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Evidence-Based Cancer Control Programs
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Resource Development
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CDC
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NCI
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The EBCCP (formerly RTIPs) website is a searchable database of evidence-based cancer control programs and is designed to provide program planners and public health practitioners easy and immediate access to program materials.
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Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)
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Research Initiative
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CDC
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NIA
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This collaboration between NIA and NIOSH supports exploratory and developmental research projects (R21) that address/mitigate/improve issues related to diagnostic or treatment uncertainty with respect to individuals, including enrolled World Trade Center (WTC) responders and certified-eligible WTC survivors, receiving monitoring and/or treatment under subtitle B, of the James Zadroga 9/11 health and Compensation Act (Public Law 111-347). A suitable mix of exploratory and developmental research projects are sought to help advance treatment and diagnostic effectiveness and the understanding of the health and well-being of the WTC Health Program members related to the September 2001 terrorist attacks.
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Extracellular Ribonucleic Acid (RNA) Communication
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Research Initiative
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FDA
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OD/DPCPSI/OSC, NCATS
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Recent advances have indicated that ribonucleic acids (RNAs) can play a role in a variety of complex cellular functions, including newly discovered mechanisms of cell-to-cell communication. RNA can be exported from cells in extracellular vesicles or bound to lipids or proteins, to circulate through the body and affect cells at a distance. However, the actual impact of the extracellular RNAs, or exRNAs, is currently unknown. NIH and FDA have coordinated efforts on the preclinical and clinical use of exRNAs to address human health and disease. To date, several PIs have had pre-pre-IND meetings with FDA/CBER. They have been provided information necessary to submit applications, for example, a biomarkers device.
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Extracting Adverse Reactions and Indexing the Content of Structured Product Labels (SPLs)
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Resource Development
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FDA
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NLM
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The objective of this initiative is for the National Library of Medicine (NLM) to assist the US Food and Drug Administration (FDA) in indexing the content of structured product labels (SPL) for drugs. Natural language processing technology is used to extract drug-drug interaction information from SPLs which will be validated by FDA subject matter experts. Transforming the narrative text to structured information encoded in national standard terminologies is a prerequisite to the effective deployment of drug safety information in drug labels for clinical decision support. Starting in FY16, the Labeling and Health Communication (LHC) and the FDA's Center for Drug Evaluation and Research (CDER) collaborate on advancing automated extraction of Adverse Reactions (ARs) from drug listing information companies have submitted to FDA in the form of Structured Product Labels (SPLs). The goals of the initial agreement were to develop optimal MetaMap settings for extracting ARs from SPLs and provide FDA with the software necessary to replicate the results. To evaluate the extraction quality, LHC and FDA needed to develop a test collection of SPLs annotated with ARs. Working together, LHC and FDA have developed annotation guidelines. LHC have annotated 200 SPLs and coded the results to MedDRA, the official controlled vocabulary used by FDA to normalize the labeled ARs. In FY18, the collaboration continues with the goals to conduct a community-wide evaluation of the available AR extraction tools. The evaluation venue is NIST Text Analysis Conference (TAC). Over 130 new labels have been annotated with DDIs in FY18.
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Extraction of adverse drug events from MEDLINE indexing to support a multimodal model for pharmacovigilance.
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Resource Development
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FDA
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NLM
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Renewal (2019) of an IAA between Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) and the Lister Hill National Center for Biomedical Communications (LHNCBC) at the National Library of Medicine (NLM). The collaboration delivers monthly MEDLINE dataset files derived from the Medical Subject Heading (MeSH) indexing (resulting from a 2012 FDA/CDER – NIH/NLM/LHNCBC IAA research collaboration) to harness MEDLINE as a source to support prospective detection of drug-adverse event safety signals from published scientific literature. CDER is responsible for protecting the public health by regulating over-the-counter and prescription drugs, biological therapeutics, and generic drugs. CDER is developing novel, integrative, validated analytic informatics tools to access and analyze new data sources for drug-adverse event signal detection. PEARL (an acronym for ‘Prospective Detection of Emerging Drug-Adverse Event Safety Signals from Relevant Scientific Literature through Quantitative Data Mining of MEDLINE Indexing Terms’) is a prototype, automated, web-based data mining and visual analytics tool that supports the detection of drug-adverse event (ADE) safety signals from published literature reports in MEDLINE through quantitative data mining of Medical Subject Heading (MeSH) indexing terms. MEDLINE dataset file refreshes are needed on a regular monthly basis so that the data mining and safety signal detection outputs from PEARL reflect the most current subset of MeSH-indexed citations in PubMed.
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Extramural Interagency Filovirus Team
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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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Coordination across USG agencies of filovirus MCM activities
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Eye Research Collaboration
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Research Initiative
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FDA
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NEI
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The National Eye Institute (NEI) is collaborating with the Food and Drug Administration (FDA) on uveitis research and on the ocular manifestations of Zika virus and Ebola virus. Uveitis is an autoimmune disease that targets the eye. If left untreated the disease can cause permanent vision loss. Current treatments consist of steroids to suppress the immune system. However, chronic use of these drugs has many side-effects and complications. Recent outbreaks of Ebola virus and Zika virus have highlighted the unique immunological responses to these infections in the “immune privileged” eye. The virus persists in ocular fluids, even after virus is cleared from other parts of the body.
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Factor VIII Inhibitors: Generating a National Blueprint for Future Research
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Meeting/ Workshop
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CDC
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NHLBI, NCI, NICHD, NLM
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A State of the Science meeting was planned and executed on May 15-16, 2018 in collaboration with the national and international hemophilia community. The national and international hemophilia community. The details of the planning effort, the proceedings and work of 4 working groups, and the synthesized research blueprint have been submitted to the journal Haemophilia blueprint have been submitted to the journal Haemophilia as a series of 6 papers that are currently under review. Once published they will dissiminate the consensus research hemophilia community. In so doing, the strategic priorities for future National Heart, Lung, and Blood Institute (NHLBI) funding in this field were better defined.
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Fast Track Action Committee on Biosafety and Biosecurity (FTAC)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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OD/OSP, NIAID
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Examines relevant biosafety regulations and further explores options for enhancing biosafety oversight.
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FDA Acute Radiation Syndrome (ARS) Action Team
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Committee, Work group, Advisory group, or Task Force
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FDA, OS
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NIAID
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This working group is collaborating on non-human primate (NHP) control animal data and meta analysis. Collaboration includes exchange of study data, study reports, development of a NHP control database and statistical analysis plan and report. The objective is to provide a data package to the Food and Drug Administration (FDA) to support vaccine product development and licensure.
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