Opportunity Information: Apply for PAR 11 296
Apply for PAR 11 296
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Cooperative Program in Translational Research Small Business Awards (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 Apr 10, 2012 and posted on Aug 8, 2011.
- Applicants must submit their applications by Jan 7, 2013. (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 $1,000,000.00 in funding.
- 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. 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 can be no more than 49 percent participation by foreign business entities in the joint venture 3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for profit business concern that is at least 51 percent owned and controlled by another for profit business concern that is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States and 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The NINDS Cooperative Program in Translational Research Small Business Awards (U44) is a National Institutes of Health funding opportunity designed to move promising neurological therapies through the preclinical pipeline and toward readiness for human testing. The focus is strictly on therapy development for neurological disorders, with the intent of accelerating translation from earlier scientific discoveries into concrete therapeutic candidates that are mature enough to enter the regulatory pathway. This program is structured as a milestone-driven SBIR cooperative agreement, meaning the applicant and NINDS staff work closely together to shape the project plan, set measurable development milestones, and monitor progress as the work unfolds.
Only Phase II and Fast Track applications are supported under this announcement. Phase I is not available as a standalone award, but it can be included as the first stage of a Fast Track. In that Fast Track Phase I portion, the work is meant to cover early, enabling steps that set up a viable preclinical development program, rather than basic discovery. To move into Phase II (either coming from a successful prior Phase I or as part of a Fast Track submission), projects must already have therapeutic leads in hand and must have demonstrated in vivo proof of concept showing efficacy. In other words, applicants need to be beyond the idea stage and beyond initial in vitro promise; the program expects credible animal or other in vivo data supporting that the therapy can work.
Phase II funding supports the more advanced and resource-intensive stages of preclinical development, such as optimization and rigorous testing of the therapeutic leads. A key requirement is that the project must be sufficiently advanced that, by the end of the Phase II project period, the company is positioned to submit an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the FDA. This signals that the award is intended to bridge the gap between early preclinical evidence and a regulatory-ready data package. Consistent with that purpose, Phase II funds cannot be used for early-stage therapeutic discovery activities like screening, which are considered too preliminary for the goals of this program.
The scope is intentionally narrow. The FOA excludes clinical research, basic research, and studies aimed primarily at understanding disease mechanisms. It also does not support development of diagnostics, biomarkers, or rehabilitation strategies, even if those areas relate to neurological disorders, because the program is limited to therapy development activities. The overall message is that NINDS is looking for projects that are already moving along a translational track and need targeted support to complete late preclinical work and reach an IND or IDE submission point.
Eligibility is limited to United States small business concerns (SBCs) that meet standard SBIR requirements at the time of award for Phase I (if part of Fast Track) and Phase II. The business must be organized for profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the US economy. It must be in an allowable legal form (such as an LLC, corporation, partnership, or similar structure), be at least 51 percent owned and controlled by US citizens or permanent residents (with specific limits and conditions for joint ventures, including limits on foreign participation), and have no more than 500 employees including affiliates. There is no cost sharing or matching requirement listed for this opportunity.
Administratively, this opportunity (Funding Opportunity Number PAR 11-296) falls under NIH and NINDS, with the activity category in health and the CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The award ceiling is listed as $1,000,000. Key dates provided include a posted date of August 8, 2011, an original closing date of September 7, 2012, a current closing date of January 7, 2013, and an archive date of February 7, 2013. The full announcement was available through the NIH Grants Guide at the link provided in the source, and NIH Office of Extramural Research webmaster contacts were included for access or technical issues.
Frequently Asked Questions (FAQs) - NINDS Cooperative Program in Translational Research Small Business Awards (U44)
1) What is this funding opportunity and what is it trying to accomplish?
The NINDS Cooperative Program in Translational Research Small Business Awards (U44) is an NIH/NINDS funding opportunity intended to move promising neurological therapies through late-stage preclinical development and toward readiness for human testing. The goal is to accelerate translation from earlier research into a concrete therapeutic candidate that is mature enough to enter the FDA regulatory pathway.
2) What types of projects are a fit for this program?
