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The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Technology Transfer (STTR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

The purpose of this Funding Opportunity Announcement (FOA) is to develop clinical-grade prototypes intended for use as 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 Notice of Special Interest (NOSI) encourages the translation of the novel neurotechnologies, funded through the Helping to End Addiction Long-Term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical validation for subsequent clinical feasibility studies. Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.

More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance in the prescription of opioids for chronic pain despite their poor ability to improve function and high addiction liability. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative pain treatment options are thus critically needed. Through targeted research efforts, the NIH HEAL Initiative aims to support the development of safe and effective devices to treat pain with little or no addiction liability. This funding opportunity announcement (FOA) is designed to support interdisciplinary research teams of multiple PD/PIs to investigate the mechanism of action of pain relief by medical devices with the overall goal of optimizing therapeutic outcomes for FDA-approved or -cleared technologies. Program teams are expected to accomplish goals that require considerable synergy and collaborative interactions. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider objectives that will produce major advances in the field of pain relief by medical devices.

The purpose of this Notice of Special Interest (NOSI) is to encourage the development and validation of animal models that recapitulate the phenotypic and physiologic characteristics of a defined pain type/indication and/or disease-associated pain condition and endpoints or outcome measures that can be used therein. The goal of this NOSI is to promote a significant improvement in the translational relevance of animal models and/or outcome measures that will be utilized to facilitate future development of non-addictive analgesics. Ideally, models or measures proposed for this NOSI would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings.

The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and validation of novel therapeutic targets to facilitate the development of pain therapeutics. Specifically, the focus of this FOA is on the basic science discovery of targets in the peripheral nervous system, central nervous system, immune system or other tissues in the body that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability. Research supported by this FOA must include rigorous validation studies to demonstrate the robustness of the target as a pain treatment target. This will lower the risk of adopting the target in translational projects to develop small molecules, biologics, natural substances, or devices that interact with this target for new pain treatments. Translational research to develop new medical devices are not the focus of this FOA. Basic science studies of pain and related systems in the body are responsive to this FOA and are encouraged in the context of novel pain therapeutic target discovery. This FOA is not specific for any one or group of pain conditions. Projects to identify novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, etc. will be considered. Projects to identify novel targets for a combination of chronic overlapping pain conditions or for specific pathological conditions will be considered. Projects that seek to identify novel targets in specific populations such as women, children, older adults or other underrepresented groups will also be responsive to this FOA.