Opportunity Information: Apply for PAR 13 278
Apply for PAR 13 278
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Phase III Investigator Initiated Efficacy Clinical Trials (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.583 Refugee and Entrant AssistanceWilson/Fish Program 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jan 16, 2014 and posted on Jul 22, 2013.
- Applicants must submit their applications by Sep 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments Special district governments Public housing authorities/Indian housing authorities Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NINDS Phase III Investigator Initiated Efficacy Clinical Trials (U01) funding opportunity (PAR-13-278) was an NIH grant program designed to support large, multi-site Phase 3 clinical trials in neurology. Its core purpose was to give investigators a formal route to submit applications for randomized, controlled efficacy studies that test whether an intervention works in a rigorous, real-world clinical trial setting. Because the announcement is tied to the National Institute of Neurological Disorders and Stroke (NINDS), the proposed trials needed to fit within NINDS mission areas and research interests, meaning topics broadly related to neurological disorders, stroke, and the neurosciences as defined by NINDS priorities and scope.
This opportunity used the U01 mechanism, which is a cooperative agreement rather than a traditional research project grant. In practice, that signals a more hands-on partnership between the funded research team and the NIH/NINDS program staff compared with standard investigator-initiated awards. While the investigators still lead the scientific design and execution, cooperative agreements typically involve substantial NIH involvement in key aspects such as oversight, milestones, performance monitoring, and coordination expectations that are common for complex, multi-center Phase 3 trials. The funding activity category was listed under Health, consistent with clinical trial support.
The FOA specifically emphasized multi-site randomized controlled Phase 3 trials. That generally implies large participant enrollment, a strong emphasis on methodological rigor (randomization, blinding when feasible, predefined endpoints, data and safety monitoring), and an operational structure capable of coordinating multiple clinical sites. Phase 3 efficacy trials are usually intended to provide definitive evidence on whether an intervention provides clinical benefit and is safe enough to justify changes in medical practice, guideline updates, or regulatory discussions, depending on the intervention and context.
Eligibility under PAR-13-278 was broad and included many types of U.S. and non-U.S. organizations. Eligible applicants included public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) nonprofits), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities (state, county, city/township, special district governments, and certain housing authorities). The announcement also included eligibility for tribal governments and tribal organizations, including federally recognized tribal governments as well as other tribal entities. In addition, it explicitly allowed foreign participation: non-U.S. organizations could apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by NIH policy) were permitted, which can matter for international multi-site trials or studies requiring recruitment in specific geographic regions.
The announcement indicated that cost sharing or matching was not required, which is important for budgeting because applicants were not expected to provide a formal institutional match as a condition of eligibility. The administering agency was the National Institutes of Health, and the relevant NIH program home was NINDS. The opportunity was posted on July 22, 2013, with an original and final closing date of September 7, 2016, and it was archived on October 8, 2016, meaning it is no longer active for new submissions under that specific announcement.
For reference and full requirements, the FOA pointed applicants to the NIH grants guide page for PAR-13-278. It also provided standard NIH Office of Extramural Research (OER) webmaster contacts for technical issues accessing or linking to the announcement.
Frequently Asked Questions (FAQs)
What is the NINDS Phase III Investigator Initiated Efficacy Clinical Trials (U01) opportunity (PAR-13-278)?
PAR-13-278 was an NIH funding opportunity announcement (FOA) from the National Institute of Neurological Disorders and Stroke (NINDS) created to support large, multi-site Phase 3 clinical trials in neurology. It offered investigators a formal pathway to apply for support for randomized, controlled efficacy studies intended to test whether an intervention works under rigorous Phase 3 clinical trial conditions.
What was the main purpose of this FOA?
The core purpose was to fund definitive Phase 3 randomized controlled efficacy trials that evaluate whether an intervention provides clinical benefit and is sufficiently safe in a real-world clinical trial setting. These kinds of trials are typically designed to generate strong evidence that could inform clinical practice, guidelines, or other high-stakes decisions depending on the intervention and context.
