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The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information 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. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

The purpose of this funding opportunity announcement (FOA) is to support clinical studies that will fill gaps in the design of upcoming clinical trials in rare neurological or neuromuscular diseases by validating clinical outcome measures or biomarkers, or by characterizing cohorts of relevant patients. Through the support of trial readiness studies, NINDS expects to accelerate the initiation of clinical trials for rare diseases and to increase the likelihood of success in those trials.

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

This funding opportunity announcement (FOA) seeks to develop and nurture a national innovation ecosystem that builds upon biomedical research to develop technologies, products and services that benefit society. Toward meeting this objective, the I-Corps program is being offered. The I-Corps at NIH program is focused on educating researchers and technologists on how to translate technologies from the lab into the marketplace. Under this FOA, participating NIH and CDC Institutes and Centers will continue providing administrative supplement awards to currently-funded SBIR and STTR Phase I grantees. The program is designed to provide three-member project teams with access to instruction and mentoring in order to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and STTR funding. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies. Prospective applicants are strongly encouraged to contact NIH or CDC Scientific/Research staff for more information about the program before applying.

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Innovation Research (SBIR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through the BRAIN initiative or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience research.

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Innovation Research (SBIR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through the BRAIN initiative or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.

This R34 FOA solicits applications that offer a limited scope of aims and an approach that will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent Targeted Brain Circuits Projects - TargetedBCP R01, as described in the companion FOA (RFA-NS-18-009). Applications should be exploratory research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior.

A central goal of the BRAIN Initiative is to develop new and improved perturbation technologies suitable for controlling specified cell types and circuits to modulate function in the central nervous system. This FOA seeks applications to systematically characterize, model, and validate the membrane, cellular, circuit, and adaptive-biological responses of neuronal and non-neuronal cells to various types of stimulation. Development of new technologies and therapies, as well as of disease models are outside the scope of this FOA. However, activities related to combining multiple recording modalities are allowed. As part of this program, investigators will be required to participate in a consortium to develop standards and model systems for the evaluation of current and next generation neuromodulation technologies.

The purpose of the Academic Research Enhancement Award (AREA) program is to stimulate research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. AREA grants create opportunities for scientists and institutions otherwise unlikely to participate extensively in NIH research programs to contribute to the Nation's biomedical and behavioral research effort. AREA grants are intended to support small-scale research projects proposed by faculty members of eligible, domestic institutions, to expose undergraduate and/or graduate students to meritorious research projects, and to strengthen the research environment of the applicant institution.