Opportunity Information: Apply for PAR 11 295
Apply for PAR 11 295
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Cooperative Program in Translational Research Multi Component Research Projects (U54)" 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: Small businesses For profit organizations other than small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public housing authorities/Indian housing authorities County governments State governments Independent school districts Native American tribal governments (Federally recognized) City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NINDS Cooperative Program in Translational Research Multi Component Research Projects (U54) (Funding Opportunity Number PAR 11 295) is a National Institutes of Health cooperative agreement designed to push promising neurological therapies through the preclinical development stage and toward readiness for first-in-human testing. The central purpose of the program is to accelerate translation by supporting projects that already have a defined therapeutic lead and have demonstrated in vivo proof of concept for efficacy. In other words, applicants need to come in with more than an idea or a basic science observation; the work must be anchored in an actual candidate therapy that has shown meaningful effects in animal models or other in vivo systems relevant to the neurological disorder being targeted.
This opportunity focuses specifically on the later steps of preclinical therapy development, including optimization and rigorous testing needed to prepare a credible regulatory package. Supported activities generally include refining the lead (for example, improving potency, selectivity, delivery, stability, dosing, manufacturability, or device performance), expanding efficacy studies where appropriate, and completing the kinds of preclinical studies that regulators expect prior to clinical testing. A key expectation is that the project will be advanced enough by the end of the award period to enable submission of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the US Food and Drug Administration. That IND or IDE readiness requirement is a defining feature of the program and signals that the program is meant for teams that are already fairly far along on the translational path.
Just as important as what the program funds is what it does not fund. It does not support early stage discovery work such as therapeutic screening campaigns or fishing expeditions to identify initial hits. It also excludes clinical research, basic research, and studies focused primarily on understanding disease mechanisms. The scope is limited to therapy development, so projects centered on diagnostics, biomarker development (as a primary goal), or rehabilitation strategies are not eligible under this FOA. Biomarkers might be relevant as supportive tools in a development plan, but the announcement is clear that the core mission is to develop treatments rather than diagnostic or rehabilitative approaches.
The award mechanism is a U54 cooperative agreement, which means it is milestone-driven and involves substantial scientific and programmatic involvement from NINDS staff. Rather than a hands-off grant, this model is structured like a managed partnership: NINDS staff participate in shaping the project plan, establishing milestones, and monitoring progress over time. The milestone emphasis typically implies clear go/no-go decision points tied to development objectives such as demonstrating reproducible in vivo efficacy, defining pharmacology or device performance benchmarks, addressing safety or tolerability signals, and completing the preclinical work needed to support regulatory submission. This structure is intended to keep projects tightly focused on deliverables that move a therapy toward the clinic.
Administratively, this is a discretionary health-related funding opportunity listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It does not require cost sharing or matching. The FOA was posted August 8, 2011, created April 10, 2012, had an original closing date of September 7, 2012, and a later closing date of January 7, 2013, with an archive date of February 7, 2013. Eligibility is broad and includes many organization types, including small businesses, other for-profit organizations, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, special district governments, public housing authorities, and a range of other categories specified in the announcement. Additional eligible applicants explicitly include certain serving institutions (such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities), eligible federal agencies, faith-based or community-based organizations, US territories or possessions, and also non-US entities (foreign organizations) and regional organizations.
In practical terms, the best fit applicants are teams that already have a therapeutic candidate with demonstrated in vivo efficacy and now need structured support to do the hard, expensive translational work that bridges academic discovery and regulatory-grade development. The program is geared toward generating a therapy package mature enough that, by the end of the project, an IND or IDE submission is realistic, credible, and supported by the required preclinical evidence.
Frequently Asked Questions (FAQs)
What is the NINDS Cooperative Program in Translational Research Multi Component Research Projects (U54)?
It is a National Institutes of Health (NIH) cooperative agreement program run by the National Institute of Neurological Disorders and Stroke (NINDS) to advance promising neurological therapies through the later stages of preclinical development and toward readiness for first-in-human testing.
What is the funding opportunity number (FOA) for this program?
The Funding Opportunity Number is PAR 11 295.
What is the main purpose of this program?
