RFA-HL-27-009-Revised-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Single Source: HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Data Translation Center (U54 Clinical Trial Optional)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of

RFA-HL-21-016

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-HL-27-009

Companion Notice of Funding Opportunity

RFA-HL-27-008

, U01 Research Project (Cooperative Agreements)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.837

Notice of Funding Opportunity Purpose

This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invites an application from an eligible organization to apply. Please see Section III. Eligibility for additional information. The NHLBI is announcing its intent to issue a single source cooperative agreement to Northwestern University. This NOFO solicits a renewal of the Data Translation Center for an ongoing NHLBI phenomics program, HeartShare, to coordinate the overall project, continue to oversee enrollment of a cohort of patients with heart failure with preserved ejection fraction (HFpEF), curate and analyze prospective deep phenotyping data, and support planning, implementation, and data analysis for clinical trials. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

Companion NOFO RFA-HL-27-008 will support Clinical Centers for recruitment and follow-up of heart failure patients and a Clinical Trial Center for new clinical trial activities.

Funding Opportunity Goal(s)

The Division of Cardiovascular Sciences fosters heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants.

Key Dates

Posted Date

May 19, 2026

Open Date (Earliest Submission Date)

June 09, 2026

Not Applicable

July 09, 2026

Not Applicable

April 2027

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

July 10, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite an application from an eligible organization to apply. Please see Section III. Eligibility for additional information. The NHLBI is announcing its intent to issue a single source cooperative agreement to Northwestern University. This NOFO solicits a renewal of the Data Translation Center for an ongoing NHLBI phenomics program, HeartShare, to coordinate the overall project, continue to oversee enrollment of a cohort of patients with heart failure with preserved ejection fraction (HFpEF), curate and analyze prospective deep phenotyping data, and support planning, implementation, and data analysis for clinical trials. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

Background The prevalence of heart failure with preserved ejection fraction (HFpEF) is rising due to an aging population and contributing comorbidities, such as obesity and diabetes. Epidemiologic studies have shown an increase in the proportion of HFpEF patients, and this trajectory continues to rise. Hospitalized HFpEF patients have a poor 5-year outcome with a 50% mortality rate, and emerging data suggest that HFpEF may be the dominant HF subtype in the future, affecting approximately 1 in 10 adults during their lifetime.

In addition to its increasing prevalence, HFpEF is a heterogeneous syndrome with multiple pathophysiological processes and varied clinical presentations. Phenomapping studies have identified between two and six HFpEF clusters or phenogroups with shared features. Of these, three overlapping phenotypes repeatedly arise: an ‘older, vascular aging’ phenotype, a ‘metabolic, obese’ phenotype, and ‘relatively younger, natriuretic peptide (NP) deficiency’ phenotype. Further refinement of these HFpEF subtypes is ongoing in HeartShare 1.0 with a focus on evaluating the underlying biologic and molecular mechanisms of disease. Defining clinically actionable phenotypes or clusters and their associated biomarkers will form the basis for designing precision clinical trials for HFpEF patients.

Research Approach HeartShare represents a new paradigm in longitudinal observational cardiovascular studies. The first HeartShare iteration (HeartShare 1.0; September 2021 – August 2026) uses deep phenotyping, imaging, multi-omics, and advanced analytics to deconstruct the HFpEF syndrome.

HeartShare 1.0’s has two components: 1) a retrospective portion responsible for aggregating, harmonizing, and analyzing extant datasets from NHLBI trials and cohorts along with multi-omics on available biospecimens using NHLBI’s Trans-Omics for Precision Medicine (TOPMed) program; and 2) a prospective, observational, longitudinal cohort. Data from both components will become available through the NHLBI BioData Catalyst (BDC) cloud-based platform.

The prospective component consists of three parts: 1) electronic health record (EHR) data from HF patients at the HeartShare Clinical Centers is collected from the previous 7 years and followed prospectively; 2) a virtual registry of patients (HF individuals and age- and sex-matched comparators), who complete surveys longitudinally and agree to be consented for future trials; and 3) a deep phenotyping cohort, which aims to enroll up to 1,000 participants (75% with HFpEF and 25% age- and sex-matched individuals without HFpEF). The goal of the deep phenotyping study is to identify clinical and omics biomarkers of distinct HFpEF subtypes. A rich BDC repository of clinical data [e.g., demographic, social determinants of health (SDOH), physiological, laboratory], images, and multi-omics (blood and tissue samples) will serve as a resource for all investigators and ultimately, the research community.

