Opportunity Information: Apply for PAR 14 300
Apply for PAR 14 300
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (U44)" 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: Small businesses.
- Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (U44) is a National Institutes of Health funding opportunity designed to help small businesses move therapeutic neurological devices from late-stage development into early clinical evaluation, with the specific goal of producing evidence that guides the final device design. The program focuses on the practical, high-effort work that sits between a promising prototype and a device that is truly ready for larger clinical trials and, eventually, market approval. Rather than funding open-ended discovery, it supports targeted translational activities that reduce technical, safety, regulatory, and clinical-risk uncertainties for devices intended to treat neurological disorders.
This opportunity uses a cooperative agreement mechanism (U44), meaning NIH is expected to have substantial involvement during the project. In practice, that usually implies closer coordination with NIH program staff than in a standard grant, with milestones and go/no-go decision points being an important part of how progress is managed. A central expectation is that awardees will prepare for and obtain the needed regulatory and ethics permissions for human testing, specifically by supporting submission of an Investigational Device Exemption (IDE) to the FDA when required, or securing Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study when an IDE is not necessary. After those clearances, the award supports execution of a small clinical study.
The clinical study supported under this FOA is not meant to be a pivotal, large-scale trial. Instead, it is intended to generate focused clinical data that directly informs the final device design. The concept is that by running a carefully scoped early clinical study, developers can identify design refinements, usability issues, performance limitations, safety signals, or procedural considerations that need to be addressed before committing to expensive later-stage trials. Importantly, the FOA notes that once a final design is selected based on these findings, that final design would typically need to undergo most, if not all, of the preclinical testing again (or at least be supported by an appropriate preclinical package) on the path toward more advanced trials and regulatory approval. In other words, this program helps teams decide what the final device should be, using translational and early clinical evidence, rather than assuming the existing prototype is already the final product.
The scope of supported activities is broad but clearly oriented around readiness for human use and learning from early human data. It includes building and implementing clinical prototype devices, conducting preclinical safety and efficacy testing appropriate to the device and intended use, and performing design verification and validation work to demonstrate the device meets specifications and performs as intended. It also explicitly supports the regulatory steps needed to initiate the clinical study (IDE submission or NSR pathway preparation and IRB approval), and then carrying out a small clinical study. In addition to therapeutic applications, the FOA also allows support for devices intended to test scientific hypotheses that cannot be feasibly or practically addressed in animal models, when those human-use studies are considered critical for enabling next-generation devices.
Eligibility is limited to U.S. small business concerns. Applicants must be for-profit entities with a place of business in the United States that operate primarily in the U.S. (or otherwise make a significant contribution to the U.S. economy), and they must meet SBA size standards, including having no more than 500 employees when affiliates are counted. The FOA lays out ownership and control rules consistent with SBIR/STTR-style requirements, including pathways for majority ownership by U.S. individuals/permanent residents, certain qualifying majority venture-backed structures under SBIR rules, and qualifying joint venture arrangements. There is no cost sharing or matching requirement stated for this opportunity.
Administratively, the opportunity is issued by NIH under NINDS (the National Institute of Neurological Disorders and Stroke) as part of its extramural research programs in neurosciences and neurological disorders (CFDA 93.853). It was posted July 28, 2014, and the original and final closing date listed is May 7, 2017 (now archived June 7, 2017). The official announcement link is provided through the NIH Grants Guide, and NIH’s Office of Extramural Research webmaster contacts are listed for access or linking issues.
Overall, this FOA is best understood as a bridge for small businesses developing neurological therapeutic devices that are far enough along to justify a regulated human study, but still need carefully chosen translational and early clinical work to lock in the final design. It funds the hard, detail-oriented tasks that make early clinical evaluation possible and meaningful: prototype readiness, safety and performance testing, verification/validation, regulatory submissions and approvals, and a small clinical study whose results directly shape the device that will move forward into the next stage of development.
FAQs: NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (U44)
What is the NINDS CREATE Devices Translational and Clinical Studies to Inform Final Device Design (U44) opportunity?
It is an NIH funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) intended to help U.S. small businesses move therapeutic neurological devices from late-stage development into early clinical evaluation. The goal is to generate evidence that informs and supports selection of the final device design.
What is the main purpose of this program?
The program supports targeted translational work and a small early clinical study to reduce technical, safety, regulatory, and clinical-risk uncertainties. It is meant to bridge the gap between a promising prototype and a device that is ready for larger clinical trials and, ultimately, market approval.
Is this opportunity meant for basic discovery research?
No. The focus is not on open-ended discovery. It supports practical, high-effort translational activities and early clinical evaluation steps that directly prepare a device for human use and help determine the final design.
What funding mechanism is used, and what does that imply?
