Opportunity Information: Apply for PAR 12 072
Apply for PAR 12 072
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (STTR R42)" 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 Sep 18, 2014 and posted on Jan 11, 2012.
- Applicants must submit their applications by May 7, 2015. (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 $100,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NINDS Exploratory Clinical Trials for Small Business (STTR R42) opportunity (Funding Opportunity Number PAR 12 072) is a National Institutes of Health discretionary grant program designed to help small business concerns run investigator-initiated exploratory clinical trials that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). In plain terms, it is meant to support small companies that are ready to move a neuroscience-related product into clinical testing, particularly in areas tied to neurological disorders and stroke, while leveraging the STTR model that requires formal collaboration between a small business and a nonprofit research institution.
This FOA is specifically aimed at exploratory clinical trials, meaning early-stage clinical testing intended to generate initial human evidence about safety, feasibility, dosing, or early signs of activity and clinical promise. The scope is broad in the types of interventions that can be studied, as long as the work fits NINDS priorities. Supported products and approaches can include drugs and other therapeutics, biologics, medical devices, and diagnostics, and it can also extend to non-product interventions such as surgical approaches, behavioral treatments, or rehabilitation therapies. The key expectation is that the proposed trial is clinically focused and tied to an intervention intended to prevent, diagnose, treat, or improve outcomes related to neurological conditions within NINDS interests.
The mechanism is STTR R42, and the FOA restricts applicants to later-stage small business STTR pathways. Only Phase II and Fast Track applications are supported under this program. Standalone Phase I applications are not supported here; Phase I is only permitted when bundled into a Fast Track application (which typically proposes a Phase I effort followed by a Phase II effort, with clear milestones that justify the transition). As a result, the program is geared toward applicants who already have a reasonable foundation of preclinical or earlier clinical evidence and are prepared to pursue a more advanced development step, rather than those seeking very early feasibility funding alone.
Eligibility is limited to small businesses, consistent with the STTR program structure. There is no cost sharing or matching requirement stated for this opportunity, which can make budgeting and planning more straightforward for eligible companies. The listing sits within the NIH health funding area and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), signaling its fit within NIH extramural neuroscience research investments.
Timing and administrative details in the source indicate it was posted January 11, 2012, with later administrative creation metadata dated September 18, 2014. The original closing date was January 7, 2015, with a current closing date listed as May 7, 2015, and an archive date of June 6, 2015, meaning the opportunity is now archived rather than active. The award ceiling is listed as 100,000 in the provided record, though applicants would normally verify current budget rules and limits in the full FOA text because NIH small business clinical trial budgets often depend on the mechanism, the specific FOA, and justified clinical costs.
For applicants looking for the full official announcement and detailed requirements (such as clinical trial definition, allowable costs, review criteria, human subjects protections, data and safety monitoring expectations, and STTR collaboration requirements), the additional information link points to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/pa-files/PAR-12-072.html. The contact provided for access or technical issues is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV), which is intended for problems retrieving or linking to the announcement rather than scientific or programmatic questions about fit with NINDS.
Frequently Asked Questions (FAQs)
1) What is the NINDS Exploratory Clinical Trials for Small Business (STTR R42) opportunity?
It is a National Institutes of Health (NIH) discretionary grant opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) intended to help eligible small business concerns run investigator-initiated exploratory clinical trials that align with the NINDS mission. The funding opportunity is identified as PAR-12-072.
2) What is the goal of this program in plain terms?
The program is meant to support small companies that are ready to move a neuroscience-related intervention into early-stage clinical testing, particularly in areas tied to neurological disorders and stroke, while using the STTR model that requires formal collaboration between a small business and a nonprofit research institution.
3) Which NIH institute is associated with this FOA?
The opportunity is associated with the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH).
4) What is the funding mechanism used?
The mechanism is STTR R42.
5) Is this opportunity for Phase I, Phase II, or both?
This FOA supports only Phase II and Fast Track applications. Standalone Phase I applications are not supported. Phase I is only allowed when included as part of a Fast Track application that proposes Phase I followed by Phase II, with milestones that justify moving from Phase I to Phase II.
6) What does "exploratory clinical trial" mean in the context provided?
In this opportunity, exploratory clinical trials are described as early-stage clinical testing intended to generate initial human evidence such as safety, feasibility, dosing, or early signs of activity and clinical promise.
7) What kinds of interventions or products can be supported?
The scope is broad as long as the proposed work fits NINDS priorities. Examples listed include drugs and other therapeutics, biologics, medical devices, diagnostics, and also non-product interventions such as surgical approaches, behavioral treatments, or rehabilitation therapies.
8) Does the trial have to be clinically focused?
Yes. The key expectation described is that the proposed work is clinically focused and tied to an intervention intended to prevent, diagnose, treat, or improve outcomes related to neurological conditions within NINDS interests.
9) Who is eligible to apply?
Eligibility is limited to small businesses, consistent with the STTR program structure.
10) Does this program require collaboration with a nonprofit research institution?
Yes. The STTR model referenced requires formal collaboration between a small business and a nonprofit research institution.
11) Is this intended for very early feasibility work?
Not primarily. Because standalone Phase I is not supported and the FOA is focused on Phase II and Fast Track, it is geared toward applicants who already have a reasonable foundation of preclinical or earlier clinical evidence and are prepared for a more advanced development step.
12) Is there a cost sharing or matching requirement?
No cost sharing or matching requirement is stated for this opportunity in the provided information.
13) What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
14) What are the key dates and current status of the opportunity?
The record indicates it was posted on January 11, 2012. The original closing date was January 7, 2015, with a current closing date listed as May 7, 2015. The archive date is June 6, 2015. Based on these dates, the opportunity is archived rather than active.
15) What award ceiling is listed in the provided record?
The award ceiling is listed as 100,000 in the provided record. The information also notes that applicants would normally verify current budget rules and limits in the full FOA text, since NIH small business clinical trial budgets can depend on the mechanism, the FOA, and justified clinical costs.
16) Where can applicants find the full official announcement and detailed requirements?
The additional information link provided points to the NIH Grants Guide page: http://grants.nih.gov/grants/guide/pa-files/PAR-12-072.html
17) What types of detailed requirements are typically found in the full FOA (per the description provided)?
The description indicates the full FOA includes detailed requirements such as the clinical trial definition, allowable costs, review criteria, human subjects protections, data and safety monitoring expectations, and STTR collaboration requirements.
18) Who is the listed contact, and what is that contact intended for?
The contact provided is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV). The description indicates this contact is intended for access or technical issues retrieving or linking to the announcement, rather than scientific or programmatic questions about fit with NINDS.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 12 072) also looked into and applied for these:
| Funding Opportunity |
|---|
| NINDS Exploratory Clinical Trials for Small Business (SBIR R44) Apply for PAR 12 073 Funding Number: PAR 12 073 Agency: National Institutes of Health Category: Health Funding Amount: $150,000 |
| NINDS Competing Renewal Awards of STTR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (STTR R42) Apply for PAR 12 074 Funding Number: PAR 12 074 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS Competing Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (SBIR R44) Apply for PAR 12 075 Funding Number: PAR 12 075 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS Competing Renewal Awards of SBIR Phase II (Phase IIB) Grants (SBIR R44) Apply for PAR 12 077 Funding Number: PAR 12 077 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS Competing Renewal Awards of STTR Phase II (Phase IIB) Grants (STTR R42) Apply for PAR 12 076 Funding Number: PAR 12 076 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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