Which NIH institute administered this opportunity?
The administering agency was the National Institutes of Health (NIH), and the relevant program home for this FOA was the National Institute of Neurological Disorders and Stroke (NINDS).
What research areas needed to fit under PAR-13-278?
Applications needed to be within NINDS mission areas and research interests. That broadly includes neurological disorders, stroke, and the neurosciences as defined by NINDS priorities and scope.
What type of clinical trial did this FOA emphasize?
The FOA specifically emphasized multi-site, randomized controlled Phase 3 trials focused on efficacy. This generally implies substantial participant enrollment, rigorous methodology (including randomization and blinding when feasible), predefined endpoints, and appropriate data and safety monitoring.
What does "Phase 3 efficacy" mean in the context of this funding opportunity?
Within this FOA, Phase 3 efficacy trials refer to large, definitive studies intended to determine whether an intervention works (efficacy) and to further evaluate safety in a way that can support high-confidence conclusions.
What funding mechanism did PAR-13-278 use?
It used the U01 mechanism, which is a cooperative agreement rather than a traditional research project grant.
How is a U01 cooperative agreement different from a traditional NIH research grant?
A U01 cooperative agreement signals a more hands-on partnership between the funded research team and NIH/NINDS program staff than is typical for standard investigator-initiated awards. Investigators still lead the scientific design and execution, but cooperative agreements commonly involve substantial NIH involvement in areas such as oversight, milestones, performance monitoring, and coordination expectations, which is often important for complex, multi-center Phase 3 trials.
Was this opportunity specifically designed for multi-site trials?
Yes. The FOA emphasized large, multi-site randomized controlled Phase 3 trials, which generally require an operational structure capable of coordinating multiple clinical sites.
What funding activity category was associated with this FOA?
The funding activity category was listed under Health, consistent with clinical trial support.
Who was eligible to apply?
Eligibility was broad and included many types of U.S. and non-U.S. organizations. Eligible applicants included public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities.
What types of U.S. government entities were eligible?
The FOA listed eligibility for governmental entities such as state, county, and city/township governments, special district governments, and certain housing authorities.
Were tribal governments and tribal organizations eligible?
Yes. The announcement included eligibility for tribal governments and tribal organizations, including federally recognized tribal governments as well as other tribal entities.
Were non-U.S. (foreign) organizations allowed to apply?
Yes. The FOA explicitly allowed foreign participation. Non-U.S. organizations could apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by NIH policy) were permitted. This can be relevant for international multi-site trials or studies that require recruitment in particular regions.
Did this FOA require cost sharing or matching funds?
No. The announcement indicated that cost sharing or matching was not required, meaning applicants were not expected to provide a formal institutional match as a condition of eligibility.
When was PAR-13-278 posted?
The opportunity was posted on July 22, 2013.
What were the closing dates for this FOA?
The FOA listed an original closing date and a final closing date of September 7, 2016.
Is PAR-13-278 still open for applications?
No. The opportunity was archived on October 8, 2016, meaning it is no longer active for new submissions under that specific announcement.
Where were applicants directed to find the full official requirements?
The FOA pointed applicants to the NIH Grants Guide page for PAR-13-278 for the complete requirements and official details.
Who was listed for technical help with accessing or linking to the announcement?
The FOA provided standard NIH Office of Extramural Research (OER) webmaster contacts for technical issues related to accessing or linking to the announcement.
