Translational Neural Devices (R61/R33 - Clinical Trial Optional) | PAR 25 053

Opportunity Information: Apply for PAR 25 053

The Translational Neural Devices (R61/R33 - Clinical Trial Optional) opportunity (PAR-25-053) is an NIH grant program designed to push promising neural and neuromuscular device concepts past early development and closer to real-world use. Its focus is on therapeutic and diagnostic devices intended for disorders that affect the nervous system or neuromuscular function. In practical terms, this NOFO is meant for teams that already have a credible device concept and need support to complete the kinds of engineering, testing, regulatory steps, and early human work that typically stand between a prototype and a clinically informative product.

The program supports a fairly comprehensive set of late preclinical and early clinical translation activities. Funding can be used to build and refine clinical prototype devices, run non-clinical safety and efficacy assessments, and complete design verification and validation work that demonstrates the device performs as intended and is ready for human evaluation. It also explicitly supports the regulatory and oversight pathway required to move into people, including preparation and submission steps for an Investigational Device Exemption (IDE) when the study is considered Significant Risk (SR), or obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. After those enabling steps, the award can support a subsequent small clinical study.

A key point in this NOFO is why the clinical study is being done. NIH signals that the clinical component should be justified because it will produce information about device function or finalize aspects of the device design that cannot realistically be obtained through additional bench testing or animal studies. This is especially relevant for novel devices or novel intended uses where real human-use conditions, anatomy, physiology, workflow constraints, or patient experience can drive design decisions in ways that models cannot fully capture. The clinical trial is described as optional, but the NOFO clearly anticipates that a small, targeted human study may be the critical next step for many projects.

Structurally, this is a milestone-driven cooperative agreement using the R61/R33 phased format. That means it is not a simple “fund it and report annually” mechanism. Instead, the project is expected to be run against negotiated milestones and deliverables, and NIH program staff will be actively involved. Before an award is made, NIH staff will work with applicants to negotiate and finalize the project plan. After award, they will monitor progress toward milestones, which typically function as decision points for continued support and transition from the earlier phase to the later phase. This setup is intended to keep projects tightly focused on concrete development outcomes, reduce risk, and ensure that funded work stays aligned with a realistic translational path.

Eligibility is broad and includes many organization types that commonly participate in device translation. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other applicant types. The NOFO also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, U.S. territories or possessions, eligible federal agencies, regional organizations, and non-U.S. (foreign) entities.

Administrative details from the source include that the sponsoring agency is the National Institutes of Health, the activity category is Health, and the CFDA (Assistance Listing) number is 93.853. The opportunity was created on 2024-10-29, and the listed closing date is 2027-01-28. The entry does not provide an award ceiling or expected number of awards in the provided fields, so applicants typically would need to consult the full NOFO text and any associated NIH institute/center guidance for budget expectations, project period limits, and anticipated funding levels.

Overall, the opportunity is best understood as NIH support for the “hard middle” of neural device development: building a clinically relevant prototype, generating the safety/performance evidence needed to satisfy design controls and human research oversight, navigating IDE/IRB requirements, and running a small clinical study specifically aimed at answering device-function and final-design questions that cannot be settled through further non-clinical work.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Neural Devices (R61/R33 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2024-10-29.
• Applicants must submit their applications by 2027-01-28.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 053

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: