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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 Medical Countermeasures Enterprise (PHEMCE) Chemical Integrated Product Development 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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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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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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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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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 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 Biodosimetry 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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Team members participate in the review of white papers as well as proposals and progress reviews for Biomedical Advanced Research and Development Authority (BARDA)-funded contracts supporting the development of novel biodosimetry platforms.
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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
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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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Reciprocal Educational and Training Partnerships between FDA/CDER and the NIH Clinical Center
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Training Initiative
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FDA
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CC, NCI, NIAID, NIDCR, NIDDK, NIMH, NINDS
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This activity is sponsored by the Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education (OCRTME) at The National Institutes of Health (NIH) Clinical Center (CC). It consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND) of the US Food and Drug Administration''s (FDA) Center for Drug Evaluation and Research. It is for NIH staff, with a primary focus on clinical fellows and research fellows, who expressed an interest in learning more about FDA regulatory sciences applicable to drug development research. Rotating fellows are mentored by FDA staff on the required elements of an Investigational New Drug (IND) application and the key elements of the FDA review process from a regulatory perspective. This program also established a mechanism for FDA scientific reviewers at the OCP to rotate at the NIH CC and to interact with members of a clinical research team, thus acquiring a better perspective on clinical research protocol implementation and the requirements of an Institutional Review Board (IRB) at the NIH.
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