Opportunity Information: Apply for PAR 13 022
Apply for PAR 13 022
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Cooperative Program in Translational Research (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 Feb 13, 2014 and posted on Nov 19, 2012.
- Applicants must submit their applications by Feb 13, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Public and State controlled institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities Special district governments For profit organizations other than small businesses City or township governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) State governments County governments.
- 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NINDS Cooperative Program in Translational Research (U01) is a National Institutes of Health funding opportunity designed to push promising therapy concepts for neurological disorders through the preclinical development steps needed to reach clinical testing. The emphasis is on projects that are already past the earliest discovery phase and are ready for structured, therapy-directed development work. Applicants are expected to bring forward a defined therapeutic lead (such as a small molecule, biologic, or device concept), a clear biological rationale for why the approach should work in the target neurological condition, and, when available, in vivo proof-of-concept evidence showing potential efficacy. The main purpose is to turn those leads into more clinic-ready candidates by supporting the optimization, characterization, and preclinical testing activities that reduce risk and build a credible regulatory package.
A central feature of this program is its focus on regulatory readiness within the award period. Projects must be advanced enough that, by the end of the funded work, the team can submit an appropriate FDA application tied to the therapeutic modality, such as an Investigational New Drug (IND) application for drugs, an Investigational Device Exemption (IDE) for devices requiring it, or a 510(k) or 510(k) de novo submission pathway for certain medical devices. In addition to preclinical development, the program can also support limited early clinical activities in specific circumstances: Phase 0 clinical trials for small-molecule drugs (typically very early human studies focused on pharmacokinetics or target engagement rather than therapeutic benefit), proof-of-concept clinical efforts for biologics, and proof-of-concept or pilot clinical trials for therapeutic devices. Outside of these defined exceptions, the program is not intended to fund general clinical research.
The FOA draws firm boundaries around what it will not support, which is important for applicants shaping their aims. It does not fund early-stage therapeutic discovery tasks such as broad screening campaigns or fishing expeditions to find starting hits. It also excludes basic research and studies aimed primarily at understanding disease mechanisms. Similarly, mechanistic or mechanism-of-action studies of the intended therapeutic are not the focus; the scope is restricted to the practical development activities required to advance a therapy toward the clinic. The program is also not a fit for projects centered on diagnostics, biomarker development, or rehabilitation strategies, even if those efforts relate to the same diseases, because the supported scope is explicitly therapy development.
This award uses a cooperative agreement (U01) structure rather than a standard research grant, which signals that NINDS expects to be actively involved. The program is milestone-driven: investigators work with NINDS program staff to develop a detailed project plan with clear go/no-go decision points, and progress is monitored against those milestones throughout the project. In practice, that means applicants need to propose a development path that is realistic, measurable, and aligned with regulatory expectations, because continued progress and overall project direction are tied to predefined deliverables.
Administratively, the opportunity is identified as PAR-13-022 and falls under the NIH activity category for health, linked to CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It is a discretionary funding opportunity using the cooperative agreement instrument, and it does not require cost sharing or matching. Eligibility is broad and includes many U.S. and non-U.S. entities: public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), state and local governments, school districts, housing authorities, tribal governments and tribal organizations, and a range of mission-focused institutions such as HBCUs, Hispanic-serving institutions, and Alaska Native and Native Hawaiian-serving institutions. Foreign organizations and foreign components are allowed consistent with NIH policy, making it accessible to international applicants where appropriate. The sponsoring agency is the NIH, through the National Institute of Neurological Disorders and Stroke, and the full announcement is available via the NIH Grants Guide at the link provided in the source materials.
Frequently Asked Questions (FAQs)
What is the NINDS Cooperative Program in Translational Research (U01)?
It is an NIH/NINDS funding opportunity designed to move promising therapy concepts for neurological disorders through the preclinical development work needed to reach clinical testing. It targets projects that are beyond early discovery and ready for structured, therapy-directed development.
What is the main goal of this program?
