Opportunity Information: Apply for RFA HL 12 002
Apply for RFA HL 12 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Heart Failure Clinical Research Network Coordinating Center (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 $33,600,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Private institutions of higher education City or township governments Native American tribal governments (Federally recognized) 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 State governments Independent school districts Small businesses For profit organizations other than small businesses 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 County 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 United States Institutions
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Opportunity Summary:
The Heart Failure Clinical Research Network Coordinating Center (U10) opportunity (RFA HL 12 002) is a National Institutes of Health cooperative agreement designed to continue and strengthen a national clinical trials network focused on improving outcomes for people with heart failure. The core goal is to speed up practical, high-quality clinical research that tests strategies to diagnose, manage, and treat all forms of heart failure. Rather than funding one massive, definitive Phase III program, this network is intended to run multiple small to intermediate sized randomized clinical trials in parallel, with each study generally expected to finish within about 2 to 5 years. NIH is looking for trials that are clinically meaningful, that also provide pathophysiologic insights, and that clearly push the heart failure field forward.
A key feature of this solicitation is that it funds a single Coordinating Center that combines two major roles under one roof: the Data Coordinating Center responsibilities and the Clinical Coordinating Center responsibilities. In practice, that means the awardee is expected to lead and manage essentially all network-wide operations needed to develop, coordinate, and execute the randomized trials. The expectation is that the data and clinical coordination functions are integrated at the same institution so the network has one central hub for trial design support, operational coordination, data management, and overall trial oversight. NIH also strongly encourages a Multiple Principal Investigator structure to ensure the Coordinating Center has enough leadership bandwidth and the right mix of expertise to carry out all required functions.
This Coordinating Center award is part of a larger network structure that also includes Regional Clinical Centers, which are competed under a separate solicitation (RFA HL 12 001). The Coordinating Center is responsible not only for its own coordinating activities but also for administering protocol-related funds that flow out to the participating Regional Clinical Centers and to any necessary Core Laboratories through subcontracts. In other words, the Coordinating Center functions as both the operational brain of the network and the administrative hub that helps resource the sites and specialized labs needed to carry out the trials.
The funding mechanism is a U10 cooperative agreement, which typically indicates substantial scientific and/or programmatic involvement by NIH staff compared with a standard research grant. Total planned funding is $33.6 million over 7 years for the Coordinating Center. Of that amount, $16.8 million is allocated to support the Coordinating Center functions themselves (the central coordinating and management work). The other $16.8 million is set aside as Protocol Funds that the Coordinating Center will distribute via subcontracts to the Regional Clinical Centers and any required Core Laboratories to support conduct of the network trials. NIH anticipates making a single award to a single institution.
Eligibility is broad and includes many types of domestic organizations and governments, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and other than small businesses), and a wide range of government entities (state, county, city/township, special district, independent school districts), as well as tribal governments and tribal organizations. The eligibility language also explicitly includes various institution types and communities such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, as applicable under NIH rules.
Important timing details in the notice indicate it was posted June 4, 2010, with an original (and current) closing date of December 1, 2010, and an archive date of January 1, 2011. The opportunity falls under the NIH health funding category and is associated with CFDA number 93.837 (Cardiovascular Diseases Research). There is no cost sharing or matching requirement noted. For full details, applicants were directed to the NIH grants page for RFA HL 12 002, with NIH Office of Extramural Research contact support listed for access or technical linking issues.
FAQs - Heart Failure Clinical Research Network Coordinating Center (U10) (RFA HL 12 002)
What is the Heart Failure Clinical Research Network Coordinating Center (U10) opportunity?
This opportunity (RFA HL 12 002) is a National Institutes of Health (NIH) cooperative agreement to support a single Coordinating Center for a national clinical trials network focused on improving outcomes for people with heart failure.
What is the main purpose of this network?
The core goal is to speed up practical, high-quality clinical research that tests strategies to diagnose, manage, and treat all forms of heart failure, with the intent to generate clinically meaningful results and advance the field.
