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NCI/FDA Memorandum of Understanding for Proteomics
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Research Initiative
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FDA
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NCI
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This Memorandum of Understanding (MOU), signed in 2007 and renewed in 2012, establishes an official relationship in clinical proteomic regulatory science between the National Cancer Institute''s (NCI) Office of Cancer Clinical Proteomics Research and the Food and Drug Administration (FDA). Active areas of research collaboration include sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.
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NCI/FDA/HRSA/CMS Task Force on Cancer Diagnostic Devices (CD2) for Near-Patient Use
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA, HRSA
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NCI
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The primary goal of this initiative is to develop opportunities that accelerate the pace by which point of care diagnostic devices get to patients for the earlier detection and screening of cancer. The Task Force and Initiative will address cancer types for geographically isolated, medically underserved, and otherwise vulnerable communities, with emphasis to: 1) Cancer types with clear, existing need and highly prevalent, for example cervical cancer; and 2) Cancer types that have evidence of future need from emerging at-risk populations, for example liver cancers derived from nonalcoholic steatohepatitis (NASH).
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Networking and Information Technology Research and Development (NITRD)
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Research Initiative
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AHRQ
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NIGMS
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The Networking and Information Technology Research and Development (NITRD) Program provides a framework in which many Federal agencies come together to coordinate their networking and information technology (IT) research and development (R&D) efforts.
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Neutron Radiobiology and Dosimetry Workshop Meeting Report
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Other
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BARDA
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NIAID
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The purpose of this meeting was to work with stakeholders to discuss the current state of dosimetery used in research involving neutrons and mixed field radiation. The discussion examined gaps in knowledge and discuss strategies to plan studies to better inform the research community on the impact neutrons on drug efficacy studies. A meeting report is now being drafter for for submisson in 2020, as an open source of information for other researchers.
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New Molecular Methods for Evaluation of Antibody Responses Following RSV Vaccination and Infection
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Other
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FDA
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NIAID
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The goal of the project is to identify the key protective epitopes in F and G membrane proteins and to develop new tools to measure virus neutralization and antibody affinity.
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Newborn Screening Coding and Terminology Guide
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Resource Development
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CDC, FDA, HRSA, OS
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NLM, NHGRI, NHLBI, NICHD
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This ongoing collaboration develops, supplements, and publicizes a free online resource with guidance to help promote the efficient electronic exchange of standardized newborn screening data. Related efforts include studying the screening process for diseases including severe combined immunodeficiency (SCID), lysosomal storage disorders (LSDs), and critical congenital heart disease (CCHD), and developing standard codes for ordering and reporting the results of newborn screening for SCID, CCHD, and other conditions added to the Uniform Recommended Screening Panel by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.
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Newborn Screening Federal Partners Committee
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, FDA, HRSA
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NICHD, NHLBI, NLM
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The federal members of the Advisory Committee on Heritable Disorders in Newborns and Children meet monthly to share information about newborn screening activities.
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NGSP (formerly the National Glycohemoglobin Standardization Program)
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Resource Development
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CDC
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NIDDK
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The purpose of the NGSP (formerly the National Glycohemoglobin Standardization Program) is to standardize Hemoglobin A1c test results to those of the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), which established the direct relationships between HbA1c levels and outcome risks in patients with diabetes.
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NIAID-CDC Joint US Partnership Implementing TB Elimination Research (JUPITER)
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Committee, Work group, Advisory group, or Task Force
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CDC
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NIAID
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Through weekly teleconferences, the Joint US Partnership Implementing TB Elimination Research (JUPITER) facilitates cooperation, communication, and collaboration on tuberculosis between the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC). This approach helps ensure that Federal activities are coordinated and not duplicated, and stimulates collaborations where appropriate.
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NIAID/CDC Dual Use Research of Concern (DURC) Risk Mitigation Reviews
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Other
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CDC
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NIAID
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The Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins Division will provide technical assistance in evaluating the sufficiency of the biosecurity and/or biosafety measures incorporated into risk mitigation plans received from institutions, and cross-check risk mitigation plans and research conducted using select agents and toxins against information in the Federal Select Agent Program (FSAP) database.
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