Opportunity Information: Apply for RFA HL 12 001
Apply for RFA HL 12 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Heart Failure Clinical Research Network Regional Clinical Centers (U10)" 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 Jun 4, 2010 and posted on Jun 4, 2010.
- Applicants must submit their applications by Dec 1, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $29,120,000.00 to eligible and selected applicants.
- Eligible applicants include: County governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) City or township governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Small businesses Private institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Heart Failure Clinical Research Network Regional Clinical Centers (U10) funding opportunity (RFA HL 12 001) is an NIH cooperative agreement designed to continue and strengthen a national clinical trials network focused on heart failure. The main goal is to support Regional Clinical Centers (RCCs) that can help rapidly develop, coordinate, and carry out multiple collaborative randomized clinical trials aimed at improving outcomes for patients with all forms of heart failure. This program is meant to keep heart failure clinical research moving efficiently by giving the network stable infrastructure and experienced sites that can consistently recruit participants and implement protocols across several studies.
A key feature of this opportunity is its emphasis on small to intermediate sized randomized clinical trials that can run concurrently and be completed in roughly 2 to 5 years. The solicitation is explicit that it is not meant to fund large, definitive Phase III trials. Instead, the trials supported through this network are expected to generate clinically meaningful pathophysiologic insights and produce evidence that can directly inform and advance heart failure management and treatment strategies. In practice, that means studies should be designed to answer important, actionable questions while still being realistic in scope, timeline, and budget.
RCCs funded under this announcement are expected to do more than simply enroll patients. They are intended to provide scientific leadership and participate in shaping the network-wide research agenda, working collaboratively with other centers to propose, refine, and prioritize trial concepts. The RCC model also allows applicants to propose a hub-and-spoke type structure, where a main center partners with geographically or organizationally connected satellites. This is meant to improve operational efficiency, broaden access to diverse patient populations, and strengthen recruitment capacity so trials can be launched and completed on schedule. Both new applicants and centers already involved in the existing network are eligible to apply.
The funding mechanism is a U10 cooperative agreement, which typically means the NIH will have substantial programmatic involvement compared with a standard research grant. The total estimated funding is about $29.12 million spread over seven years, with NIH anticipating up to nine RCC awards. Within that overall amount, $4.2 million over seven years is set aside for four Clinical Research Skills Development Cores, which are intended to build and strengthen clinical research workforce capabilities. Separately, RCCs and their satellites can also receive trial-specific Protocol Funds that are administered by the network Coordinating Center (which is competed under a different solicitation, RFA HL 12 002). The total pool of Protocol Funds available for actually conducting the clinical trials, including any needed core laboratories, is $16.8 million. This structure separates support for site/network infrastructure from study-by-study operational funds, which is typical for multi-trial networks.
Administratively, this is a discretionary health research opportunity under CFDA 93.837 (Cardiovascular Diseases Research). It does not require cost sharing or matching. The announcement was posted June 4, 2010, with an original and current closing date of December 1, 2010, and an archive date of January 1, 2011. Even though the dates indicate it is now archived, the description is still useful as a model for how NIH structures cooperative clinical trial networks in heart failure and similar disease areas.
Eligibility is broad and includes many types of domestic and non-domestic institutions and organizations. Eligible applicants include state, county, city/township, special district, and certain housing authorities; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; small businesses and other for-profit organizations (other than small businesses are also listed as eligible); independent school districts; federally recognized and other tribal governments and tribal organizations; and a variety of mission-specific institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities. Faith-based and community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions are also included, and foreign (non-U.S.) entities are listed as eligible as well.
In short, this opportunity is about building a coordinated set of high-performing regional trial sites that can jointly run multiple, efficient randomized trials in heart failure, with a practical scope and timeline, under a cooperative NIH network model. The RCCs serve as both operational engines for recruitment and trial delivery and as scientific partners responsible for helping steer the network toward studies that can measurably improve heart failure care within a few years rather than a decade.
Frequently Asked Questions (FAQs)
What is the Heart Failure Clinical Research Network Regional Clinical Centers (U10) opportunity?
This funding opportunity (RFA HL 12 001) is an NIH cooperative agreement (U10) intended to continue and strengthen a national clinical trials network focused on heart failure. It supports Regional Clinical Centers (RCCs) that can help rapidly develop, coordinate, and carry out multiple collaborative randomized clinical trials aimed at improving outcomes for patients with all forms of heart failure.
What is the main goal of the program?
The main goal is to maintain a stable, efficient clinical trials infrastructure and a set of experienced clinical sites that can consistently recruit participants and implement protocols across several studies, so multiple heart failure trials can be launched, run concurrently, and completed on practical timelines.
What types of studies are expected to be supported through this network?
The network is designed to support small to intermediate sized randomized clinical trials that can run concurrently and be completed in roughly 2 to 5 years. The intent is to generate clinically meaningful pathophysiologic insights and produce evidence that can directly inform and advance heart failure management and treatment strategies.
Are large Phase III trials supported under this announcement?
