Opportunity Information: Apply for RFA HL 21 016
The HeartShare: Next Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets Data Translation Center (U54 Clinical Trial Not Allowed) funding opportunity (RFA-HL-21-016) is a National Heart, Lung, and Blood Institute (NHLBI) initiative under the National Institutes of Health (NIH) that aims to build a coordinated, large-scale phenomics program focused on heart failure with preserved ejection fraction (HFpEF). The central scientific purpose is to bring together deep phenotypic information, medical imaging, and multi-omics data from HFpEF patients, then analyze these data at scale to better define distinct HFpEF subtypes, clarify underlying biological mechanisms, and identify actionable treatment targets. In practical terms, the program is meant to move the field beyond broad clinical labels toward more precise, mechanism-based groupings of patients that could eventually support targeted therapies and improved outcomes.
This specific FOA solicits applications for a Data Translation Center (DTC), funded as a U54 cooperative agreement, meaning the award is designed for substantial involvement and coordination with NIH/NHLBI program staff rather than functioning like a typical investigator-initiated research grant. The DTC is positioned as the program hub: it is expected to handle overall project coordination across the HeartShare consortium, support and enable the development of a new HFpEF patient cohort (being enrolled and phenotyped through separately funded Clinical Centers), and curate, harmonize, and analyze existing datasets from NIH cohorts and clinical trials that already include relevant HFpEF participants and measurements. The DTC role is therefore both operational and scientific, combining program management, data infrastructure, data governance, and cross-study analytics to translate complex, heterogeneous data streams into interpretable findings and usable research assets.
The HeartShare structure is explicitly multi-component. While this FOA supports the DTC, a companion announcement (RFA-HL-21-015) supports the Clinical Centers that would recruit and characterize participants and generate new data for the program. The DTC is expected to interface tightly with these Clinical Centers, setting common data standards where appropriate, ensuring consistent data flow and documentation, enabling integration of new cohort data with legacy NIH datasets, and facilitating consortium-wide analyses. The “clinical trial not allowed” designation indicates the DTC award itself is not intended to run an interventional clinical trial; instead, it is focused on data coordination, cohort support activities, and advanced analysis of observational and existing trial-derived data to uncover subtypes and targets.
In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as allowed by NIH. The announcement also highlights additional eligible categories 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and regional organizations. Foreign institutions (non-U.S. entities) are not eligible to apply as prime applicants, but non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in NIH policy, which typically means specific, justified parts of the work can be performed outside the U.S. under the direction of an eligible U.S. applicant.
Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism (U54) within the health funding activity category (CFDA 93.837). The original closing date provided is January 8, 2021, and the posted award ceiling is $2,445,000. While the notice text included “ExpectedAwards:” without a number, the ceiling indicates the maximum budget level anticipated for a single award under this announcement. The overall framing suggests a consortium-style award where the DTC is expected to provide sustained, high-capacity data and coordination services rather than conduct a narrow, stand-alone research project.
Overall, this FOA is best understood as a call to build and operate the data and analytics backbone for a major NHLBI HFpEF phenomics effort. The DTC is expected to make it possible to combine new cohort data with existing NIH study resources, apply modern integrative analytics across clinical phenotypes, imaging, and omics, and produce refined HFpEF subtyping and therapeutic target hypotheses that can be validated and eventually translated into more personalized approaches to prevention and treatment.Apply for RFA HL 21 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "HeartShare: Next Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets Data Translation Center (U54 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837.
- This funding opportunity was created on 2020-09-10.
- Applicants must submit their applications by 2021-01-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $2,445,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the HeartShare funding opportunity (RFA-HL-21-016) in plain terms?
RFA-HL-21-016 funds a Data Translation Center (DTC) for the HeartShare program, an NHLBI/NIH initiative focused on heart failure with preserved ejection fraction (HFpEF). The purpose is to serve as the data and coordination hub that helps bring together deep clinical phenotypes, medical imaging, and multi-omics data from HFpEF participants and analyze those data at scale to define HFpEF subtypes and identify treatment targets.
Which NIH Institute is sponsoring this opportunity?
This opportunity is an initiative of the National Heart, Lung, and Blood Institute (NHLBI) under the National Institutes of Health (NIH).
What is the main scientific goal of the HeartShare program?
The central goal is to move beyond broad clinical labels and use large-scale, integrated data (phenotypes, imaging, multi-omics) to identify distinct HFpEF subtypes, clarify underlying biological mechanisms, and surface actionable treatment targets.
What does "Next Generation Phenomics" mean in the context of this FOA?
