Opportunity Information: Apply for RFA NS 13 016
Apply for RFA NS 13 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Stroke Trials Network National Data Management Center (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 Apr 10, 2013 and posted on Apr 10, 2013.
- Applicants must submit their applications by Aug 14, 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 $1,125,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Small businesses Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses County governments State governments Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Special district governments 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 Independent school districts 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 - National Data Management Center (U01) opportunity (Funding Opportunity Number RFA-NS-13-016) is a National Institutes of Health cooperative agreement meant to fund a single organization to serve as the network-wide data hub for a national stroke clinical trials infrastructure. The central idea behind the Stroke Trials Network is to make stroke studies faster, more consistent, and more cost-effective by building an organized system that can repeatedly run high-quality multi-site trials instead of reinventing processes for every new study. This particular award focuses on the data side of that system: building and operating the National Data Management Center that will support the network's clinical trials and closely related biomarker validation work.
The network itself is designed to cover the full stroke continuum by supporting studies in stroke prevention, acute treatment, and recovery/rehabilitation, with an explicit goal of maintaining a balanced portfolio across those three areas. Within that broad mission, the network is expected to run both exploratory early-stage trials (phase 1/2) and larger confirmatory trials (phase 3). In addition, it will support biomarker validation studies when they are immediately preparatory to clinical trials, meaning the biomarker work should be tightly connected to an upcoming interventional trial rather than basic discovery research. Structurally, the Stroke Trials Network is made up of multiple Regional Coordinating Stroke Centers distributed across the United States, each linked to additional community stroke centers to expand patient access and enrollment capacity. Those regional sites are coordinated through two national-level cores: a National Clinical Coordinating Center (solicited under a separate FOA, RFA-NS-13-012) and this National Data Management Center (RFA-NS-13-016). Another separate FOA covers the Regional Coordinating Stroke Centers (RFA-NS-13-011).
As a cooperative agreement (U01), this award mechanism signals that NIH and the awardee are expected to work collaboratively, with NIH having substantial programmatic involvement compared to a standard research project grant. In practice, that typically means the funded Data Management Center would be expected to coordinate closely with NINDS program staff and the other network components on study start-up, data standards, reporting, oversight, and the operational details required to run multiple trials under a shared network umbrella. While the announcement summary provided does not list every task, a National Data Management Center in a clinical trials network context generally serves as the system-of-record for trial data, ensures data quality and consistency across sites, supports secure data capture and management workflows, and enables timely analysis and reporting needed for trial monitoring and decision-making.
From a funding and administrative standpoint, NIH expected to make one award under this FOA. The estimated total funding listed is $1,125,000, with an award ceiling of $750,000. There is no cost sharing or matching requirement. The opportunity was posted April 10, 2013, with an original and current closing date of August 14, 2013, and an archive date of September 14, 2013, indicating this was a time-limited solicitation for that funding cycle. The activity category is Health, and the CFDA number is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), which aligns with NINDS's neuroscience and neurological disorder research mission.
Eligibility is broad and includes many types of domestic U.S. organizations and governments. Eligible applicants listed include small businesses; for-profit organizations (including those other than small businesses); nonprofits with and without 501(c)(3) status (with the usual distinction that institutions of higher education are treated separately); private institutions of higher education; public and state-controlled institutions of higher education; state, county, city/township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; and tribal governments and tribal organizations (both federally recognized and other than federally recognized). The FOA also explicitly includes a range of mission-driven or designated institution types such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, as well as faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, it clearly excludes non-domestic (non-U.S.) entities from applying, excludes non-domestic components of U.S. organizations, and does not allow foreign components as defined by the NIH Grants Policy Statement.
In short, RFA-NS-13-016 is NIH's call for one lead organization to run the centralized data management operation for a national stroke trials network, working in tandem with a national clinical coordinating center and multiple regional stroke centers. The overall program goal is to create a durable, efficient clinical trials platform capable of conducting rigorous multi-site phase 1/2 and phase 3 stroke trials and closely trial-ready biomarker validation studies across prevention, treatment, and recovery, with consistent processes and shared infrastructure across the United States.
Frequently Asked Questions (FAQs): NINDS Stroke Trials Network - National Data Management Center (U01)
1) What is the funding opportunity covered by these FAQs?
This opportunity is the NINDS Stroke Trials Network - National Data Management Center (U01), Funding Opportunity Number (FOA) RFA-NS-13-016. It is a National Institutes of Health (NIH) cooperative agreement intended to fund a single organization to serve as the network-wide data hub for a national stroke clinical trials infrastructure.
2) What does "National Data Management Center" mean in this program?
In this Stroke Trials Network, the National Data Management Center (NDMC) is the centralized, network-wide data hub. The NDMC is expected to support the clinical trials conducted within the network and closely related biomarker validation work that is immediately preparatory to clinical trials.
3) What is the main goal of the NINDS Stroke Trials Network overall?
The central goal of the Stroke Trials Network is to make stroke studies faster, more consistent, and more cost-effective by building an organized system that can repeatedly run high-quality multi-site trials rather than recreating processes and infrastructure for each new study.