This program is strictly focused on therapy development for neurological disorders. It supports projects that are already on a translational track and need targeted resources to complete advanced preclinical work so the company can be positioned to submit an IND (Investigational New Drug) or IDE (Investigational Device Exemption) application by the end of the Phase II period.
3) Is this an SBIR grant, and what does "cooperative agreement" mean here?
Yes. This is a milestone-driven SBIR cooperative agreement (U44). In a cooperative agreement, the applicant and NINDS staff work closely together to shape the project plan, set measurable development milestones, and monitor progress during the project.
4) Which application phases are supported under this announcement?
Only Phase II and Fast Track applications are supported. Phase I is not available as a standalone award under this announcement, but it can be included as the first stage of a Fast Track application.
5) If Phase I is only allowed through Fast Track, what should the Fast Track Phase I work cover?
The Fast Track Phase I portion is intended for early, enabling steps that set up a viable preclinical development program. It is not meant for basic discovery work.
6) What level of development is expected to apply for Phase II?
To move into Phase II (either from a prior successful Phase I or as part of a Fast Track submission), projects must already have therapeutic leads in hand and must have demonstrated in vivo proof of concept showing efficacy. The opportunity expects applicants to be beyond the idea stage and beyond initial in vitro promise, with credible animal or other in vivo data supporting that the therapy can work.
7) What activities does Phase II funding support?
Phase II funding supports advanced and resource-intensive stages of preclinical development, such as optimization and rigorous testing of therapeutic leads, with the expectation that the project will be positioned for an IND or IDE submission by the end of Phase II.
8) Are early-stage discovery activities allowed (for example, screening)?
No. Phase II funds cannot be used for early-stage therapeutic discovery activities like screening, because those activities are considered too preliminary for the goals of this program.
9) Does this program support clinical research?
No. The FOA excludes clinical research.
10) Does this program support basic research or studies of disease mechanisms?
No. The scope explicitly excludes basic research and studies aimed primarily at understanding disease mechanisms.
11) Does this program fund diagnostics, biomarkers, or rehabilitation strategies?
No. The opportunity does not support development of diagnostics, biomarkers, or rehabilitation strategies, even if they relate to neurological disorders, because the program is limited to therapy development activities.
12) What is the end goal expected by the end of the Phase II project period?
By the end of the Phase II project period, the project must be sufficiently advanced that the company is positioned to submit an IND application or an IDE application to the FDA.
13) Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs) that meet standard SBIR requirements at the time of award for Phase I (if included as part of Fast Track) and Phase II.
14) What are the key SBIR small business requirements described in the opportunity?
Based on the information provided, the business must be organized for profit, have a place of business in the United States, operate primarily in the United States or make a significant contribution to the U.S. economy, be in an allowable legal form (such as an LLC, corporation, partnership, or similar structure), be at least 51 percent owned and controlled by U.S. citizens or permanent residents (with specific limits and conditions for joint ventures, including limits on foreign participation), and have no more than 500 employees including affiliates.
15) Is cost sharing or matching required?
No cost sharing or matching requirement is listed for this opportunity.
16) What is the award ceiling listed for this opportunity?
The award ceiling is listed as $1,000,000.
17) Which NIH institute is associated with this announcement?
This opportunity is associated with NIH and the National Institute of Neurological Disorders and Stroke (NINDS).
18) What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number listed is PAR 11-296.
19) What CFDA number is associated with this program?
The CFDA number provided is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
20) What are the key dates shown for this opportunity?
The posted date is August 8, 2011. The original closing date is September 7, 2012. The current closing date is January 7, 2013. The archive date is February 7, 2013.
21) Where was the full announcement made available?
The full announcement was available through the NIH Grants Guide at the link provided in the source information.
22) Who is listed for help with access or technical issues?
NIH Office of Extramural Research webmaster contacts were included for access or technical issues.
23) Is the scope broad across health areas, or focused?
The scope is intentionally narrow and focused on therapy development for neurological disorders, with the intent of reaching regulatory readiness for an IND or IDE submission.
24) What does the program expect regarding progress tracking?
The program is milestone-driven. The applicant and NINDS staff work closely to set measurable development milestones and monitor progress as work unfolds.
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