Opportunity Information: Apply for PAR 11 294
Apply for PAR 11 294
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Cooperative Program in Translational Research Single Component Research Projects (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 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.)
- Eligible applicants include: Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses City or township governments State governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts Nonprofits having 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 Cooperative Program in Translational Research Single Component Research Projects (U01) (Funding Opportunity Number PAR 11 294) is a National Institutes of Health cooperative agreement designed to push promising neurological therapies through the last major stretch of preclinical development so they are ready to enter clinical testing. The central focus of the announcement is translation: taking a therapy concept that already has real traction and helping it become a credible therapeutic candidate that can be advanced to the FDA. Rather than funding broad exploratory science, the program concentrates on therapy-directed work that reduces risk, strengthens the data package, and prepares a project for regulatory submission.
A key eligibility and readiness requirement is that an applicant must already have a therapeutic lead (for example, a drug candidate, biologic, or device concept positioned as a therapy) and must already have in vivo proof-of-concept evidence showing efficacy. In other words, the program is not meant to generate the first hints that something might work; it is meant to optimize and validate something that has already shown it can work in an animal model or other in vivo system. From there, the funded work is expected to cover the practical, preclinical steps needed to move the lead forward, such as lead optimization, preclinical testing, and other development activities aimed at meeting regulatory expectations and de-risking the move into humans.
The program is explicitly not intended for early discovery activities. Projects focused on therapeutic discovery screening, hit finding, or other front-end identification efforts are not supported. It also draws a bright line excluding clinical research and studies that are primarily basic science, including investigations centered on disease mechanisms. The aim is not to learn more about the biology for its own sake, but to develop a therapy candidate with a clear, testable path toward the clinic. Likewise, the scope is restricted to therapy development, meaning that work focused on diagnostics, biomarkers, or rehabilitation strategies is outside the allowable project space under this FOA, even if such work might be valuable in parallel.
A defining expectation of the award is that the project should be advanced enough that, by the end of the project period, the investigators can submit either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration. That endpoint signals the maturity level NINDS is looking for: the research plan should be built around generating the preclinical and development package needed for a real regulatory filing, not simply producing academic publications or incremental evidence. Applicants therefore need a development-oriented strategy that ties planned experiments to concrete deliverables and decision points that support an IND or IDE submission.
This FOA uses the cooperative agreement mechanism (U01), which means it is not a standard, hands-off research grant. It is milestone-driven and includes active participation by NINDS staff. In practice, that means NINDS program staff collaborate in shaping the project plan and play an ongoing role in monitoring progress against defined milestones, with an emphasis on accountability and forward motion. The cooperative structure is intended to keep projects tightly aligned with translational goals, help identify and resolve development bottlenecks, and ensure that funded work stays focused on producing a therapy candidate that is ready for the next step toward clinical testing.
Administratively, the opportunity sits in the NIH health funding category (CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders) and does not require cost sharing or matching. The eligible applicant pool is broad, spanning public and private institutions of higher education, nonprofit and for-profit organizations (including entities beyond small businesses), and multiple levels of government. Eligibility also extends to a wide range of mission-focused institutions and organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, non-U.S. (foreign) entities, U.S. territories or possessions, and other regional or tribal organizations as specified in the announcement. The FOA was posted August 8, 2011, with later dates indicating creation and closing windows that ended in early 2013, and an archived status thereafter.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the NINDS Cooperative Program in Translational Research Single Component Research Projects (U01), Funding Opportunity Number PAR 11 294. It is a National Institutes of Health (NIH) cooperative agreement intended to move promising neurological therapies through the final major stages of preclinical development so they are positioned to enter clinical testing.
What is the main purpose of the program?
The program is focused on translation: taking a therapy concept that already has strong supporting evidence and helping it become a credible therapeutic candidate that can be advanced toward the U.S. Food and Drug Administration (FDA). The work is meant to reduce development risk, strengthen the preclinical data package, and prepare the project for regulatory submission.
What kind of projects does NINDS want to fund under this FOA?
The FOA supports therapy-directed preclinical development projects that are mature enough to be optimized and validated for regulatory readiness. Supported work can include practical development steps such as lead optimization and preclinical testing aimed at meeting regulatory expectations and de-risking the transition into humans.
What readiness level is required before applying?