4) What parts of the stroke continuum are included in this network's scope?
The network is designed to cover the full stroke continuum by supporting studies in (1) stroke prevention, (2) acute treatment, and (3) recovery/rehabilitation. The program also has an explicit goal of maintaining a balanced portfolio across these three areas.
5) What trial phases are expected to be supported by the network?
The network is expected to conduct both exploratory early-stage trials (phase 1/2) and larger confirmatory trials (phase 3).
6) Are biomarker studies included, and if so, what kinds?
Yes. The network will support biomarker validation studies when they are immediately preparatory to clinical trials. In other words, biomarker work should be tightly connected to an upcoming interventional trial rather than basic discovery research.
7) How is the Stroke Trials Network structured?
The network includes multiple Regional Coordinating Stroke Centers distributed across the United States. Each regional center is linked to additional community stroke centers to expand patient access and enrollment capacity. These regional sites are supported and coordinated through two national-level cores: a National Clinical Coordinating Center and the National Data Management Center described in this FOA.
8) What other related funding opportunities are part of the overall network build-out?
This FOA (RFA-NS-13-016) covers the National Data Management Center. A separate FOA covers the National Clinical Coordinating Center (RFA-NS-13-012), and another separate FOA covers the Regional Coordinating Stroke Centers (RFA-NS-13-011).
9) What does the "U01" cooperative agreement mechanism imply?
U01 is an NIH cooperative agreement mechanism, which generally means NIH and the awardee are expected to work collaboratively. Compared to a standard research project grant, NIH has substantial programmatic involvement in the supported activities.
10) What kind of collaboration is implied under this cooperative agreement?
Based on the description provided, the funded Data Management Center would be expected to coordinate closely with NINDS program staff and with other network components (such as the National Clinical Coordinating Center and Regional Coordinating Stroke Centers) on operational details that support network trials, including study start-up, data standards, reporting, oversight, and related activities needed to operate multiple trials under a shared network umbrella.
11) What types of functions would the National Data Management Center typically perform in a clinical trials network?
While the summary does not list every task, a data management center in a clinical trials network context generally serves as the system-of-record for trial data, supports secure data capture and management workflows, ensures data quality and consistency across sites, and enables timely analysis and reporting needed for trial monitoring and decision-making.
12) How many awards did NIH expect to make under RFA-NS-13-016?
NIH expected to make one award under this FOA.
13) What is the estimated total funding and the award ceiling for this opportunity?
The estimated total funding listed is $1,125,000, and the award ceiling is $750,000.
14) Is there a cost sharing or matching requirement?
No. The opportunity states there is no cost sharing or matching requirement.
15) What are the key dates for this funding opportunity?
The opportunity was posted on April 10, 2013. The original and current closing date is August 14, 2013. The archive date is September 14, 2013, which indicates it was a time-limited solicitation for that funding cycle.
16) What is the activity category for this opportunity?
The activity category is Health.
17) What is the CFDA number associated with this opportunity, and what does it correspond to?
The CFDA number is 93.853, which is labeled as Extramural Research Programs in the Neurosciences and Neurological Disorders, aligning with NINDS's neuroscience and neurological disorder research mission.
18) Who is eligible to apply?
Eligibility is broad for domestic U.S. applicants and includes: small businesses; for-profit organizations (including those other than small businesses); nonprofits with and without 501(c)(3) status; private institutions of higher education; public and state-controlled institutions of higher education; state, county, city/township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; and tribal governments and tribal organizations (both federally recognized and other than federally recognized).
19) Are specific designated institution types included in eligibility?
Yes. The FOA explicitly includes institution types such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, as well as faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
20) Are non-U.S. (foreign) entities allowed to apply?
No. The FOA excludes non-domestic (non-U.S.) entities from applying.
21) Can a U.S. organization include a non-domestic component or foreign component in the application?
No. The FOA excludes non-domestic components of U.S. organizations and does not allow foreign components as defined by the NIH Grants Policy Statement.
22) What is the geographic footprint of the network described in the opportunity?
The Regional Coordinating Stroke Centers are distributed across the United States, and they link to additional community stroke centers to expand patient access and enrollment capacity.
23) How does this Data Management Center fit with the other network cores?
The Data Management Center is one of two national-level cores supporting the regional network sites. The other national-level core is the National Clinical Coordinating Center, which is solicited under a separate FOA.
24) What is the program trying to improve compared to traditional one-off clinical trial approaches?
The program is designed to reduce repeated set-up work and inconsistency by creating shared infrastructure and processes that can be reused for multiple high-quality multi-site trials, supporting faster execution, greater consistency, and improved cost-effectiveness.
25) What is the overall purpose of RFA-NS-13-016 in one sentence?
RFA-NS-13-016 seeks a single lead organization to build and operate the centralized data management operation for the NINDS Stroke Trials Network, supporting network clinical trials and closely trial-ready biomarker validation studies across prevention, acute treatment, and recovery/rehabilitation.
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