Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18) | RFA RM 16 027

Opportunity Information: Apply for RFA RM 16 027

The Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18) opportunity is a National Institutes of Health (NIH) funding announcement under the SPARC Common Fund program. It focuses on advancing neuromodulation research by supporting pre-clinical development work that uses devices already approved for the market, but aimed at expanding those devices into new therapeutic uses. The award mechanism is a cooperative agreement (U18), which generally means NIH expects substantial involvement and coordination with awardees during the project, rather than operating strictly as a hands-off grant.

This FOA is narrowly centered on non-clinical testing in animal models. The intent is to generate rigorous safety and efficacy data needed to justify moving an existing, market-approved neuromodulation device toward a new clinical indication. In practice, the work supported here is meant to create the kind of evidence base that can underpin an Investigational Device Exemption (IDE) submission to the FDA, setting the stage for a future pilot clinical study. In other words, the program is positioned as a translational bridge: it does not fund human trials under this announcement, but it funds the crucial animal-model studies that make a credible regulatory path to first-in-indication clinical testing possible.

A defining feature of the opportunity is that it is limited to a set of neuromodulation devices made available through SPARC industry partners. Those partnering companies have agreed to provide their neuromodulation technology to investigators funded by SPARC, and applicants are expected to rely on the specific technologies listed through the program’s Device Portal. This structure is designed to reduce barriers to entry for academic and other research teams by providing access to established device platforms, while still demanding that the proposed studies be sufficiently rigorous and directly relevant to demonstrating safety and potential effectiveness for the targeted new indication.

Eligibility is broad across U.S.-based organizations and includes many common applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private universities; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible institutional categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, there are clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA allows “foreign components” as defined by the NIH Grants Policy Statement, which typically means a U.S. applicant can include certain well-justified activities performed outside the U.S. as part of the overall project, so long as NIH policy requirements are met and the applicant organization itself is domestic and eligible.

Administratively, the opportunity is cataloged as RFA-RM-16-027, categorized as discretionary funding, and aligned with NIH’s health research mission (CFDA 93.310). The original posting dates included a creation date of October 19, 2016 and an original closing date of December 21, 2016. While the summary provided does not specify an award ceiling or expected number of awards, the core program purpose is clear: to support pre-clinical, animal-model testing using selected, partner-provided neuromodulation devices so that investigators can build the safety and efficacy package needed for an IDE and eventual early-stage clinical evaluation in a new disease or condition area.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2016-10-19.
• Applicants must submit their applications by 2016-12-21. (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 RFA RM 16 027

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