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Pathogen Detection Project and Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS)
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Resource Development
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CDC, FDA
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NLM
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The Pathogen Detection Project is a multi-agency collaboration that is combining data from pathogen outbreaks with other information to determine the major source of contamination. The project is conducted via a centralized system that integrates sequence data for bacterial pathogens obtained from food, the environment, and human patients. A number of public health agencies in the US and internationally are collecting samples from these sources to facilitate active, real-time surveillance of pathogens and foodborne disease. The agencies sequence the samples and submit the data to the National Center for Biotechnology Information (NCBI), a division of the National Library of Medicine (NLM) at the National Institutes of Health (NIH), which analyzes the sequences against others in its database to identify closely related sequences. The aim is to uncover potential sources of contamination by linking isolates from food or the environment to human illness and to quickly report the sequence relationships to public health scientists in order to aid traceback investigations and outbreak response. Collaborating agencies include the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), United States Department of Agriculture (USDA) Food Safety and Inspection Service, and Public Health England. The US agencies formalized their collaboration in a charter document (Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS)) that includes coordinating activities on antimicrobial resistance.
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Pathways to Prevention (P2P) Workshop Program
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Meeting/ Workshop
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AHRQ
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OD/DPCPSI/ODP
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The Pathways to Prevention (P2P) program is a workshop series hosted by the Office of Disease Prevention (ODP) to identify research gaps in a selected scientific area, identify methodological and scientific weaknesses in that scientific area, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue. P2P workshops are designed for topics that have incomplete or underdeveloped research and for which there is a need for a systematic evidence review that synthesizes the published literature. After each workshop, ODP also organizes a meeting of all Federal Partners who have an interest in or activities related to the workshop topic to discuss ways that the Federal Partners might collaborate to implement workshop recommendations.
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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 Grants Program
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Research Initiative
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FDA
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NICHD
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The goal of the Food and Drug Administration (FDA) Pediatric Device Consortia (PDC) Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of nonprofit consortia.
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PFI Biopharmaceutical Classification System (BCS) Task Specific Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD, NLM
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The Pediatric Formulations Initiative (PFI) is designed to look at all the factors that affect the development of pediatric drugs. The goals are to create a roadmap for removing/mitigating barriers to pediatric drug development and to connect researchers and experts in pediatric formulation to discuss issues and challenges that may stimulate further research in the field. This working group examined the application of the BCS and BDDS to pediatric medicines and addresses knowledge gaps in absorption, distribution, metabolism, and excretion (ADME) at different developmental stages.
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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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Other
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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 Food and Drug Administration (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-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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