Part 1. Overview Information

Key Dates

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.

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 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.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of the NHLBI Outstanding Investigator Award (OIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Director/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards or are in the 6th or 7th year of support of an NHLBI R35 award and whose outstanding record of research demonstrates their ability to make major contributions to the heart, lung, blood and sleep (HLBS) research. The OIA is intended to support a research program, rather than a research project, by providing the primary, and most likely sole, source of NHLBI funding.

The OIA will support the research program of NHLBI-funded investigators for up to seven years and will provide increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer time frame. Research supported by the OIA must be within the scope of the NHLBI mission.

Applicants are strongly encouraged to review the NHLBI R35 Program Frequently Asked Questions (FAQs) and consult with the appropriate scientific research contacts.

Overview

This Notice of Funding Opportunity (NOFO) is intended for established investigators who have the potential to conduct outstanding, innovative research. For this reason, eligibility is limited. Please refer to Section III. Eligibility Information for specific details.

It is anticipated that the NHLBI OIA will:

• Provide a stable funding environment, thereby improving productivity and facilitating ambitious and creative research;
• Accelerate scientific innovation by enabling flexibility in pursuing new research directions as they arise, since PDs/PIs will not be bound to specific aims proposed in advance of the studies;
• Reduce the time researchers spend writing grant applications and managing multiple grant awards, thereby allowing more time to be devoted to conducting research;
• Facilitate PD/PIs' commitment to research through increased stability of funding; and
• Enable PD/PIs to devote more time and energy to mentoring junior scientists and providing scientific service.

An OIA is intended to be the primary, and in most cases, sole support for all the NHLBI-related research conducted by an investigator. Research supported through the OIA must be related to HLBS research areas as described within the scope of the NHLBI mission. Within these bounds, investigators will have the freedom and flexibility to explore new avenues of inquiry that arise during the course of their research. Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component requires prior approval of NHLBI according to existing policies and procedures.

It is expected that the OIA will replace current NHLBI funding on other NHLBI individual research grants, as described below. 

Research involving human subjects is permitted under this NOFO. Specifically, mechanistic trials and/or fundamental or basic experimental studies with humans (BESH) are permitted. NIH defines a mechanistic study as “a study designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention”. NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena or of observable facts without specific applications towards processes or products in mind”. However, Phase I, II, III, and T4 non-mechanistic clinical trials are not permitted under this NOFO.

The funding levels of an OIA will be determined by NHLBI, based on the recommendations of the Scientific Peer Review Committee, the National Heart, Lung, and Blood Advisory Council (NHLBAC), evaluation of the needs, expected productivity, current funding levels and availability of the funds. NHLBI will continue to implement NOT-OD-12-140, "Notice of NIH Special Council Review of Research Applications from PDs/PIs with More than $1.0 Million Direct Costs in Annual NIH Support" in considering all sources of investigator support.

Investigators should consider the following features of the OIA award when deciding to apply:

• OIAs will be for up to seven years;
• Existing individual Research Project grants will be relinquished when the OIA is awarded;
• The OIA is not tied to predefined scope or specific aims and thus provides increased flexibility to pursue new ideas and new research directions as the scientific opportunities arise; and
• A reduction in administrative burden associated with writing multiple grant applications and managing multiple grant awards.

PDs/PIs who are current R35 recipients in their sixth year of the R35 award can submit single PI R01 applications(s) and a new OIA application in parallel. If the R35 application is not successful and if the R01 application(s) meet the payline for the originally intended Fiscal Year, the R01(s) will be held across the Fiscal Year for funding considerations in the next Fiscal Year (see NHLBI R35 Program Frequently Asked Questions (FAQs)). Eligible PDs/PIs who are not current NHLBI R35 recipients can submit R01 application(s) and an OIA application in parallel. Should the R01 application(s) and the OIA be selected for funding, the PD/PI will be permitted to accept either the R01(s) or the OIA, but not both. 

