Opportunity Information: Apply for RFA HL 12 026
Apply for RFA HL 12 026
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Regional Clinical Centers for the Cardiovascular Cell Therapy Research Network (CCTRN) (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837 Cardiovascular Diseases Research.
- This funding opportunity was created on Apr 20, 2011 and posted on Apr 20, 2011.
- Applicants must submit their applications by Jun 22, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal governments (Federally recognized) Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Public and State controlled institutions of higher education County governments State governments Private institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) 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.
- 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 Non domestic (non U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are not allowed.
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Opportunity Summary:
This funding opportunity, RFA HL 12 026, comes from the National Institutes of Health (NIH) and supports the continuation of the Cardiovascular Cell Therapy Research Network (CCTRN) through awards to Regional Clinical Centers (RCCs). It is offered as a cooperative agreement (UM1), which generally means NIH expects to be actively involved in the program alongside the awardees rather than simply providing funds with minimal interaction. The overall focus is on cardiovascular diseases research (CFDA 93.837), specifically advancing and evaluating stem cell based therapeutic strategies for people with cardiovascular disease. The intent is not to fund a single stand-alone clinical study, but to sustain a multi-site clinical trials infrastructure that can efficiently design, coordinate, and run multiple collaborative trials aimed at improving cardiovascular outcomes.
The RCCs are envisioned as the clinical backbone of the network. In practical terms, an RCC would be a participating clinical site (or site hub) expected to help the network develop, coordinate, and conduct clinical trials in cardiovascular cell therapy. The emphasis on infrastructure signals that funded centers are expected to maintain readiness and capability for rigorous clinical research across several studies over time, including patient recruitment and retention, clinical operations, protocol implementation, intervention delivery as relevant, adverse event monitoring, regulatory compliance, and high-quality data collection. Because the CCTRN is structured as a network, the work is inherently collaborative and multi-center, with RCCs operating in coordination with other network components and other funded clinical centers.
A separate but related solicitation, RFA HL 12 025, is identified for a Data Coordinating Center (DCC). This is important because it clarifies how responsibilities are split across the network: the DCC typically centralizes data management, statistical support, randomization processes, and cross-site coordination of data standards, while RCCs primarily execute the clinical aspects of the trials at the regional/site level. Applicants to this RCC announcement should therefore expect close operational linkage with the DCC, using shared network procedures for trial conduct and common approaches to data capture and quality control. The structure reflects NIHs goal of having a durable, efficient system capable of running multiple trials rather than repeatedly building new trial infrastructures from scratch.
The opportunity is categorized as discretionary funding and falls under the health activity category. There is no cost sharing or matching requirement, meaning applicants are not required to provide non-federal funds as a condition of the award. The announcement was posted on April 20, 2011, with an application closing date of June 22, 2011, and an archive date of July 23, 2011, indicating it was a time-limited competition tied to that cycle.
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status (with the noted limitation that some categories exclude institutions of higher education), for-profit organizations (other than small businesses, which are also eligible), and multiple levels of government such as state, county, city or township, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The announcement also explicitly includes various mission-focused institution types and community-serving 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, and faith-based or community-based organizations, as well as federally recognized and other tribal governments and tribal organizations. U.S. territories or possessions and eligible federal agencies are also included. At the same time, the FOA is clear that non-U.S. entities (foreign organizations) are not eligible to apply, and foreign components of U.S. organizations are not allowed, reinforcing that the network is intended to operate entirely within the United States.
In summary, this FOA funds Regional Clinical Centers to participate in an NIH-led cooperative clinical trials network focused on stem cell and related cell-therapy approaches for cardiovascular disease. The awards are meant to preserve and strengthen a coordinated clinical research infrastructure capable of launching and executing multiple collaborative trials, with centralized data coordination handled under a companion funding opportunity for a Data Coordinating Center. The end goal is to accelerate careful, multi-center evaluation of novel cell-based treatments with the potential to improve outcomes for patients with cardiovascular disease.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is NIH funding opportunity RFA HL 12 026 to support continuation of the Cardiovascular Cell Therapy Research Network (CCTRN) by awarding Regional Clinical Centers (RCCs).
