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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 purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

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.

Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative. The invention, proof-of-concept investigation, and optimization of new technologies through iterative feedback from end users are key components of the BRAIN Initiative. This FOA seeks applications to optimize existing or emerging technologies through iterative testing with end users. The technologies and approaches should have potential to address major challenges associated with recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). These technologies and approaches should have previously demonstrated their transformative potential through initial proof-of-concept testing and are now ready for accelerated refinement. In conjunction, the manufacturing techniques should be scalable towards sustainable, broad dissemination and user-friendly incorporation into regular neuroscience research. Proposed technologies should be compatible with experiments in behaving animals, validated under in vivo experimental conditions, and capable of reducing major barriers to conducting neurobiological experiments and making new discoveries about the CNS. Technologies may engage diverse types of signaling beyond neuronal electrical activity such as optical, electrical, magnetic, acoustic or genetic recording/manipulation. Applications that seek to integrate multiple approaches are encouraged. If suitable, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

Understanding the dynamic activity of brain circuits is central to the NIH BRAIN Initiative. This FOA seeks applications for proof-of-concept testing and development of new technologies and novel approaches for recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). This FOA seeks exceptionally creative approaches to address major challenges associated with recording and modulating CNS activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain. It is expected that the proposed research may be high-risk, but if successful, could profoundly change the course of neuroscience research. Proposed technologies should be compatible with experiments in behaving animals, validated under in vivo experimental conditions, and capable of reducing major barriers to conducting neurobiological experiments and making new discoveries about the CNS. Technologies may engage diverse types of signaling beyond neuronal electrical activity such as optical, magnetic, acoustic and/or genetic recording/manipulation. Applications that seek to integrate multiple approaches are encouraged. If suitable, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

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.

There is increasing evidence that exposures from the external environment are important factors in overall human health in a variety of diseases and disorders including Alzheimer's Disease-Related Dementia (ADRD). The NIH supports research on environmental risk factors (ERFs) for ADRD. This Notice of Funding Opportunity (NOFO) will support research projects that takethis research further by determining how exogenous ERFs affect ADRD disease mechanisms and phenotypic outcomes through innervated human surfaces. Exogenous ERFs include toxins and toxic chemicals, other pathogens, and other environmental exposures that reach innervated human surfaces. These surfaces include the gut, mouth, throat, lungs, nasal passages, skin and other surfaces that interface with the outside world. The scope of this NOFO includes mechanistic research relevant to ADRD to determine the effect(s) of exogenous ERFs at nervous system biological interfaces. Human studies (No Clinical Trials Allowed) to identify exogenous ERFs at these biological interfaces are also allowed if the mechanistic influence of these exposures is also included in the research plan. This initiative will require team science between neuroscientists that have deep expertise in ADRD research with experts in environmental science with knowledge of toxicity to the nervous system.

This Notice of Funding Opportunity (NOFO) supports the optimization of promising genome editing-based therapeutic leads for Alzheimer's Disease-Related Dementias (ADRD), towards IND-enabling studies. Specifically, it supports the characterization and optimization of therapeutic lead(s) that show promise as potential genome editing therapeutics, as evidenced by convincing proof-of-concept studies in appropriate models. At the end of the funding period, successful projects will have optimized a genome editing therapeutic candidate with demonstrated bioactivity, manufacturability, biodistribution, in vivo efficacy, and/or target engagement (measurement of proximal downstream effects) and optimal dosing, combined with other properties consistent with the desired clinical application. This NOFO is not specific for any one or group within the ADRD spectrum of disorders. Disorders include; Frontotemporal dementia (FTD), Lewy body dementias (LBD) (including Dementia with Lewy bodies (DLB), Parkinson Disease Dementia (PDD)), Vascular contributions to Cognitive Impairment and Dementia (VCID), and Multiples Etiology Dementias (MED).