Opportunity Information: Apply for RFA NS 13 011

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Stroke Trials Network Regional Coordinating Stroke Centers (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 Feb 21, 2013 and posted on Feb 21, 2013.
  • Applicants must submit their applications by May 15, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $8,750,000.00 to eligible and selected applicants.
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments County governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:

The NINDS Stroke Trials Network Regional Coordinating Stroke Centers (U10) funding opportunity (RFA-NS-13-011) is a National Institutes of Health cooperative agreement designed to build a coordinated, high-performing infrastructure for running multi-site stroke clinical trials. The core idea is to make stroke research faster, more consistent, and more efficient across many hospitals and research institutions by linking regional coordinating centers into a single national network. This network is meant to support a balanced slate of studies across the full stroke continuum: prevention (reducing stroke risk and recurrence), acute treatment (interventions delivered around the time of stroke), and recovery (rehabilitation and longer-term functional improvement).

Under this program, awardees serve as Regional Coordinating Stroke Centers within the larger NINDS Stroke Trials Network. These regional centers are expected to help develop, promote, and execute high-quality clinical trials that involve multiple sites, with an emphasis on rigorous operations, strong recruitment and retention practices, and consistent trial conduct across locations. The network is structured so that major trial coordination functions are centralized through separate National Clinical Coordinating and Data Management Centers, which handle key cross-network responsibilities for trial implementation and data. In practical terms, the regional centers plug into a broader system that is meant to reduce duplication, standardize procedures, and allow trials to ramp up more quickly.

The opportunity explicitly spans exploratory early-stage clinical trials (phase 1 and phase 2) as well as larger confirmatory phase 3 trials. It also includes biomarker validation studies, but specifically those that are immediately preparatory to clinical trials, meaning biomarker work that directly enables or strengthens near-term interventional studies rather than purely exploratory discovery. The overall goal is a streamlined pipeline where promising ideas can move more efficiently from early testing to definitive evaluation, using shared processes and coordinated oversight.

A major feature of the network model is operational efficiency. The announcement highlights the use of master trial agreements and a central institutional review board (IRB) as mechanisms to reduce administrative delays that typically slow down multi-site studies. Master agreements can simplify contracting across many institutions, while a central IRB can reduce redundant ethics review and enable faster site activation, without compromising participant protections. Together, these elements reflect a broader intent to modernize stroke trial execution so that high-priority studies can start sooner, enroll faster, and produce results with fewer procedural bottlenecks.

Another key expectation is that the scientists at these centers, including both clinical and basic researchers, will actively contribute to the intellectual engine of the network. This includes helping to develop clinical trial concepts and applications that can be submitted for peer review, as well as participating in planning and execution for stroke clinical trials funded by NINDS that originate outside the network. The network is also positioned to support trials that emerge from Collaborative Research and Development Agreements (CRADAs) between NINDS and industry partners, which signals an interest in facilitating well-governed public-private collaborations when they align with NINDS priorities.

The program also emphasizes readiness and interoperability with other research systems. The network is described as being uniquely poised to rapidly collaborate with other established networks, such as the NINDS Neurological Emergencies Treatment Trials Network (NETT), and with international consortia. This matters because stroke trials often require large sample sizes and broad geographic coverage to answer questions definitively, especially for acute treatment studies or when evaluating modest but clinically important effects. The ability to quickly align protocols and operations across networks is intended to make larger, more definitive trials feasible in a shorter timeframe.

Administratively, this opportunity is a discretionary NIH cooperative agreement (U10), meaning NIH is expected to have substantial involvement in the project’s conduct compared with a standard research project grant. The activity falls under the health category, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The opportunity did not require cost sharing or matching. The total estimated funding amount listed for the announcement was $8,750,000.

Eligibility was broad across U.S.-based organizational types, spanning public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including those other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special district, and independent school districts), as well as tribal governments and tribal organizations. The eligibility text also explicitly includes various mission-focused institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, along with eligible federal agencies and U.S. territories or possessions. Foreign institutions were not eligible, and foreign components of U.S. organizations were not allowed under NIH policy as described in the notice.

Key dates show the announcement was posted on February 21, 2013, with an original and current closing date of May 15, 2013, and an archive date of June 15, 2013. The sponsoring agency is the National Institutes of Health, and the announcement points applicants to the full funding opportunity text at the NIH grants site for detailed requirements, expectations, and application instructions. Contact support for access or linking issues is routed through the NIH Office of Extramural Research (OER) webmaster.

Frequently Asked Questions (FAQs)

What is the NINDS Stroke Trials Network Regional Coordinating Stroke Centers (U10) opportunity?

This is a National Institutes of Health (NIH) cooperative agreement (U10) funding opportunity (RFA-NS-13-011) intended to build a coordinated, high-performing infrastructure for multi-site stroke clinical trials by establishing Regional Coordinating Stroke Centers that operate as part of the larger NINDS Stroke Trials Network.

