Opportunity Information: Apply for PAR 10 143
Apply for PAR 10 143
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory/Developmental Projects in Translational Research for Resistant Epilepsy and Epileptogenesis (R21)" 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 19, 2010 and posted on Mar 19, 2010.
- 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.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Small businesses Native American tribal governments (Federally recognized) Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) County governments State governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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.
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Opportunity Summary:
The NINDS Exploratory/Developmental Projects in Translational Research for Resistant Epilepsy and Epileptogenesis (R21) funding opportunity (PAR-10-143) is designed to push promising epilepsy therapies through early, practical preclinical development steps, with a clear end goal in mind: generating the specific kinds of data and progress that would set up a follow-on project capable of completing the remaining work needed for an FDA submission. The scientific focus is tightly centered on therapy development for three related needs: curing epilepsy, preventing epilepsy from developing after a brain insult (including events such as status epilepticus, traumatic brain injury, stroke, encephalitis, and similar injuries), and improving treatment options for people with intractable (treatment-resistant) epilepsy. In other words, the FOA is about advancing candidate drugs, biologics, devices, or other interventions toward a stage where the next logical step is an IND (Investigational New Drug) or IDE (Investigational Device Exemption) package, rather than exploring broad scientific questions about epilepsy.
A defining feature of this FOA is what it will and will not support. NINDS is explicit that only aims that are required for therapy development are appropriate here. That means the work should be directly tied to the preclinical development pipeline: activities that reduce risk, establish feasibility, and build a defensible translational case for moving the therapeutic forward. At the same time, the program excludes clinical research, basic research, and studies primarily aimed at understanding disease mechanisms. So even if a project is scientifically strong, it is not a fit if the main objective is discovering new mechanisms, characterizing pathways, or conducting human studies. The intended outcome is concrete development progress that positions the project for a subsequent, more comprehensive effort aimed squarely at FDA-enabling milestones.
The mechanism is the NIH R21 Exploratory/Developmental Grant, which generally supports early-stage, high-impact development work that can establish the key proof points needed to justify a larger, later-stage project. This FOA also “runs in parallel” with a companion announcement of identical scientific scope using a different mechanism: a cooperative agreement (U01; PAR-10-144). The parallel structure signals that NINDS is supporting the same kind of translational epilepsy development across two funding approaches, with the R21 serving as one pathway and the U01 as another, depending on the maturity of the project and the level of programmatic involvement required.
From a funding and planning perspective, NINDS indicated an overall funding plan of up to $900,000 in total costs to support this FOA, which was described as sufficient for at least one new award per year over a three-year period. Award size and duration could vary because the scope of development tasks can differ widely across therapeutic modalities and maturity levels. The listed award ceiling in the opportunity information is $200,000, and the ultimate number and size of awards would depend on application quality, requested budgets, project periods, and the mix of applications received.
Eligibility is broad and includes many organization types: public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and multiple levels of government (state, county, city/township, special district), as well as independent school districts and public housing authorities/Indian housing authorities. The FOA also identifies additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, tribal governments and tribal organizations (including those not federally recognized, as specified), eligible federal agencies, faith-based or community-based organizations, U.S. territories/possessions, regional organizations, and non-U.S. entities (foreign organizations). Cost sharing or matching is not required.
Administratively, this is an NIH discretionary grant opportunity in the health area (CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders). It was posted March 19, 2010, and the original and final closing date listed is May 7, 2013, with an archive date of June 7, 2013. The sponsoring agency is the National Institutes of Health, specifically NINDS, and the full announcement was hosted through the NIH Grants Guide (with an additional information link provided in the posting).
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the NINDS Exploratory/Developmental Projects in Translational Research for Resistant Epilepsy and Epileptogenesis (R21) Funding Opportunity Announcement (FOA), PAR-10-143. It supports exploratory and developmental translational work intended to move promising epilepsy therapies through early, practical preclinical development steps.
What is the main goal of the FOA?
The goal is to generate the specific data and development progress needed to set up a follow-on project that can complete the remaining work required for an FDA submission pathway (such as an IND for a drug/biologic or an IDE for a device). The emphasis is on concrete therapy-development milestones rather than broad scientific exploration.
What scientific areas does this FOA focus on?
The FOA is tightly centered on therapy development for three related needs: (1) curing epilepsy, (2) preventing epilepsy from developing after a brain insult (including status epilepticus, traumatic brain injury, stroke, encephalitis, and similar injuries), and (3) improving treatment options for people with intractable (treatment-resistant) epilepsy.
What kinds of interventions are in scope?
Projects may involve candidate drugs, biologics, devices, or other interventions, as long as the work is aimed at advancing a therapeutic toward the next logical stage where an IND or IDE package would be pursued in a subsequent effort.
Is this FOA intended for basic research on epilepsy mechanisms?
No. NINDS is explicit that this program does not support basic research or projects primarily aimed at understanding disease mechanisms (for example, discovering new mechanisms, characterizing pathways, or answering broad biological questions) even if the science is strong.
Does this FOA support clinical research in humans?
No. The program excludes clinical research. The supported activities are focused on early, practical preclinical development steps that directly advance therapy development.
What types of aims are considered appropriate under this FOA?
Only aims required for therapy development are appropriate. The work should be directly tied to the preclinical development pipeline and should reduce risk, establish feasibility, and build a defensible translational case for moving the therapeutic forward.
What is the grant mechanism used for this opportunity?
The FOA uses the NIH R21 Exploratory/Developmental Grant mechanism, which generally supports early-stage, potentially high-impact development work used to establish key proof points needed to justify a larger, later-stage project.
Is there a companion or parallel funding opportunity?
Yes. This FOA runs in parallel with a companion announcement of identical scientific scope that uses a cooperative agreement mechanism (U01; PAR-10-144). The parallel structure reflects support for the same translational epilepsy development goals through two different funding approaches.
How much funding did NINDS plan for this FOA overall?
NINDS indicated an overall funding plan of up to $900,000 in total costs to support this FOA, described as sufficient for at least one new award per year over a three-year period.
What is the listed award ceiling?
The listed award ceiling in the opportunity information is $200,000.
Will award size and project duration be the same for all projects?
No. Award size and duration could vary because the scope of development tasks can differ widely across therapeutic modalities and maturity levels. The final number and size of awards depends on application quality, requested budgets, project periods, and the mix of applications received.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofits (including 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses); and government entities (state, county, city/township, special district), as well as independent school districts and public housing authorities/Indian housing authorities.
Are specific institution types and communities explicitly included as eligible applicants?
Yes. The FOA identifies additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, tribal governments and tribal organizations (including those not federally recognized, as specified), eligible federal agencies, faith-based or community-based organizations, U.S. territories/possessions, regional organizations, and non-U.S. entities (foreign organizations).
Are foreign organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are listed among eligible applicants.
Is cost sharing or matching required?
No. Cost sharing or matching is not required.
Which NIH institute sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS).
What is the program classification (CFDA) number for this opportunity?
The opportunity is associated with CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders.
When was this FOA posted and when did it close?
It was posted on March 19, 2010. The original and final closing date listed is May 7, 2013, and the archive date is June 7, 2013.
Where was the full announcement made available?
The full announcement was hosted through the NIH Grants Guide, and the posting referenced an additional information link.
What does “translational research” mean in the context of this FOA?
In this FOA, “translational” is used in a practical therapy-development sense: the proposed work should advance a candidate therapeutic through preclinical development steps that build toward a follow-on, FDA-focused effort (IND/IDE enabling), rather than serving primarily to expand general knowledge about epilepsy.
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