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The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing research on current topics in Alzheimer's disease (AD) and its related dementias (ADRD). Further information on the high-priority topics of interest will be announced through a series of Notices published subsequent to this FOA.

The purpose of this Notice of Special Interest (NOSI) is to stimulate novel epidemiological research to address key knowledge gaps within and between subpopulations of Asian Americans, Native Hawaiians, and Pacific Islanders. These populations are frequently aggregated in research, potentially masking important social and health differences. Given clear heterogeneity in ancestry, culture, immigration patterns among Asian Americans, socioeconomic position, and acculturation into American life, a critical need exists for epidemiological research to enhance our understanding of the interplay of environmental exposures, lifestyle, behavioral, genomics, social, neighborhood, and biological factors that impact the health of Asian American, Native Hawaiian, and Pacific Islander subpopulations.

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for projects to transfer technology out of the NIH intramural research labs into the private sector. If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive patent license agreement for internal research use for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public.

The purpose of this FOA is to provide investigators with a mechanism to access contract research/medical organizations (CROs/CMOs) and subject matter experts (SMEs) within the NINDS Ultra-Rare Gene-based Therapy (URGenT) Network to support planning, manufacturing, and limited nonclinical therapeutic development efforts.

The Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this funding opportunity announcement (FOA) is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the intended approach in a model system relevant to a specified patient population towards an IND filing and the initiation of a clinical trial.

Functional Neurological Disorders (FNDs) are characterized by symptoms of altered voluntary motor or sensory function with clinical findings providing evidence of incompatibility between the symptoms and recognized neurological or medical conditions. FNDs are highly prevalent and associated with significant morbidity, health care costs, and even mortality. In some respects, this group of conditions sits at the intersection of neurology and psychiatry, but the majority of cases first come to the attention of neurologists. Management is complex and requires interdisciplinary approaches. Given the disability caused by the symptoms, and the high cost in healthcare utilization and loss of productivity, FNDs amount to a significant missed opportunity for therapeutic intervention and therefore, a healthcare crisis. Diagnosis and management of FNDs remain very challenging. Diagnostic criteria have been proposed but they are not universally agreed upon. Diagnosis is based on positive clinical findings, and can be supported by laboratory or ancillary investigation findings. Certain FND subtypes are more difficult to correctly diagnose than others. More importantly, laboratory-supported diagnosis is possible, and biomarkers can be developed, but significantly more research is needed in these areas to advance clinical management of FNDs. Therapies exist and have been studied in select populations but gathering high-level evidence through clinical trials is hampered by limitations in available outcome measures. Differential responses to treatments have been recorded, and thus, prediction of aggregate treatment response has been difficult. This FOA invites researchers to submit prospective clinical projects that address critical needs for clinical trial readiness in FNDs. Projects appropriate for this FOA include the validation of biomarkers, endpoints and clinical outcome assessments (COA) that are fit-for-purpose and have a defined context of use for clinical trials.

The purpose of this Notice is to inform potential applicants an area of special interest to NHLBI, NINDS and NIA in research to understand mechanisms of vascular contributions to cognitive impairment and dementia (VCID) and to develop new approaches for the treatment of VCID.

This funding opportunity announcement (FOA) invites research projects that seek to model the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in health, illness, recovery, and overall wellbeing. Both animal and human subjects research projects are welcome. Researchers proposing basic science experimental studies involving human participants should consider the companion FOA TEMP-14931 "Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required)".

This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing. Types of projects submitted under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to social connectedness and isolatedness. NIH considers such studies as prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024) 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. Applications proposing studies that include but not limited to model animal research or observational studies involving humans should submit under the companion Clinical Trials Not Allowed version of this FOA.

NINDS is issuing this Notice of Special Interest to encourage the submission of applications focused on the development and validation of biomarkers for functional neurological disorders (FND). FND are a complex and heterogeneous group of neuropsychiatric syndromes. They are characterized by symptoms of altered voluntary motor or sensory function and frequently have comorbid medical, neurological, and psychiatric disorders. Although patients with FND represent the second commonest category of referrals to neurology outpatient clinics after headache, management is complex and requires interdisciplinary approaches. The high prevalence of FND, the disability caused by symptoms, high cost in healthcare utilization and loss of productivity points to an important opportunity for development of effective therapeutic interventions. This common, disabling, and costly group of conditions sits at the intersection of neurology and psychiatry. In the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) the term functional is used as the primary descriptor in the term for this group of conditions, although the term conversion disorder is still accepted as an alternative expression that acknowledges unconscious processes in patients, though it emphasizes the implicit inference of causative psychological stressors, which are not always present or may not be readily identifiable. Diagnostic criteria for FND have been proposed, but are not universally accepted, and have varying rates of interrater reliability, depending on the symptom presentation (high for non-epileptic psychogenic seizures; poor for other FND). For this reason, diagnosis remains very challenging. Recent recommendations suggest that diagnosis should be based on positive clinical findings and supported, when necessary, by laboratory or ancillary investigation findings. Certain FND subtypes are more difficult to correctly diagnose than others.