BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02) | PAR 15 345

Opportunity Information: Apply for PAR 15 345

The funding opportunity titled "BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02)" (Funding Opportunity Number PAR-15-345) is a National Institutes of Health (NIH) program designed to speed up human clinical research using advanced, invasive neurotechnology. The core idea is to help clinical investigators team up with device manufacturers to study next-generation devices that can stimulate and/or record activity in the human central nervous system. These are FDA Class III devices, meaning they are invasive and considered to carry significant risk, so human studies normally face major regulatory and logistical hurdles before they can even begin.

A major barrier in this area is the amount of safety and utility data required to support regulatory approval for human research. Generating that evidence can be extremely expensive and time-consuming, and it often has to be repeated or supplemented when a new research group wants to use a device in a new study. NIH created the BRAIN Public-Private Partnership program (BRAIN PPP) to reduce these bottlenecks by making it easier to form investigator-manufacturer partnerships and by encouraging studies to build directly on manufacturers existing safety and performance data rather than starting from scratch. In practical terms, this program is structured so that researchers can gain earlier access to certain cutting-edge devices that already have enough supporting data to help researchers pursue either a Non-Significant Risk (NSR) determination or an Investigational Device Exemption (IDE) pathway, without needing large amounts of additional pre-testing. That matters because NSR and IDE decisions often determine whether a study can proceed, how burdensome the oversight will be, and how quickly patients can be enrolled.

This FOA is specifically framed as a pre-application mechanism (X02), which typically signals that NIH is looking for an initial, streamlined submission that helps match investigators with suitable industry partners and devices before a larger, full research proposal is developed. The emphasis is on facilitating the partnership and access to qualified devices, not simply funding a standard, investigator-initiated trial in isolation. The devices in question are described as "latest-generation" stimulating and/or recording tools for the central nervous system, and the program is structured around NIH having already negotiated agreements with a number of manufacturers. Those prior agreements are important because they are meant to reduce negotiation friction (for example, around data use, device access, responsibilities, and other terms that can stall collaborations), while ensuring clinical studies can leverage existing datasets generated by the companies.

In terms of who can apply, eligibility is broad across the U.S. research ecosystem. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional categories of eligible organizations, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions are not eligible to apply as non-domestic entities, but non-domestic components of U.S. organizations can participate, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning certain parts of the work can be conducted abroad under NIH rules if properly justified and structured.

Administratively, this is an NIH discretionary grant opportunity within the broad federal activity category of Education, Health, Income Security and Social Services. It is associated with multiple CFDA numbers (93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting that NIH Institutes and Centers supporting the BRAIN Initiative and related neuroscience work may contribute to or align with the program. The original closing date listed is 2015-11-18, and the opportunity was created on 2015-09-17. The award ceiling and expected number of awards are not specified in the provided listing, which often means applicants need to consult the full FOA text and NIH guidance for budget and submission expectations, or that the pre-application step is not primarily defined by a large direct-cost budget.

Overall, the opportunity is aimed at one specific outcome: accelerating responsible, regulatorily feasible human CNS research with invasive stimulation/recording devices by lowering the practical barriers that slow down or prevent investigator access. Instead of each research team independently negotiating device access and rebuilding safety justifications, the program tries to standardize and streamline collaborations so studies can begin sooner, rely on existing manufacturer data when appropriate, and expand what can be learned from advanced neurotechnologies in clinical settings under the BRAIN Initiative umbrella.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2015-09-17.
• Applicants must submit their applications by 2015-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 15 345

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