In September 2022, the Foundation for NIH (FNIH) Accelerating Medicines Partnership in Heart Failure (AMP HF) was launched to form a 5-year pre-competitive partnership with HeartShare, industry partners, non-profit organizations, NHLBI, and the FDA. HeartShare 1.0/AMP HF consists of a Data Translation Center (DTC) and 7 Clinical Centers (CCs). Projected outcomes from the HeartShare 1.0/AMP HF program include a large deeply phenotyped cohort of HFpEF patients; a virtual registry of participants who have agree to be contacted for recruitment into precision HFpEF trials; identification of subtypes of HFpEF patients; and exploration of new subtype-specific biomarkers and pathways for therapeutic development. The identified subtypes and potential biomarkers will be used for stratification of HFpEF patients into precision clinical trials in HeartShare 2.0.

HeartShare’s competitive continuation (HeartShare 2.0) is critical to realizing HeartShare 1.0/AMP HF goals. A Data Translation Center (DTC) will continue to support overall HeartShare 2.0 activities, including oversight of deep phenotyping protocol, follow-up, tissue biopsies (myocardial, skeletal, adipose) and data management/analysis. A new Clinical Trial Center (CTC) will coordinate HFpEF trial activities, including master protocol development, project management, recruitment oversight, performance milestones, and scientific conduct of trials. Up to seven CCs will be selected to serve as the performance sites for the deep phenotyping protocol, biopsy (myocardial, skeletal, adipose) collection, and future clinical trials.

The overall objectives of HeartShare 2.0 are described here along with their associated components:

This NOFO describes the objectives of the DTC, while the CTC and CC objectives are described in a companion NOFO (RFA-HL-27-008).

Data Translation Center Objectives The primary role of the DTC will be to provide overall management and oversight for the HeartShare program, including coordination and communication across all subsections and cores of the program. The prospective component of the study will continue in HeartShare 2.0 with ongoing cohort enrollment, follow-up, and tissue/sample collection/analysis for up to 6 years. The DTC will provide oversight for timely completion of HeartShare’s prospective component, tissue profiling, experimental validation of targets and mechanistic signals associated with HFpEF, and research training in addition to administrative, data, and biostatistical support for future HFpEF clinicals. The DTC will be expected to work with future trial investigators to meet NHLBI's expectations for performance-based, milestone-driven study designs with metrics for overall recruitment/enrollment and retention goals, including demographic accrual goals to ensure results are generalizable to the U.S. population. Future trial investigators will be required to include either the CTC, DTC, or both components in their study infrastructure.

DTC staff must possess strong scientific qualifications related to bioinformatics, clinical/health informatics, biostatistics, machine learning, data science, and omics. The DTC must have experience in the supervision of complex, multi-center clinical studies, as well as experience in the statistical analysis of high volume demographic, clinical, laboratory, and imaging data. The activities of the DTC will require effective communication with the clinical communities to achieve HeartShare goals. Therefore, they must have personnel capable of serving as liaisons and translators among clinical researchers, clinicians, and bioinformaticians. DTC personnel should also have experience with phenotype ontology and harmonization, as well as experience in coordinating biospecimens and linking to a biospecimen repository(ies).

The DTC’s responsibilities will cover three broad areas:

For both the retrospective and prospective components of HeartShare, the selected recipient will maintain a web-based interface to enable access to aggregated HeartShare project datasets and ancillary studies. Rapid and broad data-sharing of clinical and molecular data is intended to be a hallmark of the HeartShare program to enable the detection of markers of disease, progression, subtypes, and novel therapeutic targets. The Data Management Core will support data curation, data storage, and advanced analytics. It will link various data types and support timely and open sharing of a common data and image repository focused on HFpEF. The Data Management Core will also provide data access to relevant partners to promote interoperability and data sharing. The Steering Committee (SC), in collaboration with NHLBI, will oversee timeliness, policies, and standards for data sharing in the “open science” concept supported by AMP HF.

