Opportunity Information: Apply for RFA NS 11 010
Apply for RFA NS 11 010
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT DCC) (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 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 $13,200,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,250,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities County governments For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments Independent school districts State governments Private institutions of higher education Nonprofits having 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).
- 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), released this funding opportunity to support a single Data Coordinating Center (DCC) for the Network for Excellence in Neuroscience Clinical Trials (NEXT). The overall goal of NEXT is to create a dependable, standardized national infrastructure that can quickly stand up and run multiple exploratory neuroscience clinical studies, especially those that test the most promising therapies coming from academia, foundations, or industry. Rather than focusing on one specific neurological disease, the network is designed to be flexible and responsive across many neurological disorders affecting adults and/or children, with the ability to assemble the right specialist investigators and sites when a disease-specific opportunity arises.
Within that broader network, this particular announcement is specifically for the DCC, which is the hub responsible for the data side of the enterprise. In practical terms, the DCC role is to provide the coordinating backbone that makes multi-site neuroscience trials run consistently and credibly: building and managing standardized systems for data collection, data quality control, and data management; supporting trial operations from a data perspective; and ensuring that results can be analyzed and reported in a rigorous, reproducible way. The network’s intended portfolio includes scientifically sound, potentially biomarker-informed Phase 2 trials as well as clinical research studies aimed at validating biomarkers and clinical outcome measures so that future definitive trials can be designed with better endpoints and stronger methodology. The emphasis on biomarkers and outcome validation signals that the network is meant to speed translation by improving how studies measure whether a therapy is working and by ensuring those measures hold up across sites and populations.
This opportunity uses the U01 cooperative agreement mechanism, meaning NIH expects substantial involvement during the project rather than a hands-off grant. Cooperative agreements typically come with active collaboration between the awardee and NIH program staff, which fits a network model where common standards, shared infrastructure, and cross-project coordination are essential. The FOA also makes clear that the DCC is only one component of a larger three-part structure: separate solicitations cover the Clinical Sites and the Clinical Coordinating Center, which together with the DCC form the operational network needed to design and execute studies efficiently.
Funding details indicate NIH anticipated making one award under this announcement, with an estimated total funding level of $13.2 million. The award ceiling is listed as $1,250,000, reflecting the upper limit per year or per budget period as defined in the full FOA. There is no cost sharing or matching requirement. The opportunity is categorized as discretionary funding and falls under the health activity category, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The posting date was December 7, 2010, with an original and current closing date of March 11, 2011, and an archive date of April 11, 2011, indicating it is an older, archived opportunity rather than an active competition today.
Eligibility is broad and includes many types of organizations that can credibly run a national-level data coordinating center. Eligible applicants include public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) organizations), for-profit organizations (including small businesses), state, county, city, township, and special district governments, independent school districts, public housing authorities/Indian housing authorities, and tribal governments and tribal organizations. The eligibility section also highlights a wide range of institution types often named in federal programs, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based and community-based organizations, regional organizations, and U.S. territories or possessions, as well as eligible federal agencies.
In short, this FOA was designed to stand up one central data coordinating center that would enable the NEXT network to move quickly from promising neuroscience discoveries to well-run, exploratory clinical trials and biomarker/outcome validation studies. By standardizing data systems and supporting consistent execution across multiple diseases and populations, the DCC is positioned as a key piece of infrastructure intended to reduce start-up friction, improve data quality, and accelerate decision-making about which therapies and measures are ready for larger confirmatory trials.
Frequently Asked Questions (FAQs)
What is this NIH funding opportunity for?
This opportunity from NIH (through NINDS) was released to support a single Data Coordinating Center (DCC) for the Network for Excellence in Neuroscience Clinical Trials (NEXT). The DCC is intended to serve as the central hub for the data infrastructure and data operations needed to run multi-site neuroscience clinical studies in a consistent, credible, and reproducible way.
What is NEXT?
NEXT is a national clinical trials network designed to provide a dependable, standardized infrastructure that can rapidly stand up and run multiple exploratory neuroscience clinical studies. It is meant to be flexible across many neurological disorders rather than focused on only one disease area.
