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Medicare Benefit Postcard
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Public Education Campaign
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CMS
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NEI
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The National Eye Institute (NEI) worked with the Centers for Medicare and Medicaid Services (CMS) to develop and disseminate a Medicare benefit card in English and Spanish which describes eligibility for the Medicare benefit for glaucoma and diabetic eye disease. The postcards are distributed to Medicare beneficiaries, the general public, and to health professionals.
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Memorandum of Understanding (MOU) between the FDA Center for Devices and Radiological Health and NIH/NINDS
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Other
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FDA
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NINDS
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This MOU provides a mechanism for addressing cross-cutting issues related to the development of devices for neurological disorders, from bench science to clinical studies and FDA approval.
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Memorandum of Understanding (MOU) between the FDA/Center for Biologics Evaluation and Research (FDA/CBER) and NIH/NINDS
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Other
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FDA
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NINDS
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This Memorandum of Understanding (MOU) provides a mechanism for addressing cross-cutting issues related to therapy development for neurological disorders, from bench science to clinical trials and FDA approval and licensure.
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Memorandum of Understanding Between National Toxicology Program (NTP) and NIH/NIEHS, FDA, and CDC/NIOSH
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Other
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CDC, FDA
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NIEHS
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The interagency NTP, established in 1978 and administratively headquartered at NIH/NIEHS, is an ongoing cooperative effort to evaluate substances of public health concern, develop improved methods, strengthen the science base in toxicology, and provide information important for decisions to safeguard public health. This MOU between FDA, NIH/NIEHS, CDC/NIOSH and NTP affirms a commitment to provide resources dedicated toward carrying out NTP’s mission and outlines various administrative and managerial actions the agencies will take to support NTP’s activities.
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Microbiological Testing of Live Biotherapeutic Products
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Resource Development
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FDA
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NIAID
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The research and manufacturing community has a need for regulatory tools to determine the identity, potency, and purity of new probiotic products currently under development. This project will develop tools for identifying these products, therefore satisfying one of the regulatory requirements for product characterization needed by the FDA for evaluation.
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Microphysiological Systems for Drug Efficacy and Toxicity Testing
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Research Initiative
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FDA
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NCATS, NCI, NEI, NHLBI, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NINDS, NINR, OD/DPCPSI, OD/DPCPSI/ORWH
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The Microphysiological systems initiative aims to develop 3-D human tissue chips that accurately model the structure and function of human organs, such as the lung, liver and heart. Once developed, researchers can use these models to predict whether a candidate drug, vaccine or biologic agent is safe or toxic in humans in a faster and more cost-effective way than current methods. More than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. These organs-on-chips will enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies. To help streamline the therapeutic development pipeline, NIH, in collaboration with the Defense Advanced Research Projects Agency (DARPA) and the U.S. Food and Drug Administration (FDA), is leading this initiative to improve the process for predicting whether drugs will be safe in humans.
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Microsystems Team
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIDDK, NINDS
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The NIH has identified a critical need for improved model systems to predict efficacy, safety, bioavailability, and toxicology outcomes for candidate therapeutics. This NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund and participating NIH IC''s, invites applications for projects that will develop accurate cellular and organ microsystems representative of human physiology for the evaluation of drug efficacy and toxicity. By definition, these cellular and organ microsystems will have a multicellular architecture representing the characteristics and functions of the tissue of origin and will demonstrate a reproducible and viable operation under physiological conditions over a long culture period. It is anticipated that these bio-engineered human tissue models could lead to the development and commercialization of microsystems that will enable rapid and high fidelity evaluation of safety and efficacy for candidate therapeutics.
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Mind Your Risks
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Public Education Campaign
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CDC, CMS
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NINDS
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The Mind Your Risks campaign is designed to create awareness and action about the fact that risk factors for stroke, particularly hypertension, may be linked to cognitive impairment and dementia.
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Minority Health Outreach
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Public Education Campaign
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AHRQ
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NEI
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The National Eye Health Education Program (NEHEP) worked with the Office of Minority Health throughout the year to promote eye health awareness.
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Minority HIV/AIDS Prevention and Treatment Activities
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Training Initiative
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OS
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NICHD
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The purpose of this IDDA is to provide support for prevention and treatment activities in the Consolidated and Further Continuing Appropriations Act, 2015 (P.L. 113-235). The goal is to improve retention in care for HIV+ youth through service defragmentation, best practices, and training on motivational interviewing for outreach workers.
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