The central purpose is to accelerate translation by supporting projects that already have a defined therapeutic lead and have demonstrated in vivo proof of concept for efficacy, and then helping them complete the optimization and preclinical work needed to be ready for an FDA regulatory submission.
What stage of research is this program designed to support?
This opportunity focuses on later-stage preclinical therapy development. It is intended for teams that are beyond discovery and have already shown meaningful in vivo efficacy for a defined therapeutic candidate.
What does "defined therapeutic lead" mean in the context of this FOA?
Based on the description provided, a defined therapeutic lead means the application is anchored in an actual candidate therapy (not just a concept), and that candidate has already produced in vivo proof of concept for efficacy in an animal model or other relevant in vivo system for the targeted neurological disorder.
Is in vivo proof of concept required to apply?
Yes. The program description emphasizes that applicants must already have demonstrated in vivo proof of concept for efficacy for their candidate therapy. The program is not meant for ideas or early observations that have not been validated in vivo.
What types of activities are generally supported under this program?
Supported activities generally include later steps of preclinical therapy development such as refining and optimizing the lead (for example, improving potency, selectivity, delivery, stability, dosing, manufacturability, or device performance), expanding efficacy studies where appropriate, and completing the types of preclinical studies typically expected for a credible regulatory package.
What are examples of "lead optimization" activities mentioned in the opportunity description?
Examples explicitly mentioned include improving potency, selectivity, delivery, stability, dosing, manufacturability, or device performance.
What is the expected outcome by the end of the award period?
A defining expectation is that the project will be advanced enough by the end of the award period to enable submission of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the US Food and Drug Administration (FDA).
Is IND or IDE readiness a requirement or just a preference?
The description characterizes IND or IDE readiness as a key expectation and a defining feature of the program, indicating it is central to program fit.
Does this program support projects that are still in the discovery phase (for example, screening for hits)?
No. The program does not support early-stage discovery work such as therapeutic screening campaigns or "fishing expeditions" to identify initial hits.
Does this FOA fund basic research or studies focused on disease mechanisms?
No. The description states that it excludes basic research and studies focused primarily on understanding disease mechanisms.
Does this program support clinical research?
No. The description explicitly excludes clinical research.
Are diagnostics, biomarkers, or rehabilitation strategies eligible as primary project goals?
No. The scope is limited to therapy development. Projects centered on diagnostics, biomarker development (as a primary goal), or rehabilitation strategies are described as not eligible under this FOA.
Can biomarkers be included in a project at all?
Yes, but only in a supportive role. The description notes that biomarkers might be relevant as supportive tools in a development plan, while clarifying that the core mission is to develop treatments rather than diagnostic approaches.
What does it mean that this is a U54 cooperative agreement?
A U54 cooperative agreement is a milestone-driven award mechanism that involves substantial scientific and programmatic involvement from NINDS staff. It is described as a managed partnership rather than a hands-off grant.
How involved is NINDS staff in funded projects?
NINDS staff are described as participating in shaping the project plan, establishing milestones, and monitoring progress over time.
What are "milestone-driven" expectations in this program?
The milestone emphasis implies clear go/no-go decision points tied to development objectives. Examples provided include demonstrating reproducible in vivo efficacy, defining pharmacology or device performance benchmarks, addressing safety or tolerability signals, and completing the preclinical work needed to support regulatory submission.
What types of organizations are eligible to apply?
Eligibility is described as broad and includes small businesses, other for-profit organizations, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, special district governments, public housing authorities, and other categories specified in the announcement.
Are specific types of serving institutions included as eligible applicants?
Yes. The description explicitly includes serving institutions such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.
Are federal agencies eligible to apply?
Yes. The description states that eligible applicants explicitly include eligible federal agencies.
Are faith-based or community-based organizations eligible?
Yes. The description includes faith-based or community-based organizations among eligible applicants.
Are US territories or possessions eligible?
Yes. The description includes US territories or possessions among eligible applicants.
Are foreign organizations eligible to apply?
Yes. The description states that non-US entities (foreign organizations) and regional organizations are eligible.
Is cost sharing or matching required?
No. The opportunity is described as not requiring cost sharing or matching.
What is the CFDA number for this funding opportunity?
It is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was this FOA posted and what are the key dates provided?
