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Human Papillomavirus (HPV) Working Group for the Advisory Committee on Immunization Practices (ACIP)
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Committee, Work group, Advisory group, or Task Force
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CDC
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NCI
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The Human Papillomavirus (HPV) Working Group for the Advisory Committee on Immunization Practices (ACIP) Work Groups (WGs) serves in a key scientific role in support of vaccine policy development by the ACIP. ACIP WGs conduct extensive background reviews of relevant research data to develop options for recommendations for use of vaccines in the civilian population of the United States. WGs are convened solely to gather scientific information related to vaccines and the diseases they prevent, to analyze relevant issues and data, and to draft policies or options for review, deliberation, and vote by the ACIP.
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I-Corps @ NIH
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Training Initiative
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CDC
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NCI, NCATS, NCCIH, NHGRI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDCR, NIEHS, NIMH, NINDS
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The I-Corps™ at the National Institutes of Health (NIH) program is focused on educating researchers and technologists on how to translate technologies from the lab into the marketplace. The program is designed to provide three-member project teams with access to instruction and mentoring in order to accelerate the translation of technologies currently being developed with NIH and the Centers for Disease Control and Prevention (CDC) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding. It is anticipated that outcomes for the I-Corps™ teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies.
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Identifying Early Psychosis in Primary Care and Connecting to Care
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Research Initiative
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HRSA
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NIMH
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The Health Resources and Services Administration (HRSA) and National Institute of Mental Health (NIMH) are supporting testing of a brief early psychosis screening instrument. This instrument may be used in a primary care setting to identify people with psychosis at the earliest possible opportunity and connect them to an early psychosis treatment program.
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Image-guided Interventional Therapeutics
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Research Initiative
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FDA
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CC, NCI
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This collaboration will lead to safer and more effective treatment planning and performance of image-guided interventions and therapeutic drug delivery. The results of all of these studies of image-guided interventions and related technologies and the models used to study them will have a direct impact on the effectiveness and consistency of the Food and Drug Administration (FDA) Center for Devices and Radiological Health''s preclinical review of device applications while meeting the primary research goal of optimizing image-guided interventions and pre-clinical modeling of those interventions. Regulatory science and translational therapeutics have overlapping goals when it comes to drugs and devices combination therapies.
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Immunology Interest Group
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Meeting/ Workshop
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FDA
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NCI, CC, NCCIH, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, OD/OIR
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The National Institute of Health (NIH) Immunology Interest Group (IIG) brings together immunologists from across all NIH institutes as well as the Food and Drug Administration (FDA). The two major activities of the IIG are a Wednesday afternoon lecture series highlighting world-class immunologists and intramural immunologists and an annual workshop where up to 350 NIH/FDA immunologists get together to present their work to the community.
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Implementing Early Intervention Services for Clinical High Risk for Psychosis in U.S. Community Settings: What Do We Know and What Do We Need to Know?
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Meeting/ Workshop
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SAMHSA
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NIMH
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The National Institute of Mental Health (NIMH) collaborated with the Substance Abuse and Mental Health Services Administration (SAMHSA) in sponsoring this research meeting on July 27-28, 2017 in Bethesda, MD. The purpose of this meeting was to lay the groundwork for developing a national strategy to expand services for early psychosis to include evidence-based interventions for individuals at clinical high-risk. Leading researchers in this field presented findings on the effectiveness of clinical high-risk interventions, and directors of clinical programs presented on the challenges and opportunities in implementing these services in communities. NIMH subsequently provided SAMHSA technical expertise in developing their Funding Opportunity Announcement, "Community Programs for Outreach and Intervention with Youth and Young Adults at Clinical High Risk for Psychosis,” (SM-18-02) published April 10, 2018. The funding opportunity currently supports 21 service grants to community mental health providers for services for individuals at clinical high-risk for psychosis.
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Improving Genomics/Omics Technical Standards and Molecular Tools for Prebiotic Probiotic Research and Development Working Group
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Research Initiative
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CDC, FDA, OS
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NCCIH, NCI, NHGRI, NIDA, NLM
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The overarching workgroup effort is to enhance research initiatives/resource development as an Interagency Agreement ( IAA) workgroup members committed to sustain and accelerate translatability of validation analytics and reference datasets using omic and other multi-omic substitutable [SMART] tools, devices, and HL-7 Fast Healthcare Interoperability Resources (FHIR) technologies to support rapid and efficient interoperability with electronic health records and clinical decision support systems. A second goal is to coordinate and plan trans-NIH and Inter-agency meetings, workshops and initiatives with greater efficiency of Institute and Center Operations (ICO) resources and expertise between agencies. Innovative technologies like HL-7 SMART on FHIR have been demonstrated to enhance health information exchange, affordably and accurately. Novel device monitoring using reference standards including, Food and Drug Administration (FDA) Precision and National Institute of Standards and Technology (NIST) nanofabrication, multi-omics and modeling strategies can be integrated to improve validation and standards biosafety, risk monitoring of adverse drug events, food safety, overuse and resistance to antibiotics, and emerging infection. The intent originated in April 2016 with an Initiative planning meeting that is now ongoing for IAA partnered with the Patient-Centered Outcomes Research Institute (PCORI); other IAA collaboratives in progress.
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Improving steps in development and assessment of Fecal Microbiota for Transplantation products
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Other
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FDA
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NIAID
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The goals are to (1) examine the utility of pathogen detection methods in Fecal Microbiota for Transplantation (FMT), (2) understand the effect of manufacturing conditions on the viability and efficacy of FMT products, and (3) identify markers of potency for FMT products by leveraging a novel mouse strain (MAIT cell deficient) exhibiting unique resistance to C. difficile colonization.
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Improving the Treatment for Allergic Rhinoconjunctivitis and Asthma Through Allergen Immunotherapy
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Other
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AHRQ
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NIAID
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The National Institute of Allergy and Infectious Diseases (NIAID) and the Agency for Healthcare Research and Quality (AHRQ) organized a June 2015 workshop entitled “Improving the Treatment for Allergic Rhinoconjunctivitis and Asthma Through Allergen Immunotherapy." The goal of this meeting was to develop clinical trial protocols that could address some of the identified needs to improve the effectiveness of allergen immunotherapy, and to identify the need to improve the use of allergen immunotherapy in current medical practice. Two manuscripts, summarizing the workshop discussion and recommendations, have been developed. One is in press in the Journal of Allergy and Clinical Immunology, the second is awaiting additional input from AHRQ leadership.
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Influenza Diagnostics for Influenza (Flu) Risk Management Meeting (FRMM) Strategy Working Group
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Committee, Work group, Advisory group, or Task Force
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BARDA, CDC, FDA
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NIAID
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Reviewing a draft strategic plan for senior leadership
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