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Reissue of RFA-NS-20-010: The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

To enable the development and validation of real-world remote digital endpoints from wearable devices for monitoring pain experience and progression, response to interventions, and impact on quality of life. In the context of this RFA, endpoints will include biosignatures derived from functional and physiological assessments detected from wearable devices. These biosignatures can be used to monitor the effects of therapeutics developed for the treatment of pain.

This notice of funding opportunity (NOFO) seeks to support research aimed at holistic understanding of inter-individual or between-person differences in human pain conditions, focusing on Whole Person Health and enhancing pain treatment and management strategies towards personalized pain medicine. The goal of this NOFO is to support studies that focus on the collection of clinical and/or preclinical data to enable evidence-based modeling and understanding of inter-individual differences and/or heterogeneity of pain occurring with use of pain therapy/management, or with conditions such as a second pain condition, a comorbid health condition, a comorbid mental health condition, or conditions of use / misuse of opioids, alcohol or other substances. Applicants are encouraged to develop and implement novel, multidisciplinary research approaches, and include investigators with complementary expertise to fulfill the project and program goals. Input from patients and caregivers on the goals of the project is highly encouraged. Rigorous data-driven and evidence-based research approaches supported under this NOFO are expected to provide better understanding of biological and/or biopsychosocial underpinnings of inter-individual differences, heterogeneity, and stratification of persons with lived pain experience, which would accelerate the development of evidence-based solutions toward precision pain medicine.

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 Funding Opportunity Announcement (FOA) is to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects in pain management to the commercialization stage by providing additional assistance for private partnering activities through the Commercialization Readiness Pilot (CRP) program. Specifically, this FOA supports the addition of entrepreneurial expertise into small business leadership teams along with supporting partnering activities to aid in commercialization through private third-party funding or partnership with industry.

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to support a cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible outstanding postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM.

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to enhance workforce diversity in the research workforce and maintain a strong cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the pool of diverse and independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, an ancillary clinical trial, or an independent Basic Experimental Studies with Humans (BESH). Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (RFA-NS-22-025).

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to support a cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible outstanding postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM.

The purpose of the NIH HEAL InitiativeSM Pathway to Independence Award (K99/R00) program is to enhance workforce diversity in the research workforce and maintain a strong cohort of new and talented independent investigators conducting Pain and/or SUD research, in order to increase the pool of diverse and independent investigator workforce in research areas supported by the NIH HEAL InitiativeSM. This program is designed to facilitate a timely transition of eligible postdoctoral researchers from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition to help awardees establish independent research programs in areas supported by the NIH HEAL InitiativeSM. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, an ancillary clinical trial, or an independent Basic Experimental Studies with Humans (BESH). Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing an independent clinical trial, a clinical trial feasibility study, an ancillary clinical trial, or an independent BESH as lead investigator, should apply to the companion FOA (RFA-NS-22-024).

This funding opportunity announcement (FOA) is designed to support integrated efforts of three or more (up to six) PDs/PIs to pursue bold, impactful, and challenging research in basic and clinical pain domains to understand the biology of specific human pain conditions as well as pain associated with diverse diseases/disorders, including mechanistic underpinning of heterogeneity and stratification of patients with specific pain conditions and co-morbidities. The research approach should be interdisciplinary in nature, and the research teams are expected to establish a common goal that requires collaboration, synergy, and managed team interactions. Proposed research should not represent a collection of individual efforts or parallel projects. Proposed research should support a cohesive, single, well-integrated research plan with a singular focus, one set of aims, and a budget without subprojects. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for experimentation, analysis, and interpretation. Teams are encouraged to consider transformative objectives with defined 5-year outcomes that will produce major advances in the understanding of human pain conditions and are likely to improve strategies for effective managementof human pain.