The goal is to turn a defined therapeutic lead into a more clinic-ready candidate by supporting optimization, characterization, and preclinical testing that reduces risk and supports a credible regulatory package.
What types of projects are a good fit for this opportunity?
Projects that already have a defined therapeutic lead (for example, a small molecule, biologic, or device concept), a clear biological rationale for the approach in a specific neurological condition, and (when available) in vivo proof-of-concept evidence suggesting potential efficacy.
What is meant by "past the earliest discovery phase"?
This program is intended for projects that have moved beyond open-ended discovery activities and are prepared for focused development work aimed at advancing a therapy toward clinical testing.
Do applicants need to have a specific therapeutic lead identified?
Yes. Applicants are expected to bring forward a defined therapeutic lead, such as a small molecule, biologic, or device concept.
Is a biological rationale required?
Yes. Applications are expected to include a clear biological rationale explaining why the therapeutic approach should work in the targeted neurological condition.
Is in vivo proof-of-concept data required?
When available, applicants are expected to provide in vivo proof-of-concept evidence showing potential efficacy. The opportunity description indicates this is expected when it exists, rather than framing it as universally mandatory in all cases.
What kinds of activities does the program support?
The program supports optimization, characterization, and preclinical testing activities needed to advance a therapy toward clinical testing and to reduce development risk while building a regulatory-ready package.
What does "regulatory readiness within the award period" mean?
Projects are expected to be advanced enough that, by the end of the funded work, the team can submit the appropriate FDA application tied to the modality (for example, IND for drugs, IDE for certain devices, or 510(k)/510(k) de novo for certain medical devices).
Which FDA submissions are specifically mentioned as end-of-award targets?
The opportunity explicitly references Investigational New Drug (IND) applications for drugs, Investigational Device Exemptions (IDE) for devices requiring it, and 510(k) or 510(k) de novo submission pathways for certain medical devices.
Does this FOA fund clinical research?
In general, it is not intended to fund broad or general clinical research. However, it can support limited early clinical activities in specific circumstances described in the announcement.
What early clinical activities may be supported under this program?
The opportunity states that it can support Phase 0 clinical trials for small-molecule drugs, proof-of-concept clinical efforts for biologics, and proof-of-concept or pilot clinical trials for therapeutic devices, under defined circumstances.
What is a Phase 0 clinical trial in the context of this program?
Phase 0 studies are described as very early human studies for small-molecule drugs that typically focus on pharmacokinetics or target engagement rather than therapeutic benefit.
What types of work are explicitly not supported?
The FOA draws firm boundaries and excludes early-stage therapeutic discovery (such as broad screening campaigns or open-ended searches for starting hits), basic research, studies primarily aimed at understanding disease mechanisms, and mechanistic or mechanism-of-action studies of the intended therapeutic as a primary focus.
Does the program support broad screening or hit-finding campaigns?
No. It does not fund early-stage therapeutic discovery tasks such as broad screening campaigns or "fishing expeditions" to find starting hits.
Does the program support basic research or disease mechanism studies?
No. The program excludes basic research and studies aimed primarily at understanding disease mechanisms.
Are mechanism-of-action studies within scope?
Mechanistic or mechanism-of-action studies are not the focus. The scope is restricted to practical development activities required to advance a therapy toward the clinic.
Does this program support diagnostics or biomarker development?
No. Projects centered on diagnostics or biomarker development are not a fit for this program because the supported scope is explicitly therapy development.
Does this program support rehabilitation strategies?
No. The FOA indicates it is not a fit for projects centered on rehabilitation strategies, even if those efforts relate to the same neurological diseases.
What does it mean that this is a U01 cooperative agreement rather than a standard research grant?
A cooperative agreement structure signals that NINDS expects to be actively involved. Investigators work with NINDS program staff on the project plan, milestones, and monitoring throughout the award.
How are projects managed under this program?
The program is milestone-driven. Investigators collaborate with NINDS program staff to develop a detailed project plan with clear go/no-go decision points, and progress is monitored against those milestones.
