Opportunity Information: Apply for PAR 10 199
Apply for PAR 10 199
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials (R01)" 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 Mar 25, 2013 and posted on May 14, 2010.
- Applicants must submit their applications by Sep 7, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments Native American tribal governments (Federally recognized) State governments County governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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.
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Opportunity Summary:
The NINDS Exploratory Clinical Trials (R01) funding opportunity (PAR-10-199) is a National Institutes of Health discretionary grant program designed to support investigator-initiated exploratory clinical trials that fit within the mission and priorities of the National Institute of Neurological Disorders and Stroke (NINDS). In practical terms, it creates a clear pathway for researchers to propose early-stage or exploratory studies in humans that test a clinical idea, generate initial evidence of feasibility, and inform whether a larger, later-phase trial is justified. The program is focused specifically on neurological disorders and stroke-related research questions aligned with NINDS goals, and applicants are expected to ensure their trial concept fits NINDS scientific interests as described in NINDS strategic materials and on the NINDS website.
This opportunity uses the NIH Research Project Grant (R01) mechanism, which is a standard NIH award structure commonly used for substantial, hypothesis-driven projects, including clinical research. Under this FOA, the R01 mechanism is applied to exploratory clinical trials, meaning the proposed work should be clinical in nature (involving human participants) and structured as a trial to evaluate an intervention, while still being exploratory rather than definitive. The interventions that may be studied are broad and include drugs, biologics, devices, and also non-pharmacologic approaches such as surgical procedures, behavioral interventions, or rehabilitation therapies. This breadth signals that NINDS is open to a wide range of therapeutic and clinical strategies, as long as the central question is relevant to neurological health and disease and the trial is designed to produce meaningful clinical research information.
Funding decisions are contingent on the availability of NIH/NINDS funds, and the FOA does not promise a set number of awards or a fixed total funding pool. Instead, how many awards are made, and how large they are, depends on the quality, scientific impact, cost, and duration of the applications received in a given cycle. This is typical of many NIH program announcements: strong applications are selected through peer review and programmatic considerations, and final award levels reflect both merit and budget realities. There is no cost-sharing or matching requirement, so applicants are not required to provide non-federal matching funds as a condition of eligibility.
Eligibility is broad and includes many types of domestic and international organizations. Eligible applicants explicitly include various levels of government (state, county, city or township, special district governments), federally recognized and other tribal governments and organizations, public housing authorities/Indian housing authorities, independent school districts, public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3) entities outside higher education), and for-profit organizations other than small businesses, as well as small businesses themselves. The FOA also notes additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and non-U.S. entities (foreign organizations). This wide eligibility range indicates NINDS is willing to consider applications from many organizational settings, provided the applicant can credibly conduct a regulated clinical trial and meet NIH expectations for human subjects protections, scientific rigor, and trial management.
Key administrative details include the posting date of May 14, 2010, with later record dates reflecting the lifecycle of the announcement (creation date March 25, 2013). The original closing date was May 7, 2013, with a current closing date listed as September 7, 2013, and an archive date of October 7, 2013, indicating the announcement is historical/archived rather than an active open solicitation today. The CFDA number associated with this program area is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), which is the federal assistance listing category tied to NINDS extramural funding. The full announcement was made available through the NIH Grants Guide, and the provided link points to the archived NIH page for PAR-10-199. For technical access issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster email.
Overall, this FOA is essentially a structured NIH/NINDS R01 pathway for exploratory clinical trials in neurology and stroke, welcoming a wide range of intervention types and applicant organizations, with awards made competitively based on scientific merit and program priorities and without a cost-sharing requirement.
FAQs: NINDS Exploratory Clinical Trials (R01) - PAR-10-199
What is the NINDS Exploratory Clinical Trials (R01) opportunity (PAR-10-199)?
PAR-10-199 is a National Institutes of Health (NIH) discretionary grant funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS). It is designed to support investigator-initiated, exploratory clinical trials in humans that align with the NINDS mission and priorities.
What is the main purpose of this funding opportunity?
The purpose is to provide a clear pathway for early-stage or exploratory clinical trials that test a clinical idea in humans, generate initial evidence of feasibility, and help determine whether a larger, later-phase trial is justified.
What grant mechanism does this program use?
This opportunity uses the NIH Research Project Grant (R01) mechanism. Under this FOA, the R01 is used specifically to support exploratory clinical trials rather than definitive, late-stage trials.
Does the proposed research need to be a clinical trial in humans?
Yes. The FOA is focused on clinical research involving human participants and is structured around a trial that evaluates an intervention, while remaining exploratory in nature.
What scientific areas does the FOA focus on?
The FOA focuses on neurological disorders and stroke-related research questions that align with NINDS goals. Applicants are expected to ensure their trial concept fits NINDS scientific interests, including those described in NINDS strategic materials and on the NINDS website.
What types of interventions are allowed under this FOA?
The intervention types are broad and can include drugs, biologics, and devices, as well as non-pharmacologic approaches such as surgical procedures, behavioral interventions, or rehabilitation therapies, as long as the central question is relevant to neurological health and disease.
Is this funding intended for exploratory or definitive trials?
This opportunity is intended for exploratory trials. The goal is to produce meaningful early clinical research information (such as feasibility or initial signals) that can inform whether a larger trial is warranted.
Does NINDS guarantee a certain number of awards or a fixed funding pool?
No. Funding decisions depend on the availability of NIH/NINDS funds, and the FOA does not promise a set number of awards or a fixed total funding amount.
What factors influence whether an application is funded?
Awards are made competitively based on peer review and programmatic considerations. Final award decisions can depend on scientific merit, potential impact, cost, duration, and overall budget realities in a given cycle.
Is cost-sharing or matching funding required?
No. There is no cost-sharing or matching requirement under this FOA.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and international organizations, including multiple levels of government, tribal governments and organizations, public housing authorities/Indian housing authorities, independent school districts, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) organizations outside higher education), and for-profit organizations (including small businesses and other for-profits).
Are international (non-U.S.) organizations eligible?
Yes. The FOA includes non-U.S. entities (foreign organizations) among eligible applicants.
Are minority-serving and community-based institutions included in eligibility?
Yes. The FOA lists additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, and regional organizations.
Are U.S. territories or possessions eligible?
Yes. The FOA includes U.S. territories or possessions among eligible applicant categories.
Can federal agencies apply?
Yes. Eligible applicant categories include eligible federal agencies.
What CFDA number is associated with this program area?
The CFDA number associated with this program area is 93.853, which corresponds to Extramural Research Programs in the Neurosciences and Neurological Disorders.
Is this funding opportunity currently open?
Based on the dates provided, this FOA appears to be historical/archived rather than currently open. It lists an original closing date of May 7, 2013, a current closing date of September 7, 2013, and an archive date of October 7, 2013.
Where was the full announcement published?
The full announcement was made available through the NIH Grants Guide, and the link provided points to the archived NIH page for PAR-10-199.
Who should be contacted for technical access issues related to the announcement page?
For technical access issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster email.
What does it mean that this is an NIH discretionary grant program?
It means the program is supported through NIH/NINDS discretionary funding, and awards are contingent on available funds and competitive review outcomes rather than being guaranteed.
What is the practical value of this FOA for researchers?
Practically, it creates an R01-based pathway for researchers to propose early-stage clinical trials in neurology and stroke, gather feasibility and early clinical evidence in humans, and build justification for a larger, later-phase study if warranted.
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