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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 NIH Blueprint for Neuroscience Research, with participating NIH Institutes and Centers (ICs), intends to promote the new Blueprint MedTech program by publishing a Funding Opportunity Announcement (FOA) to solicit applications to establish incubator hubs to provide medical device developers (innovators) with resources to support development of human-grade prototypes. The FOA intends to utilize the U54 activity code and is expected to be published in Summer 2021 with an expected application due date in Fall 2021. Incubator hubs will coordinate and manage resources for the Blueprint MedTech program, working as a consortium to provide: (1) infrastructure for identifying the most promising technologies, (2) the distribution of sub-award funding for innovators and resources to support product definition (e.g., needs assessment, product design, prototype development), and (3) access to relevant expertise (e.g., scientific, design, business development, and project management). Details of the planned program are provided below. This Notice is being provided for informational purposes to allow potential applicants additional time to develop responsive applications and meaningful collaborations. NIH reserves the right to modify the scope and objectives as described in this Notice. Final scope, objectives, and requirements will be set forth in the published FOAs.

This initiative is to support studies to better comprehend Immune-CNS interactions in people living with HIV on Anti-Retroviral therapy.

This initiative is to support studies to better comprehend Immune-CNS interactions in people living with HIV on Anti-Retroviral therapy.

The purpose of this Funding Opportunity Announcement (FOA) is to solicit studies that will advance the mechanistic understanding of small vessel vascular contributions to cognitive impairment and dementia (VCID) through the development of new technologies and innovative methods that enable the imaging and/or functional assessment of the small blood and lymphatic vessels and perivascular spaces of the brain.

This is one of two Funding Opportunity Announcements (FOAs) that together aim to facilitate teaching of fundamental principles of rigorous biomedical research by developing an online educational resource for use by a broad range of researchers in an array of learning environments. The purpose of this FOA is to support the establishment of a center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER), which will build, evaluate, and disseminate a user-friendly, harmonized, and openly accessible educational resource to promote awareness, understanding, and utilization of the principles of rigorous biomedical research.

This FOA invites investigation of biological and clinical measures of TBI-related progressive neurodegeneration and neurocognitive decline associated with increased risk for dementia and /or traumatic encephalopathy syndrome (TES) (clinicopathologic diagnostic counterpart to the neuropathological diagnosis of Chronic Traumatic Encephalopathy (CTE)). Investigations should be based on existing, well-characterized populations of patients with a history of TBI that are enriched for increased risk of cognitive impairment or dementia and can continue to be followed longitudinally; additional subjects may be recruited as appropriate. The overall goal is to advance knowledge of the underlying pathophysiology and clinical characterization of the chronic effects of TBI that distinguish static-chronic TBI cognitive impairment from those that lead to progressive neurodegeneration associated with TES and dementia. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data and to create a data and associated biofluid resource for the broader community to further advance research in this area.

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven clinical research applications that are focused on discovering novel diagnostic, prognostic, and/or therapeutic biomarkers for the Lewy Body Dementias (LBD).Biomarker research must be conducted in patients with LBD, must follow Parkinson's Disease Biomarker Program (PDBP) protocols for clinical assessment and biospecimen collection,and must be broadly shareable through the PDBP repositories.

Recent findings have raised the hypothesis that systemic immune responses could play direct or indirect roles in brain neurodegeneration leading to AD/ADRD, and has been significantly less studied compared to innate immune mechanisms such as microglia in the brain. This initiative will capitalize on growing interest in the research community and will support partnerships and new collaborations between neuroscientists and immunologists to expand the research base in this area with the long-term goal of bringing more immunology expertise into the AD/ADRD field. This is a new initiative seeking research into the role of systemic immune responses and inflammation in AD/ADRD. Individual projects are sought and collaborations between neuroscientists with expertise in AD/ADRDs and immunologists will be highly encouraged. Through these awards, a more solid research base in this area will be established that can support further work in this area through investigator-initiated and other mechanisms.

The purpose of this funding opportunity announcement is to expand the use of existing ADRD data resources to drive, via computational model development and dissemination, new discoveries that can lead to better understanding of mechanisms, clinical risk assessment and outcomes, and to identify novel candidate biomarkers for ADRD.