The OIA is intended to provide the primary, and most likely sole source of NHLBI funding on individual grant awards. The OIA does not eliminate the eligibility of the PD/PI for the following separate sources of NHLBI funding:

• Grants supporting research resources (e.g., P30, R24, or U24 awards);
• Contracts;
• Cooperative agreements;
• Grants supporting training (K01, K08, K12, K22, K23, K25, K99, R25, T32, T35);
• Grants supporting workforce development or diversity building;
• Clinical trials that are not permitted under this NOFO (see above for allowable clinical trials);
• SBIR/STTR grants;
• Conference grants;
• NHLBI program project or center grants;
• NHLBI Catalyze Program Grants
• R35-eligible supplements (R35 recipients should check R35 eligibility on funding opportunities for supplements).

The NHLBI will not consider funding future individual PD/PI research grants from an OIA recipient during the OIA except when the existing OIA is within the last few months of the project period or in a No Cost Extension (NCE).  Alternatively, a recipient may receive R01 funding at any point during the OIA period if the OIA is bilaterally terminated.  Note that in this scenario, the PI cannot receive both R01 and OIA funding in the same Fiscal Year unless the R01 is reduced by the amount expended on the OIA.  For more information regarding R01 submission during recipient's 6th year to prevent a lapse of funding at the conclusion of the R35 award, see FAQs.

Applications Not Responsive to this NOFO:

The following types of projects are not responsive to this NOFO and will not proceed to review:

• Research outside the scope of the NHLBI mission; and
• Research that includes Phase I, II, III, or T4 non-mechanistic clinical trials (see NOT-OD-15-015 for the NIH definition of a clinical trial and NOT-HL-18-611 for NHLBI's Policy Regarding Submission of Clinical Trial Applications)
  • Please see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts for a list of all available NOFOs in which NHLBI participates, including those that support clinical trials.

Applications missing Letters of Support from the institution’s Authorized Organizational Official (AOR) will be considered not responsive and will not proceed to peer review.

Diversity Statement

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. For more information, see the Notice of NIH's Interest in Diversity.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted. Applications that do not meet eligibility requirements will not be reviewed.

Eligibility is determined by NHLBI after the receipt of the applications on the intended application due date. Eligibility to apply to this NOFO is limited to PDs/PIs who meet all the following criteria. 

• Are currently PD/PI of an NHLBI R35 award in the 6th or 7th year of support (please refer to NHLBI R35 FAQ for additional guidance) OR
• Are currently PD/PI on at least two NHLBI R01-equivalent (defined here as R01, DP1, or DP2) awards.
  • At least one of the R01-equivalent awards must meet all the following requirements:
    • Be a single-PD/PI award, AND
    • Not be in a no-cost extension (NCE), AND
    • Not be an NIH-defined clinical trial, unless that clinical trial meets the definition of a mechanistic clinical trial or a BESH trial, as defined in Section I of this NOFO.
  • The additional qualifying R01-equivalent(s) can be multiple-PD/PI, and/or in a first NCE, and/or an NIH-defined clinical trial.
• PDs/PIs must commit six person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the OIA.
• PDs/PIs must have received continuous R01-equivalent support from the NHLBI for at least the past four years as a PD/PI. Continuous support is defined having an active NHLBI support as PD/PI for an eligible NHLBI R01-equivalent grant in each Federal Fiscal Year (FY) beginning in FY 2022 (for February 2025 submission) or beginning in FY 2023 (for February 2026 submission) or beginning in FY 2024 (for February 2027 submission).

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

It is anticipated that the OIA will be highly competitive. To prevent a lapse in funding, PDs/PIs who are current R35 recipients in their sixth year of the R35 award can submit single PI R01 application(s) in parallel. If the R35 application is not successful and if the R01 application(s) meet the payline for the originally intended FY, the R01(s) will be held across FY for funding considerations in the next FY (see FAQ). Eligible PDs/PIs who are not current R35 recipients can submit R01 application(s) and an OIA application in parallel. Should both R01 and OIA applications be selected for funding, the PD/PI will be permitted to accept either the OIA or the R01 award but not both.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected] with copy to [email protected]

Page Limitations

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.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

Biographical Sketch: The OIA is intended for investigators with track records of creativity and consistent productivity with significant scientific impact. The PD/PI must, in the Biographical Sketch, address these considerations and demonstrate a history of conducting rigorous and reproducible research and reporting it transparently. In addition, the PD/PI must demonstrate their suitability for funding through the OIA, including flexibility and adaptability to new research opportunities. Explicitly address intellectual and technical contributions to any publications and highlight contributions since becoming an independent investigator. Include experience as a mentor of undergraduate and graduate students, postdoctoral or clinical fellows, medical students or junior faculty.

