Opportunity Information: Apply for PAR 13 281
Apply for PAR 13 281
- 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): 93.583 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 23, 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 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 For profit organizations other than small businesses Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education County governments Native American tribal governments (Federally recognized) Small businesses Native American tribal organizations (other than Federally recognized tribal 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 State governments 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.
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Opportunity Summary:
The NINDS Exploratory Clinical Trials (R01) opportunity (Funding Opportunity Number PAR-13-281) is a National Institutes of Health (NIH) discretionary grant program designed to support investigator-initiated exploratory clinical trials that align with the mission and strategic priorities of the National Institute of Neurological Disorders and Stroke (NINDS). In practical terms, this announcement exists to give researchers a clear NIH R01 pathway for proposing and running early-stage or exploratory clinical trials in neurology and related neurological disorders, so long as the central research question fits within NINDS goals. NINDS points applicants to its website for its mission, strategic plan, and specific research interests, which serves as the primary guide for determining whether a proposed trial topic is a good fit.
The clinical trials supported under this FOA can involve a wide range of interventions and approaches, reflecting the broad scope of neurological research. Proposed studies may evaluate drugs and biologics (for example, pharmaceuticals or biologically derived therapeutics), medical devices, and also non-pharmacologic interventions such as surgical procedures, behavioral therapies, and rehabilitation approaches. The key requirement is not the type of intervention, but that the trial is exploratory and addresses a scientifically meaningful question relevant to neurological disorders and stroke, consistent with NINDS priorities. As an R01 mechanism, the intent is to fund substantial, hypothesis-driven clinical research projects, while this particular FOA emphasizes trials that are exploratory in nature rather than late-stage definitive efficacy trials.
From an administrative standpoint, the opportunity is categorized as a grant within the NIH health funding activity area. It does not require cost sharing or matching funds, which means applicants are not obligated to commit non-federal funds as a condition of award. The listing includes CFDA numbers 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), which is the primary programmatic home for NINDS research, and 93.583, which appears in the source data listing even though the FOA itself is clearly centered on NINDS clinical trials.
Eligibility is broad and includes many common applicant types across academia, government, nonprofit, and certain for-profit entities. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (with the usual NIH distinctions), for-profit organizations other than small businesses, small businesses, independent school districts, and a range of government entities such as state governments, county governments, and city or township governments, plus special district governments and public housing authorities/Indian housing authorities. The eligibility language also explicitly encompasses a wide set of mission-serving and community-based institutions and organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies.
A notable feature of this FOA is that it allows non-U.S. participation. Non-domestic (non-U.S.) entities (both foreign organizations and foreign institutions) are eligible to apply, and non-domestic components of U.S. organizations may also participate. In addition, foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed. This means international institutions can serve as applicants and/or formal components of the work, which is especially relevant for neurological trials that may require specific patient populations, multi-site recruitment, or specialized clinical expertise not limited to the United States.
In terms of timing and status, the FOA was posted on July 23, 2013, with an original and current closing date of September 7, 2016, and an archive date of October 8, 2016. That timeline indicates the announcement is no longer active for new submissions under that specific FOA number and dates, though similar NINDS clinical trial funding opportunities may exist under updated NIH announcements. The full archived announcement was made available through the NIH Grants Guide page referenced in the source data, and NIH provides standard technical contact points through the NIH Office of Extramural Research (OER) webmaster emails for applicants who have trouble accessing or linking to the announcement online.
Frequently Asked Questions (FAQs)
What is the NINDS Exploratory Clinical Trials (R01) opportunity?
This opportunity (Funding Opportunity Number PAR-13-281) is an NIH discretionary grant program from the National Institute of Neurological Disorders and Stroke (NINDS). It is designed to support investigator-initiated, exploratory clinical trials that align with the NINDS mission and strategic priorities.
What is the main purpose of this FOA?
The announcement provides an NIH R01 pathway for proposing and running early-stage or exploratory clinical trials focused on neurology and neurological disorders (including stroke), as long as the central research question fits within NINDS goals and priorities.
What kinds of clinical trials does this FOA support?
The FOA supports exploratory clinical trials. While it uses the R01 mechanism (typically substantial, hypothesis-driven projects), this specific announcement emphasizes exploratory trials rather than late-stage, definitive efficacy trials.
What types of interventions can be studied under this FOA?
The scope is broad and can include drugs and biologics (such as pharmaceuticals or biologically derived therapeutics), medical devices, and non-pharmacologic interventions. Examples of non-pharmacologic interventions mentioned include surgical procedures, behavioral therapies, and rehabilitation approaches.
Is the intervention type the main eligibility factor for the study?
No. The key requirement is not the intervention type but that the trial is exploratory and addresses a scientifically meaningful question relevant to neurological disorders and stroke, consistent with NINDS priorities.
How do applicants determine whether a proposed topic is a good fit for NINDS?
NINDS directs applicants to its website for its mission, strategic plan, and specific research interests. Those materials are described as the primary guide for determining whether a proposed trial topic aligns with NINDS goals.
What funding mechanism is used?
This is an NIH R01 funding opportunity, tailored specifically to support exploratory clinical trials within NINDS mission areas.
Is this a grant or another type of funding instrument?
It is categorized as a grant within the NIH health funding activity area.
Does this opportunity require cost sharing or matching funds?
No. The listing states that cost sharing or matching is not required, meaning applicants are not obligated to commit non-federal funds as a condition of award.
What CFDA number(s) are associated with this opportunity?
The listing includes CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders) as the primary programmatic home for NINDS research. It also lists CFDA 93.583 in the source data, even though the FOA itself is centered on NINDS clinical trials.
Who is eligible to apply?
Eligibility is broad and includes many common applicant types across academia, government, nonprofit, and for-profit entities. Examples listed include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations other than small businesses, small businesses, independent school districts, and government entities (state, county, city or township, special district governments, and public housing authorities/Indian housing authorities).
Are community-based and mission-serving institutions included in the eligibility language?
Yes. The eligibility language explicitly includes a range of institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and also faith-based or community-based organizations.
Are federal agencies eligible to apply?
Yes. The eligibility language includes eligible federal agencies.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are eligible to apply under this FOA.
Can non-U.S. components of U.S. organizations participate?
Yes. Non-domestic components of U.S. organizations may participate.
Are foreign components allowed under NIH definitions?
Yes. Foreign components (as defined by NIH in the NIH Grants Policy Statement) are allowed.
Why might international participation be especially relevant for trials in this area?
The information notes that international participation can be important for neurological trials that may require specific patient populations, multi-site recruitment, or specialized clinical expertise not limited to the United States.
When was this FOA posted?
The FOA was posted on July 23, 2013.
What were the closing date and archive date for this opportunity?
The original and current closing date listed is September 7, 2016, and the archive date is October 8, 2016.
Is PAR-13-281 still active for new submissions?
No. Based on the listed closing date (September 7, 2016) and archive date (October 8, 2016), this announcement is no longer active for new submissions under that specific FOA number and dates.
If this FOA is archived, are there potentially similar opportunities?
Yes. The information notes that while this specific FOA is no longer active, similar NINDS clinical trial funding opportunities may exist under updated NIH announcements.
Where was the full archived announcement made available?
The full archived announcement is described as being available through the NIH Grants Guide page referenced in the source data.
Who should applicants contact if they have trouble accessing or linking to the announcement online?
NIH provides standard technical contact points through the NIH Office of Extramural Research (OER) webmaster emails for applicants who have trouble accessing or linking to the announcement online.
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