Opportunity Information: Apply for PAR 15 277
Apply for PAR 15 277
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R44)" 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 Jun 15, 2015 and posted on Jun 15, 2015.
- Applicants must submit their applications by Apr 5, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. See full announcement for details.
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Opportunity Summary:
The NINDS Exploratory Clinical Trials for Small Business (R44) funding opportunity (PAR 15-277) is an NIH SBIR grant program designed specifically to help U.S. small business concerns move promising neurology-focused products into investigator-initiated exploratory clinical trials. The central aim is to create a clear funding pathway for small companies that are ready to test early clinical questions in humans for innovations that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS), which supports research aimed at reducing the burden of neurological disease and improving outcomes for patients with disorders of the brain, spinal cord, and peripheral nerves.
This opportunity supports a wide range of intervention and technology types, as long as they are relevant to neurological disorders and stroke and are being evaluated in an exploratory clinical trial setting. Eligible projects can involve therapeutics such as drugs and biologics, medical devices, and diagnostics, and the program also allows clinical evaluation of non-pharmacologic approaches including surgical procedures, behavioral interventions, and rehabilitation therapies. In other words, the FOA is not limited to one category of product; it is meant to accommodate different kinds of clinical-stage innovations that a small business might be developing, provided the work is grounded in an appropriate clinical trial plan and fits NINDS priorities.
A key structural feature of this FOA is that it only supports later-stage SBIR mechanisms: SBIR Phase II and SBIR Fast-Track applications. Standalone SBIR Phase I applications are not accepted under this announcement; Phase I is only permitted when it is included as the Phase I component of a Fast-Track submission. Practically, that means the program is oriented toward companies that have already completed early feasibility work or otherwise have sufficient evidence and preparation to justify moving into, or rapidly progressing toward, human testing with a defined clinical protocol and a development plan that can support Phase II-level execution.
Eligibility is limited to United States small business concerns, consistent with SBIR rules, and the funding instrument is a grant (not a contract or cooperative agreement). The opportunity falls under the health funding activity category, with CFDA listing 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost sharing or matching requirement stated for this program, which is typical for many NIH SBIR grant opportunities and can be important for small companies trying to manage cash flow while conducting regulated clinical research.
Administratively, this was a discretionary NIH funding opportunity posted on June 15, 2015, with an original and current closing date of April 5, 2018, and it was archived on May 6, 2018. While the specific announcement is no longer active, it is still useful as a reference point for understanding how NINDS structures SBIR support for exploratory clinical trials, including the expectation that applicants are positioned for Phase II or a Fast-Track trajectory and that the proposed clinical work directly advances a product with a plausible path toward future development and eventual patient impact.
The official announcement and details were hosted on the NIH grants site at http://grants.nih.gov/grants/guide/pa-files/PAR-15-277.html, and NIH provided contact support through the NIH Office of Extramural Research (OER) webmaster for access or linking issues (FBOWebmaster@OD.NIH.GOV).
FAQs: NINDS Exploratory Clinical Trials for Small Business (R44) - PAR 15-277
What is PAR 15-277 (NINDS Exploratory Clinical Trials for Small Business - R44)?
PAR 15-277 is an NIH Small Business Innovation Research (SBIR) grant funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS). It is designed to help U.S. small business concerns move promising neurology-focused products into investigator-initiated exploratory clinical trials in humans.
What is the main goal of this funding opportunity?
The central aim is to create a clear funding pathway for small companies that are ready to test early clinical questions in humans for innovations aligned with the NINDS mission: reducing the burden of neurological disease and improving outcomes for people with disorders of the brain, spinal cord, and peripheral nerves, including stroke.
Who is this program intended for?
This opportunity is oriented toward U.S. small business concerns that are prepared for later-stage SBIR work and have enough evidence and preparation to justify moving into (or rapidly progressing toward) human testing using a defined clinical protocol and a development plan suitable for Phase II-level execution.
What types of studies does this FOA support?
It supports investigator-initiated exploratory clinical trials in humans that evaluate interventions or technologies relevant to neurological disorders and stroke, as long as the work is grounded in an appropriate clinical trial plan and fits NINDS priorities.
What kinds of products or technologies are eligible for support?
The program supports a wide range of intervention and technology types, provided they are relevant to neurological disorders and stroke and are being evaluated in an exploratory clinical trial setting. Examples described include:
- Therapeutics such as drugs and biologics
- Medical devices
- Diagnostics
- Non-pharmacologic approaches such as surgical procedures
- Behavioral interventions
- Rehabilitation therapies
Is the opportunity limited to a single category of product (for example, only drugs or only devices)?
No. The FOA is described as intentionally broad and not limited to one product category. It is meant to accommodate different types of clinical-stage innovations from small businesses, as long as they align with NINDS priorities and include an appropriate exploratory clinical trial plan.
Which SBIR mechanisms are supported under this FOA?
This FOA supports later-stage SBIR mechanisms: SBIR Phase II and SBIR Fast-Track applications.
Are standalone SBIR Phase I applications allowed under PAR 15-277?
No. Standalone SBIR Phase I applications are not accepted under this announcement. Phase I is only permitted when included as the Phase I component of a Fast-Track submission.
What does the Phase II / Fast-Track focus imply about readiness expectations?
It implies the program is geared toward companies that have already completed early feasibility work or otherwise have sufficient supporting evidence and operational preparation to propose a defined clinical protocol and execute a Phase II-level clinical development plan.
Who is eligible to apply?
Eligibility is limited to United States small business concerns, consistent with SBIR rules.
What is the funding instrument used for this opportunity?
The funding instrument is a grant (not a contract or cooperative agreement).
What NIH institute sponsors this opportunity?
The opportunity is from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH).
What is the relevant CFDA number for this program?
The CFDA listing provided is 93.853, titled "Extramural Research Programs in the Neurosciences and Neurological Disorders."
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for this program.
When was this funding opportunity posted?
It was posted on June 15, 2015.
What were the closing date(s) for PAR 15-277?
The original and current closing date listed is April 5, 2018.
Is PAR 15-277 still active?
No. The announcement was archived on May 6, 2018, which indicates the specific FOA is no longer active.
If the FOA is archived, why might it still be useful?
Even though it is no longer active, it can still be useful as a reference for understanding how NINDS structures SBIR support for exploratory clinical trials, including the emphasis on Phase II or Fast-Track readiness and the expectation that proposed clinical work directly advances a product with a plausible path toward future development and eventual patient impact.
Where can I find the official FOA text and details?
The official announcement was hosted on the NIH grants site at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-277.html
Who was listed as a contact for access or linking issues?
NIH provided contact support through the NIH Office of Extramural Research (OER) webmaster for access or linking issues: FBOWebmaster@OD.NIH.GOV
What disease areas are explicitly within scope?
The scope includes neurological disorders and stroke, consistent with the NINDS mission and its focus on disorders of the brain, spinal cord, and peripheral nerves.
Does the FOA describe the supported trials as "investigator-initiated"?
Yes. The opportunity is described as supporting investigator-initiated exploratory clinical trials, meaning the proposed clinical study is initiated and designed by the applicant rather than being a pre-specified government-designed trial.
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