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NIH-CDC-IDSA Guidelines for Treatment of HIV Related Opportunistic Infections Among Adults and Adolescents
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Committee, Work group, Advisory group, or Task Force
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CDC
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CC
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The National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, and the Centers for Disease Control and Prevention (CDC) have developed guidelines for treatment of opportunistic infections (OIs) among adults and adolescents infected with human immunodeficiency virus (HIV). These guidelines are intended for clinicians and other health-care providers who care for HIV-infected adults and adolescents, including pregnant women; they complement companion guidelines for treatment of OIs among HIV-infected children and previously published guidelines for prevention of OIs in these populations.
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NIH-CMS Coordinating Committee for trials and data sharing
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Committee, Work group, Advisory group, or Task Force
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CMS
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NIDDK, NCATS, NCI, NIA
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The National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services meet periodically to discuss areas of common interest with respect to both clinical trials and research data.
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NIH-FDA Interagency Clinical Outcome Assessments Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI, CC, NCCAM, NHLBI, NIA, NIAMS, NICHD, NIDA, NIDDK, NIMH, NINDS, OD/DPCPSI
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The Interagency Clinical Outcome Assessments Working Group (ICOA WG) works to foster the development, evaluation and qualification of Clinical Outcomes Assessments (COAs) for use in both medical product development and clinical research. Leveraging the unique strengths, knowledge, and resources at both the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the objectives of the ICOA WG are: 1) To increase communication between the relevant groups at FDA and the many separate efforts at NIH to advance measurement science by exchanging information about specific COA projects of common interest, thereby improving the knowledge base for COA development; 2) To clarify and disseminate information about the regulatory processes for evaluation of medical product development tools; 3) To foster appropriate interagency scientific efforts to generate evidence toward the development and potential qualification of novel COAs; and 4) To leverage public and private efforts toward consensus and standards development in this area. The ICOA WG is composed of representatives and selected senior staff of each agency.
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NIH-FDA Leadership Council
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/OSP, NCI, NHLBI, NIAID, NIDDK, NIGMS, NIMH, NINDS
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The Joint Leadership Council will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process. Such collaboration and integration will advance the development of new products for the treatment, diagnosis and prevention of common and rare diseases and enhance the safety, quality, and efficiency of the clinical research and medical product approval enterprise. The formation of the Leadership Council represents a commitment on the part of both agencies to forge a new partnership and to leverage the strengths of each agency toward this common goal.
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NIH-FDA Tobacco Regulatory Science Workgroup
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIGMS, CSR, FIC, NCI, NEI, NHGRI, NHLBI, NIAAA, NICHD, NIDA, NIDCD, NIDCR, NIEHS, NIMH, NINDS, NINR, NLM, OD/DPCPSI/OBSSR
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The Food and Drug Administration (FDA)-National Institutes of Health (NIH) Tobacco Regulatory Science Workgroup was established in June 2011 through an NIH interagency partnership with the FDA''s Center for Tobacco Products. The FDA-NIH Tobacco Regulatory Science Workgroup is comprised of NIH staff and staff from the FDA Center for Tobacco Products. The purpose of the group is to coordinate, develop, and disseminate information about the Tobacco Regulatory Science Program and to leverage the research experience and capability of NIH to maximize the opportunity available in authorities given in the Family Smoking Prevention and Tobacco Control Act to reduce tobacco related morbidity and mortality. The Working Group meets quarterly.
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NIH/PEPFAR Collaboration for Advancing Implementation Science in Prevention of Maternal-Child HIV Transmission
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Research Initiative
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CDC
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OD/DPCPSI/ORWH, FIC, NICHD, NIMH
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2010 World Health Organization (WHO) recommendations to provide antiretroviral prophylaxis or treatment to mothers or infants during the breastfeeding period have not been adopted in resource poor countries. The goal of this study is to evaluate the effect of a "feeding buddy" to support mothers to adhere to prevention of mother to child HIV transmission. This is a prospective cohort intervention study set within a comprehensive ongoing national program addressing maternal and child health.
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NIH/PEPFAR Collaboration for Implementation Science and Impact Evaluation
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Research Initiative
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CDC
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NIAID, NCI, NICHD, NIMH, OD/DPCPSI/OAR
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In FY11 a National Institutes of Health (NIH)/President''s Emergency Plan for AIDS Relief (PEPFAR) Request for Application (RFA) was issued for 3-year grant projects on Implementation Science in PEPFAR. Funding began in FY12. This RFA went out concurrently with a Centers for Disease Control and Prevention (CDC) RFA. The two agencies worked together to ensure awards were complementary and that there was no overlap.
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NNI Nanotechnology Signature Initiative on Nanotechnology for Sensors and Sensors for Nanotechnology: Improving and Protecting Health, Safety, and the Environment
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NCI, NIBIB
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Interagency effort to coordinate and stimulate creation of the knowledge, tools, and methods necessary to develop and test nanosensors and to track the fate of engineered nanomaterials in the body, consumer products, the workplace, and the environment.
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NNI Nanotechnology Signature Initiative on Nanotechnology Knowledge Infrastructure: Enabling National Leadership in Sustainable Design
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NCI, NIBIB
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Interagency effort to provide a community-based, solutions-oriented knowledge infrastructure to accelerate nanotechnology discovery and innovation.
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Non-Allergic Rhinitis Workshop
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Meeting/ Workshop
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FDA
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NIAID
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The National Institute of Allergy and Infectious Diseases (NIAID) and the Food and Drug Administration (FDA) collaborated on this workshop, which comprised 13 experts in the field of non-allergic rhinitis (NAR), representatives from seven stakeholder organizations, and National Institutes of Health (NIH) and FDA staff. The goal of this workshop was to better define NAR, clinical testing, phenotypes and pathophysiology for NAR, as well as to identify future clinical research opportunities and the potential for drug development.
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