Opportunity Information: Apply for PAR 13 343
Apply for PAR 13 343
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NeuroNEXT Clinical Trials (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Aug 30, 2013 and posted on Aug 30, 2013.
- Applicants must submit their applications by Dec 3, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) State governments Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities.
- 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 Organizations) and foreign components of U.S. Organizations are eligible to apply, but will have to work with the U.S. based NeuroNEXT infrastructure. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NeuroNEXT Clinical Trials (U01) opportunity (Funding Opportunity Number PAR 13-343) is a National Institutes of Health (NIH) cooperative agreement run through the National Institute of Neurological Disorders and Stroke (NINDS). It is designed to support exploratory, early-stage clinical trials that test investigational agents such as drugs, biologics, surgical approaches, or medical devices in neurological disorders. The main point is to generate the kind of practical, decision-making evidence that helps a field move forward: data that can justify and shape a later, larger definitive trial, studies aimed at validating biomarkers, or proof-of-mechanism work that shows whether an intervention is doing what it is supposed to do in humans.
A defining feature of this program is that awardees gain access to the NeuroNEXT national clinical trial infrastructure rather than having to build everything from scratch. After peer review, NINDS does not simply fund every meritorious proposal in a standard queue; instead, it prioritizes and sequences which trials will actually receive access to the NeuroNEXT system. Once a project is selected, the NeuroNEXT Clinical Coordinating Center (CCC) partners with the awardee to operationalize the study efficiently, while the NeuroNEXT Data Coordinating Center (DCC) provides statistical expertise along with data management support. In addition, the NeuroNEXT clinical sites contribute hands-on capacity for implementing the protocol, as well as recruitment and retention support, which can be one of the hardest and most expensive parts of neurological clinical research. Importantly, applicants do not need to already be part of NeuroNEXT to apply, which opens the door to investigators and sponsors who have a strong clinical trial concept but lack a ready-made multi-site network.
The trials proposed under this FOA are expected to align with the NINDS strategic plan and the institute's clinical research priorities, meaning applicants should choose diseases and research questions that map clearly to NINDS program interests (as referenced in the NINDS funding areas listing). Practically speaking, competitive applications typically frame a clear clinical question, explain why the proposed intervention is ready for an exploratory human study, and emphasize how the results will inform a concrete next step, such as powering assumptions for a phase II/III trial, advancing a biomarker toward qualification, or demonstrating target engagement or mechanistic activity in a patient population.
From an administrative standpoint, this opportunity is categorized as discretionary funding and uses the U01 cooperative agreement mechanism, which usually implies substantial NIH programmatic involvement during project conduct compared to a standard research grant. It falls under the health funding activity category and is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost sharing or matching requirement stated for applicants.
Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Domestic eligible applicants include state, county, city/township, special district governments, public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, small businesses, other for-profit organizations (not only small businesses), and nonprofit organizations with or without 501(c)(3) status. The FOA also explicitly includes a wide range of additional eligible entities 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 and Native American Pacific Islander serving institutions (AANAPISIs), faith-based or community-based organizations, and eligible federal agencies. Foreign organizations and non-U.S. entities may apply as well, including foreign components of U.S. organizations as defined in NIH policy, but they must work with the U.S.-based NeuroNEXT infrastructure, reflecting that the operational backbone for trial conduct is anchored in the United States.
Key dates indicate that the announcement was posted and created on August 30, 2013, with an original and current closing date of December 3, 2015, and an archive date of January 3, 2016, meaning this specific FOA is no longer active but remains a useful reference point for understanding how NINDS structures NeuroNEXT-enabled clinical trial funding. The full announcement was linked through the NIH Grants Guide (PAR-13-343), and general technical help contacts were directed to the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs): NeuroNEXT Clinical Trials (U01) - PAR-13-343
What is the NeuroNEXT Clinical Trials (U01) opportunity?
NeuroNEXT Clinical Trials (U01) is a National Institutes of Health (NIH) cooperative agreement funding opportunity administered through the National Institute of Neurological Disorders and Stroke (NINDS). It was designed to support exploratory, early-stage clinical trials in neurological disorders using the NeuroNEXT national clinical trial infrastructure.
What is the Funding Opportunity Number (FOA) for this program?
The Funding Opportunity Number is PAR 13-343.
What type of NIH funding mechanism is used?
This opportunity uses the U01 cooperative agreement mechanism, which generally involves substantial NIH programmatic involvement during the conduct of the project compared with a standard research grant.
What kinds of studies were intended to be supported?
