Opportunity Information: Apply for RFA NS 11 008
Apply for RFA NS 11 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NEXT sites) (U10)" 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 Dec 7, 2010 and posted on Dec 7, 2010.
- Applicants must submit their applications by Mar 11, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $52,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- The number of recipients for this funding is limited to 25 candidate(s).
- Eligible applicants include: Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts State governments Public and State controlled institutions of higher education City or township governments Private institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized).
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIH, through the National Institute of Neurological Disorders and Stroke (NINDS), issued this funding opportunity (RFA-NS-11-008) to build out the Clinical Site component of a national clinical research network called the Network for Excellence in Neuroscience Clinical Trials (often referred to as NEXT). The central idea is to create a dependable, ready-to-activate set of clinical research sites that can rapidly launch and run multiple exploratory neuroscience studies, using consistent standards and shared infrastructure rather than starting from scratch for each new trial. The network is meant to support well-designed clinical research across a wide range of neurological disorders and is explicitly not limited to a single disease area, so sites are expected to be flexible and able to pivot to disease-specific opportunities as they arise.
Scientifically, the program is focused on exploratory clinical trials and preparatory clinical studies that help move promising therapies toward later-stage testing. The announcement highlights examples such as Phase 2 clinical trials and clinical research intended to validate biomarkers and clinical outcome measures, including studies that are biomarker-informed. In practice, that means the network is set up to test therapies coming from academic labs, foundations, or industry, and to do the kind of groundwork that makes future definitive trials more feasible and more informative, such as confirming that a biomarker tracks disease activity or that a clinical endpoint is reliable and sensitive enough to detect change.
Operationally, this FOA is specifically for applicants that want to serve as “Clinical Sites” within the NEXT network. These sites would be the places where participants are recruited, enrolled, assessed, and followed, and where study interventions and protocol-driven evaluations are carried out under standardized procedures. A key point in the description is the promise of “robust, standardized, and accessible infrastructure,” which signals that NINDS is trying to ensure the network can implement protocols efficiently, consistently, and quickly across many locations. The network is also described as having the capacity to coordinate a cadre of specialist investigators, which implies that sites should have access to disease-relevant clinical expertise (adult and/or pediatric, depending on the site’s strengths) and the ability to integrate that expertise into multi-site trials on relatively short timelines.
The award mechanism is a cooperative agreement (U10), which generally means NIH expects substantial involvement in the conduct and oversight of the program compared with a traditional research grant. Under a cooperative agreement structure, funded sites typically collaborate closely with NIH and with the network’s leadership on common procedures, performance expectations, and network priorities. This FOA sits alongside separate companion solicitations for the Clinical Coordinating Center and the Data Coordinating Center (referenced as RFA-NS-11-009 and RFA-NS-11-010). Those companion awards would provide centralized coordination and data management, while the U10 site awards supply the on-the-ground clinical capacity to execute studies.
From a funding and scale standpoint, the opportunity anticipated up to 25 awards, with an estimated total funding level of $52.5 million. The listed award ceiling is $200,000 (as presented in the source data), and there is no cost-sharing or matching requirement. The program is categorized under health, uses the discretionary opportunity category, and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The FOA was posted December 7, 2010, with an application due date of March 11, 2011, and an archive date of April 11, 2011.
Eligibility is broad and includes many types of organizations that could realistically operate clinical research sites, including public and private institutions of higher education, state and local governments, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses), and small businesses. The listing also includes a wide range of mission-focused and historically underrepresented institution types and community-based entities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, federally recognized and other tribal governments/organizations, and U.S. territories or possessions. That breadth reflects an intent to build a geographically and institutionally diverse clinical trials network capable of reaching different patient populations and supporting both adult and pediatric neuroscience research.
Overall, this FOA is best understood as an infrastructure-and-execution award for clinical trial readiness within neuroscience. NINDS is not funding a single pre-specified disease trial through this announcement; instead, it is investing in a standing network of capable clinical sites that can repeatedly run multiple exploratory trials and biomarker/outcome validation studies as opportunities emerge, with centralized coordination provided through separate coordinating center awards.
Frequently Asked Questions (FAQs)
What is this funding opportunity (RFA-NS-11-008) trying to build?
This NIH/NINDS funding opportunity supports the Clinical Site component of a national clinical research network called the Network for Excellence in Neuroscience Clinical Trials (NEXT). The goal is to establish a dependable group of clinical research sites that can be activated quickly to launch and run multiple exploratory neuroscience studies using shared infrastructure and consistent standards.
Which NIH institute is sponsoring this opportunity?
The opportunity is issued by the National Institutes of Health (NIH) through the National Institute of Neurological Disorders and Stroke (NINDS).
What does NEXT stand for, and what is its purpose?
