NINDS Cooperative Program in Translational Research Single Component Research Projects (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the NINDS Cooperative Program in Translational Research Single Component Research Projects (U01)?

It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) designed to advance promising neurological therapies through late-stage preclinical development so they are positioned to enter clinical testing.

What is the main goal of this program?

The central goal is translation: moving a therapy from an already-identified, credible lead into a well-supported therapeutic candidate. The program is focused on completing the targeted preclinical optimization and testing typically needed to support a regulatory submission.

What stage of research is this program meant to support?

This opportunity is meant for the last major stretch of preclinical development. It is intended for teams that already have a therapeutic lead with demonstrated activity against the intended disease target and now need development-focused work to reduce risk and strengthen the evidence package for regulatory submission.

What should be achievable by the end of the project period?

By the end of the project period, the work is expected to be advanced enough to support submission of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the FDA, indicating the project is on a clear path toward first-in-human studies.

What types of activities are within the scope of funding?

The scope is narrow and development-focused. Examples of supported activities include refining or optimizing lead candidates, generating key preclinical efficacy and safety data, improving formulation or delivery strategies, and completing other studies typically needed for an IND or IDE submission.

Does the program support lead optimization and candidate refinement?

Yes. The program explicitly supports refining or optimizing lead candidates as part of the preclinical development work needed to reach a regulatory submission-ready stage.

Does the program fund preclinical efficacy and safety studies?

Yes. Generating key preclinical efficacy and safety data is described as a type of activity the program supports to reduce risk and strengthen the evidence package for a future clinical program.

Does the program support formulation or delivery improvements?

Yes. Improving formulation or delivery strategies is included among the example development activities supported under this funding opportunity.

Is this funding opportunity intended for early-stage discovery or finding new hits?

No. The FOA states it does not support early-stage discovery work, including high-throughput screening efforts intended to find initial hits.

Does this program support basic research or studies primarily about disease mechanisms?

No. The FOA draws firm boundaries and excludes basic research and studies focused primarily on disease mechanisms. The emphasis is on advancing an already plausible and active therapy toward clinic readiness, not exploring why a disease happens or opening new biological questions.

Does this program fund clinical research?

No. Clinical research is explicitly excluded. The funding is meant for late-stage preclinical development work leading toward an IND or IDE submission, not for conducting clinical studies.

What does "U01 cooperative agreement" mean in this context?

This opportunity uses the U01 cooperative agreement mechanism, which differs from a standard research project grant because it involves substantial programmatic involvement from NINDS staff. NINDS staff participate in shaping the project plan and overseeing progress.

How involved is NINDS during the project?

NINDS involvement is described as substantial. Staff participate in shaping the project plan and actively monitor progress, reflecting a translational, go/no-go approach and an emphasis on accountability and timely advancement toward an IND or IDE.

What does "milestone-driven" mean for applicants?

Applicants are expected to propose a structured development plan with clear, measurable milestones. Progress is monitored against those milestones during the award, and NINDS staff are involved in oversight consistent with the milestone-based, development-focused nature of the program.

What is the funding opportunity number and title?

The funding opportunity number is PAR-08-233. The title is "NINDS Cooperative Program in Translational Research Single Component Research Projects (U01)."

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 93.853, labeled "Extramural Research Programs in the Neurosciences and Neurological Disorders."

Is cost sharing required?

No. The information provided indicates cost sharing is not required.

Is this opportunity currently open?

No. The dates provided indicate it is archived. It lists a posted date of December 3, 2008, a closing date of March 15, 2011, and an archive date of April 15, 2011.

Who is eligible to apply?

Eligibility is broad and includes many domestic and non-domestic organizations. Examples listed include state and local governments, public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) nonprofits), small businesses and other for-profit organizations, public housing authorities/Indian housing authorities, federally recognized tribal governments and other tribal organizations, eligible federal agencies, and foreign (non-U.S.) entities.

Are small businesses eligible?

Yes. Small businesses are explicitly included among eligible applicants, and other for-profit organizations are also listed as eligible.

Are nonprofits eligible to apply?

Yes. The eligibility list includes nonprofit organizations, including 501(c)(3) nonprofits and certain non-501(c)(3) nonprofits.

Can universities and colleges apply?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized tribal governments and other tribal organizations are included in the eligibility description, along with related categories such as Tribally Controlled Colleges and Universities (TCCUs).

Are U.S. territories or possessions included in eligible applicants?

Yes. U.S. territories or possessions are specifically referenced in the eligibility description.

Are foreign (non-U.S.) entities eligible?

Yes. The eligibility description includes foreign (non-U.S.) entities.

Is this program best suited for teams that already have a validated lead?

Yes. The program is described as being for projects that already have a therapeutic lead with demonstrated activity against the intended disease target and need focused preclinical development to reach regulatory submission readiness.

Is the program intended to bridge the gap between lab results and first-in-human studies?

Yes. It is described as a development grant intended to bridge the gap between promising laboratory results and a clinic-ready therapeutic candidate under a milestone-based plan with active NINDS engagement, culminating in readiness for an IND or IDE submission.