EXPIRED
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
U01 Research Project – Cooperative Agreements
This is a non-competitive funding opportunity intended to fund a single award. The NHLBI is announcing its intent to issue a single source cooperative agreement to Cincinnati Children’s Hospital Medical Center. This Notice of Funding Opportunity (NOFO) solicits transition of the Bench-to-Bassinet (B2B) Program Administrative Coordinating Center into a B2B CHANGE (Congenital Heart disease Advancing New understanding in GEnomics) Cohort Data Coordinating Center (CC).
The CC will leverage and maintain the existing data platform (HeartsMart) of the B2B Pediatric Cardiac Genomics Consortium (PCGC); therefore, only the current B2B Coordinating Center is eligible to apply to this NOFO. The CC will also administer subawards to sites that have enrolled participants into the PCGC Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) to enable expanded data collection as a longitudinal cohort. Follow-up will involve deep clinical phenotyping. Limited new enrollment at the sites contracted through subawards will be supported as necessary to enhance representation within the cohort. The CC will be responsible for making the current and future data readily available to the scientific community and serve as the B2B CHANGE liaison to the broader congenital heart disease (CHD) research community.
To foster 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.
30 days prior to the application due date.
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 |
March 18, 2025 | Not Applicable | Not Applicable | July 2025 | October 2025 | December 2025 |
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 instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the 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.
Background
The B2B Program was launched by the NHLBI in 2009 as a novel approach to break through the major barriers of translational research, identify the causes of human congenital heart disease (CHD), and ultimately improve outcomes for individuals with CHD. It included two consortia designed to inform each other’s work: the Pediatric Cardiac Genomics Consortium (PCGC) and the Cardiac Developmental Data Research Center (CDDRC). The initial focus of B2B was data generation describing the developmental biology and genetic basis of CHD. Through the CHD GENES study, the PCGC enrolled and conducted genomic sequencing on over 13,000 participants with CHD and 18,000 family members. CHD GENES data is a valuable resource of human genetic data shared through the NHLBI BioData Catalyst platform; developmental biology data is shared through the CDDRC (https://cddrc.org/).
The PCGC’s CHD GENES cohort is one of the largest CHD cohorts to date with genomic and clinical data. Using this robust cohort, the PCGC has changed the landscape of CHD genetics through discoveries that now account for an estimated 25% of previously unexplained CHD. In the final project cycle of the PCGC, ending in 2025, the B2B has expanded its focus beyond studying genetic etiology to investigate clinical outcomes through phenotyping of this cohort. This necessitated consortium members working with the current Coordinating Center (CC) to develop processes to capture clinical data through electronic medical records. Although CHD GENES was not originally designed as a longitudinal cohort, the NHLBI recognizes the opportunity provided by this unique cohort to couple genomics data with deep longitudinal phenotyping. Through this solicitation, NHLBI directs the CC to coordinate deep phenotyping of a subset of CHD GENES participants and make the data available to the scientific community as the B2B CHANGE Cohort.
Research Objectives and Scope
The B2B PCGC will evolve into the B2B CHANGE Cohort to conduct ongoing clinical follow-up and deep phenotyping on cohort participants. The overall objectives of the B2B CHANGE Cohort are:
The B2B CHANGE Cohort will include longitudinal follow-up and deep phenotyping on an estimated 6,000 individuals in the current PCGC cohort. The B2B CHANGE Cohort should be racially and ethnically comprehensive to adequately represent the CHD population; this complexity should be achieved through community engagement to retain the current cohort and limited continued enrollment at the clinical research sites to increase representation. Consistent with existing NIH practices and applicable law, NIH does not use the race, ethnicity, or sex of prospective participants, participants, or faculty in the application review process or funding decisions.
The B2B CHANGE Cohort will provide a platform for independently funded, investigator-initiated, ancillary studies to answer important clinical and mechanistic questions. The role of the CC will be to lead, advance, and coordinate critical outreach, data and resource management, and administrative activities of the B2B CHANGE Cohort. The CC will issue subawards to clinical research sites that have previously enrolled participants into CHD GENES to engage cohort participants and deepen clinical phenotyping (e.g., using registry and electronic health record extraction) under a B2B CHANGE protocol. The CC will support the clinical research sites to perform a one-time in-person assessment, which will include a questionnaire, vital signs and anthropomorphic measurements, blood specimen collection, ancillary study testing and other testing as determined by the CC and investigators.
CC functions, which may be supported by subawards or provided in-house, include but are not limited to:
1. Operations:
2. Cohort Engagement and Follow up:
3. Protocol Development and Implementation:
4. Core Facilities and Data Management:
5. Establish a governance process
Specific Areas of Research Interest
To enhance the scientific value of the B2B CHANGE Cohort, it is anticipated that investigators will apply for grants or other funding mechanisms to conduct ancillary studies. The CC will provide advice and consultation to investigators in ancillary study design and protocol development process. Approved ancillary studies will allow for additional testing or data collection either during an in-person baseline assessment or through longitudinal data extraction efforts. The CC will coordinate with the ancillary study PIs and the subaward sites to facilitate this process.
Examples of Research Questions for Future Ancillary Studies include, but are not limited to:
Data Sharing
A critical mission of the B2B program is to expand resources to the broader scientific community to advance research. Data generated by the B2B CHANGE Cohort are expected to be made available to the broader research community through open, shared databases such as dbGaP or NHLBI BioData Catalyst. Appropriate controls will be implemented to ensure patient privacy and regulatory compliance.
