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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 HHS and in cooperation with PHEMCE interagency partners. NIAID has representatives on many groups within PHEMCE.
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Public Health Emergency Management Countermeasures Enterprise (PHEMCE)
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Committee, Work group, Advisory group, or Task Force
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ACF, CDC, FDA, IOS, SAMHSA
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NLM, NIAMS
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The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) determines the various MCMs that are needed and oversees their development and procurement. The PHEMCE also advances national preparedness against chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease (EID) threats, including pandemic influenza, by coordinating medical countermeasure related efforts within HHS and in cooperation with interagency PHEMCE partners. In order to accomplish this objective, the PHEMCE uses a multitier approach. Each tier comprises multiple agencies within HHS and/ or DHS that work together in a collaborative fashion to further the preparedness of the nation. The first tier includes the Biological, Chemical, Radiological/Nuclear Working Groups; the Blood/Tissue MCM Requirements Working Group; and Integrated Program Teams (IPTs). The Working Groups (WG) utilize scenario-based analyses to determine which medical countermeasures are needed for the SNS, or affiliated repositories. The IPTs provide an end-to-end vision of medical countermeasures needed for a particular threat type (e.g., anthrax, rad/nuc, etc.). The scope of their work includes setting requirements for the stockpiling of MCMs, MCM delivery and dispensing and monitoring MCM development. The IPTs also advise the Enterprise Executive Committee as to threat- or capability-specific MCM priorities for improving preparedness, to inform leadership consideration of cross-threat prioritizations and strategic goal setting. Agencies represented on the PHEMCE WGs and IPTs include; National Institute of Health(NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Department of Defense (DOD), Assistant Secretary for Preparedness and Response ( ASPR), Biomedical Advanced Research and Development Authority (BARDA), Department of Homeland Security (DHS) and the Department of Veterans Affairs (VA). The second tier of this process is the Enterprise Executive Committee (EEC). The EEC is comprised of senior program managers across the partner agencies. It provides the critical interface and organizing capability between the strategic focus of the Enterprise Senior Council (ESC) and the tactical-level efforts conducted within the subordinate IPTs and WGs. This committee serves as a Senior Advisor-level coordination mechanism across the federal agencies involved in PHEMCE-related activities to facilitate vetting and prioritization of policy decision materials to be presented to the ESC. The third and most senior tier of the PHEMCE and the forum for cooperation and overall mission fulfillment is the Enterprise Senior Council (ESC). Structurally, the ESC is led by the Assistant Secretary for Preparedness and Response and comprised of the senior leadership of National Institute of Allergy and Infectious Disease (NIAID) within the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) with comparable senior level representatives from the Department of Defense (DoD) , the Department of Homeland Security (DHS), the Department of Veterans Affairs (VA) , and the U.S. Department of Agriculture (USDA) As the most senior level in the PHEMCE structure, this group approves major policies, product requirements, and large-scale procurement actions. It also oversees strategic reviews of the activities in each of the major threat portfolios (e.g., anthrax, smallpox, rad/nuc) and is the final reporting body for high priority actions identified as gaps in these reviews.
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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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Resource Development
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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 reagents, 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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Racial/Ethnic Variation of HPV Type Distribution in High-Grade Cervical Precancers and Invasive Cancers in the United States
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Research Initiative
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CDC
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NCI
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The National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating in pooled anlaysis of seven U.S. studies conducted between 1997-2015 to examine HPV genotype attribution for cervical precancer and cancer by race/ethnicity.
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Radiation and Chemical Defense 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, NIEHS, NIAMS
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This group is responsible for ensuring that any scientific or budgetary overlap between the chemical defense and radiation defense missions are identified and leveraged to advance the missions of both research areas. Goals are to understand areas of synergy in chemical and radiological insults, identify key pathways, foci of intervention, MCM development. The group includes staff from across the NIH, FDA and ASPR. Special Journal Issue and Government staff positional paper are planned.
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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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