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The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support: 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity.

This Notice of Funding Opportunity (NOFO) supports translational exploratory/developmental research that directly advances the discovery of novel treatment strategies, i.e., medical countermeasures (MCMs), that address serious morbidity and mortality after acute exposure to highly toxic chemical threats. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pesticides, and ultra-potent synthetic (UPS) opioids. This NOFO supports translational research that includes, but is not limited to, preliminary efficacy and/or early preclinical development studies towards discovery and validation of novel molecular entities or biologics as candidate MCMs. In addition to novel agents, new treatment strategies may involve repurposing already FDA-approved products or combinations of interventions based on established mechanisms of action. Projects supported by this NOFO are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement program and/or other related initiatives.

To develop a national, interdisciplinary, patient-centered research consortium to advance Temporomandibular Disorders (TMDs) basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications focused on the neurological and/or mental health-related manifestations of infection-associated chronic illnesses, including the post-acute sequelae of COVID-19 (Neuro-PASC) as well as other chronic illnesses with a potential infectious trigger (post-treatment Lyme Disease, myalgic encephalomyelitis/chronic fatigue syndrome [ME/CFS], postural orthostatic tachycardia syndrome [POTS], post-viral fatigue syndromes, etc.). Projects that investigate common neurological and/or mental health-related mechanisms across multiple infection-associated chronic illnesses would be of particular interest, although this is not a requirement (i.e., applications can focus on a single condition). Neurologically focused clinical research investigating scientifically compelling pathways that contribute to the development of infection-associated chronic illnesses - including basic experimental studies in humans (BESH) or mechanistic clinical trials that will accelerate the development of effective treatments - are within the scope of this initiative. Preclinical studies utilizing animal, cell culture, and/or human tissue models are also encouraged. All applications must propose such studies in the context of a post-infectious etiology.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications focused on the neurological and/or mental health-related manifestations of infection-associated chronic illnesses, including the post-acute sequelae of COVID-19 (Neuro-PASC) as well as other chronic illnesses with a potential infectious trigger (post-treatment Lyme Disease, myalgic encephalomyelitis/chronic fatigue syndrome [ME/CFS], postural orthostatic tachycardia syndrome [POTS], post-viral fatigue syndromes, etc.). Projects that investigate common neurological and/or mental health-related mechanisms across multiple infection-associated chronic illnesses would be of particular interest, although this is not a requirement (i.e., applications can focus on a single condition). Neurologically focused clinical research investigating scientifically compelling pathways that contribute to the development of infection-associated chronic illnesses - including basic experimental studies in humans (BESH) or mechanistic clinical trials that will accelerate the development of effective treatments - are within the scope of this initiative. Preclinical studies utilizing animal, cell culture, and/or human tissue models are also encouraged. All applications must propose such studies in the context of a post-infectious etiology.

The NIH Blueprint for neuroscience is soliciting applications to pilot the establishment of an integrated resource for users to explore, analyze and download processed deidentified human brain single-cell transcriptomics and epigenomics data that is harmonized across reference and disease datasets. The resource will generate a unified cell type taxonomy, provide users with a draft annotatable cell-type nomenclature, and the ability to map community generated single cell omics data to the taxonomy. This pilot will lay the groundwork for an expanded and sustained effort to increase utility and accessibility of human cell-type classification data across multiple NIH consortia. BD

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.

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.

The purpose of this one-year administrative supplement is to provide support for currently active NINDSAlzheimers Disease and Alzheimers Disease Related Dementias (AD/ADRD) awards to add/include APOE genotype and fluid-based AD/ADRD biomarkers to ongoing AD/ADRD human subjects research studies and generate new data that should enhance the clinical and scientific content of the study, now and in the future via data sharing.

The purpose of this one-year administrative supplement is to provide support for currently active NINDSAlzheimers Disease and Alzheimers Disease Related Dementias (AD/ADRD) awards to add/include APOE genotype and fluid-based AD/ADRD biomarkers to ongoing AD/ADRD human subjects research studies and generate new data that should enhance the clinical and scientific content of the study, now and in the future via data sharing.