Translational Neural Devices (R61/R33 - Clinical Trial Optional)

The National Institutes of Health (NIH), in collaboration with the National Institute of Neurological Disorders and Stroke (NINDS), is offering a phased grant opportunity titled "Translational Neural Devices (R61/R33 Clinical Trial Optional)" under Funding Opportunity Number PAR-25-053. The purpose of this funding opportunity is to support the translational development of low-risk therapeutic and diagnostic neural devices targeting nervous system or neuromuscular disorders. Through this grant, applicants can advance their device from prototype to clinical testing, including activities like device validation, safety and efficacy assessments, and obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) clinical study in the initial R61 phase. Projects that achieve defined milestones in this exploratory phase may transition to the R33 phase, where a small clinical study will provide additional data to support device functionality and refine design for broader clinical use. The initiative emphasizes a milestone-driven approach, requiring applicants to present quantifiable success criteria for the R61 to R33 phase transition, which will be administratively reviewed by NIH staff. This structure ensures that only projects demonstrating substantial progress in non-clinical testing will move forward. Applicants are encouraged to engage with NIH program staff before applying to refine project scope, timeline, and milestones. Additionally, a required Plan for Enhancing Diverse Perspectives (PEDP) must be included in applications, outlining strategies for inclusivity and diverse contributions, which will be evaluated as part of the review process. Funding is not limited by a specific budget cap; applicants should present a realistic budget reflecting the scope of the proposed work. The R61 phase can span up to two years, and the R33 phase up to three years, with a combined maximum project period of five years. Eligible applicants include institutions of higher education, nonprofit and for-profit organizations, local governments, tribal entities, and foreign institutions. Comprehensive registration across systems like SAM, eRA Commons, and Grants.gov is mandatory before application submission. Applicants must include various supporting attachments, including a Gantt chart for the project timeline, an Intellectual Property (IP) Strategy, a Needs Assessment outlining device design needs based on stakeholder input, a Long-Term Care Plan for patient post-trial needs, and, if applicable, communication records with the IRB or FDA. These attachments will help assess the feasibility, impact, and sustainability of the proposed work, as well as the alignment with regulatory requirements. Reviewers will assess the applications on scientific merit, emphasizing the project's significance, innovation, and feasibility. Specific evaluation factors include the potential clinical impact, the robustness of experimental designs, data reproducibility, inclusivity of diverse perspectives (via the PEDP), and a clear regulatory and commercialization pathway. The device's long-term usability and patient care provisions post-study will also be scrutinized. Milestone plans should be achievable and consistent with NIH expectations, particularly the readiness for IRB NSR designation by the end of the R61 phase. The application submission opens on December 28, 2024, with due dates throughout 2025-2027. Each submission cycle includes scientific merit review, advisory council review, and possible award dates several months post-review. Applicants seeking over $500,000 in direct costs annually must consult NIH staff six weeks before submission.