The FOA was intended to support exploratory, early-stage clinical trials that generate practical, decision-making evidence. Examples described include work that can justify and shape a later, larger definitive trial, studies aimed at validating biomarkers, and proof-of-mechanism studies showing whether an intervention is doing what it is intended to do in humans.
What types of interventions could be tested under this FOA?
The FOA described investigational agents that may include drugs, biologics, surgical approaches, or medical devices for neurological disorders.
What is the main goal of the program?
The main goal is to produce evidence that helps the field decide what to do next, such as informing the design of a future larger trial, supporting biomarker validation efforts, or demonstrating target engagement or mechanistic activity in a patient population.
What is a defining feature of NeuroNEXT in this FOA?
A defining feature is access to the NeuroNEXT national clinical trial infrastructure, so awardees do not need to build a multi-site operational system from scratch.
Do applicants need to already be part of NeuroNEXT to apply?
No. The FOA states that applicants do not need to already be part of NeuroNEXT to apply.
How are projects selected to use the NeuroNEXT infrastructure?
After peer review, NINDS does not simply fund every meritorious proposal in a standard queue. Instead, NINDS prioritizes and sequences which trials will receive access to the NeuroNEXT system.
What role does the NeuroNEXT Clinical Coordinating Center (CCC) play?
Once a project is selected, the NeuroNEXT Clinical Coordinating Center (CCC) partners with the awardee to operationalize the study efficiently.
What role does the NeuroNEXT Data Coordinating Center (DCC) play?
The NeuroNEXT Data Coordinating Center (DCC) provides statistical expertise as well as data management support.
How do NeuroNEXT clinical sites support funded trials?
The NeuroNEXT clinical sites contribute hands-on capacity for implementing the protocol and provide recruitment and retention support.
Why is recruitment and retention support highlighted?
The FOA notes that recruitment and retention can be among the hardest and most expensive parts of neurological clinical research, and NeuroNEXT sites provide support in this area.
What scientific alignment is expected for applications?
Trials proposed under this FOA were expected to align with the NINDS strategic plan and NINDS clinical research priorities. Applicants were advised to select diseases and research questions that map clearly to NINDS program interests, as referenced in the NINDS funding areas listing.
What characteristics are implied for a competitive application?
The FOA indicates that competitive applications typically frame a clear clinical question, explain why the intervention is ready for an exploratory human study, and emphasize how results will inform a concrete next step (for example, powering assumptions for a phase II/III trial, advancing a biomarker toward qualification, or demonstrating target engagement or mechanistic activity).
What funding category does this opportunity fall under?
The FOA is categorized as discretionary funding and is listed under the health funding activity category.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for applicants in the information provided.
Who is eligible to apply (in general terms)?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations, including government entities, higher education institutions, for-profit organizations, and nonprofit organizations.
Which U.S. government entities are listed as eligible applicants?
The FOA lists domestic eligible applicants including state governments, county governments, city or township governments, special district governments, and public housing authorities or Indian housing authorities.
Are colleges and universities eligible?
Yes. Eligible domestic applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are K-12 school districts eligible?
Yes. Independent school districts are included among eligible domestic applicants.
Are businesses eligible to apply?
Yes. The FOA includes small businesses and other for-profit organizations (not only small businesses).
Are nonprofits eligible to apply?
Yes. Nonprofit organizations with or without 501(c)(3) status are listed as eligible.
Are minority-serving institutions and specific community-based entities included?
Yes. The FOA explicitly includes entities 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 and Native American Pacific Islander serving institutions (AANAPISIs), faith-based or community-based organizations, and eligible federal agencies.
Can foreign organizations apply?
Yes. Foreign organizations and non-U.S. entities may apply, including foreign components of U.S. organizations as defined in NIH policy.
If a foreign organization applies, must the trial be conducted within the NeuroNEXT system?
The information provided states that foreign organizations must work with the U.S.-based NeuroNEXT infrastructure, reflecting that the operational backbone for trial conduct is anchored in the United States.
When was this FOA posted and created?
The announcement was posted and created on August 30, 2013.
What was the closing date for applications?
The original and current closing date listed is December 3, 2015.
Is this FOA still active?
No. The archive date is January 3, 2016, which indicates the FOA is no longer active.
If it is archived, why might it still be useful?
The information provided notes that it remains a useful reference point for understanding how NINDS structures NeuroNEXT-enabled clinical trial funding.
Where was the full announcement linked?
The full announcement was linked through the NIH Grants Guide as PAR-13-343.
Where were applicants directed for general technical help contacts?
General technical help contacts were directed to the NIH Office of Extramural Research (OER) webmaster.
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