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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.

The purpose of this Funding Opportunity Announcement (FOA) is to promote collaborative biomedical research between the United States and Brazil under the U.S.-Brazil Biomedical Collaborative Research Program. Research areas supported under this program include allergy, immunology, and infectious diseases, including HIV/AIDS and its co-morbidities; cancer; mother-to-child transmission of HIV and other congenital infections, early infant diagnosis and treatment; HIV/AIDS in relation to mental health; and neurological disorders and stroke.

The purpose of the NIH Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to lead basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the companion PA-18-375.

The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and "protected time" for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to lead basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the companion PA-18-370.

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to lead basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the companion PA-18-397.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to lead basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the companion PA-18-372.