Opportunity Information: Apply for PAR 18 422
The NINDS Efficacy Clinical Trials (U01) funding opportunity (PAR 18 422) is a National Institutes of Health (NIH) discretionary grant program that supports investigator-initiated clinical trials designed to test the efficacy of interventions relevant to neurological disorders and stroke. The central goal is to move beyond early feasibility work and directly evaluate whether a treatment works under controlled clinical trial conditions, focusing on questions that fall within the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS). Projects proposed under this announcement must be clinical trials, meaning applicants are expected to prospectively assign human participants to one or more interventions and measure health-related outcomes to determine the intervention's efficacy.
This announcement is specifically intended for efficacy studies and is broad in the types of interventions it will consider, as long as they align with NINDS interests. Proposed trials may evaluate drugs and other therapeutics, biologics, and medical devices, and they may also examine surgical approaches, behavioral interventions, and rehabilitation therapies. In practical terms, the FOA is meant to enable well-justified, scientifically rigorous trials that can answer decisive questions about clinical benefit in neurological conditions, including the kinds of studies that could change clinical practice, support later-stage development, or clarify whether a promising approach should or should not move forward.
The funding mechanism is a U01 cooperative agreement, which typically indicates substantial scientific and/or programmatic involvement by the NIH institute staff compared with a traditional research project grant. While investigators still lead the study, a cooperative agreement usually comes with closer coordination with NINDS on elements such as trial milestones, performance expectations, and oversight structures appropriate for human subjects research. The activity category is Health, and the listed CFDA number is 93.853, which corresponds to NINDS-related NIH assistance.
Eligibility is intentionally expansive and includes a wide range of organizations that might be capable of running an efficacy clinical trial. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status) that are not institutions of higher education; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This breadth signals NINDS interest in attracting strong trial teams wherever they are based, provided they can meet U.S. federal requirements for clinical research and can credibly execute the proposed study.
From the source details provided, the opportunity was created on 2017-11-29, and the original closing date listed is 2021-05-07. No award ceiling or expected number of awards is specified in the provided data, which often means applicants should consult the full FOA text and NINDS guidance for budget expectations, allowable costs, and any typical funding ranges or constraints. Anyone considering this opportunity is also directed to review NINDS mission and research interest areas on the NINDS website (http://www.ninds.nih.gov/) to ensure the clinical question and target condition fit the institute's priorities.
In short, this FOA supports carefully designed, investigator-led efficacy clinical trials in neurology and stroke across a wide range of intervention types, using the U01 cooperative agreement mechanism, and it is open to a diverse set of eligible organizations, including academic, nonprofit, governmental, tribal, community-based, for-profit, and international applicants, as well as U.S. territories and specialized minority-serving institutions.Apply for PAR 18 422
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Efficacy Clinical Trials (U01) - Clinical Trial Required" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2017-11-29.
- Applicants must submit their applications by 2021-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NINDS Efficacy Clinical Trials (U01) - PAR 18 422
What is this funding opportunity?
This opportunity is the NINDS Efficacy Clinical Trials (U01) funding announcement (PAR 18 422), a National Institutes of Health (NIH) discretionary grant program. It supports investigator-initiated clinical trials that are designed to test the efficacy of interventions relevant to neurological disorders and stroke and that fit within the mission and research priorities of the National Institute of Neurological Disorders and Stroke (NINDS).
What is the central purpose of this FOA?
The central goal is to move beyond early feasibility work and directly evaluate whether a treatment works under controlled clinical trial conditions. In other words, the FOA is intended to support well-justified and scientifically rigorous efficacy studies that can answer decisive questions about clinical benefit in neurological conditions and stroke.
Does the proposed project have to be a clinical trial?
Yes. Projects proposed under this announcement must be clinical trials. Applicants are expected to prospectively assign human participants to one or more interventions and measure health-related outcomes to determine the intervention's efficacy.
