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The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility Studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE), with the option of also supporting the following Early Feasibility Study. It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility Studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE), with the option of also supporting the following Early Feasibility Study. It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to more advanced clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and a small clinical study.

This Funding Opportunity Announcement (FOA) encourages and assists the development of future leaders in the field of aging by supporting clinically trained (primarily physician) faculty members early in their careers to gain additional research training and to establish independent programs in aging research. The John A. Hartford Foundation (http://www.jhartfound.org/) and The American Federation for Aging Research (http://www.afar.org/) are interested in independently funding applications submitted under this initiative.

This Funding Opportunity Announcement (FOA) encourages and assists the development of future leaders in the field of aging by supporting clinically trained (primarily physician) faculty members early in their careers to gain additional research training and to establish independent programs in aging research. The John A. Hartford Foundation (http://www.jhartfound.org/) and The American Federation for Aging Research (http://www.afar.org/) are interested in independently funding applications submitted under this initiative.

The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN receive funding for activities to be conducted in their own laboratories and the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize well-validated hit compounds through medicinal chemistry, or at the Development stage, to advance development candidates through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN participants receive intellectual property rights to drug candidates developed through the program.

The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN receive funding for activities to be conducted in their own laboratories and the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize well-validated hit compounds through medicinal chemistry, or at the Development stage, to advance development candidates through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN participants receive intellectual property rights to drug candidates developed through the program.

This Funding Opportunity Announcement (FOA) is dedicated to the discovery of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. It supports the optimization of therapeutic lead(s) showing convincing proof-of-concept. At the end of the funding period, projects that successfully advance through support from this program will have identified a optimized candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, and will be ready for entry into the CREATE Bio Development track for further development to enable filing for an Investigational New Drug (IND).

This Funding Opportunity Announcement (FOA) is dedicated to the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission.An identified candidate, which has 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 the CREATE Bio Development Track. The FOA supports Investigational New Drug (IND)-enabling studies for the candidate and early-phase clinical trials. At the end of the funding period, a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum.The program supports early-phase clinical trials, although these are not required.