Opportunity Information: Apply for PAR 14 298
Apply for PAR 14 298
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Devices Translational and Early Feasibility Studies on the Path to Pre Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jul 28, 2014 and posted on Jul 28, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Private institutions of higher education Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities City or township governments Public and State controlled institutions of higher education For profit organizations other than small businesses Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NINDS CREATE Devices Translational and Early Feasibility Studies program (PAR-14-298) is a National Institutes of Health funding opportunity designed to move therapeutic device concepts for neurological disorders out of the lab and toward real-world clinical use. The central aim is to fund the hands-on translational work needed to reach an Investigational Device Exemption (IDE) submission to the FDA, and, when appropriate, to also support the early clinical testing that follows under that IDE. In practical terms, the program is meant to help teams bridge the difficult gap between promising device innovation and the regulatory and clinical milestones required to ultimately pursue either a Pre-Market Approval (PMA) pathway or a Humanitarian Device Exemption (HDE) pathway.
This opportunity uses a cooperative agreement mechanism (UH2/UH3), which generally signals a more involved partnership between NIH/NINDS staff and the awardee than a typical research grant. Rather than simply funding exploratory research, the structure is built around clear, product-focused deliverables and milestone-driven progress that aligns with regulatory expectations. The two-phase format reflects that reality: the earlier phase (UH2) supports key preclinical and translational activities needed to justify human testing and assemble a credible IDE submission, while the later phase (UH3) can support an Early Feasibility Study once the project is ready to enter the clinic. The design implies a go/no-go progression: projects are expected to demonstrate readiness and meet defined targets before advancing to the clinical phase.
The scope of supported work is strongly oriented toward development and validation of a clinical prototype and the evidence package required to test it in humans. Supported activities include implementation and refinement of clinical-grade prototype devices, preclinical safety and efficacy testing relevant to the intended neurological indication, and the engineering and quality work that regulators and clinical sites expect to see before first-in-human use. This includes design verification and validation activities, which are typically the formal processes used to show the device was built correctly (verification) and that it meets the user needs and intended use in realistic conditions (validation). Just as importantly, the FOA explicitly supports the regulatory path itself, including efforts tied to pursuing approval to conduct the clinical study, culminating in submission of an IDE. If the application proposes it and the project reaches readiness, the program may also support an Early Feasibility Study, which is usually a small, carefully monitored first-in-human study intended to evaluate initial safety, device functionality, and practical use in the clinical setting.
The program’s end goal is not to stop at early human testing. NINDS frames the funded work as a stepping stone to the next standard stages of device development: after the Early Feasibility Study, the expected immediate next steps are a full Feasibility Study and then a Pivotal Trial that could support a PMA submission or an HDE submission. That framing matters because it communicates what reviewers and program staff are looking for: a realistic development plan that anticipates the full clinical and regulatory journey, not a stand-alone pilot study. Applicants are effectively being asked to propose a credible, end-to-end translational trajectory where the deliverables produced under this award directly set up the later, larger trials required for marketing authorization.
In terms of who can apply, eligibility is broad across U.S.-based organizations and includes many types of public and private entities. Eligible applicants listed include state, county, city/township, special district governments, and independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; small businesses; for-profit organizations other than small businesses; nonprofits with and without 501(c)(3) status; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations (including federally recognized tribes and other tribal entities). The announcement also notes additional eligible categories such as Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander-serving institutions, as well as faith-based or community-based organizations and certain eligible federal agencies. At the same time, the FOA is clear that non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed, which keeps the funded development and clinical work firmly within the U.S. regulatory and operational environment. There is no cost sharing or matching requirement, which reduces a common barrier for academic groups and smaller companies trying to advance device prototypes toward clinical readiness.
From an administrative standpoint, the opportunity falls under the NIH “Discretionary” category and the Health funding activity category, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It was posted and created on July 28, 2014, and the final closing date was May 7, 2017, with an archive date of June 7, 2017, meaning it is now an archived opportunity rather than an open competition. The sponsoring agency is the National Institutes of Health, with NINDS as the relevant institute, and the full announcement was hosted on the NIH grants site.
Taken together, this FOA can be understood as a targeted translational device-development bridge: it funds the engineering, preclinical evidence generation, quality/reliability work, regulatory preparation, and initial human evaluation needed to move a therapeutic neurological device to the point where larger feasibility and pivotal trials become the logical next step. It is geared toward teams that are beyond basic discovery and are prepared to operate with a product-development mindset, including a serious regulatory strategy and a clear plan for how early clinical experience will de-risk the path to PMA or HDE.
FAQs: NINDS CREATE Devices Translational and Early Feasibility Studies (PAR-14-298)
What is the NINDS CREATE Devices Translational and Early Feasibility Studies program?
It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) intended to move therapeutic device concepts for neurological disorders out of the lab and toward real-world clinical use. The program focuses on the practical translational work needed to prepare an FDA Investigational Device Exemption (IDE) submission and, when appropriate, to support early clinical testing under that IDE.
What is the main goal of this funding opportunity?
The central goal is to fund the hands-on development, testing, and regulatory preparation needed to reach an IDE submission to the FDA. If the project reaches readiness and the application proposes it, the program can also support an Early Feasibility Study (small first-in-human clinical testing) conducted under the IDE.
What kinds of devices or projects are a fit for this FOA?
Projects aimed at developing therapeutic devices for neurological disorders, especially those that are beyond basic discovery and are ready for product-focused translational work. The FOA is positioned for teams prepared to build and validate a clinical prototype and generate the evidence package expected for first-in-human testing and regulatory review.
What stage of development does NINDS expect applicants to be in?
