Opportunity Information: Apply for PAR 11 154
Apply for PAR 11 154
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (U01)" 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 Mar 15, 2011 and posted on Mar 15, 2011.
- Applicants must submit their applications by May 7, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,600,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses State governments County governments Special district governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (U01) is a National Institutes of Health funding opportunity designed to push promising epilepsy therapies through the last major stretch of preclinical development so they are ready to enter formal clinical testing. The central focus is on developing treatments that can either cure epilepsy, prevent epilepsy from developing after a known brain insult, or improve outcomes for people whose seizures remain uncontrolled with existing options. The prevention angle is aimed at situations where the risk of epilepsy is elevated because of a clear triggering event or condition, including status epilepticus, traumatic brain injury, stroke, encephalitis, or similar injuries. In practical terms, the program is meant to bridge the gap between strong basic science findings and an actual therapeutic candidate that is mature enough to be taken to the FDA.
A key feature of this program is that it is not meant for early discovery. Projects must already have a therapeutic lead in hand, and that lead must have demonstrated activity against the intended disease target. In other words, applicants are expected to come in with something that already works at a proof-of-concept level and then use the award to optimize, validate, and complete the preclinical package required to move forward. The supported work typically includes preclinical optimization and rigorous testing of the lead, with the explicit expectation that, by the end of the project period, the team will be positioned to submit an IND (Investigational New Drug) or IDE (Investigational Device Exemption) application to the FDA. That end point is a clear signal that the FOA is targeting translation-ready projects, not exploratory research.
Because the goal is to accelerate tangible therapeutic development, the program explicitly excludes several categories of work. It does not support early stage therapeutic discovery activities such as high throughput screening, and it also excludes clinical research, basic research, and studies focused primarily on disease mechanisms. The intent is to keep the portfolio tightly centered on therapy-directed, preclinical translation activities that directly reduce the remaining barriers between a validated lead and first-in-human testing.
This is a milestone-driven cooperative agreement (U01), which means it is not a hands-off grant. NIH staff are expected to participate in shaping the project plan and to monitor progress against predefined milestones. Cooperative agreements typically involve more active programmatic involvement than standard research project grants, and here that involvement is aligned with the translational mission: keeping projects on track, ensuring that go/no-go decisions are made based on data, and emphasizing deliverables that support regulatory submission.
From an administrative standpoint, the opportunity is identified as PAR-11-154. It is a discretionary funding opportunity using the cooperative agreement instrument, and it falls under the health activity category. The program anticipated a very small number of awards (expected awards: 1), indicating a highly selective competition or a narrowly scoped budget in that cycle. The estimated total funding level listed is $3,600,000, with an award ceiling of $1,000,000, suggesting that individual awards could be substantial but capped, and that budgets would need to be aligned with the practical work required to reach IND/IDE readiness. There is no cost sharing or matching requirement.
Eligibility is broad and includes academic institutions (public and state-controlled and private institutions of higher education), nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education), small businesses, for-profit organizations other than small businesses, and a wide range of government entities (state, county, city/township, special districts, independent school districts, and public housing authorities). It also includes tribal governments and tribal organizations, and the additional eligibility language expands coverage to Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). Foreign components of U.S. organizations are also allowed, which is important for teams that may need specialized capabilities or models located outside the United States.
Key dates show that the FOA was posted and created on March 15, 2011, with an original and current closing date of May 7, 2013, and an archive date of June 7, 2013. The CFDA number associated with the program is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The sponsoring agency is the National Institutes of Health, specifically NINDS. The full announcement was hosted at the NIH grants site, and NIH provided standard technical contact points through the NIH Office of Extramural Research webmaster for access or linking problems.
Overall, this FOA is best understood as a translation accelerator for epilepsy therapeutics: it targets projects that have already crossed the discovery threshold, requires a realistic path to an IND/IDE submission by project end, uses a milestone-based structure to manage risk and progress, and concentrates funds on the preclinical development work needed to move an intervention toward clinical testing for resistant epilepsy and epileptogenesis prevention.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (U01). It is a National Institutes of Health (NIH) funding opportunity focused on advancing promising epilepsy therapies through the final major stages of preclinical development so they are ready to enter formal clinical testing.
Which NIH institute is sponsoring the program?
The sponsoring agency is the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS).
What is the FOA number for this program?
The funding opportunity is identified as PAR-11-154.
