National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
U54 Specialized Center- Cooperative Agreements
See Section III. 3. Additional Information on Eligibility.
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.
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.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | July 09, 2026 | Not Applicable | November 2026 | January 2027 | 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.
Not Applicable
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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.
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.
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).
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. accrual goals for women, minorities, and individuals of all ages. 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'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.
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.
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.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The NHLBI intends to commit up to $2,541,000 in total costs to fund up to one (1) new award in FY2027.
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.
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.
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.
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.
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.
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.
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.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
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:
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.
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.
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.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 6 | Required | 1 | 1 |
| Admin Core | Admin Core | 6 | Required | 1 | 1 |
| Data Portal Core | Data Portal Core | 6 | Required | 1 | 1 |
| Data Management Core | Data Management Core | 6 | Required | 1 | 1 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
The application should consist of the following components:
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.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
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.
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.
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.
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.
Research Strategy:
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:
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.
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.
All instructions in the How to Apply- Application Guide must be followed.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
Specific to this NOFO
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:
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.
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:
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.
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.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
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 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.
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:
Letters of Support: Only letters of support specific to ‘Data Portal 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:
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.
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.
When preparing your application, use Component Type ‘Data Management Core.’
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
Specific to this NOFO: Describe the previous experience, if any, of the Data Management Core Lead in participating in large-scale collaborative programs involving coordination of data generation across multiple projects.
Budget forms appropriate for the specific component will be included in the application package.
Specific to this NOFO: The suggested budget for the Data Management Core is $400,000 direct costs per year for Years 1-6 to execute data handling and provide shared data resources.
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.
Specific Aims: Describe how the specific aims for the Data Management Core will be accomplished.
Research Strategy: Describe plans for data handling, including but not limited to:
Letters of Support: Only letters of support specific to ‘Data Management 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:
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.
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.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this NOFO:
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this NOFO:
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
For clinical trials, does the project use innovative designs such as platform trials, real-time adaptive methods, seamless Phase I/II designs, Bayesian designs or decentralized trial elements, as applicable?
Specific to this NOFO:
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO:
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this NOFO:
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.”
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have primary responsibility for:
The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NHLBI for the performance and proper conduct of the research supported by the U01 award in accordance with these terms and conditions of the award. As such, the recipient PD(s)/PI(s) will be responsible for all aspects of the study and cohort, as well as any modification(s), unless otherwise provided for in these terms or by action of the cohort Steering Committee.
Specific responsibilities include:
The recipient will be required to provide updated descriptive and meta-data to the NHLBI upon request, including cohort characteristics, study protocols, basic counts of study participants, enrollment progress, biospecimen availability, and study variable definitions. Recipients must also provide analytical data files (illustrative examples include: derived/calculated data variables; finalized questionnaire data; data from procedures, such as spirometry, echocardiography, ECG, exercise testing, polysomnography, etc.; participant follow-up data; clinical event outcomes data) to the NHLBI periodically based upon a mutually agreed schedule and format and at the end of the period of this award, along with documentation necessary for their use.
Recipients will be expected to evaluate and document compliance with NCI's Best Practices for Biospecimen Resources for collection, processing, and storage of previously collected biospecimens (https://biospecimens.cancer.gov/bestpractices/). Recipients will be required to explore, with NHLBI staff, the feasibility of data harmonization and pooling with other cohorts and studies. Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
Recipients agree to the governance of the study through a Steering Committee and to accept and implement decisions approved by the Steering Committee (see "Joint Responsibilities" section below).
Recipients are expected to make their data widely available to other investigators per NIH and NHLBI data sharing policies (https://sharing.nih.gov/data-management-and-sharing-policy, https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing). Study investigators are strongly encouraged to publish and disseminate results, tools, resources, and other products of the study, in accordance with the study protocols and governance. It is expected that all methods, analyses, software, and algorithms will be made available in a timely manner to the scientific community.
Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party; involvement of study resources; citing the name of the study or NHLBI support; or special access to study results, data, findings, or resources requires notification of and concurrence by NHLBI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to and concurrence by NHLBI.
NHLBI staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
A designated NHLBI Project Scientist(s) will have the following responsibilities:
In addition to the Project Scientist, a separate NHLBI Program Official will be responsible for the normal program stewardship of the cooperative agreement, and will be in the Notice of Award. However, the NHLBI may elect to have a dual-role approach where a single individual may act as both the NHLBI Project Scientist and Program Official. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist. The responsibility for final decision making may reside with Senior Institute management, separate organizational components, and/or oversight committees. Because it is anticipated that the Program Official will participate in activities that rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest (e.g., co-publication), other staff members such as direct line supervisor and/or other Senior NHLBI Program management staff may serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award. Additional NHLBI staff members may be designated to have substantial involvement in the study.
The NHLBI policy on authorship and manuscript review of NHLBI-sponsored extramural research protects against conflicts of interest with the Program Officer.
The NHLBI reserves the right to withhold funding or curtail the study in the event that any of the following occur:
Areas of Joint Responsibility:
Each cohort established under this NOFO shall have a Steering Committee (SC) that serves as its main governing board. The SC voting membership shall be determined jointly by the PDs/PIs and the NHLBI, but shall minimally consist of the study center(s) PI(s), the NHLBI Project Scientist(s), the Data Translation Center PI(s) (if applicable), and the Clinical Trial Center PI(s) (if applicable). Additional members may be added by majority vote of the SC. Meetings of the SC will ordinarily be held by teleconference, video conference, or in-person. All NIH staff members will share one combined vote in support of the project.
The appointed voting Steering Committee members will be required to attend all Steering Committee meetings and tele/video conferences, or to appoint a substitute that will be fully briefed on the issues at hand. Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members. The Steering Committee may also form an Executive Committee (EC) and/or subcommittees as needed. The NHLBI Project Scientist(s) may serve on the EC and on subcommittees as deemed appropriate. The Chair(s) of the Steering Committee will be selected from the SC voting members.
The Steering Committee will have primary responsibility for:
All investigators/staff within the study will be required to accept and implement the policies approved by the Steering Committee to the extent consistent with applicable grant regulations.
Where applicable, the recipient will work with the NHLBI on efforts to harmonize data across NHLBI cohorts and studies, and explore the feasibility of using common data standards and elements.
NHLBI will partner with the PD(s)/PI(s) to ensure dataset and documentation preparation is congruent for submission to the Biological Specimen and Data Repository Information Coordinating Center (BioLINCC (https://biolincc.nhlbi.nih.gov/submit_datasets/)) as described in the NHLBI Supplement to the NIH Policy for Data Management and Sharing (https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing). Large-scale genomic data generated by the recipient are to be deposited along with associated phenotype data into the database of Genomic and Phenotype Data (dbGaP, accessed at (https://www.ncbi.nlm.nih.gov/gap/)) in accordance with the NIH Genomic Data Sharing Policy available at https://sharing.nih.gov/genomic-data-sharing-policy.
NHLBI will partner with the recipient to create a transition plan to enable the transfer of resources and responsibilities to a new recipient when this award concludes (if applicable).
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Division of Cardiovascular Sciences, HeartShare Team
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: N/A
Email: nhlbiheartshare@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBIOGMInbox@nhlbi.nih.gov
Subject: RFA-HL-27-009
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.