No. The solicitation is explicit that it is not meant to fund large, definitive Phase III trials. The emphasis is on smaller, practical randomized trials that answer important and actionable questions within realistic scope, timeline, and budget.
How many trials can the network run at once?
The program emphasizes the ability to run multiple collaborative randomized clinical trials concurrently. RCCs are supported as part of a network intended to keep heart failure clinical research moving efficiently across several studies, rather than focusing on a single large trial.
What is an RCC (Regional Clinical Center) in this program?
An RCC is a regional trial site (or a hub with connected sites) that contributes both operational capacity and scientific leadership to the network. RCCs are expected to support rapid trial startup and execution by recruiting participants, implementing protocols, and collaborating across the network to deliver high-quality randomized clinical trials.
Are RCCs expected to do more than enroll participants?
Yes. RCCs are intended to provide scientific leadership and participate in shaping the network-wide research agenda. They work collaboratively with other centers to propose, refine, and prioritize trial concepts, not just implement studies.
What is the hub-and-spoke model mentioned in the opportunity?
The RCC model allows applicants to propose a hub-and-spoke type structure where a main center partners with geographically or organizationally connected satellites. This structure is meant to improve operational efficiency, broaden access to diverse patient populations, and strengthen recruitment capacity so trials can be launched and completed on schedule.
What are “satellites” in the RCC model?
Satellites are partner sites connected to a main RCC (the hub) through geography or organizational relationships. They are used to expand reach, enhance recruitment, and support efficient trial operations across the region.
Who is eligible to apply for RCC funding?
Eligibility is broad and includes many types of domestic and non-domestic institutions and organizations. Both new applicants and centers already involved in the existing network are eligible to apply.
Are foreign (non-U.S.) organizations eligible?
Yes. Foreign (non-U.S.) entities are listed as eligible applicants under the opportunity.
What kinds of U.S. organizations are eligible to apply?
Eligible applicants include (as described in the opportunity): state, county, city/township governments; special districts; certain housing authorities; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; small businesses; other for-profit organizations; independent school districts; federally recognized and other tribal governments and tribal organizations; HBCUs; Hispanic-serving institutions; Alaska Native and Native Hawaiian-serving institutions; tribally controlled colleges and universities; faith-based and community-based organizations; eligible federal agencies; regional organizations; and U.S. territories or possessions.
What is the funding mechanism and what does it imply?
The mechanism is a U10 cooperative agreement. This typically means NIH has substantial programmatic involvement compared with a standard research grant, reflecting the collaborative, network-based nature of the work.
How much total funding is estimated for this program?
The total estimated funding is about $29.12 million spread over seven years, with NIH anticipating up to nine RCC awards.
How many RCC awards does NIH anticipate making?
NIH anticipates up to nine RCC awards under this announcement.
Are there separate funds for workforce or skills development?
Yes. Within the overall funding, $4.2 million over seven years is set aside for four Clinical Research Skills Development Cores, which are intended to build and strengthen clinical research workforce capabilities.
What are Protocol Funds and how do they relate to RCC funding?
Protocol Funds are trial-specific funds that RCCs and their satellites can receive to conduct the clinical trials. These funds are administered by the network Coordinating Center (which is competed under a different solicitation, RFA HL 12 002). This approach separates support for site/network infrastructure (RCC awards) from study-by-study operational funds (Protocol Funds).
How large is the pool of Protocol Funds for conducting the trials?
The total pool of Protocol Funds available for actually conducting the clinical trials, including any needed core laboratories, is $16.8 million.
What is the role of the Coordinating Center in relation to Protocol Funds?
The Coordinating Center administers the trial-specific Protocol Funds. The Coordinating Center itself is competed under a separate solicitation (RFA HL 12 002), distinct from the RCC funding opportunity (RFA HL 12 001).
Does the opportunity require cost sharing or matching?
No. The announcement states that it does not require cost sharing or matching.
What CFDA number is associated with this opportunity?
The opportunity is a discretionary health research program under CFDA 93.837 (Cardiovascular Diseases Research).
When was the announcement posted and when did it close?
The announcement was posted on June 4, 2010. The original and current closing date listed is December 1, 2010, and the archive date is January 1, 2011.
Is this opportunity still active?
Based on the dates provided (closing date December 1, 2010 and archive date January 1, 2011), it is archived. The description remains useful as an example of how NIH structures cooperative clinical trial networks in heart failure and similar disease areas.
What patient population is the network focused on?
The network is focused on patients with all forms of heart failure, with the goal of improving outcomes through collaborative randomized clinical trials.
What is the expected timeline for trials supported by this network?
The trials emphasized in the solicitation are expected to be completed in roughly 2 to 5 years, reflecting the focus on small to intermediate sized randomized trials that are practical and efficient.
How does this program aim to improve trial efficiency?
It aims to improve efficiency by funding stable network infrastructure, supporting experienced regional sites capable of consistent recruitment and protocol implementation, enabling concurrent trials, and allowing hub-and-spoke arrangements that broaden access to patient populations and strengthen recruitment capacity.
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