Is NEXT focused on a specific neurological disease?
No. The network is designed to be responsive across many neurological disorders affecting adults and/or children. When a disease-specific opportunity arises, the network is intended to assemble the right specialist investigators and clinical sites for that particular study.
What is the main purpose of the Data Coordinating Center (DCC) in NEXT?
The DCC serves as the data-focused coordinating backbone for the network. Its role includes building and managing standardized systems for data collection, data quality control, and data management, and supporting trial operations from a data perspective so that study results can be analyzed and reported rigorously and reproducibly.
What kinds of activities would the DCC be expected to support?
Based on the description, the DCC would be expected to support multi-site trial execution by providing standardized data systems and processes, ensuring consistent data quality practices, and enabling rigorous analysis and reporting across network studies.
What types of studies are intended to be run through NEXT?
The network portfolio is intended to include scientifically sound, potentially biomarker-informed Phase 2 clinical trials, as well as clinical research studies aimed at validating biomarkers and clinical outcome measures to strengthen endpoints and methodology for future definitive trials.
Why does the opportunity emphasize biomarkers and outcome measure validation?
The emphasis signals that NEXT is meant to speed translation by improving how studies measure whether a therapy is working and by ensuring those measures are robust across sites and populations. Stronger biomarkers and outcome measures can support better-designed future trials.
What funding mechanism is used for this opportunity?
This opportunity uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply about NIH involvement?
A cooperative agreement indicates NIH expects substantial involvement during the project rather than a hands-off approach. This typically includes active collaboration between the awardee and NIH program staff, which aligns with a network model requiring common standards, shared infrastructure, and coordination across projects.
How many awards did NIH anticipate making under this announcement?
NIH anticipated making one award under this announcement.
What was the estimated total funding level for the opportunity?
The estimated total funding level was $13.2 million.
What is the award ceiling listed in the opportunity?
The award ceiling is listed as $1,250,000 (as described in the opportunity as the upper limit per year or per budget period, as defined in the full FOA).
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What type of funding category is this?
The opportunity is categorized as discretionary funding and falls under the health activity category.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.853, identified as Extramural Research Programs in the Neurosciences and Neurological Disorders.
What are the key dates for this opportunity?
The posting date was December 7, 2010. The original and current closing date was March 11, 2011. The archive date was April 11, 2011.
Is this an active funding opportunity today?
No. The dates indicate it is an older, archived opportunity (closing date March 11, 2011; archive date April 11, 2011), not an active competition today.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) organizations); for-profit organizations (including small businesses); and various government entities such as state, county, city, township, and special district governments, independent school districts, public housing authorities/Indian housing authorities, tribal governments, and tribal organizations. The eligibility description also includes U.S. territories or possessions and eligible federal agencies.
Are minority-serving institutions and community-based organizations included in the eligibility description?
Yes. The eligibility section highlights institution types commonly named in federal programs, including HBCUs, Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), as well as faith-based and community-based organizations and regional organizations.
Is the DCC the only component of NEXT?
No. The FOA describes the DCC as one part of a three-part structure. Separate solicitations cover the Clinical Sites and the Clinical Coordinating Center, which together with the DCC form the operational network.
How does the DCC fit into the overall NEXT network structure?
The DCC is positioned as the central data hub within a broader network that also includes Clinical Sites and a Clinical Coordinating Center. Together, these components are intended to enable efficient study design and execution, with standardized infrastructure and coordinated operations.
What is the overarching goal of establishing this DCC?
The goal is to reduce start-up friction, improve data quality, and accelerate decision-making by providing standardized data systems and rigorous, reproducible analysis and reporting capabilities across multiple exploratory clinical trials and biomarker/outcome validation studies.
Does the opportunity mention the intended study populations?
Yes. The network is described as covering neurological disorders affecting adults and/or children.
What is meant by a "single" DCC in this opportunity?
The announcement states it is intended to support one Data Coordinating Center, and NIH anticipated making one award, indicating a single central awardee would serve as the data hub for NEXT.
Browse more opportunities from the same category: Health
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Previous opportunity: Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NEXT sites) (U10)
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