What are go/no-go milestones?
They are predefined decision points tied to measurable deliverables that determine whether the project is progressing appropriately and should continue along the planned development path.
What should applicants emphasize in their project plan?
Applicants should propose a development path that is realistic, measurable, aligned with regulatory expectations, and capable of producing the deliverables needed for regulatory submission readiness by the end of the award period.
What is the FOA identification number?
The opportunity is identified as PAR-13-022.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Which agency and institute sponsor this funding opportunity?
The sponsoring agency is the NIH, through the National Institute of Neurological Disorders and Stroke (NINDS).
Is cost sharing or matching required?
No. The opportunity states that it does not require cost sharing or matching.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), state and local governments, school districts, housing authorities, tribal governments and tribal organizations, and mission-focused institutions such as HBCUs, Hispanic-serving institutions, and Alaska Native and Native Hawaiian-serving institutions.
Are non-U.S. applicants allowed?
Yes. Foreign organizations and foreign components are allowed consistent with NIH policy, making the opportunity accessible to international applicants where appropriate.
Where can applicants find the full announcement?
The full announcement is available via the NIH Grants Guide at the link provided in the source materials.
What is the general topic area of this funding opportunity?
It is an NIH activity category for health focused on translational therapy development for neurological disorders, with emphasis on advancing candidates toward clinical testing and regulatory submission readiness.
Browse more opportunities from the same category: Health
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 13 022) also looked into and applied for these:
| Funding Opportunity |
|---|
| NINDS Exploratory/Developmental Projects in Translational Research (R21) Apply for PAR 13 023 Funding Number: PAR 13 023 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Determinants and Consequences of Personalized Health Care and Prevention (U01) Apply for RFA RM 12 024 Funding Number: RFA RM 12 024 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Trans Agency Research Consortium for Trauma Induced Coagulopathy (TACTIC) (UM1) Apply for RFA HL 13 025 Funding Number: RFA HL 13 025 Agency: National Institutes of Health Category: Health Funding Amount: $4,800,000 |
| NIDCD Research Core Centers (P30) Apply for PAR 13 024 Funding Number: PAR 13 024 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Affordable Care Act Maternal, Infant and Early Childhood Home Visiting Program Grants to Nonprofit Organizations Apply for HRSA 13 255 Funding Number: HRSA 13 255 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Centers of Excellence for Translational Research (CETR) (U19) Apply for RFA AI 12 044 Funding Number: RFA AI 12 044 Agency: National Institutes of Health Category: Health Funding Amount: $4,000,000 |
| Morris K. Udall Centers of Excellence for Parkinsons Disease Research (P50) Apply for RFA NS 13 006 Funding Number: RFA NS 13 006 Agency: National Institutes of Health Category: Health Funding Amount: $1,500,000 |
| Selected Topics in Transfusion Medicine (R21) Apply for PAR 13 025 Funding Number: PAR 13 025 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Selected Topics in Transfusion Medicine (R01) Apply for PAR 13 026 Funding Number: PAR 13 026 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Health Workforce Research Center (HWRC) Program Apply for HRSA 13 185 Funding Number: HRSA 13 185 Agency: Health Resources and Services Administration Category: Health Funding Amount: $500,000 |
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| HIV Early Intervention Services (EIS) Program Existing Geographic Service Areas (EISEGA) Apply for HRSA 13 168 Funding Number: HRSA 13 168 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
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| Medical Home Implementation for Children with Special Health Care Needs Apply for HRSA 13 216 Funding Number: HRSA 13 216 Agency: Health Resources and Services Administration Category: Health Funding Amount: $800,031 |
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| Coordinating Center for an Undiagnosed Diseases Network (UDN) (U01) Apply for RFA RM 12 020 Funding Number: RFA RM 12 020 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Evaluation of Multi omic Data in Understanding the Human Microbiomes Role in Health and Disease (U54) Apply for RFA RM 12 021 Funding Number: RFA RM 12 021 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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