Applicants must already have a therapeutic lead (for example, a drug candidate, biologic, or a device concept positioned as a therapy) and must already have in vivo proof-of-concept evidence showing efficacy. The program is not intended to generate the first evidence that a concept might work.
Does the program support early discovery work, screening, or hit finding?
No. The FOA explicitly does not support early discovery activities such as screening, hit finding, or other front-end identification efforts. The emphasis is on developing and validating an existing therapeutic lead rather than discovering one.
Is clinical research allowed under this funding opportunity?
No. Clinical research is excluded. The FOA is focused on preclinical translation and development activities that prepare a therapeutic candidate for regulatory submission, not on conducting studies in humans.
Are basic science or disease mechanism studies supported?
No. Studies that are primarily basic science, including investigations centered on disease mechanisms, are outside the intended scope. The aim is not to learn biology for its own sake, but to execute therapy development work with a clear path toward the clinic.
Are diagnostics, biomarkers, or rehabilitation projects eligible?
No. The FOA restricts the scope to therapy development. Work focused on diagnostics, biomarkers, or rehabilitation strategies is outside the allowable project space under this announcement.
What is the expected endpoint by the end of the project period?
A defining expectation is that the project will be advanced enough that, by the end of the project period, investigators can submit either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the FDA.
What does it mean that this award is a U01 cooperative agreement?
A U01 is a cooperative agreement, which is not a standard hands-off research grant. It is milestone-driven and includes active participation by NINDS staff. NINDS program staff collaborate in shaping the project plan and monitor progress against defined milestones with an emphasis on accountability and forward motion.
How does the milestone-driven cooperative structure affect project management?
The project is expected to be organized around concrete deliverables and decision points tied to translational progress and IND/IDE readiness. NINDS staff involvement is intended to help keep the work aligned with translational goals, identify and resolve development bottlenecks, and maintain focus on producing a therapy candidate ready for the next step toward clinical testing.
What health and funding category is this opportunity associated with?
The opportunity sits in the NIH health funding category under CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders.
Is cost sharing or matching required?
No. The announcement indicates that cost sharing or matching is not required.
Who is eligible to apply?
The eligible applicant pool is broad and includes public and private institutions of higher education, nonprofit and for-profit organizations (including entities beyond small businesses), and multiple levels of government.
Are mission-focused and special designation institutions eligible?
Yes. Eligibility extends to a wide range of organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, and other regional or tribal organizations as specified in the announcement.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The announcement states that non-U.S. (foreign) entities are included in the eligible applicant pool.
Are U.S. territories or possessions eligible?
Yes. The FOA includes U.S. territories or possessions among eligible applicants.
When was the FOA posted and what is its current status?
The FOA was posted on August 8, 2011. The information provided indicates the opportunity had creation and closing windows that ended in early 2013, and it is archived thereafter.
What types of outcomes is this FOA aiming for (beyond publications)?
The program is designed around generating a credible preclinical and development package that supports a real regulatory filing (IND or IDE). The focus is on tangible development progress and regulatory readiness rather than primarily producing academic publications or incremental evidence.
Browse more opportunities from the same category: Health
Next opportunity: NINDS Cooperative Program in Translational Research Multi Component Research Projects (U54)
Previous opportunity: NINDS Exploratory/Developmental Projects in Translational Research (R21)
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 294) also looked into and applied for these:
| Funding Opportunity |
|---|
| NINDS Cooperative Program in Translational Research Multi Component Research Projects (U54) Apply for PAR 11 295 Funding Number: PAR 11 295 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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| Research Resource for Systematic Reviews of Complementary and Alternative Medicine Clinical Trials (R24) Apply for RFA AT 12 001 Funding Number: RFA AT 12 001 Agency: National Institutes of Health Category: Health Funding Amount: $600,000 |
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| Implementation Science Research to Support Programs under the Presidents Emergency Plan for AIDS Relief (PEPFAR) Apply for APS OAA 11 000002 Funding Number: APS OAA 11 000002 Agency: Agency for International Development Category: Health Funding Amount: $1,800,000 |
| Tracking Electronic Health Record Adoption And Capturing Related Insights in U.S. Hospitals Apply for EP NARRA AHA 11 001 Funding Number: EP NARRA AHA 11 001 Agency: Office of the National Coordinator Category: Health Funding Amount: $204,000 |
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