This opportunity uses a cooperative agreement mechanism (U44). That means NIH is expected to have substantial involvement in the project, typically including close coordination with NIH program staff, the use of milestones, and go/no-go decision points to manage progress.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns that are for-profit entities with a place of business in the United States and that operate primarily in the U.S. (or otherwise make a significant contribution to the U.S. economy). Applicants must meet SBA small business size standards, including no more than 500 employees when affiliates are counted.
Are there specific ownership and control requirements?
Yes. The opportunity includes ownership and control rules consistent with SBIR/STTR-style requirements. These include pathways such as majority ownership by U.S. individuals/permanent residents, certain qualifying majority venture-backed structures under SBIR rules, and qualifying joint venture arrangements.
Does this opportunity require cost sharing or matching funds?
No cost sharing or matching requirement is stated for this opportunity.
What types of devices are in scope?
The focus is on therapeutic neurological devices intended to treat neurological disorders. The opportunity also allows support for devices intended to test scientific hypotheses that cannot be feasibly or practically addressed in animal models, when human-use studies are critical for enabling next-generation devices.
What stage of development should a device be at to fit this program?
The program is aimed at devices in late-stage development that are far enough along to justify a regulated human study, but that still need translational work and early clinical data to finalize the device design before pursuing larger trials.
What activities can the award support?
Supported activities include building and implementing clinical prototype devices, conducting preclinical safety and efficacy testing appropriate to the device and intended use, performing design verification and validation, completing the regulatory steps needed to initiate a human study (IDE submission when required or NSR pathway preparation with IRB approval when an IDE is not necessary), and conducting a small clinical study.
Does the program support building clinical prototype devices?
Yes. The scope includes building and implementing clinical prototype devices as part of readiness for human use and early clinical evaluation.
Does the program support preclinical testing?
Yes. It supports preclinical safety and efficacy testing that is appropriate to the device and its intended use, as part of reducing risk and enabling a human study.
What is meant by design verification and validation in this program?
The opportunity supports verification and validation work to demonstrate that the device meets specifications and performs as intended, which is part of preparing a device for human testing and for decisions about the final design.
What regulatory and ethics approvals are expected before the clinical study?
A central expectation is that awardees will prepare for and obtain the needed regulatory and ethics permissions for human testing. This includes supporting submission of an Investigational Device Exemption (IDE) to the FDA when required, or securing Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study when an IDE is not necessary.
Is an IDE always required?
No. The program anticipates either an IDE submission when required or an NSR pathway where an IDE is not necessary, along with IRB approval.
What kind of clinical study does this FOA support?
It supports a small, carefully scoped early clinical study intended to produce focused clinical data that directly informs the final device design.
Is the supported clinical study intended to be a pivotal or large-scale trial?
No. The FOA states the study is not meant to be a pivotal, large-scale trial. Its purpose is to generate targeted evidence that guides final design decisions before committing to expensive later-stage trials.
How is the clinical study expected to influence the device design?
The early clinical study is intended to surface design refinements, usability issues, performance limitations, safety signals, and procedural considerations that should be addressed before moving forward. The results are meant to drive selection of the final design.
What happens after a final device design is selected based on the study findings?
The FOA notes that once a final design is selected, that final design would typically need to undergo most, if not all, of the preclinical testing again, or otherwise be supported by an appropriate preclinical package, on the path toward advanced trials and regulatory approval.
What is the overall role of this FOA in the development pathway?
It functions as a bridge between late-stage prototype development and the next phase of development. It funds the detail-oriented work needed to make early clinical evaluation possible and meaningful, with the intent of locking in the final device design prior to larger clinical trials and eventual market approval efforts.
Which NIH institute issues this opportunity?
The opportunity is issued by NIH under the National Institute of Neurological Disorders and Stroke (NINDS) as part of its extramural research programs in neurosciences and neurological disorders.
What is the CFDA number associated with this program?
The CFDA number listed is 93.853.
Is this funding opportunity still open?
No. The opportunity was posted on July 28, 2014, with an original and final closing date listed as May 7, 2017, and it is noted as archived on June 7, 2017.
Where is the official announcement posted?
The official announcement link is provided through the NIH Grants Guide. The information also mentions NIH Office of Extramural Research webmaster contacts for access or linking issues.
What makes this opportunity different from a standard NIH grant?
Two distinguishing features described are (1) the cooperative agreement (U44) structure with substantial NIH involvement and (2) the emphasis on milestones and go/no-go decision points, alongside the practical regulatory and translational work needed to initiate and complete a small early clinical study.
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Previous opportunity: NINDS CREATE Devices Translational and Early Feasibility Studies on the Path to Pre Market Approval (PMA) or Humanitarian Device Exemption (HDE) (U44)
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