This program is meant to bridge the gap between promising device innovation and the regulatory/clinical milestones needed for eventual marketing authorization pathways. It is not framed as exploratory research; it supports teams that can commit to milestone-driven, product-development-style execution that aligns with regulatory expectations.
What is the funding mechanism used by this opportunity?
The FOA uses a cooperative agreement mechanism (UH2/UH3). This structure generally reflects a more involved partnership between NIH/NINDS staff and the awardee than a typical research grant, and it is designed around clear deliverables and progress milestones.
What do the UH2 and UH3 phases represent?
The program is organized into two phases. UH2 supports preclinical and translational activities needed to justify human testing and assemble a credible IDE submission. UH3 can support an Early Feasibility Study after the project demonstrates readiness to enter the clinic.
Is there a go/no-go transition between UH2 and UH3?
Yes. The program design implies a milestone-based progression where projects are expected to meet defined targets and demonstrate readiness before advancing from UH2 (translational/preclinical work) to UH3 (early clinical testing).
What types of activities are supported in the translational (UH2) phase?
Supported UH2 activities are strongly oriented toward developing and validating a clinical prototype and generating the evidence package needed for first-in-human use. This includes implementing and refining clinical-grade prototype devices, conducting preclinical safety and efficacy testing relevant to the intended neurological indication, and completing engineering and quality work expected by regulators and clinical sites.
Does the FOA support design verification and validation?
Yes. The FOA supports design verification and validation activities. Verification is described as demonstrating the device was built correctly, while validation is described as demonstrating the device meets user needs and intended use in realistic conditions.
Does the FOA support regulatory work with the FDA?
Yes. The FOA explicitly supports the regulatory path, including work tied to pursuing approval to conduct the clinical study, culminating in submission of an IDE to the FDA.
What is an IDE and why does it matter in this program?
An IDE (Investigational Device Exemption) is the FDA authorization framework that allows a device to be studied in a clinical setting. In this program, reaching an IDE submission is a central milestone, and early clinical testing (if supported) is expected to occur under that IDE.
Does the program fund an Early Feasibility Study?
It may. If the application proposes early clinical testing and the project reaches readiness to enter the clinic, UH3 can support an Early Feasibility Study. The FOA describes this as a small, carefully monitored first-in-human study to evaluate initial safety, device functionality, and practical clinical use.
Is the program intended to end after Early Feasibility Study work?
No. NINDS frames the funded work as a stepping stone to subsequent standard stages of device development. After an Early Feasibility Study, the expected next steps are a full Feasibility Study and then a Pivotal Trial that could support a Pre-Market Approval (PMA) submission or a Humanitarian Device Exemption (HDE) submission.
What is the bigger regulatory/clinical path this FOA is trying to enable?
The program is designed to de-risk and prepare a project for later, larger clinical studies and regulatory steps that align with PMA or HDE pathways. Reviewers and program staff are described as looking for a realistic development plan that anticipates the full clinical and regulatory journey, rather than a stand-alone pilot study.
What deliverables or outcomes are implied by the FOA?
The FOA emphasizes product-focused deliverables and milestone-driven progress, including a clinical-grade prototype, preclinical safety/efficacy evidence relevant to the intended neurological indication, design verification/validation outputs, and a regulatory package culminating in an IDE submission. If UH3 is pursued, an additional outcome is the execution of an Early Feasibility Study.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations. Examples listed include state, county, city/township, special district governments, and independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; small businesses; for-profit organizations other than small businesses; nonprofits with and without 501(c)(3) status; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations (including federally recognized tribes and other tribal entities).
Are minority-serving institutions and community-based organizations included as eligible applicants?
Yes. The announcement notes additional eligible categories such as Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander-serving institutions. It also mentions faith-based or community-based organizations and certain eligible federal agencies.
Are non-U.S. (foreign) entities allowed to apply?
No. The FOA states that non-U.S. entities are not eligible to apply.
Can a U.S. organization include a non-U.S. component or foreign component?
No. The FOA states that non-U.S. components of U.S. organizations are not eligible and that foreign components (as defined by NIH policy) are not allowed. The intent is to keep funded development and clinical work within the U.S. regulatory and operational environment.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What are the program categories and identifiers mentioned?
The opportunity is listed under the NIH "Discretionary" category and the Health funding activity category, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Which agency and institute sponsor this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the relevant institute for this FOA is NINDS. The full announcement is hosted on the NIH grants site.
Is this funding opportunity still open?
No. The FOA is described as archived. It was posted and created on July 28, 2014, the final closing date was May 7, 2017, and the archive date was June 7, 2017.
What does it mean that the FOA is archived?
Based on the dates provided, it means this is not an open competition anymore. The final closing date has passed and the opportunity is listed as archived.
How involved is NIH/NINDS expected to be during the project?
Because the mechanism is a cooperative agreement (UH2/UH3), the FOA signals a more involved partnership between NIH/NINDS staff and the awardee than a typical research grant, with a focus on milestones and product-oriented deliverables.
What is the practical focus of the program compared to typical research funding?
The program is described as funding the practical, hands-on translational work needed for regulatory and clinical readiness: building and refining clinical-grade prototypes, generating preclinical evidence tied to the intended indication, completing verification/validation work, preparing for and submitting an IDE, and potentially conducting a small early clinical study.
What kind of development mindset does the FOA expect?
The FOA is geared toward teams that can operate with a product-development mindset, including a serious regulatory strategy and a plan showing how early clinical experience will reduce risk on the path toward PMA or HDE and later-stage trials.
Browse more opportunities from the same category: Health
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Previous opportunity: NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (UH2/UH3)
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