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The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and limited-size clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and effectivenesting, design verification and validation activities leading to submission of an Investigational Device Exemption (IDE) to the FDA or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. For more information see: https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medte…

The purpose of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of early career, independent investigators from diverse backgrounds conducting research in NIH mission areas. The long-term goal of this program is to enhance diversity in the basic biomedical sciences research workforce. The MOSAIC K99/R00 program is designed to facilitate a timely transition of outstanding postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions at research-intensive institutions. The MOSAIC K99/R00 program will provide independent NIH research support during this transition to help awardees launch competitive, independent research careers. Additionally, MOSAIC K99/R00 scholars will be part of organized scientific cohorts that will be expected to participate in mentoring, networking, and professional development activities coordinated by MOSAIC Institutionally-Focused Research Education Award to Promote Diversity (UE5) grantees.

The purpose of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of early career, independent investigators from diverse backgrounds conducting research in NIH mission areas. The long-term goal of this program is to enhance diversity in the basic biomedical sciences research workforce. The MOSAIC K99/R00 program is designed to facilitate a timely transition of outstanding postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions at research-intensive institutions. The MOSAIC K99/R00 program will provide independent NIH research support during this transition to help awardees launch competitive, independent research careers. Additionally, MOSAIC K99/R00 scholars will be part of organized scientific cohorts that will be expected to participate in mentoring, networking, and professional development activities coordinated by MOSAIC Institutionally-Focused Research Education Award to Promote Diversity (UE5) grantees.

The purpose of the MOSAIC Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program is to support a cohort of early career, independent investigators from diverse backgrounds conducting research in NIH mission areas. The long-term goal of this program is to enhance diversity in the basic biomedical sciences research workforce. The MOSAIC K99/R00 program is designed to facilitate a timely transition of outstanding postdoctoral researchers from diverse backgrounds (e.g., see NIHs Interest in Diversity) from their mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions at research-intensive institutions. The MOSAIC K99/R00 program will provide independent NIH research support during this transition to help awardees launch competitive, independent research careers. Additionally, MOSAIC K99/R00 scholars will be part of organized scientific cohorts that will be expected to participate in mentoring, networking, and professional development activities coordinated by MOSAIC Institutionally-Focused Research Education Award to Promote Diversity (UE5) grantees.

Gastrointestinal (GI) complications in children and adults with neurodevelopmental disorders have drawn attention to gaps in understanding their causes and treatment. GI dysfunction is particularly common in individuals with neurodevelopmental disorders such as autism, Fragile X syndrome, and Rett syndrome, as well as chromosomal disorders such as Down syndrome. GI disorders in these conditions can include gut malformations present at birth (such as pyloric stenosis or Hirschsprung disease) but also functional issues such as feeding problems, gastro-esophageal reflux disease (GERD), cyclic vomiting, delayed gastric emptying, diarrhea, bloating, celiac disease, irritable bowel symptoms, and constipation leading to encopresis, incontinence, and stool impaction. These GI issues may be associated with severe nutritional deficiencies, weight loss, and failure to thrive. GI symptoms are reported in between 23-70% of individuals with autism, a rate ~ 8 times higher than in the general population, with similar rates in individuals with other less common forms of intellectual and developmental disabilities (IDD) (Holingue et al., Autism Res 2018:11:24-36). Unfortunately, mechanisms to accurately diagnose GI conditions in this population are limited, and tailored treatments to address them are almost nonexistent, particularly since clinical trials for IDD populations are rare.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated efficacy clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may evaluate drugs, biologics, and devices, as well as surgical, behavioral and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (http://www.ninds.nih.gov/)

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

(Reissue of PAR-18-490) The purpose of the NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) is to diversify the pool of independent neuroscience research investigators by providing junior faculty with research cost support, protected research time and career stage appropriate professional development mentorship in neuroscience research. Individuals from backgrounds underrepresented in biomedical research are eligible for support under this award if they have doctoral research degrees (Ph.D. or equivalent) and are in the first 3 years of a faculty tenure track or equivalent position at the time of application. 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.

Reissue of the PA-18-400. The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, and optimal means of service delivery in relation to Autism Spectrum Disorders (ASD).

Reissue of the PA-18-401. The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, and optimal means of service delivery in relation to Autism Spectrum Disorders (ASD).