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NICHD-Maternal and Child Health (MCH) Electronic Health Record (EHR)
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Research Initiative
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HRSA
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NICHD
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NICHD paid money in 2012-13-14 on this Interdepartmental Delegation Authority (IDDA) that provided funds for the Maternal and Child Health (MCH) Electronic Health Record (EHR) Pediatric Practice Based Research Network (PBRN) Initiative. Although NICHD did not provide funding for this research initiative in 2015 the money paid on the first 3 years was to be used over the entire 5 year period. In 2015 the publication "Comparative Effectiveness Research Through a Collaborative Electronic Reporting Consortium" as epublished.
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Nicotine Research Cigarettes (SPECTRUM)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIDA
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This partnership with the Food and Drug Administration (FDA) is for the production of produce research cigarettes.
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NIEHS Patterns of Co-Exposure in Danish Women of Reproductive Age
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Research Initiative
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CDC
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NIEHS
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This study characterizes exposure to National Health and Nutrition Examination Survey (NHANES) chemicals in a set of 50 Danish women participating in a time to pregnancy study that will also include follow-up of offspring.
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NIH Biomarkers Consortium
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Research Initiative
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CMS, FDA
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NIMH, NCCIH, NCI, NEI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDDK, NINDS
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The Biomarkers Consortium develops, validates, and qualifies biological markers (biomarkers) to speed the development of medicines and therapies for detection, prevention, diagnosis, and treatment of disease and to improve patient care. The NIH Public Private Partnership Program coordinates NIH participation in the sponsored Biomarkers Foundation for the National Institutes of Health (FNIH) consortium. The consortium is an umbrella which encompasses research projects, ongoing working groups, as well as occasional workshops and conferences.
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NIH Gabriella Miller Kids First Common Fund Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC
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NICHD, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAID, NIAMS, NIDA, NIDCR, NIDDK, NIEHS, NINDS, OD/DPCPSI/ORIP, OD/DPCPSI/OSC
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The NIH Gabriella Miller Kids First Common Fund Working Group supports the goals and initiatives of the NIH Gabriella Miller First Common Fund Pediatric Research Program.
In fiscal year 2015, in accordance with the Gabriella Miller Kids First Research Act, Congress appropriated $12.6 million to the NIH Common Fund to support pediatric research. The Common Fund’s Gabriella Miller Kids First Pediatric Research program (Kids First) is planning to develop a data resource for the pediatric research community of well-curated clinical and genetic sequence data that will allow scientists to identify genetic pathways that underlie specific pediatric conditions but that may also be shared between apparently disparate conditions. In order to make a significant impact within the available fiscal year 2015 budget, the program will collect data from the following types of pediatric conditions:
•Childhood cancers – Either those that have a suspected genetic component, or, as a jump start for the Precision Medicine Initiative which NIH expects to launch in fiscal year 2016, the program will also collect data from childhood sarcomas that have failed to respond to treatment.
•Structural birth defects - related to a problem with body parts and structure and include conditions like cleft lip, misshaped heart valves, abnormal limbs, problems related to the growth and development of the brain and spinal cord.
The integrated data resource will allow researchers to explore whether shared genetic pathways may contribute to both cancer and structural birth defects.
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NIH Guide for Grants and Contracts
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Resource Development
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AHRQ, CDC, FDA
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OD/OER, CC, CIT, CSR, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI
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The National Institutes of Health (NIH) Guide for Grants and Contracts is the official publication for NIH medical and behavioral grant policies, guidelines, and funding opportunities, and is used by other U. S. Department of Health and Human Services (HHS) agencies to disseminate Funding Opportunity Announcements (FOAs) to its 50,000 subscribers.
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NIH Recombinant DNA Advisory Committee (RAC)
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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, NCI, NHGRI, NIAID, NINDS
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The Recombinant DNA Advisory Committee (RAC) advises the National Institutes of Health on the safe and ethical conduct of basic and clinical research involving recombinant DNA. It reviews protocols and provides recommendations for each protocol to enhance the scientific and ethical design. The RAC also discusses safety data and other emerging issues for the field of gene therapy. This year the RAC hosted a meeting to develop biosafety guidelines for gain-of-function research with H5N1 which led to the amendment of the NIH Guidelines for Research with Synthetic and Recombinant Research. The RAC also hosted a meeting of mid-level investigators to examine the scientific and other challenges that gene therapy will face in the next decade and a meeting to discuss optimization of the design of clinical trials using gene modified T cells in order to realize the potential of this immunotherapy while minimizing the risk to subjects.
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NIH Translational Research Interest Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI, CC, CIT, CSR, NCATS, NCCIH, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI, OD/OER, OD/OIR, OD/OSP
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As Chair of the National Institutes of Health (NIH) Translational Research Interest Group (TRIG), the National Cancer Institute (NCI) staff has coordinated Forums, Workshops, NIH Bench-to-Bedside Awardees’ Lecture Series, and Monthly Seminar Series to help bridge the gap between laboratory research and clinical applications; suggestions of topics and speakers for the Annual NIH Research Festivals; and nominations of speakers for the NIH Wednesday Afternoon Lecture Series and the NIH Director’s Lecture Series. NCI staff has informed TRIG members of scientific events coordinated with other NIH Scientific Interest Groups and Working Groups.
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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 senior leadership Forum
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Committee, Work group, Advisory group, or Task Force
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CMS
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NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/OBSSR, OD/OSP
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The CMS-NIH Senior Leadership Forum is comprised of NIH Director Francis Collins, CMS Administrator Marilyn Tavenner, and Senior Staff from both agencies. It convenes twice yearly. Meetings focus on identifying and troubleshooting areas where increased communication and specific activities (including policies and programs) will benefit the mission of both organizations. Recent topics have included creating a system for early alerts regarding NIH-supported research findings of interest to CMS; NIH-supported research findings of interest to Centers for Medicare & Medicaid Services (CMS) in high impact conditions such as diabetes, schizophrenia, post-acute stroke care, prevention of pre-term birth, lung cancer computed tomography screening, tobacco cessation, genomics, etc.; enhancing investigator access to CMS data through the use of Data Enclaves; development of common data elements (CDEs) to enhance the conduct of clinical research; and collaboration with the CMS Innovation Center to develop a Funding Opportunity Announcement , “Low Cost, Pragmatic Patient-Centered Randomized Controlled Intervention Trials,” issued and funded by NIH.
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