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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 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.

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.

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.

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.

The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities.

The National Institutes of Health (NIH) hereby notify Small Business Concerns (SBCs) holding Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that funds are available for administrative supplements to enhance the diversity of the research and entrepreneurial workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research or in the SBIR and STTR programs. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project.

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, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities.