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Exposure Science in the 21st Century (ES21) Working Group
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Research Initiative
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CDC, FDA
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NIEHS, NCI
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ES21 is a working group chartered by the Toxics and Risk subcommittee of the OSTP Committee on Environment, Natural Resources, and Sustainability. The group focuses on coordinating efforts to advance exposure science through research and development. The primary emphasis is on information sharing and cataloging federal activities on biomonitoring, community engagement, data management, environmental monitoring, modeling and the development of sensors and dosimeters.
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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, NCATS, OD/DPCPSI/OSC
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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 NLM to assist the U.S. 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, LHC and FDA/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 FY17, 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).
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Extreme Events and the Elderly: Scientific Evidence, Cultural Considerations and Sustainable Solutions
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Meeting/ Workshop
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CDC
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NIEHS, NIA
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The purpose of this workshop was to explore research, service, and policy needs of the elderly in the context of extreme events (natural and manmade catastrophes such as hurricanes floods oil spills fires). The workshop highlighted existing resources and sustainable solutions for the elderly within the context of specific cultural needs of a variety of elder populations (African American, Hispanic, native American, Asian and rural/remote and low SES elderly).
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Eye Research Collaboration
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Other
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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. 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.
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Fast Track Action Committee on Biosafety and Biosecurity
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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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This Committee examines relevant biosafety regulations and further explore other options for biosafety oversight
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FastTrack Action Committee - Mapping the Microbiome (FTAC-MM)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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OD/DPCPSI, NHGRI, OD/DPCPSI/OSC
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The purpose of the FTAC-MM was to identify areas of current Federal investment, research needs, and resource gaps for the development of an integrated Federal plan for microbiome research, and to identify priority areas for Federal agency coordination and cooperation on achieving a predictive understanding of microbiomes and their functions.
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FDA Cancer Imaging Program (CIP) Bi-annual Meeting
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Meeting/ Workshop
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FDA
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NCI
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This collaboration is a bi-annual meeting to enhance communication between the Cancer Imaging Program (CIP) and the Division of Medical Imaging Products of CDER in the FDA. This allows for a two-way exchange of information and discussion of issues that are important for each side. Topics that have been discussed include CIP''s standardization efforts of medical imaging scanners in NCI Cancer Centers, presentation and discussion of specific new molecular imaging modalities, and discussion of recent FDA decisions regarding new medical imaging innovations.
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FDA Drug Safety Oversight Board
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, CMS, FDA, HRSA, IHS
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OD/OSP, NCI
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The FDA Drug Safety Oversight Board (DSB), created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the FDA''s Center for Drug Evaluation and Research (CDER) Director on the handling and communicating of important and often emerging drug safety issues and regulatory science. The DSB is composed of representatives from two FDA Centers and eight other federal government agencies: the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Department of Veterans Affairs (VA). An important role of the DSB is to help FDA assess the impact of their safety decisions on the healthcare systems of its Federal Partners. The Board, with its broad representation from federal healthcare organizations, can provide valuable input and allows FDA to hear other perspectives on drug safety issues.
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FDA Medical Countermeasures Initiative (MCMi) Regulatory Science Steering Committee
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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 committee provides guidance to the Medical Countermeasures Initiative (MCMi) stakeholders.
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