What is the main goal of this funding opportunity?

The goal is to make stroke research faster, more consistent, and more efficient across many hospitals and research institutions by linking regional coordinating centers into a single national network with shared processes and coordinated oversight.

What kinds of stroke studies does the network aim to support?

The network is meant to support a balanced slate of studies across the full stroke continuum, including prevention (reducing risk and recurrence), acute treatment (interventions around the time of stroke), and recovery (rehabilitation and longer-term functional improvement).

What role do awardees play under this program?

Awardees serve as Regional Coordinating Stroke Centers within the NINDS Stroke Trials Network and are expected to help develop, promote, and execute high-quality multi-site clinical trials with rigorous operations, strong recruitment and retention practices, and consistent trial conduct across locations.

How is the overall network organized?

Major trial coordination functions are centralized through separate National Clinical Coordinating and Data Management Centers, which handle key cross-network responsibilities for trial implementation and data. Regional Coordinating Stroke Centers connect into this broader system to reduce duplication and standardize procedures.

What trial phases are included in the scope of this opportunity?

The opportunity explicitly spans exploratory early-stage clinical trials (phase 1 and phase 2) as well as larger confirmatory phase 3 trials.

Are biomarker studies included?

Yes. The opportunity includes biomarker validation studies, specifically those that are immediately preparatory to clinical trials (biomarker work that directly enables or strengthens near-term interventional studies rather than purely exploratory discovery).

What does it mean that this is a cooperative agreement (U10)?

A U10 is an NIH cooperative agreement, which means NIH is expected to have substantial involvement in the project’s conduct compared with a standard research project grant.

How does this program aim to improve operational efficiency for multi-site trials?

The announcement highlights master trial agreements and the use of a central institutional review board (IRB) to reduce administrative delays common in multi-site studies, simplify contracting across institutions, and reduce redundant ethics review while maintaining participant protections.

What are master trial agreements in the context of this network?

Master trial agreements are described as a mechanism to simplify contracting across many institutions, helping to reduce administrative delays and speed up trial start-up for multi-site studies.

What is the purpose of a central IRB in this program?

A central IRB is intended to reduce redundant ethics review across participating sites and enable faster site activation without compromising participant protections.

Are Regional Coordinating Stroke Centers expected to contribute scientifically, not just operationally?

Yes. Scientists at these centers, including clinical and basic researchers, are expected to contribute to the network’s intellectual work by helping develop clinical trial concepts and applications for peer review and by participating in planning and execution of NINDS-funded stroke trials that originate outside the network.

Does the network support trials that involve industry collaborations?

The network is positioned to support trials that emerge from Collaborative Research and Development Agreements (CRADAs) between NINDS and industry partners when they align with NINDS priorities.

Can this network collaborate with other research networks?

Yes. The network is described as uniquely poised to rapidly collaborate with other established networks such as the NINDS Neurological Emergencies Treatment Trials Network (NETT) and with international consortia.

Why is interoperability with other networks and consortia important for stroke trials?

Stroke trials often require large sample sizes and broad geographic coverage, especially for acute treatment studies or when detecting modest but clinically important effects. Rapid alignment of protocols and operations across networks is intended to make larger, more definitive trials feasible in a shorter timeframe.

Which agency sponsors this opportunity?

The sponsoring agency is the National Institutes of Health (NIH), and the program is associated with the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Trials Network.

What is the CFDA number and program category associated with this opportunity?

The opportunity is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders) and falls under the health category.

Was cost sharing or matching required?

No. The opportunity did not require cost sharing or matching.

What was the total estimated funding amount for the announcement?

The total estimated funding amount listed was $8,750,000.

Who was eligible to apply?

Eligibility was broad across U.S.-based organizational types, including public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including those other than small businesses); small businesses; and multiple levels of government (state, county, city/township, special district, and independent school districts), as well as tribal governments and tribal organizations.

Are U.S. territories or possessions eligible?

Yes. The eligibility text explicitly includes U.S. territories or possessions.

Does the eligibility list include mission-focused institution types (for example, HBCUs and HSIs)?

Yes. The eligibility text explicitly includes institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, along with eligible federal agencies.

Are foreign institutions eligible to apply?

No. Foreign institutions were not eligible.

Are foreign components of U.S. organizations allowed?

No. Foreign components of U.S. organizations were not allowed under NIH policy as described in the notice.

When was the opportunity posted, and what were the key dates?

The announcement was posted on February 21, 2013. The original and current closing date was May 15, 2013. The archive date was June 15, 2013.

Where are applicants directed for detailed requirements and application instructions?

The announcement points applicants to the full funding opportunity text on the NIH grants site for detailed requirements, expectations, and application instructions.

Who should be contacted for access or linking issues related to the opportunity text?

Contact support for access or linking issues is routed through the NIH Office of Extramural Research (OER) webmaster.

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