Which NIH mechanism is being used for these awards?
The opportunity uses a cooperative agreement mechanism (UM1). This generally indicates NIH expects to be actively involved in the program with awardees, not just provide funding with minimal interaction.
What is the main purpose of the award?
The goal is to sustain a multi-site clinical trials infrastructure that can efficiently design, coordinate, and run multiple collaborative trials evaluating stem cell-based (and related) therapeutic strategies for people with cardiovascular disease.
Is this intended to fund a single stand-alone clinical trial?
No. The intent is not to fund a single stand-alone clinical study, but to maintain and strengthen an ongoing network infrastructure capable of running multiple trials over time.
What disease area and research focus does this program support?
The focus is cardiovascular diseases research (CFDA 93.837), specifically advancing and evaluating stem cell-based therapeutic strategies aimed at improving cardiovascular outcomes.
What is a Regional Clinical Center (RCC) in the CCTRN?
An RCC is a participating clinical site (or site hub) that serves as part of the clinical backbone of the CCTRN. RCCs are expected to help the network develop, coordinate, and conduct clinical trials in cardiovascular cell therapy.
What types of responsibilities are RCCs expected to handle?
RCC responsibilities emphasize clinical trial execution and readiness across multiple studies, including patient recruitment and retention, clinical operations, protocol implementation, intervention delivery as relevant, adverse event monitoring, regulatory compliance, and high-quality data collection.
Why does the opportunity emphasize "infrastructure"?
The infrastructure emphasis signals that funded centers should maintain ongoing capability and readiness for rigorous, multi-center clinical research across several studies over time, rather than building trial capacity from scratch for each new study.
How collaborative is the work under this program?
The work is inherently collaborative and multi-center. RCCs operate as part of a network and are expected to coordinate closely with other network components and other funded clinical centers.
Is there a separate funding opportunity for a Data Coordinating Center (DCC)?
Yes. A companion solicitation, RFA HL 12 025, is identified for the Data Coordinating Center (DCC).
How are responsibilities split between RCCs and the DCC?
Based on the description provided, the DCC typically centralizes data management, statistical support, randomization processes, and cross-site coordination of data standards. RCCs primarily execute the clinical aspects of the trials at the regional/site level.
What kind of operational relationship should RCCs expect with the DCC?
Applicants should expect close operational linkage with the DCC, including use of shared network procedures for trial conduct and common approaches to data capture and quality control.
What type of funding is this categorized as?
This opportunity is categorized as discretionary funding and falls under the health activity category.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement, so applicants are not required to provide non-federal funds as a condition of the award.
When was this opportunity posted, and what were the key dates?
The announcement was posted on April 20, 2011. The application closing date was June 22, 2011, and the archive date was July 23, 2011.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (with a noted limitation that some categories exclude institutions of higher education); for-profit organizations (including small businesses); and many levels of government (state, county, city or township, special district governments, independent school districts, and public housing authorities/Indian housing authorities).
Are mission-focused and community-serving institutions included in eligibility?
Yes. The announcement explicitly includes HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, as well as federally recognized and other tribal governments and tribal organizations.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among eligible applicants.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are included.
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-U.S. entities (foreign organizations) are not eligible to apply.
Are foreign components of U.S. organizations allowed?
No. Foreign components of U.S. organizations are not allowed, reinforcing that the network is intended to operate entirely within the United States.
What is the overall intended outcome of funding RCCs through this FOA?
The end goal is to accelerate careful, multi-center evaluation of novel cell-based treatments that have the potential to improve outcomes for patients with cardiovascular disease, by preserving and strengthening a coordinated clinical trials network.
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Previous opportunity: Data Coordinating Center for the Cardiovascular Cell Therapy Research Network (CCTRN) (UM1)
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