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ICCVAM Read Across Workgroup (RAWG)
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Committee, Work group, Advisory group, or Task Force
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ATSDR, FDA
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NIEHS, NLM
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ICCVAM workgroup established to build read-across capacity within member agencies, raise awareness of the state of the science, and work towards harmonization of read-across approaches.
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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, NIDDK, NHLBI, NIAID, NINDS, NIEHS, CC, NIAMS, NEI, NIDCR, NICHD, NIAAA, NIMH, NHGRI
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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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Implementation Research in HRSA Ryan White Sites: Screening and Treatment for Mental and Substance Use Disorders to Further the National “Ending the HIV Epidemic” (EHE) Goals
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Research Initiative
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HRSA
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NIMH, NIDA
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The National Institute of Mental Health (NIMH) and National Institute on Drug Abuse (NIDA) collaborated with the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau to develop a research funding opportunity (RFA-MH-20-520 and RFA-MH-20-521) on methods to enhance screening and treatment for mental and substance use disorders in HRSA Ryan White HIV/AIDS Program funded sites through implementation research, in order to advance the goals of the Federal End the HIV Epidemic initiative. The research initiative seeks to strengthen the research/service delivery collaboration between NIH grantees and HRSA-funded HIV care sites, with the goal of increasing retention in HIV care and viral suppression through implementation of evidence-based mental disorder and substance use screening, prevention, and treatment. The research initiative was published in 2020. Eight grants were funded through this initiative (6 NIMH grants and 2 NIDA grants). The NIMH maintains ongoing communication with HRSA to discuss progress and outcomes.
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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 a 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. NIMH subsequently released a Notice, "NIMH Priorities for Research to Inform Stepped-Care Interventions for Persons at Clinical High Risk for Psychosis" (NOT-MH-19-003), on December 11, 2018. The Notice highlights NIMIH interest in receiving grant applications for clinical research that will advance diagnosis, risk assessment, and indicated prevention methods for persons at Clinical High Risk (CHR) 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 omics and other multi-omics 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 the Development and Assessment of Live Microbiome-Based Products: Fecal Microbiota for Transplantation (FMT) and Live Biotherapeutic Products (LBPs)
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Resource Development
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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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In Vitro Assessment of Dermal Hypersensitivity: Using Alternative Methods to Predict Skin Sensitization
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Research Initiative
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FDA
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NIEHS
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The primary goal of these efforts is to assess the untility of non-animal test methods for prediciting human skin sensitization hazard in an expanded chemical space
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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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Incorporating a Sex-and Gender Lens from Bench to Bedside: Neurology
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Meeting/ Workshop
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FDA
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OD/DPCPSI/ORWH
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This event had one presenter and it took place on September 1, 2020. Dr. Clayton also spoke at the event
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