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Patient-Centered Outcomes Research Clinical Decision Support Learning Network (PCOR CDS-LN) Advisory Council
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Committee, Work group, Advisory group, or Task Force
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AHRQ, OS
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NLM
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This council provides a forum for stakeholders to assess both barriers and facilitators to implementing PCOR findings in CDS and make recommendations for optimizing PCOR-enabled CDS to facilitate improvements in care and outcomes. The PCOR CDS-LN is funded through a cooperative agreement with the Agency for Healthcare Research and Quality
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Pediatric Device Consortia Grant Program
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Other
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FDA
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NICHD
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FDA funds consortia which provide expert advising and support services to innovators of children''s devices. These services include business and regulatory consulting, as well as device testing capabilities.
Specific areas of expertise provided by the consortia include intellectual property advising; prototyping; engineering; laboratory and animal testing; grant-writing; and clinical trial design.
A successful Pediatric Device Consortium brings together individuals and institutions that can support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization. The consortia are expected to support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing.
To accomplish this work, the consortia unite individuals, groups, or institutions to provide the following capabilities: knowledge of the clinical needs for pediatric devices, business planning, regulatory advising, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.
This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases.
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Physical Activity and Healthcare Utilization and Costs in Older Adults
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Research Initiative
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CDC
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NCI
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Through this initiative, CDC and NCI plan to investigate the association between physical activity over the life-course on later life health care utilization and costs in Medicare recipients in the AARP Cohort.
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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 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. 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)/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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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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Fact sheets 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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