This is a non-competitive funding opportunity intended to fund a single award. NHLBI is announcing its intent to issue a single source cooperative agreement to Cincinnati Children’s Hospital Medical Center for the transition of the Bench-to-Bassinet (B2B) Program Administrative Coordinating Center into a B2B CHANGE (Congenital Heart disease Advancing New understanding in GEnomics) Cohort Data Coordinating Center (CC). This award is single-source in order to continue and maintain long-term infrastructure investments. The award will enable the current PCGC Administrative Coordinating Center to build on its existing infrastructure, including its robust datahub, to support the goals of the B2B CHANGE Cohort.
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 provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
NHLBI intends to commit an estimated total costs of up to $$6,416,600 annually in FY2026, FY2027, FY2028, FY2029, FY2030, and FY2031 to fund 1 award.
Application budgets may not exceed $4,010,000 in direct costs per year.
The maximum period is 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: Cincinnati Children's Hospital Medical Center. Please refer to Section I. Notice of Funding Opportunity Information for more details.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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 the 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.
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 their 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(s)/PD(s) associated with award issued under RFA-HL-21-002 to the Cincinnati Children's Hospital Medical Center 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 Definition of Terms.
Number of Applications
Special Requirements
Only a single award will be issued to the Cincinnati Children's Hospital Medical Center 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
Facilities and Other Resources: Describe special or unique strengths that are relevant to B2B infrastructure and research. An example could include the availability of state-of-the art biomedical or research informatics systems (e.g., innovative tools, methods and algorithms), which may be shared or may be available to develop and expand scientific productivity of the B2B.
All instructions in the How to Apply- Application Guide must be followed.
Without duplicating information from the individual biosketches, investigators are encouraged to describe special or unique strengths that may be relevant to B2B infrastructure and research. Examples could include significant previous experience coordinating genomics research programs or prior participation in research funded by NIH cooperative agreements. Describe previous experience in organizing, supporting, and conducting annual in-person, monthly teleconference, and video conference meetings, and preparation of minutes and other related reports. Demonstrate experience in providing logistical services for multi-center translational or clinical research.
All instructions in the How to Apply- Application Guide must be followed.
In addition, the budget should designate a minimum of 2.4 person months effort for the PD/PI, or a minimum of 2.4 person months combined effort for all PDs/PIs if the application includes multiple PDs/PIs.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
The main focus of the application should be to propose a plan to meet the research coordination activities to support the B2B CHANGE Cohort objectives. The Research Strategy must consist of the following subsections:
A. Management Strategy
Provide a description of the leadership approach, governance, and organizational structure including an organized, feasible strategy for the coordination of the clinical research sites through subawards. Include detailed timelines for the initiation and completion of key activities (operations, core facilities and data management).
Include a statement indicating willingness to engage in collaborative activities across the B2B, in partnership with NHLBI staff, to support the goals of the B2B CHANGE Cohort and to accelerate translation of study findings to the scientific community and clinical practice.
B. Operations
Expertise and Experience in Logistical and other Support Services: The CC will provide arrangements for logistical support associated with meetings and conference calls for the SC, working groups, the EOC, the OSMB, and other meetings as required. Describe plans for organizing, supporting, and conducting monthly videoconference meetings, and preparation of minutes and other related reports. Describe plans for providing logistical services for multi-center translational or clinical research.
Describe a plan to review applications submitted to the SC, including ancillary study applications.
Electronic Information and Data Systems: Describe plans to produce, maintain, and disseminate all documents including a Manual of Operations and procedures manuals. Dissemination is expected to include an interactive website to publicize the B2B CHANGE Cohort to investigators and cohort participants, to announce the availability of B2B-supported resources, and to receive input from CHD investigators; and provide a mechanism for rapid and routine exchange of materials (e.g., manuscripts, reports, etc.) among the B2B investigators, the NHLBI Project Scientists, and other NHLBI staff. Internal communications infrastructure is to include a web portal for document sharing, scheduling, announcements, and other activities as needed.
Provide details of prior experience with electronic information and data systems activities, including innovative systems for management and archiving of email traffic and electronic reports, development of standard operating procedures, and ensuring data safety and confidentiality.
Describe plans for development and implementation of a program to enable CHD researchers to readily access the B2B CHANGE Cohort data in a secure manner. Describe plans to facilitate trainees and early-career investigators interested in working with the data for their research. Describe plans for periodic updates.
Cohort Outreach: The CC will work with the subaward sites to actively re-engage and communicate with previously enrolled B2B participants. Describe plans for outreach efforts to the cohort either on a national or site level, and plans on how to incentivize participation in the cohort. A subaward may be considered to enhance outreach efforts.
C. Protocol Development
Describe a plan to support the development, coordination, implementation, and conduct of B2B collaborative research protocols to include but not limited to:
D. Subaward Sites and Data Management
Applicants must describe plans for:
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.
Other Plan(s):
All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.
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). 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 the 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.
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) 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. See Section III of this NOFO for information on registration requirements.
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 the 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 the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.
Significance
Innovation
Specific to this NOFO:
Approach
Rigor:
Feasibility:
Specific to this NOFO:
Investigator(s)
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Environment
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
Specific for this NOFO:
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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 research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
Not Applicable.
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.
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate 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) convened by the NHLBI, in accordance with NIH peer review policy and procedures, 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.
Appeals 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, consistent with applicable law.
Please note that reviewers will not consider race, ethnicity, age, or sex of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its 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 his or her 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.
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.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
Successful recipients under this NOFO agree that:
Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.
Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.
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:
Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.
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 the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS regulation 45 CFR Part 16.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
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)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Bryanna Schwartz, MD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-594-8868
Email: Bryanna.schwartz@nih.gov
Charlene Schramm, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0510
Email: SchrammC@mail.nih.gov
Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
E-Bijan Cox
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-8628
Email: e-bijan.cox@nih.gov
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.