The DTC will work with the TOPMed program for biospecimen and tissue analyses. The DTC will be expected to develop procedures for data harmonization and standardization for omics analyses, as necessary. As new tissue analysis methods become available through TOPMed, an X01 application may be necessary.

For the prospective component of HeartShare, the DTC provides a patient-facing interface (Eureka) to support remote consent, completion of forms, and collection of mobile health data. Personal data will be made available to participants, according to their individual preferences. Applications are expected to use and integrate the existing platforms, tools, and workspaces of BDC. The DTC supports an up-to-date electronic “registry” of HFpEF patients that may be recruited for future HFpEF trials.

The DTC provides oversight to conduct a state-of-the art deep phenotyping protocol at the CCs. The DTC coordinates and implements EHR data acquisition from each CC to collect baseline and longitudinal information on enrolled patients. It provides oversight for research testing; acquisition of biospecimens; oversight for omics analyses in collaboration with TOPMed and other resources as necessary; integration of various data types to form a common data resource; and advanced analysis and interpretation of results. In addition to the funds awarded directly to the DTC for conducting DTC responsibilities, funds to conduct the phenotyping protocol will be part of the DTC’s grant award and will be distributed by the DTC as capitation to the CCs in accordance with protocol budgets (see RFA-HL-27-008) as determined by NHLBI and the SC. The DTC has established core laboratories as determined by the needs of the common protocol with input from NHLBI and the SC.

The DTC will interact with a new Clinical Trial Center (CTC; see RFA-HL-27-008), which will coordinate all new trial efforts while completing deep phenotyping activities with the CCs in HeartShare 2.0. It is anticipated that several activities will be completed or soon to be accomplished (e.g., extant data set collection, harmonization, and analysis; deep phenotyping protocol establishment; equipment purchase; and EHR data portal creation) in addition to new efforts being launched (e.g., longitudinal follow-up and experimental validation) in the HeartShare 1.0 to 2.0 extension. New activities for the DTC will include assisting the CTC with the planning and development of a clinical trial network and master protocol, partnering with academic and industry investigators who are planning and submitting potential trials, helping CCs complete deep phenotyping and transition to clinical trial recruitment, and performing data analysis functions for all clinical trials, as requested.

HeartShare Organization and Governance HeartShare's Steering Committee (SC), consisting of all academic investigators, meets monthly and provides oversight and direction for the entire program. The AMP HF SC, consisting of all private partners, meets monthly as well. A leadership team (NHLBI, FNIH, HeartShare/AMP HF study co-chairs, DTC) connects both SC meetings. The new CTC investigator will join the HeartShare SC and the leadership team and will be invited to attend the AMP HF SC meeting. New and renewed CC investigators will continue to participate in the HeartShare SC.

NHLBI will provide overall support for HeartShare. The NHLBI Program Office and Office of Grants Management are responsible for the federal stewardship of the award (management, financial and administrative oversight). In addition to regular award oversight, the NHLBI Project Scientists will be involved substantially with the recipients as partners, consistent with the Cooperative Agreement mechanism. The NHLBI has appointed an independent Observational Safety and Monitoring Board (OSMB) to provide ongoing review of HeartShare activities. The CTC will be expected to work with NHLBI on a Data and Safety Monitoring Board (DSMB) when clinical trials begin. NHLBI has appointed external study co-Chairs to oversee all study activities and scientific activities. An independent External Advisory Committee (EAC) may be appointed by NHLBI to provide periodic reviews of HeartShare operations and scientific directions.

HeartShare will support a Research Skills component that will bring together early career clinical researchers (fellows and junior investigators) and early career data science experts (in masters or PhD programs for data science, computer science, or statistics) to foster cross-disciplinary learning application of data science principles in clinical research. The DTC will coordinate the skills development activities across HeartShare by forming a Research Skills Committee (RSC), composed of an identified senior investigator from each CC, DTC, and CTC. The DTC, CTC, and CCs will share responsibilities for development and implementation of the Research Skills component. Skills development activities will be finalized and agreed upon across HeartShare after funding.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

Renewal

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NHLBI intends to commit up to $2,541,000 in total costs to fund up to one (1) new award in FY2027.

