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Promoting Semantic Interoperability of Laboratory Data Test Results
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Resource Development
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CDC, FDA
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NLM
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The Centers for Disease Control and Prevention (CDC) and the National Library of Medicine (NLM) encourage considering ways that the Food and Drug Administration (FDA) could accelerate specifications of LOINC codes that apply to each test result that a lab/test instrument or kit can generate. Availability of the right LOINC codes with each instrument test kit will greatly simplify the correct assignment of codes by a laboratory for sending to clinician''s medical record system.
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Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE)
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Committee, Work group, Advisory group, or Task Force
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ACF, CDC, FDA, OS, SAMHSA
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NIAID, NIAMS, NICHD, NINDS, NLM
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The Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE) advances national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within the Department of Health and Human Services (HHS) and in cooperation with PHEMCE interagency partners. The National Institute of Allergy and Infectious Diseases (NIAID) has representatives on many groups within PHEMCE.
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Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Pediatrics and Obstetrics Integrated Program Team (IPT)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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NICHD, NIGMS
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The Public Health Emergency Medical Countermeasures Enterprise''s (PHEMCE) mission is to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners. The Pediatrics and Obstetrics Integrated Program Team (IPT) provide a complete, end-to-end vision of medical countermeasures for pregnant women, mothers, and their children. The IPT considers requirement-analysis, development and production, stockpiling, delivery and dispensing to the end user, adverse event monitoring, communications, guidance and policy development, and evaluating medical countermeasures'' effectiveness and replacement needs.
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Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Preparedness Against Chemical Threats (PACT) Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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NINDS, NIAID
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The US Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) leads the mission to develop and acquire medical countermeasures that will improve public health emergency preparedness as well as prevent and mitigate the adverse health consequences associated with chemical, biological, radiological and nuclear (CBRN), and naturally occurring threats.
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Quantitative Data Mining for Drug-Adverse Event Safety Signal Detection Using MEDLINE
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Research Initiative
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FDA
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NLM
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The objective of this initiative between the National Library of Medicine (NLM) Cognitive Science Branch and the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA) is to develop a mutually beneficial automated data mining analytical tool in which NLM’s electronic databases and resources (including MEDLINE) are utilized to support the FDA’s mission related to enhancing postmarket drug safety surveillance and safe use.
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Quantum Barcoding for analysis of Ebola infection
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Other
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FDA
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NIAID
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Viral MIBI and Quantum barcoding: These projects are part of an Food and Drug Administration (FDA) contract with Dr. Gary Nolan''s group at Stanford. The first project will develop and validate an assay for nucleic acid-based method for viral detection on the MIBI, compatible with Formalin-Fixed Paraffin-Embedded tissue, and then apply to Ebola samples.The second will use quantum barcoding to develop anti-human and anti-macaque antibody reagants, to hep develop a system that will replace multiplexing technologies such as high parameter FACS and CyTOF with a platform based on sequence tags (rather than fluorophores or mass tags) that uses decontaminated and ambient temperature-stable samples. This will be applied to BSL-3/4 samples.
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Radiation Biodosimetry Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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This working group is focused on regulatory and scientific issues regarding technologies and devices for radiation biodosimetry. The working group assisted in drafting the new Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) guidance for industry.
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Radiation Emergency Medical Management (REMM)
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Resource Development
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CDC, OS
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NLM, NCI
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This activity is to develop a comprehensive web resource and mobile app. Radiation Emergency Medical Management (REMM) is a mechanism to collect, evaluate, collate, store, and make available electronically to health care professionals immediate, up-to-date, evidence-based clinical information they would use to treat civilian patients and others affected by radiation incidents.
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Radiation/Nuclear Technical Evaluation Review Panel
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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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The National Institute of Allergy and Infectious Diseases (NIAID) participates on the Radiation/Nuclear Technical Evaluation Review Panel to review white papers and proposals received by the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for the development of radiation and nuclear medical countermeasures. NIAID provides scientific and programmatic critiques and reviews of selected submissions.
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Radiobiology Bioterrorism Research and Training Group (RABRAT)
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Meeting/ Workshop
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FDA, OS
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NCI, NIAID
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This activity involves monthly meetings to discuss research initiatives, funding opportunities, training, conferences, publications, and other events and information related to preparing the US Government to respond to nuclear terrorism.
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