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Improving Steps in the Development and Assessment of Live Microbiome-Based Products: Fecal Microbiota for Transplantation (FMT) and Live Biotherapeutic Products (LBPs)
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Other
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FDA
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NIAID
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This project seeks to support the development and assessment of live microbiome-base products for the treatment and prevention of infection. Fecal microbiota for transplantation (FMT) utilizes stool from healthy donors to reestablish the gut microbiota of individuals with recurrent C. difficile infection. Whereas live biotherapeutic products (LBPs) are drugs that consist of purified bacteria developed for the prevention, treatment or cure of bacterial vaginosis in women. In the context of this IAA, FMT and LBPs are being developed to prevent disease (or reinfection) after antibiotic treatment by interacting with the human microbiome.
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Inclusion Across the Lifespan
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Meeting/ Workshop
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FDA
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NIA, NCI, NHLBI, NICHD, NIDCR, NIMHD, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH, OD/OER
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In response to scientific need and a congressional mandate in the 21st Century Cures Act (P.L. 114-255), the National Institutes of Health (NIH) convened a workshop of experts on the appropriate inclusion of pediatric and older populations in research studies involving human subjects. The workshop brought together experts in clinical research to discuss barriers and opportunities for participation of these populations in clinical studies, including those supported by NIH.
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Influenza Diagnostics 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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Influenza Risk Management Meeting
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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NIAID
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The Influenza Risk Management Meetings provide members including the Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority(BARDA), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH)) with a venue to discuss issues relating to the US Department of Health and Human Services (HHS) response to pandemic influenza. Subjects for discussion include but are not limited to considerations of vaccine and antiviral stockpiles and clinical trial response to influenza outbreaks such as H7N9 and H3N2v.
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Inter-Agency Working Group on the National Healthcare Quality and Disparities Report
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Committee, Work group, Advisory group, or Task Force
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ACF, AHRQ, CDC, CMS, HRSA, IHS, OS
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NIMHD, NCI, NHLBI, OD/DPCPSI
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This working group provides expert scientific guidance for the National Healthcare Quality and Disparities Report. These annual reports measure trends in effectiveness of care, patient safety, timeliness of care, patient centeredness, and efficiency of care. The reports present, in chart form, the latest available findings on quality of and access to health care.
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Inter-Society Coordinating Committee (ISCC) for Practitioner Education in Genomics (PEG)
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Committee, Work group, Advisory group, or Task Force
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CDC, HRSA
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NHGRI, CC, NCATS, NCI, NEI, NHLBI, NIAAA, NICHD, NLM
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This education collaborative facilitates sharing interactions among professional societies, agencies, and health systems. It intends to enhance the accrual of knowledge and skill among practitioners applying genomic results to clinical care. In its start-up phase, the ISCC-PEG focused primarily on physicians and dentists. It has since expanded to engage and collaborate with allied practitioner groups such as nurse practitioners, physician assistants, pharmacists, genetic counselors, and nurses comprising integrated health care teams. It will continue to add other relevant professions and add to the reviewed and searchable educational resources on its website.
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Interagency Adult Literacy Research Group
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Committee, Work group, Advisory group, or Task Force
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ACF
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NICHD
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This is an intra-government, trans-agency group shares updates on research relevant to adults with lower literacy skills (i.e., reading and writing) as well as practices and programs that are being implemented to assist these learners in various agencies. The goal is for staff and corresponding agencies to be informed of broader efforts occurring around adult literacy within the federal government and to keep abreast of research and promising programs that might inform their work.
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Interagency Agreement with the Food and Drug Administration (FDA)
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Other
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FDA
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NIAID
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Interagency Agreement with FDA to determine antibody signatures to respiratory syncytial virus (RSV) infection and vaccination to identify correlates of protection.
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Interagency Artificial Pancreas Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIDDK, NIBIB, NICHD
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The Interagency Artificial Pancreas Working Group is a group of multi-disciplined scientists and clinicians from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to support the Artificial Pancreas Initiative. The goals of this initiative are to provide infrastructure for narrowing the gap between basic biomedical knowledge and clinical application of novel technologies, and to cross-fertilize and partner with stakeholders in order to identify and overcome the clinical and scientific challenges to the development of an artificial pancreas. Through collaborative efforts, such as workshops, the group strives to develop innovative strategies to achieve their goals.
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Interagency Autism Coordinating Committee (IACC)
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Committee, Work group, Advisory group, or Task Force
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ACF, ACL, AHRQ, CDC, CMS, FDA, HRSA, IHS
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NIMH, NICHD, NIDCD, NIEHS, NINDS
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The Interagency Autism Coordinating Committee (IACC) is a Federal advisory committee that coordinates all efforts within the Department of Health and Human Services (HHS) concerning autism spectrum disorder (ASD). Through its inclusion of both Federal and public members, the IACC helps to ensure that a wide range of ideas and perspectives are represented and discussed in a public forum. The IACC was reauthorized under the Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2019. The IACC is being reconstituted under the most recent authorization and is expected to resume meeting in 2020.
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