What types of studies is NIH expecting the network to run?
The network is intended to conduct multiple small to intermediate sized randomized clinical trials in parallel, rather than one massive, definitive Phase III program.
How long are the trials expected to take?
Each study is generally expected to finish within about 2 to 5 years.
What is NIH looking for in the trials supported by this network?
NIH is looking for trials that are clinically meaningful, provide pathophysiologic insights, and clearly push the heart failure field forward.
What does it mean that this is a Coordinating Center award?
The award supports one Coordinating Center that serves as the central hub for the network, leading and managing the network-wide operations needed to develop, coordinate, and execute the randomized trials.
What roles must the Coordinating Center include?
A key feature is that the Coordinating Center must combine both Data Coordinating Center responsibilities and Clinical Coordinating Center responsibilities at the same institution, integrating trial design support, operational coordination, data management, and overall oversight.
Is NIH expecting data coordination and clinical coordination to be integrated?
Yes. The expectation is that the data and clinical coordination functions are integrated at the same institution so the network has one central hub for both functions.
Does NIH encourage Multiple Principal Investigators (Multiple PIs)?
Yes. NIH strongly encourages a Multiple Principal Investigator structure to ensure sufficient leadership bandwidth and the right mix of expertise to carry out all required Coordinating Center functions.
How does this Coordinating Center relate to Regional Clinical Centers?
The Coordinating Center is part of a larger network structure that also includes Regional Clinical Centers, which are competed under a separate solicitation (RFA HL 12 001).
Will the Coordinating Center manage funds for other network participants?
Yes. The Coordinating Center will administer protocol-related funds that flow to participating Regional Clinical Centers and any necessary Core Laboratories through subcontracts.
What are "Protocol Funds" in this opportunity?
Protocol Funds are funds set aside for the conduct of the network trials that the Coordinating Center will distribute via subcontracts to Regional Clinical Centers and any required Core Laboratories.
What is the funding mechanism for this award?
The funding mechanism is a U10 cooperative agreement.
What does a U10 cooperative agreement imply about NIH involvement?
A U10 cooperative agreement typically indicates substantial scientific and/or programmatic involvement by NIH staff compared with a standard research grant.
How much total funding is planned for the Coordinating Center?
Total planned funding is $33.6 million over 7 years for the Coordinating Center award.
How is the $33.6 million budget allocated?
Of the $33.6 million total planned funding over 7 years, $16.8 million is allocated to support the Coordinating Center functions themselves, and $16.8 million is set aside as Protocol Funds to be distributed through subcontracts to Regional Clinical Centers and Core Laboratories.
How many awards does NIH anticipate making?
NIH anticipates making a single award to a single institution.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governments, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and other than small businesses), and a wide range of government entities.
What types of government entities are included in eligibility?
Eligibility includes state, county, city/township governments, special district governments, and independent school districts, as well as tribal governments and tribal organizations.
Does the eligibility language specifically include certain institution types and communities?
Yes. The eligibility language explicitly includes institution types and communities such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, as applicable under NIH rules.
Is cost sharing or matching required?
No cost sharing or matching requirement is noted for this opportunity.
When was this opportunity posted?
The notice indicates the opportunity was posted on June 4, 2010.
What is the closing date for applications?
The notice indicates an original (and current) closing date of December 1, 2010.
What is the archive date listed for this opportunity?
The archive date listed is January 1, 2011.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.837, Cardiovascular Diseases Research.
What is the NIH category or topic area for this funding?
The opportunity falls under the NIH health funding category and focuses on cardiovascular research related to heart failure clinical trials.
Where were applicants directed to find full details?
Applicants were directed to the NIH grants page for RFA HL 12 002 for full details.
Who was listed for help with access or technical linking issues?
NIH Office of Extramural Research contact support was listed for access or technical linking issues.
Browse more opportunities from the same category: Health
Next opportunity: Heart Failure Clinical Research Network Regional Clinical Centers (U10)
Previous opportunity: RESEARCH OPPORTUNITIES IN AERONAUTICS 2010
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