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The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical trials for the diagnosis, mitigation, treatment, or cure of ALS ("intermediate EA protocol for ALS"). Providing the investigational drug or biological product under an intermediate EA protocol for ALS must not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval, or otherwise compromise the potential development of medical products for the diagnosis, mitigation, treatment, or cure of ALS. Eligible applicants are clinical trial sites that participate in a phase 3 clinical trial supported by a United States (U.S.) small business concern (as defined in section 3(a) of the Small Business Act (15 U.S. C. 623(a)) that is also the U.S. Food and Drug Administration (FDA) designated sponsor of a drug or biological product for ALS that is the subject of an Investigational New Drug Application (IND). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in May 2022 with an expected application due date in June 2022. This FOA will utilize the U01 activity code.

There is an urgent need for more research to establish best practices in the pain management field, however, there is a limited workforce pipeline of pain researchers to meet NIHs long-term goals of providing effective non-opioid options for the treatment of pain conditions and better pain management overall. The Interagency Pain Research Coordinating Committee (IPRCC) has identified the workforce problem as a barrier for new pain research, and has identified factors that contributed to it such as barriers to entry into the field of pain research that have constricted growth high departure rate of senior investigators and mentors. The IPRCC also identified a need for more structured opportunities for early-stage investigators to learn from and be mentored by experienced investigators. The pain management field has further recognized that basic, translational, and clinical researchers do not regularly collaborate when developing grant applications. If pain management researchers across all disciplines were to work together, it would enhance the innovation, relevance, and practical application of pain management research. To support the NIH HEAL Initiatives response supporting new investigators, promoting multidisciplinary collaborations among pain researchers, and identifying innovate treatments to manage pain, this FOA invites applications for the Coordinating Center for National Pain Scientists (CCNPS). The CCNPS will be a central facilitator for integrating training and mentoring across a network of mentors and early-stage investigators funded by NIH (e.g., NIH trainees, NIH fellows, and Career Development Awardees). The main purpose of the CCNPS is to enhance the training experience of new pain researchers across the continuum of basic, translational, and clinical research and create a vast network of NIH-funded pain researchers to promote multidisciplinary collaborations in pain research. The CCNPS will create and run a coordination center to connect NIH-fund

This FOA solicits Research Education Grant (R25) applications to develop and implement a short course focused on (1) steps required for successful medical device development, translation, and commercialization (2) common technical and strategic challenges, and (3) best-practices and resources for each stage in the process. Applicants may choose to include an extended mentorship plan if they see fit. The short course should address a broad audience, including senior post-doctoral fellows, independent academic researchers, clinician scientists, and small business entrepreneurs interested in developing, translating, and/or commercializing medical devices to diagnose or treat a nervous system disorder.

The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements to strengthen data management, sharing and data readiness efforts within the HEAL Initiative that further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This NOSI provides an opportunity for existing HEAL Initiative awardees to increase data FAIR-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets. This NOSI is soliciting administrative supplements from existing awards funded or supplemented by the HEAL Initiative or otherwise required to meet HEALs Public Access and Data Sharing Policy. Applications from HEAL research teams that are already working with data coordinating centers as requirement of the award must provide justification for applying and will be given lower priority. Sharing HEAL-generated results and associated data as rapidly as possible will allow the broader community to ask and answer new research questions; conduct secondary analyses; and address fast-evolving challenges that surround pain management, opioid use and misuse, and overdose.

This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal of this FOA is to support team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and validation of pharmacodynamic markers efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies are also responsive. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the 5 years of the award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound assays. If the data does not currently exist, the proposal must include a strong plan for developing data linking the putative therapeutic target(s) to the proposed pain indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease. This FOA is not specific for any one or group of pain conditions. Projects to develop therapeutics for acute pain, chronic pain, painful neuropathy, musculoskeletal pain, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain, obstetric pain, gynecologic pain, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered.

The COVID-19 pandemic continues to be the source of much mortality and morbidity creating and contributing to both physical and mental health issues. Recent data suggest that over 825,000 individuals have died from COVID-19 in the United States including over 8600 deaths in the week ending January 5, 2022.However, the impact of the SARS-CoV-2 virus as well as the associated measures to prevent and treat this infection extend well beyond the issue of mortality. Although much needed information regarding the epidemiology, transmission and potential acute treatments including the development of an effective vaccine have been gleaned in unprecedented time, important issues remain to be elucidated including, but not limited to the effect of the virus and its therapy on menstrual health, fertility and the offspring of infected and/or vaccinated parents, the impact of the relatively recent Delta and Omicron variants and other emerging variants, the occurrence of viral co-infections and the many physical and mental health issues created by the pandemic itself.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This FOA is intended to support meritorious small research projects focused on analyses of genomics other -omics, clinical and phenotypic datasets related to Down syndrome research, with an emphasis on elucidating the underlying etiologies of risk and resiliencies to co-occurring health conditions. Development of approaches, tools, or algorithms appropriate for analyzing data relevant to Down syndrome and facilitating data sharing within the research community through the INCLUDE Data Hub may also be proposed.

The NIH Office of the Director intends to support a Rapid Acceleration of Diagnostics (RADx) Tribal Data Repository (RADx TDR) for American Indian and Alaska Native (AI/AN) data collected from projects supported by the RADx initiative. The RADx TDR data will allow better understanding of the impact of COVID-19, support research to better inform and develop policies to address current and future pandemics, and support and promote researchers, including AI/AN researchers.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. This initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Funding Opportunity Announcement (FOA) is soliciting Transformative Research Award applications to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research that has the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies related to Down syndrome. For the program to support the best possible researchers and research, applications are sought which reflect the full diversity of the nations research workforce. Individuals from diverse backgrounds, including those from underrepresented groups and from the full spectrum of eligible institutions in all geographic locations are strongly encouraged to apply to this Funding Opportunity Announcement. Applications are welcome in all topics relevant to Down syndrome-related research or its co-occurring conditions. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in research related to Down syndrome.