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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.

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).

This Notice of Special Interest (NOSI) encourages the development and translation of novel neurotechnologies, funded through the Helping to End Addiction Long-Term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical development and validation activities for subsequent clinical feasibility studies. Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.

The NINDS Materials to Enhance Training in Experimental Rigor (METER) UE5 will support curriculum development in the form of innovative educational materials that will be incorporated into a new cutting-edge online resource that aims to promote awareness, understanding, and practice of fundamental principles of rigorous biomedical research for researchers and other scientists in various career stages and learning environments.This UE5 FOA runs in parallel with a companion UC2 FOA that solicits applications for the NINDS center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER), described in detail in RFA-NS-21-009.

HEAL Initiative: INTERACT INTEgRAtive Back Pain Longitudinal Cohort Teams (UC2 Clinical Trial Optional). The purpose of this Notice of Funding Opportunity (NOFO) is to solicit cooperative agreement applications from interdisciplinary teams to enhance longitudinal data collection and analysis with existing large scale chronic low back pain (cLBP) cohort studies.

As part of the NIH's Helping to End Addiction Long-term (HEAL) Initiative, the National Institute of Arthritis and Musculoskeletal and Skin Diseases and other participating NIH Institutes and Centers invite applications for the HEAL KIDS Chronic Pain Collaborating Research Teams (HEAL KIDS CPT) Program to conduct interdisciplinary team-based research projects that combine clinical research, novel/cutting-edge technologies, and measurement science, which will improve our understanding of primary and secondary chronic pain conditions in children and adolescents. The results are expected to enhance and expand our capacity to pursue challenging biological problems, therapeutics development, and effective management of pediatric pain conditions.

The goal of this effort is to support the development and validation of next generation platforms and analytic approaches to precisely quantify behaviors in humans and link them with simultaneously recorded brain activity. Tools used for analyzing behavior should be multi-modal and should be able to be linked to brain activity and thus have the accuracy, specificity, temporal resolution, and flexibility commensurate with tools used to measure and modulate the brain circuits that give rise to those behaviors. This phased award will support novel tool development (i.e., hardware/software) in the R61 phase and synchronization of novel tools for measuring behavior and human brain activity in the R33 phase.