What type of award mechanism is being used?
This is a cooperative agreement using the U01 mechanism. It is milestone-driven and involves active participation by NIH staff in shaping the project plan and monitoring progress against predefined milestones.
What is the main goal of the program?
The main goal is to bridge the gap between strong basic science findings and a therapeutic candidate mature enough to move toward FDA submission and first-in-human testing. The program is designed to push an existing therapeutic lead through preclinical development to support an IND (Investigational New Drug) or IDE (Investigational Device Exemption) application.
What kinds of therapies or approaches does the program aim to develop?
The program targets treatments that can cure epilepsy, prevent epilepsy from developing after a known brain insult, or improve outcomes for people whose seizures remain uncontrolled with existing options (resistant epilepsy).
What does the program mean by "prevention" or "epileptogenesis prevention"?
The prevention focus is aimed at situations where the risk of epilepsy is elevated due to a clear triggering event or condition. Examples listed include status epilepticus, traumatic brain injury, stroke, encephalitis, or similar injuries.
Is this program intended for early-stage discovery research?
No. The program is explicitly not meant for early discovery. Applicants are expected to already have a therapeutic lead in hand, and that lead must have demonstrated activity against the intended disease target at a proof-of-concept level.
What stage should a project be in to be a fit for this FOA?
Projects should be beyond discovery and should already have a validated therapeutic lead with demonstrated activity against the target. The proposed work should focus on optimizing, validating, and completing the preclinical development package needed to move toward an IND/IDE submission.
What kinds of activities are typically supported under this program?
Supported work typically includes preclinical optimization and rigorous testing of the therapeutic lead, with the explicit expectation that the project will be positioned to submit an IND or IDE to the FDA by the end of the project period.
What is the expected endpoint or deliverable by the end of the project?
The stated endpoint is being positioned to submit an IND (for drugs/biologics) or an IDE (for devices) application to the FDA. This is a key indicator that the FOA is targeting translation-ready projects.
What types of work are explicitly excluded?
The program explicitly excludes early stage therapeutic discovery activities such as high throughput screening. It also excludes clinical research, basic research, and studies focused primarily on disease mechanisms.
Does this FOA support clinical research or clinical trials?
No. Clinical research is specifically listed among the excluded categories. The program is focused on therapy-directed preclinical translation activities to reduce remaining barriers to first-in-human testing.
Does this FOA support basic research or studies that focus mainly on mechanisms?
No. Basic research and studies focused primarily on disease mechanisms are explicitly excluded. The intent is to keep projects centered on practical, therapy-directed preclinical development.
What does "milestone-driven" mean in the context of this award?
Milestone-driven means progress is tracked against predefined milestones, and NIH staff are expected to monitor performance and help ensure that go/no-go decisions are made based on data and deliverables that support regulatory submission.
How involved is NIH staff during the project?
This is not a hands-off grant. As a cooperative agreement, NIH staff participation is expected in shaping the project plan and monitoring progress against milestones, consistent with the translational focus of the program.
How many awards were expected to be made?
The opportunity anticipated a very small number of awards, with expected awards listed as 1.
What is the estimated total funding amount for this opportunity?
The estimated total funding level listed is $3,600,000.
What is the award ceiling?
The award ceiling is $1,000,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes academic institutions (public and state-controlled and private institutions of higher education), nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education), small businesses, for-profit organizations other than small businesses, and many government entities (state, county, city/township, special districts, independent school districts, and public housing authorities). Tribal governments and tribal organizations are included, along with Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations).
Are foreign organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are included in the eligibility language.
Are foreign components of U.S. organizations allowed?
Yes. Foreign components of U.S. organizations are allowed, which can support teams that need specialized capabilities or models located outside the United States.
What is the CFDA number associated with this program?
The CFDA number is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was the FOA posted and created?
The FOA was posted and created on March 15, 2011.
What was the closing date for applications?
The original and current closing date listed is May 7, 2013.
When was the opportunity archived?
The archive date listed is June 7, 2013.
What is the overall focus area or activity category?
The opportunity falls under the health activity category and is described as a translation accelerator for epilepsy therapeutics, centered on preclinical development work that supports regulatory readiness.
Where was the full announcement hosted, and who is listed for technical website issues?
The full announcement was hosted at the NIH grants site. NIH provided standard technical contact points through the NIH Office of Extramural Research webmaster for access or linking problems.
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