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This FOA encourages 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 a future trial, for biomarker validation studies, or for proof of mechanism 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). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical trial (e.g., Early Feasibility Study). The small 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. 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 encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study). Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small 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.

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).

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) 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 practice.

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.

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.