Opportunity Information: Apply for PAR 18 617
The NINDS Exploratory Clinical Trials for Small Business (R42) - Clinical Trial Required funding opportunity (PAR 18-617) is an NIH grant program designed specifically for small business concerns that want to run investigator-initiated exploratory clinical trials in areas aligned with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). In practical terms, this announcement gives eligible small businesses a dedicated pathway to move a promising neurological product or therapy into a human study, with NINDS serving as the intended NIH institute for submission and review under this FOA.
The scope is broad as long as the work clearly fits NINDS priorities in neurological disorders and stroke. Projects can center on therapeutic or medical products such as drugs and biologics, as well as medical devices and diagnostics. The FOA also allows evaluation of intervention approaches that are not purely pharmaceutical or device-based, including surgical methods, behavioral interventions, and rehabilitation therapies. The key requirement is that the application proposes an actual clinical trial, and the clinical trial must be exploratory in nature, meaning it is generally aimed at generating early evidence in humans about feasibility, safety, dosing, initial signals of effectiveness, or operational considerations that can justify later-stage, more definitive testing.
This opportunity uses the Small Business Technology Transfer (STTR) mechanism, which is structured around collaboration between a small business and a partner research institution. Under this specific FOA, only STTR Phase II and STTR Fast-Track applications are supported. A standalone STTR Phase I application is not accepted unless it is submitted as part of a Fast-Track package (where Phase I and Phase II are submitted together in a single application with defined milestones and transition criteria). That design signals that NINDS expects applicants to be beyond the earliest proof-of-concept stage and to be positioned to carry out a clinical trial program with a clear development plan.
Eligibility is limited to small businesses that meet the STTR requirements. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some situations, which typically means discrete elements of work can be performed abroad if they are well-justified, properly documented, and compliant with NIH policy. Applicants are expected to consult the full funding opportunity text for the exact eligibility rules and definitions that NIH applies in determining what is or is not permissible.
Administratively, this is a discretionary grant program administered by the National Institutes of Health under the health funding category, associated with CFDA number 93.853. The original closing date listed for this specific announcement was 2021-04-05, and the source data does not specify an award ceiling or the expected number of awards in the fields provided. Overall, the program is best understood as a targeted NIH/STTR Phase II or Fast-Track funding route for small businesses ready to test NINDS-relevant neurological innovations in an exploratory clinical trial setting, with clear restrictions on foreign applicants and a requirement that the project includes a clinical trial rather than preclinical development alone.Apply for PAR 18 617
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R42) - Clinical Trial Required" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2018-02-01.
- Applicants must submit their applications by 2021-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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FAQs: NINDS Exploratory Clinical Trials for Small Business (R42) - Clinical Trial Required (PAR 18-617)
What is this funding opportunity?
This is an NIH grant program from the National Institute of Neurological Disorders and Stroke (NINDS) for small business concerns that want to conduct investigator-initiated exploratory clinical trials aligned with the NINDS mission in neurological disorders and stroke. The funding opportunity is titled "NINDS Exploratory Clinical Trials for Small Business (R42) - Clinical Trial Required" and is associated with FOA number PAR 18-617.
Which NIH institute is the intended institute for submission and review?
NINDS is the intended NIH institute for submission and review under this funding opportunity, as described in the opportunity information provided.
What activity mechanism does this opportunity use?
This opportunity uses the Small Business Technology Transfer (STTR) mechanism and is specifically described as an R42 opportunity.
What kinds of projects are in scope?
The scope is broad as long as the proposed work clearly fits NINDS priorities in neurological disorders and stroke. Projects may focus on therapeutic or medical products such as drugs and biologics, medical devices, and diagnostics. The opportunity also allows evaluation of intervention approaches that are not purely pharmaceutical or device-based, including surgical methods, behavioral interventions, and rehabilitation therapies.
Is a clinical trial required?
Yes. A key requirement is that the application proposes an actual clinical trial. This opportunity is explicitly described as "Clinical Trial Required," and it does not support applications that are limited to preclinical development alone.
What does "exploratory clinical trial" mean in this program?
In this program, an exploratory clinical trial is generally aimed at generating early evidence in humans. Examples of exploratory aims include feasibility, safety, dosing, initial signals of effectiveness, and/or operational considerations that can justify later-stage, more definitive testing.
Who is eligible to apply?
Eligibility is limited to small businesses that meet the STTR requirements. The mechanism is structured around collaboration between a small business and a partner research institution.
Are non-U.S. (foreign) institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply under this opportunity.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible, based on the information provided.
Are any foreign components allowed at all?
The opportunity notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some situations. This typically means discrete elements of work can be performed abroad if well-justified, properly documented, and compliant with NIH policy. The exact boundaries depend on NIH definitions and policy requirements referenced in the full FOA and NIH Grants Policy Statement.
Which STTR phases are supported under this FOA?
Only STTR Phase II and STTR Fast-Track applications are supported under this specific FOA, as described in the provided information.
Can a standalone STTR Phase I application be submitted?
No. A standalone STTR Phase I application is not accepted unless it is submitted as part of a Fast-Track package, where Phase I and Phase II are submitted together in a single application with defined milestones and transition criteria.
What does the Fast-Track option imply for applicants?
The Fast-Track option involves submitting Phase I and Phase II together in one application and includes defined milestones and Phase I-to-Phase II transition criteria. The design suggests NINDS expects applicants to be beyond the earliest proof-of-concept stage and positioned to carry out a clinical trial program with a clear development plan.
What is the practical goal of this FOA for small businesses?
Practically, the FOA provides an STTR pathway for eligible small businesses to move a promising NINDS-relevant neurological product, therapy, or intervention into a human study, generating early human evidence needed to justify more definitive later-stage testing.
What is the CFDA number associated with this program?
The program is associated with CFDA number 93.853.
What federal agency administers this grant program?
This is an NIH discretionary grant program administered by the National Institutes of Health under the health funding category.
What is the closing date listed for this announcement?
The original closing date listed for this specific announcement is 2021-04-05.
Is there an award ceiling listed in the provided information?
No. The source data described does not specify an award ceiling in the fields provided.
Is the expected number of awards provided?
No. The source data described does not specify the expected number of awards in the fields provided.
Does this opportunity require collaboration with a research institution?
Yes. The STTR mechanism is structured around collaboration between a small business and a partner research institution, and eligibility is limited to small businesses that meet STTR requirements.
What should applicants do to confirm eligibility details and foreign component rules?
Applicants are expected to consult the full funding opportunity text for exact eligibility rules and definitions, and to refer to NIH policy (including the NIH Grants Policy Statement) for definitions and requirements related to foreign components.
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