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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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Policies and Regulatory Pathways to FDA Licensure
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Meeting/ Workshop
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FDA
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NIAID
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The purpose of this meeting was to understand the policies that advance radiation countermeasure agents and biodosimetry devices towards eventual FDA approval. Manuscript preparation is ongoing with input from all agencies, with anticipated submission to Radiation Research
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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 Market Safety Study of Opioids
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/DPCPSI/ORWH, NIDA
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Participated in the oversight committee in the FDA Mandated Post-Market Opioid Safety Studies, which is a 100 million-dollar FDA mandated series of research projects related to the safety and risks associated with the long-term use of opioids for pain.
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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 Post-Traumatic Stress Disorders (PTSD), Trauma Brain Injury (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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Predictive Biodosimetry Guidance Planning Working Group
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Committee, Work group, Advisory group, or Task Force
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ASPR, FDA
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NIAID
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Working group meets monthly with the following goals: 1) Convene a subject matter expert (SME) panel to discuss target product profile (TPP) or device/assay specifications for predictive biodosimetry in early 2021; 2) Identify key SMEs. trans-agency partners and companies; 3) Host meeting, write panel consensus report; 4) Partner with FDA to generate an addendum to the Biodosimetry Guidance; 5) Identify pathways for development and potential pitfalls; 6) Identify funding to support mid-stage to advanced development of predictive biodosimetry devices/assays.
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Pregnancy and Birth to 24 Months (P/B-24) Project
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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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Pregnancy and Maternal Conditions that Increase Risk of Morbidity and Mortality Virtual Workshop
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Meeting/ Workshop
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OASH
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OD/DPCPSI/ORWH, NICHD, NHLBI, ODP
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There were various speakers that presented at this event which took place on May 19-20, 2020.
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