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Action for Health in Diabetes (Look AHEAD)
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Research Initiative
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CDC, IHS
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NIDDK, NIA
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This study is a 16-center, randomized clinical trial investigating the long-term health consequences of weight loss. Enrollment occurred between 2001-2004 with a planned follow-up of up to 13.5 years. The Look AHEAD cohort comprises approximately 5,000 overweight or obese participants with type 2 diabetes, aged 45-76. Participants were randomized to one of two interventions: an intensive lifestyle intervention designed to produce and sustain weight loss over the long term or a diabetes support and education arm. The study intervention was discontinued in Sept. 2012 on the recommendation of the Data and Safety Monitoring Board (DSMB), as there were no differences between the two groups after up to 11 years of follow-up. The study will continue to follow participants for study outcomes.
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Adjuvant Working Group
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Committee, Work group, Advisory group, or Task Force
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BARDA, FDA
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NIAID, NCI
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Staff from all National Institute of Allergy and Infectious Diseases (NIAID) Divisions, program staff from the Biomedical Advanced Research and Development Authority (BARDA), and regulatory staff from the Food and Drug Administration (FDA) exchange information about ongoing programs related to novel adjuvants for infectious disease vaccines, identify high priority research areas (and gap areas), and discuss ideas to accelerate progress in adjuvant research through better access to information and resources.
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Administrative Supplements on HIV Pre-Exposure Prophylaxis Implementation Science in CDC-Funded Public Health Demonstration Projects
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Research Initiative
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CDC
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NIMH
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The National Institute of Mental Health (NIMH), in collaboration with the Centers for Disease Control and Prevention (CDC), developed a request for applications to call for administrative supplements to currently funded NIH grants. These supplements would support implementation science research related to a CDC-funded public health initiative to reduce HIV infections in men who have sex with men (MSM) and transgender individuals through improved HIV pre-exposure prophylaxis (PrEP) planning, outreach, and delivery. Eight supplements were awarded.
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Adolescent Brain Cognitive Development (ABCD) Study
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Research Initiative
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CDC
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NIDA, NCI, NIAAA, NICHD, NIMH, NIMHD, NINDS, OD/DPCPSI/OBSSR
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The Adolescent Brain Cognitive Development (ABCD) project, a landmark longitudinal study of brain development and child health, will increase our understanding of how diverse experiences during adolescence interact with changing biology to influence brain, cognitive, and social/emotional development of youth. In partnership with area public and private schools, researchers at twenty-one research sites across the country will recruit 10,000 children at age 9-10 from diverse races and ethnicities, education and income levels, and living environments and follow them through their teens and into early adulthood. Throughout this period, researchers will assess each child’s physical and mental health, substance use, sleep patterns, genetics, childhood experiences, and cultural/environmental influences, as well as track brain and cognitive development with non-invasive magnetic resonance imaging scans at regular intervals. To enrich the value of the study, ABCD will release anonymized data annually to the research community in an open science model to allow scientists from all over the world to conduct analyses and pool resources to rapidly expand the types of scientific questions that can be answered. The actionable information coming out of this study will enable education, substance use prevention, and other health promotion policies to ensure the wellbeing and success of the Nation’s children.
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Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA)
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Committee, Work group, Advisory group, or Task Force
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CDC
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FIC, NIAID, NICHD, NIMH, OD/DPCPSI/OAR
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The Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) aims to enhance the effective use of evidence and help overcome implementation challenges related to prevention, screening, and treatment of HIV among adolescents (ages 15 to 24) in sub-Saharan Africa by catalyzing collaboration and communication among implementation scientists, program implementers, and policymakers. The goals of the Alliance are to: 1) provide a platform for cross-fertilization and exchange of ideas and information among implementation scientists and other stakeholders focusing on different aspects of HIV in adolescents; 2) enable the research to be better informed by programmatic challenges and questions; 3) inform policymakers of promising evidence and encourage use of the data in decision making; and 4) extend the reach and impact of implementation science related to adolescent HIV prevention and treatment.
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Advanced Anticonvulsant System Interagency Product Team
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Committee, Work group, Advisory group, or Task Force
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FDA, OS
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NINDS
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The Advanced Anticonvulsant System Interagency Product Team is a Department of Defense-led effort to facilitate activities, both research and regulatory, related to the FDA approval of midazolam for use in treating nerve agent exposure.
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Adverse Event Reporting and Medical Countermeasures
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Resource Development
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FDA
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NLM
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NLM is working with the FDA to provide advice on key mobile technologies for targeted adverse event reporting and medical countermeasures in emergency settings. The group helped direct the design and development of the mobile app that was co-developed with programmers from Booz Allen Hamilton (BAH), the FDA contractor. BAH was responsible for the Web app that could be encapsulated within Android or iOS frameworks. NLM focused on the iOS framework and developed plugins for encryption, data caching and communications, audio capture, and overall app development. The app can send data to a cloud-based server under the aegis of the FDA. The app was demonstrated to the FDA leadership in June, 2014, and future R&D directions were outlined at the meeting. In addition to the design of the mobile app, NLM advised the FDA team on usability issues and provided guidance on distribution strategies.
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Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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CC, NHLBI
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The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) is a 31-member federal advisory committee that provides advice to the Secretary of Health and Human Services through the Assistant Secretary for Health on a range of policy issues related to blood, blood products, and tissues.
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Advisory Committee on Heritable Disorders in Newborn and Children
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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
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The Advisory Committee on Heritable Disorders in Newborns and Children was established under the Public Health Service Act, Title XI, § 1109 (42 USC 300b-10), as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (PL 113-240). The mission of the Advisory Committee on Heritable Disorders in Newborns and Children is to reduce morbidity and mortality in newborns and children who have or are at risk for heritable disorders. The Committee recommends that every newborn screening program include a Uniform Screening Panel that screens for 32 core disorders and 26 secondary disorders. The Committee advises the Secretary, US Department of Health and Human Services on the most appropriate application of universal newborn screening tests, technologies, policies, guidelines, and standards. Specifically, the committee provides to the Secretary, the following: Advice and recommendations concerning grants and projects authorized, awarded, or funded related to screening heritable disorders in newborns and children; technical information to develop Heritable Disorders Program policies and priorities that will enhance the ability of the state and local health agencies to provide screening; counseling and health care services for newborns and children who have or are at risk for heritable disorders, and recommendations; and advice and information to enhance, expand, or improve the ability of the Secretary to reduce mortality and morbidity from heritable disorders in newborns and children. The committee was chartered on May 7, 2015.
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Advisory Committee on Organ Transplantation (ACOT)
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Committee, Work group, Advisory group, or Task Force
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HRSA
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NIAID
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The Advisory Committee on Organ Transplantation (ACOT) was established to assist the HHS Secretary in enhancing organ donation, ensuring that the system of organ transplantation is grounded in the best available medical science, and assuring the public that the system is as effective and equitable as possible, thereby increasing public confidence in the integrity and effectiveness of the transplantation system.
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