Award Budget

Application budgets may request up to $1,650,000 in total direct costs (excluding consortium F&A) in FY2027; up to $1,400,000 in total direct costs in FY2028; and up to $1,150,000 in total direct costs per year (excluding consortium F&A) in FY2029 through FY2032; and need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is six (6) years. The scope of the proposed project should determine the project period.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only the following applicant is eligible to apply for this single source funding: Northwestern University. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

Only the PI/PDs associated with the award issued under RFA-HL-21-016 (https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-21-026.html) to Northwestern University are eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only a single award will be issued to Northwestern University under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Required

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Concisely address the overall goals of the DTC and how its work supports the overall objectives of the HeartShare program, as well as future directions.

Letters of Support: An Institutional Letter of Support should be provided stating the site's endorsement for the proposed center.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide, with the following modifications:

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative (Admin) Core When preparing your application, use Component Type ‘Admin and Outreach Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Admin Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Admin Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Admin Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Admin Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Admin Core)

Specific to this NOFO

Budget (Admin Core) Budget forms appropriate for the specific component will be included in the application package.

Specific to this NOFO The suggested budget for the Admin and Outreach Core is $500,000 direct costs per year for Years 1-2 and $400,000 direct costs per year for Years 3-6 to cover the following:

Suggested Years 1-6 travel commitment for planning purposes:

PD/PI (or PDs/PIs if a multi-PD/PI plan is used) and core leaders attending one (1) SC meeting to be held in Bethesda, MD, or another convenient/central location(s). Additional meetings may be held virtually.

Allowable costs for the Research Skills Program include salary support for senior investigators and staff participating in mentoring activities; salary support and travel costs for early career investigators; supplies and equipment to support developmental activities; and costs for courses, seminars, workshops, and other activities directly related to the HeartShare program. All costs requested should be justified with respect to developmental activities and may not be used to supplement the costs of research proposed in the rest of the DTC application. The DTC, CTC, and CCs will share responsibilities for development and implementation of the Research Skills component. Skills development activities will be finalized and agreed upon across HeartShare after funding.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Admin Core) Specific Aims: Describe how the specific aims for the Admin and Outreach Core will be accomplished.

Research Strategy: Discuss how the activities listed below will be accomplished, staffed, and managed in support of the DTC. Describe how the proposed plans will leverage the experience described in the Biographical Sketch(es). Propose and justify any other coordination activities that would be useful to HeartShare, but are not listed explicitly elsewhere in this NOFO.

Describe plans for administrative and outreach activities, including but not limited to:

Letters of Support: Only letters of support specific to ‘Admin and Outreach Core’ should be attached to this section Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

Other Attachments: Provide the following information as a single PDF attachment entitled “(PD/PI name) Clinical Experience.pdf.” for the DTC PI. The attachment may not exceed 5 pages overall and must be completed and attached or the application will not be peer reviewed.

Table documenting participation in observational studies and/or clinical trials (highlight studies and/or trials with HF patients) from the last 5 years by the DTC PD(s)/PI(s): study title, intervention or observational objectives, dates, numbers of patients enrolled.

PHS Human Subjects and Clinical Trials Information (Admin Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Data Portal Core When preparing your application, use Component Type ‘Data Portal Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Data Portal Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Data Portal Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Portal Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data Portal Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Portal Core)

Specific to this NOFO: Describe the previous experience, if any, of the Data Portal Core Lead in developing and maintaining a web-based interface to support data curation, data storage, advanced analytics, and linkage to relevant partners for interoperability and data sharing.

Budget (Data Portal Core) Budget forms appropriate for the specific component will be included in the application package.

Specific to this NOFO: The suggested budget for the Data Portal Core is $100,000 direct costs per year for Years 1-6 to maintain a web-based HeartShare data portal leveraging NHLBI's BDC; integrate diverse datasets; and manage a patient engagement resource using the Eureka platform.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Portal Core) Specific Aims: Describe how the specific aims for the Data Portal Core will be accomplished.

Research Strategy: Describe plans for collection of EHR data, integration of Eureka, and other informatics activities.

Describe plans for Data Portal management, including but not limited to:

EHR…