Browse more opportunities from the same category: Health
Next opportunity: PIRO Trail Maintenance NOI, not a request for proposals
Previous opportunity: NIMHD Social, Behavioral, Health Services, and Policy Research on Minority Health and Health Disparities (R01)
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 13 278
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 13 278) also looked into and applied for these:
| Funding Opportunity |
|---|
| Money Follows the Person Rebalancing Demonstration Grant Tribal Initiative Apply for CMS 1LI 14 001 Funding Number: CMS 1LI 14 001 Agency: Centers for Medicare Medicaid Services Category: Health Funding Amount: $1,000,000 |
| NINDS Exploratory Clinical Trials (R01) Apply for PAR 13 281 Funding Number: PAR 13 281 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NEI Audacious Goals Initiative in Vision Research High Priority Research Area Molecular Therapies for Eye Disease (R01) Apply for PA 13 283 Funding Number: PA 13 283 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Advancing Newborn, Child and Reproductive Health (ANCRE) Apply for USAID BENIN 680 13 00000 RFA Funding Number: USAID BENIN 680 13 00000 RFA Agency: Benin USAID Cotonou Category: Health Funding Amount: $10,000,000 |
| NIMHD Basic and Applied Biomedical Research on Minority Health and Health Disparities (R01) Apply for RFA MD 13 008 Funding Number: RFA MD 13 008 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Veterans to Nurses and Physician Assistants Workforce Program Apply for HRSA 13 275 Funding Number: HRSA 13 275 Agency: Health Resources and Services Administration Category: Health Funding Amount: $370,000 |
| IHS National HIV Program Apply for HHS 2013 IHS OCPS HIV 0001 Funding Number: HHS 2013 IHS OCPS HIV 0001 Agency: Indian Health Service Category: Health Funding Amount: $90,000 |
| Limited Competition International Cooperative Biodiversity Groups (U19) Apply for RFA TW 13 001 Funding Number: RFA TW 13 001 Agency: National Institutes of Health Category: Health Funding Amount: $700,000 |
| Network and Infrastructure Support for Development of Interdisciplinary Aging Research (R24) Apply for PAR 13 287 Funding Number: PAR 13 287 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Transformative Research Awards (R01) Apply for RFA RM 13 008 Funding Number: RFA RM 13 008 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Impact of Japanese Encephalitis Vaccination in Cambodia Apply for RFA CK 14 001 Funding Number: RFA CK 14 001 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $150,000 |
| Institutional Research and Academic Career Development Awards (IRACDA) (K12) Apply for PAR 13 290 Funding Number: PAR 13 290 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Strengthening Facilities for Health (SFH) Project Apply for RFA 442 13 000005 Funding Number: RFA 442 13 000005 Agency: Cambodia USAID Phnom Penh Category: Health Funding Amount: $16,500,000 |
| PPHF 2013 OSTLTS Partnerships Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations financed in part by 2013 Prevention and Public Health Funds Apply for CDC RFA OT13 1302PPHF13 Funding Number: CDC RFA OT13 1302PPHF13 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $20,000,000 |
| FY14 Region 1 Massachusetts (Berkshire, Franklin, Hampshire, and Hampden Counties only)Announcement of Anticipated Availability of Funds for Family Planning Services Grants Apply for PA FPH 14 001 Funding Number: PA FPH 14 001 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $1,008,984 |
| FY14 Region 5 Minnesota (entire state) Announcement of Anticipated Availability of Funds for Family Planning Services Grants Apply for PA FPH 14 006 Funding Number: PA FPH 14 006 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $2,803,596 |
| FY14 Region 5 Indiana (entire state) Announcement of Anticipated Availability of Funds for Family Planning Services Grants Apply for PA FPH 14 007 Funding Number: PA FPH 14 007 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $5,079,823 |
| FY14 Region 5 Michigan (entire state)Announcement of Anticipated Availability of Funds for Family Planning Services Grants Apply for PA FPH 14 008 Funding Number: PA FPH 14 008 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $7,627,610 |
| FY14 Region VI Arkansas Announcement of Anticipated Availability of Funds for Family Planning Services Grants Apply for PA FPH 14 009 Funding Number: PA FPH 14 009 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $4,179,185 |
| Supplement Announcement to FOA number CDC RFA CD10 1011 Apply for CDC RFA CD10 10110401SUPP13 Funding Number: CDC RFA CD10 10110401SUPP13 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $40,000 |
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 13 278", 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.