In this context, it refers to assembling and analyzing deep phenotypic information together with medical imaging and multi-omics data from HFpEF patients. The intent is to integrate these diverse data streams to improve how HFpEF is categorized and to support more mechanism-based insights.
What is being solicited under RFA-HL-21-016 specifically?
This FOA solicits applications to establish and operate the HeartShare Data Translation Center (DTC), funded through a U54 cooperative agreement. The DTC is expected to provide program coordination, data infrastructure, data governance, dataset curation and harmonization, and cross-study analytics for the HeartShare consortium.
What is a Data Translation Center (DTC) expected to do in HeartShare?
Based on the description provided, the DTC acts as the program hub and is expected to: coordinate activities across the HeartShare consortium; support and enable development of a new HFpEF patient cohort being enrolled and phenotyped by separately funded Clinical Centers; curate, harmonize, and analyze existing datasets from NIH cohorts and clinical trials that include relevant HFpEF participants and measurements; and translate complex, heterogeneous data into interpretable findings and usable research assets.
How does the DTC relate to the Clinical Centers?
The HeartShare program is multi-component. The DTC (this FOA) is expected to interface tightly with Clinical Centers funded under a companion announcement (RFA-HL-21-015). Clinical Centers recruit and characterize participants and generate new data, while the DTC supports common data standards, consistent data flow and documentation, and integration of new cohort data with legacy NIH datasets to enable consortium-wide analyses.
Is this FOA funding the Clinical Centers that enroll participants?
No. This FOA (RFA-HL-21-016) supports the Data Translation Center. A separate, companion announcement (RFA-HL-21-015) supports the Clinical Centers that recruit and phenotype participants and generate new cohort data.
What does "U54 cooperative agreement" mean for how the award operates?
The U54 mechanism indicates a cooperative agreement with substantial involvement and coordination from NIH/NHLBI program staff. It is positioned differently from a typical investigator-initiated research grant, emphasizing coordinated program execution and consortium-style collaboration.
What does "Clinical Trial Not Allowed" mean here?
It means the DTC award itself is not intended to run an interventional clinical trial. Instead, the focus is on data coordination, cohort support activities, and advanced analysis of observational data and existing trial-derived datasets to uncover HFpEF subtypes and treatment targets.
What types of data are expected to be integrated and analyzed?
The opportunity emphasizes integrating deep phenotypic information, medical imaging, and multi-omics data from HFpEF patients. It also highlights harmonizing new cohort data with existing datasets from NIH cohorts and clinical trials that include relevant HFpEF participants and measurements.
What is the intended outcome of combining new cohort data with existing NIH datasets?
The intent is to enable large-scale, cross-study analyses that can better define HFpEF subtypes, clarify mechanisms, and generate hypotheses about actionable treatment targets. The DTC is expected to turn heterogeneous, complex datasets into interpretable outputs and usable assets for the consortium.
Who is eligible to apply as the prime applicant?
Eligibility is broad and includes U.S.-based organizations and governments. Listed eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as allowed by NIH.
Are minority-serving institutions and community-based organizations eligible?
Yes. The announcement highlights eligibility for Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and regional organizations.
Can a non-U.S. (foreign) institution apply as the prime applicant?
No. Foreign institutions (non-U.S. entities) are not eligible to apply as prime applicants under the description provided.
Are foreign components allowed in any form?
Yes. Non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in NIH policy. This typically means specific, justified parts of the work may be performed outside the U.S. under the direction of an eligible U.S. applicant.
What is the funding type and administrative category?
The opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism (U54) within the health funding activity category. The CFDA number provided is 93.837.
What is the posted award ceiling for this opportunity?
The posted award ceiling is $2,445,000, described as the maximum budget level anticipated for a single award under this announcement.
How many awards are expected?
The notice text included "ExpectedAwards:" without listing a number. Based on the information provided, an exact expected number of awards is not specified.
What is the closing date listed for the opportunity?
The original closing date provided is January 8, 2021.
Is the DTC meant to run a stand-alone research project?
No. The framing emphasizes a consortium-style award where the DTC provides sustained, high-capacity data and coordination services (program management, infrastructure, governance, harmonization, and cross-study analytics) rather than executing a narrow, independent research project.
What problem in HFpEF research is HeartShare trying to address?
The program aims to move the field beyond broad clinical labels by using integrated, large-scale datasets to define more precise HFpEF subtypes and identify mechanisms and treatment targets that could eventually support more targeted therapies and improved outcomes.
What does "data translation" imply for the DTC role?
In this FOA's context, it implies converting complex and heterogeneous data streams (phenotypes, imaging, omics, and legacy datasets) into interpretable findings and usable research assets that support subtype discovery and target identification across the consortium.
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