The FOA was posted August 8, 2011, created April 10, 2012, had an original closing date of September 7, 2012, a later closing date of January 7, 2013, and an archive date of February 7, 2013.
What kinds of projects are considered the best fit for this program?
The best fit projects are those with a therapeutic candidate that has demonstrated in vivo efficacy and that need structured support to complete the expensive and rigorous translational work required to bridge from academic discovery to regulatory-grade development, with a realistic path to IND or IDE submission by the end of the award.
Is this program intended for teams that only have an idea or early laboratory observation?
No. The description emphasizes that applicants need to come in with more than an idea or a basic science observation; the work must be based on an actual candidate therapy with in vivo proof of concept.
Does this FOA focus on developing treatments rather than tools to understand disease?
Yes. The program is described as focused on therapy development and explicitly excludes projects that are primarily basic research or disease mechanism studies.
Browse more opportunities from the same category: Health
Next opportunity: VA Grant Per Diem Program Special Need Renewals
Previous opportunity: NINDS Cooperative Program in Translational Research Single Component Research Projects (U01)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 11 295
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 295) also looked into and applied for these:
| Funding Opportunity |
|---|
| NINDS Cooperative Program in Translational Research Small Business Awards (U44) Apply for PAR 11 296 Funding Number: PAR 11 296 Agency: National Institutes of Health Category: Health Funding Amount: $1,000,000 |
| 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 |
| RG 08092011 Demo1 Title Apply for RG 0892011 S2S D1 Funding Number: RG 0892011 S2S D1 Agency: IVV Test Agency Category: Health Funding Amount: Case Dependent |
| Molecular and Cellular Substrates of Complex Brain Disorders (R01) Apply for PAR 11 299 Funding Number: PAR 11 299 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Molecular and Cellular Substrates of Complex Brain Disorders (R21) Apply for PAR 11 300 Funding Number: PAR 11 300 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Mentored Career Award for Faculty at Institutions That Promote Diversity (K01) Apply for RFA HL 12 029 Funding Number: RFA HL 12 029 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| International Centers of Excellence for Malaria Research (ICEMR) Competitive Revision (U19) Apply for RFA AI 11 046 Funding Number: RFA AI 11 046 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| 2012 NIH Directors New Innovator Award Program (DP2) Apply for RFA RM 11 005 Funding Number: RFA RM 11 005 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
| Dimensional Approaches to Research Classification in Psychiatric Disorders (R01) Apply for RFA MH 12 100 Funding Number: RFA MH 12 100 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Emerging Infections Program Apply for CDC RFA CK12 1202 Funding Number: CDC RFA CK12 1202 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $5,000,000 |
| Discovery of Genetic Basis of Mendelian or Monogenic Heart, Lung, and Blood Disorders (X01) Apply for PAR 11 307 Funding Number: PAR 11 307 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Native American Research Centers for Health (NARCH) V and VI Competitive Supplements Apply for HHS 2011 IHS NARCH 0001 Funding Number: HHS 2011 IHS NARCH 0001 Agency: Indian Health Service Category: Health Funding Amount: $700,000 |
| Secondary Analysis of Existing Alcohol Epidemiology Data (R01) Apply for PA 11 308 Funding Number: PA 11 308 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Secondary Analysis of Existing Alcohol Epidemiology Data (R03) Apply for PA 11 309 Funding Number: PA 11 309 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Tribal Self Governance Program, Planning Cooperative Agreement Apply for HHS 2011 IHS TSGP 0001 Funding Number: HHS 2011 IHS TSGP 0001 Agency: Indian Health Service Category: Health Funding Amount: $75,000 |
| Tribal Self Governance Program Negotiation Cooperative Agreement Apply for HHS 2011 IHS TSGN 0001 Funding Number: HHS 2011 IHS TSGN 0001 Agency: Indian Health Service Category: Health Funding Amount: $30,000 |
| Tribal Management Grant Program Apply for HHS 2012 IHS TMD 0001 Funding Number: HHS 2012 IHS TMD 0001 Agency: Indian Health Service Category: Health Funding Amount: $100,000 |
| 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 |
| Short Term Research Education Program to Increase Diversity in Health Related Research (R25) Apply for RFA HL 12 031 Funding Number: RFA HL 12 031 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 11 295", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.