Opportunity Information: Apply for RFA RM 16 009
Apply for RFA RM 16 009
- The HHS-NIH11 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 Feb 25, 2016 and posted on Feb 25, 2016.
- Applicants must submit their applications by May 02, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIH opportunity called "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18)" (Funding Opportunity Number RFA-RM-16-009) is a SPARC Common Fund funding announcement aimed at helping researchers repurpose already market-approved neuromodulation devices for new clinical uses. The core idea is to take devices that have already cleared the market for one indication and generate the additional pre-clinical evidence needed to justify moving those same technologies toward different, newly proposed indications. Rather than funding early concept work from scratch, this announcement focuses on practical pre-clinical development work that de-risks translation and supports a clear regulatory path toward human testing.
A defining feature of this FOA is the built-in partnership structure with SPARC industry collaborators. Companies participating through the SPARC "Device Portal" agree to provide their neuromodulation technology to investigators funded under the program. That arrangement is meant to lower barriers to access, speed up evaluation, and align academic or translational teams with commercially available platforms that can realistically be advanced. In other words, applicants are not expected to invent a new device; they are expected to test and adapt an existing, market-approved neuromodulation system supplied by program partners for a different potential therapeutic target or condition.
The work supported is explicitly pre-clinical, and the expected outcome is evidence strong enough to support an Investigational Device Exemption (IDE) submission. An IDE is the regulatory mechanism that allows a device to be used in a clinical study to collect safety and effectiveness data. This FOA is therefore oriented toward generating the types of safety and efficacy data, in relevant pre-clinical settings, that regulators and clinical investigators would need before launching a future pilot clinical trial. Put simply, the program is designed to bridge the gap between having a promising device and having a defensible package of pre-clinical results that makes a first-in-indication clinical study realistic.
Administratively, the award mechanism is a cooperative agreement (U18), which typically means NIH expects substantial involvement during the project, such as coordination, milestone tracking, or programmatic collaboration, beyond what is common with a standard research grant. The activity category is health, and the associated CFDA numbers are 93.310. The sponsoring agency is listed as HHS-NIH11. The award ceiling is $400,000, and the posted and creation dates are both February 25, 2016, with an original and current closing date of May 2, 2016.
Eligibility is broad and includes many types of domestic applicants across government, academia, nonprofit, and industry. Eligible applicants include state, county, and city or township 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA’s additional eligibility language. This wide eligibility reflects the translational nature of the program and the reality that pre-clinical device development often requires cross-sector teams with complementary expertise in physiology, engineering, regulatory strategy, and pre-clinical study execution.
Overall, this SPARC U18 opportunity is best understood as a targeted translational funding mechanism: it leverages industry-provided, already approved neuromodulation devices and funds the pre-clinical studies needed to justify expanding those devices into new therapeutic indications, with the explicit goal of producing an IDE-ready evidence package that can support a subsequent pilot clinical study.
FAQs: SPARC Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18) - RFA-RM-16-009
What is the main goal of this NIH funding opportunity?
The goal is to support pre-clinical development work that repurposes existing, market-approved neuromodulation devices for newly proposed clinical indications. The intent is to generate additional pre-clinical evidence needed to justify moving an already approved technology toward a different therapeutic use, with a clear regulatory path toward human testing.
What is the official title and funding opportunity number?
The opportunity is titled "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Pre-clinical Development of Existing Market-approved Devices to Support New Market Indications (U18)" and the Funding Opportunity Number is RFA-RM-16-009.
Which NIH program is this associated with?
This is a SPARC Common Fund funding announcement under the NIH Common Fund SPARC program.
What kind of devices does this program focus on?
The program focuses on neuromodulation devices that are already market-approved (meaning they have cleared the market for at least one existing indication). The expectation is that these devices will be evaluated and adapted for different, newly proposed indications.
Does this program fund the invention of brand-new devices?
No. The announcement is framed around repurposing existing, market-approved neuromodulation devices rather than inventing a new device from scratch.
What is meant by "new market indications" in this announcement?
It refers to new or different clinical uses (therapeutic targets or conditions) for a device that is already market-approved for another indication. The funded work is meant to create the pre-clinical evidence base to support moving toward that new proposed use.
What stage of research and development is supported?
The supported work is explicitly pre-clinical. The emphasis is on practical pre-clinical development that de-risks translation and supports a credible regulatory path toward future clinical testing.
What is the expected outcome at the end of the project?
The expected outcome is pre-clinical evidence strong enough to support an Investigational Device Exemption (IDE) submission, enabling future clinical studies that collect safety and effectiveness data.
What is an IDE, and why is it mentioned as a project goal?
An IDE (Investigational Device Exemption) is the regulatory mechanism that allows a device to be used in a clinical study to collect safety and effectiveness data. This FOA is designed to generate the types of pre-clinical safety and efficacy data needed to support an IDE submission and make a first-in-indication clinical study realistic.
How does industry participation work in this FOA?
A defining feature is a built-in partnership structure with SPARC industry collaborators. Companies participating through the SPARC "Device Portal" agree to provide their neuromodulation technology to investigators funded under the program, lowering barriers to access and aligning funded projects with commercially available platforms.
Are applicants expected to secure access to devices on their own?
The FOA describes an arrangement where SPARC industry collaborators provide neuromodulation technology through the SPARC "Device Portal" to funded investigators, with the intention of reducing access barriers and speeding evaluation.
What is the award mechanism, and what does it imply?
The award mechanism is a cooperative agreement (U18). This typically implies substantial NIH involvement during the project, such as coordination, milestone tracking, or programmatic collaboration beyond what is typical for a standard research grant.
What is the award ceiling?
The award ceiling listed for this opportunity is $400,000.
Which agency is sponsoring this opportunity?
The sponsoring agency is NIH (under HHS), listed as HHS-NIH11.
What is the activity category?
The activity category is health.
What CFDA number is associated with this FOA?
The associated CFDA number listed is 93.310.
When was this opportunity posted?
The posted date and the creation date are both February 25, 2016.
What was the closing date for applications?
The original closing date and the current closing date are both May 2, 2016.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic applicants across government, academia, nonprofit, and industry. Eligible applicants include state, county, and city or township 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA's additional eligibility language.
Why is eligibility so broad for this specific program?
The FOA reflects the translational nature of pre-clinical device development, which often requires cross-sector teams with complementary expertise such as physiology, engineering, regulatory strategy, and pre-clinical study execution.
What makes this FOA different from an early-stage concept or discovery grant?
This FOA is not focused on early concept work from scratch. It focuses on practical, translation-oriented pre-clinical development using already market-approved devices, aiming to produce an IDE-ready package that supports a future pilot clinical study.
What is the practical value of using already market-approved devices?
The FOA is designed to leverage devices that have already cleared the market for an existing indication, making it more feasible to advance toward new indications by focusing funds on the additional pre-clinical data needed to de-risk translation and support regulatory planning for human testing.
What is the role of pre-clinical safety and efficacy evidence in this program?
The program is oriented toward generating the types of safety and efficacy data in relevant pre-clinical settings that regulators and clinical investigators would need before launching a future pilot clinical trial.
Is this opportunity intended to directly fund clinical trials?
The work supported is explicitly pre-clinical. The stated aim is to produce evidence supporting an IDE submission to enable future clinical studies, rather than directly funding those clinical studies within this FOA.
What is the overall "bridge" this program is trying to build?
It is designed to bridge the gap between having a promising, market-approved neuromodulation device and having a defensible pre-clinical evidence package that makes a first-in-indication clinical study realistic.
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