NEXT stands for the Network for Excellence in Neuroscience Clinical Trials. Its purpose is to create a ready-to-activate national network that can run exploratory neuroscience clinical trials and preparatory clinical studies efficiently across multiple sites without having to rebuild operational systems for each new trial.
Is this opportunity funding a single specific clinical trial?
No. This FOA is described as an infrastructure-and-execution award for clinical trial readiness. It is not tied to a single pre-specified disease trial; instead, it supports clinical sites that can conduct multiple studies over time as opportunities arise.
What types of studies is the network designed to support?
The network is focused on exploratory clinical trials and preparatory clinical studies intended to move promising therapies toward later-stage testing. Examples highlighted include Phase 2 clinical trials and clinical research to validate biomarkers and clinical outcome measures, including biomarker-informed studies.
What is meant by "exploratory clinical trials" in this context?
Within the information provided, exploratory trials include studies such as Phase 2 clinical trials and other clinical research intended to generate evidence that supports the feasibility and informativeness of later, more definitive trials.
What kinds of preparatory clinical studies are emphasized?
Preparatory studies mentioned include validation of biomarkers and clinical outcome measures, such as confirming that a biomarker tracks disease activity or that a clinical endpoint is reliable and sensitive enough to detect change.
Is the network limited to one neurological disease area?
No. The network is explicitly not limited to a single disease area. Clinical sites are expected to be flexible and able to pivot to disease-specific opportunities as they arise.
What role do funded applicants play in NEXT under this FOA?
Applicants funded under this FOA serve as "Clinical Sites" within NEXT. These are the locations where participants are recruited, enrolled, assessed, and followed, and where study interventions and protocol-driven evaluations are performed under standardized procedures.
What operational expectations are described for the clinical sites?
Clinical sites are expected to support robust, standardized, and accessible infrastructure so protocols can be implemented efficiently, consistently, and quickly across multiple locations. The network also anticipates coordination of specialist investigators, implying sites should be able to integrate disease-relevant clinical expertise into multi-site trials on relatively short timelines.
Do sites need to support adult or pediatric research?
The information indicates sites may have adult and/or pediatric strengths. The network expects access to disease-relevant clinical expertise (adult and/or pediatric, depending on the site) and the ability to incorporate that expertise into multi-site trials.
What is the award mechanism for this opportunity?
The award mechanism is a cooperative agreement (U10).
What does a cooperative agreement (U10) imply for how the program is run?
A U10 cooperative agreement generally means NIH expects substantial involvement in the conduct and oversight of the program compared with a traditional research grant. Funded sites typically collaborate closely with NIH and network leadership on common procedures, performance expectations, and network priorities.
Are there other related funding opportunities associated with NEXT?
Yes. This FOA is described as sitting alongside companion solicitations for the Clinical Coordinating Center (RFA-NS-11-009) and the Data Coordinating Center (RFA-NS-11-010). Those awards provide centralized coordination and data management, while this FOA provides the clinical site capacity to execute studies.
How many awards were anticipated, and what was the total estimated funding?
The opportunity anticipated up to 25 awards, with an estimated total funding level of $52.5 million.
What is the listed award ceiling?
The listed award ceiling is $200,000 (as presented in the source data).
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
What is the opportunity category and program area?
The program is categorized under health and uses the discretionary opportunity category.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was the FOA posted, and what were the key dates?
The FOA was posted on December 7, 2010. The application due date was March 11, 2011, and the archive date was April 11, 2011.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, state and local governments, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses), and small businesses.
Are small businesses eligible?
Yes. Small businesses are included in the eligibility listing.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are included, and small businesses are also listed separately as eligible.
Are historically underrepresented and mission-focused institution types included in eligibility?
Yes. The eligibility listing includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and a range of tribal governments and organizations.
Are tribal governments and organizations eligible?
Yes. The eligibility information includes federally recognized and other tribal governments and organizations.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligibility listing.
What is the main value of building a standing network of sites rather than starting fresh for each trial?
The described intent is to avoid rebuilding systems for each new study by using consistent standards and shared infrastructure. This is meant to enable rapid study start-up, consistent implementation across locations, and the ability to run multiple exploratory studies efficiently over time.
What kinds of therapy sources can the network evaluate?
The network is described as being set up to test therapies coming from academic labs, foundations, or industry.
In simple terms, what is NINDS investing in through this FOA?
NINDS is investing in clinical trial readiness and execution capacity: a set of capable clinical sites with standardized infrastructure that can repeatedly conduct exploratory neuroscience trials and biomarker/outcome validation studies, with coordination and data management handled through separate coordinating center awards.
Browse more opportunities from the same category: Health
Next opportunity: Data Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT DCC) (U01)
Previous opportunity: Clinical Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT CCC) (U01)
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