), with support of multiple National Institutes of Health (NIH) Institutes and Centers, PEFPAR, and the Bill & Melinda Gates Foundation. The Requests for Application (RFA) was issued concurrently with a Centers for Disease Control and Prevention (CDC) RFA for combination prevention, and the agencies have worked together to ensure that the studies are complementary and do not overlap.
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