What does "efficacy" mean in the context of this FOA?
Based on the description provided, this FOA is specifically aimed at efficacy studies that test whether an intervention works under controlled clinical trial conditions, rather than early feasibility work.
What types of interventions can be studied?
The FOA is broad in the types of interventions it will consider, as long as they align with NINDS interests. Examples listed include drugs and other therapeutics, biologics, and medical devices, as well as surgical approaches, behavioral interventions, and rehabilitation therapies.
What diseases or conditions are in scope?
The trials must be relevant to neurological disorders and stroke and must fall within the mission and research priorities of NINDS.
How do applicants determine whether their topic fits NINDS priorities?
The provided information directs prospective applicants to review the NINDS mission and research interest areas on the NINDS website (http://www.ninds.nih.gov/) to ensure the clinical question and target condition fit the institute's priorities.
What funding mechanism is used for this opportunity?
The mechanism is a U01 cooperative agreement.
What is a U01 cooperative agreement in practical terms?
A U01 cooperative agreement typically indicates substantial scientific and/or programmatic involvement by NIH institute staff compared with a traditional research project grant. Investigators still lead the study, but the arrangement usually includes closer coordination with NINDS on items such as trial milestones, performance expectations, and oversight structures appropriate for human subjects research.
Is this opportunity investigator-initiated?
Yes. It is described as supporting investigator-initiated clinical trials designed to test the efficacy of interventions relevant to neurological disorders and stroke.
What is the activity category for this opportunity?
The listed activity category is Health.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.853, which corresponds to NINDS-related NIH assistance.
Who is eligible to apply?
Eligibility is described as intentionally expansive and includes a wide range of organizations capable of running an efficacy clinical trial, including governmental, academic, nonprofit, for-profit, tribal, community-based, and international entities, as well as U.S. territories or possessions and eligible federal agencies.
Are U.S. state and local government entities eligible?
Yes. Eligible applicants include state, county, city or township, and special district governments.
Are school districts eligible to apply?
Yes. Independent school districts are listed as eligible applicants.
Are universities and colleges eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations (with or without 501(c)(3) status) that are not institutions of higher education are listed as eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also separately listed as eligible.
Are small businesses eligible to apply?
Yes. Small businesses are explicitly included as eligible applicants.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible.
Are minority-serving institutions (MSIs) included in eligibility?
Yes. The FOA highlights additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically mentioned among additional eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicant categories.
Are non-U.S. (foreign) organizations eligible?
Yes. The eligibility list includes non-U.S. entities (foreign organizations).
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included among the additional eligible applicant categories.
Is an award ceiling listed for this opportunity?
No. The provided data states that no award ceiling is specified.
Is the expected number of awards provided?
No. The provided data states that the expected number of awards is not specified.
What should applicants do if they need budget expectations or typical funding ranges?
Because the provided information notes that award ceiling and expected number of awards are not specified, applicants are advised (per the provided description) to consult the full FOA text and NINDS guidance for budget expectations, allowable costs, and any typical funding ranges or constraints.
When was this opportunity created?
The source details provided state that the opportunity was created on 2017-11-29.
What is the listed closing date?
The original closing date listed in the provided information is 2021-05-07.
What kinds of outcomes are expected to be measured?
The FOA description states that applicants are expected to measure health-related outcomes to determine the intervention's efficacy.
What kinds of study questions is this FOA meant to answer?
It is meant to enable trials that can answer decisive questions about clinical benefit in neurological conditions, including studies that could change clinical practice, support later-stage development, or clarify whether a promising approach should or should not move forward.
Does the FOA emphasize oversight and milestones?
Yes. Because the mechanism is a U01 cooperative agreement, the provided description notes closer coordination with NINDS on elements such as trial milestones, performance expectations, and oversight structures appropriate for human subjects research.
Where can applicants find more information about NINDS?
The provided information points to the NINDS website: http://www.ninds.nih.gov/
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