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The purpose of this Funding Opportunity Announcement (FOA) is to support intramural-extramural collaborations to develop and implement the use of 3D biofabricated tissue models as novel drug screening platforms and advance pre-clinical discovery and development of non-addictive treatments for nociception, opioid use disorder (OUD) and/or overdose. In particular, support during the UH2 phase is for the application of 3D biofabrication technologies to develop novel multicellular tissue constructs for drug screening by using human iPSC-derived cells representing sensory/pain neurons, brain regions, and other tissues involved in nociception, addiction and/or overdose, including tissue models of the blood-brain barrier (BBB). Support during the UH3 is for implementation of drug screens using the 3D tissue models developed during the UH2 phase. Please limit this field to a brief description of to page in length. Brevity is appreciated. This FOA is part of the of the NIHs Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal…

NIH has identified a set of research priorities reflecting urgent unmet needs across the lifespan, areas of promising scientific opportunity, and concrete strategies capable of providing rapid and durable solutions to the opioid crisis including improved understanding of the biological underpinnings of chronic pain and discovery and testing of new non-addictive pain treatments.

HEAL Initiative: This is a HEAL Initiative UH3 FOA that will solicit device applications to treat pain.

The Purpose of this FOA is to solicit cooperative agreement applications that propose clinical trials to establish the effectiveness of existing therapies and approaches for prevention and management of pain. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate preventive strategies or interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies in well controlled trials The overall goal is to inform clinicians about the effectiveness of interventions that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions or pain presenting as a disease itself. Clinical trials will be conducted within the infrastructure of the HEAL Pain Management Effectiveness Research Network.

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management and reduce the use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to identify effective methods to improve the management of pain and reduce the need for opioid medications at the health care system level. This FOA requires that the intervention under study be embedded into health care delivery system, real world settings. Studies can propose to integrate interventions that have demonstrated efficacy into health care system; or implement health care system changes to improve adherence to evidence-based guidelines. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies in partnerships with health care delivery systems.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). As the main data manager for pain research in the HEAL Initiative, the EPPIC-Net DCC will host and manage clinical, neuroimaging, biomarker, omics, and preclinical data from EPPIC-Net and other components of the HEAL Initiatives pain research program. The DCC will also make these data and clinical biosamples available to the research community to advance the science of pain. Lastly,the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies, and the systems and processes for data collection, management, quality assurance and reporting. This FOA solicits applications for the EPPIC-Net Data Coordinating Center (DCC). Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Specialized Clinical Centers (RFA-NS-18-037). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL initiative, as described above, or from separate NIH funding announcements.

The purpose of this Funding Opportunity Announcement (FOA) is to support preclinical development and demonstration of safe, effective, and non-addictive device-based technologies and approaches to treat pain. The goal of the program is to demonstrate treatment using credible neural targets for device-based interventions and/or diagnostics for pain, building upon the latest mechanistic knowledge about the anatomy and physiology of central, spinal, and peripheral pathways involved in pain. Awarded activities will facilitate the translation of new devices up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology development and optimization, and studies to prepare for approvals for human use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

NIH has identified a set of research priorities reflecting urgent unmet needs across the lifespan, areas of promising scientific opportunity, and concrete strategies capable of providing rapid and durable solutions to the opioid crisis including improved understanding of the biological underpinnings of chronic pain and discovery and testing of new non-addictive pain treatments.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress. This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination The Common Funds Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (hubs) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIHs Helping to End Addiction Long-term (HEAL) Initiative. EPPIC-Net will provide a robust and readily accessible infrastructure for carrying out in depth phenotyping and biomarker studies in patients with specific pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain from partners in academia or industry. Studies will bring intense focus to patients with well-defined pain conditions and high unmet therapeutic needs. EPPIC-Net will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and approximately 10 specialized clinical centers (hubs). The purpose of this funding opportunity announcement (FOA) is to invite applications for the hubs within EPPIC-Net. A hub will typically be a regional medical center that will actively enroll subjects into clinical trials and studies performed in EPPIC-Net. Each hub should have ready access to patient populations with specific pain conditions and have expertise in characterization of that pain condition. A hub will additionally provide scientific leadership and administrative oversight to its multiple (2-10) satellite sites (spokes). This FOA solicits applications EPPIC-Net Specialized Clinical Centers. Separate FOAs have been issued to solicit applications for the Clinical Coordinating Center (RFA-NS-18-036) and Data Coordinating Center (RFA-NS-18-035). Clinical trials conducted through EPPIC-Net may come from a variety of sources including the HEAL Partnership, as described above, or from separate NIH funding announcements.