Current & Pending Support: Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form. List NHLBI grants first, followed by other NIH grants, followed by other sources of support.

Provide a list of all current and pending support for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications, regardless of source of support (e.g., Federal, private, non-profit). Show the total award amount for the entire award period (including indirect costs) as well as the number of person months per year to be devoted to the project by the senior/key person. Provide current and pending research support information at time of application using the format typically used for Just-in-Time information. Be sure to distinguish the direct costs per year that support research in the investigator's laboratory from support that goes to other investigators. Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice its review.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 7 years of support.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

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

Specific Aims: Do not use. Specific Aims are not required and should not be submitted.

Research Strategy: The Research Strategy should include the following information:

1. Background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed relevant to HLBS research. Describe the potential for the identified area(s) of research to be groundbreaking or paradigm-shifting. Describe future impact on HLBS research.

2. The overall vision, conceptual framework, and general strategies for furthering and sustaining the proposed research program, including plans for building on prior accomplishments to formulate a highly innovative program for advancing and transforming the research field. 

3. The importance of the research question and how the research could impact the current understanding of the problem being addressed and/or advance the field of study. Describe how the research program could evolve as the work is being performed and how the risks and challenges will be addressed. Explain how the proposed research program is in an area that will continue to be important and generate significant new discoveries within the mission of the NHLBI (e.g., describe how the research program will result in new opportunities, explore new areas of scientific inquiry, and develop new systems and strategies, if applicable).

The proposed research can be either a continuation of previous or current work of the PD/PI, or involve a new line of investigation. If the planned research diverges significantly from past/current work, explain the rationale for the changes and describe the ability of the PD/PI to undertake this new direction. A detailed experimental plan is not expected. Preliminary data are not required, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published. Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, the PD/PI will have the flexibility to change course and pursue them. Explain how the proposed research program will benefit from the flexibility, level of effort, and the longer-term funding offered by the OIA.

Letters of Support: The application must include a Letter of Support from the institution's Authorized Organizational Representative (AOR). Applications that are missing a Letter of Support will not be reviewed. The Letter of Support cannot exceed 2 pages in length.

In two pages or less, the Letter of Support must include:

• A statement that, if chosen to receive the OIA, the PD/PI will commit a minimum of six person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the OIA. Effort expended toward teaching, administrative, and/or clinical duties should not be included in the research effort calculation; however, a statement describing the overall level of professional effort devoted to research duties versus teaching, administrative, and/or clinical duties of the PD/PI is requested;
• A statement identifying the two current NHLBI R01-equivalent (defined here as R01, DP1, or DP2) awards or the existing NHLBI R35 award that render the PD/PI eligible for the OIA;
• Evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support, access to resources, protected time, space, etc.) for the duration of the award; and
• Awareness of and acceptance by the AOR that most NHLBI research awards must be relinquished as a condition of receiving an OIA, as described in this NOFO.

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): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

It is anticipated that the terms of award will include, but not be limited to, the following:

1. Awards funded under this NOFO are not subject to Streamlined Non-Competing Award Process (SNAP) authorities; annual financial reporting is required.

2. All funds must be expended within the approved project period.

3. Awards funded under this NOFO will not be provided the authority to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Grant Award, as outlined in the NIH Standard Award Terms and Conditions. All extensions, including the first extension, will require NIH prior approval.

4. A permanent change of PD/PI will not be allowed under the OIA.  A temporary change may be allowed with prior approval under circumstances such as medical conditions, disability, or personal or family situations.

5. Change of recipient institution will be allowable if the original recipient institution agrees to relinquish the OIA and the receiving institution agrees to all the required OIA terms.

6. It is expected that the OIA will replace all funded NHLBI single project/single PD/PI grants (see exceptions in Part 2, Section I of this NOFO). NHLBI-funded multiple PD/PI and multiple project grants as well as other NIH funding will be excluded; however, effort on those grants will need to be accommodated outside the requirement for six person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) that is required on the OIA.

7. It is expected that the PD/PI will renegotiate effort on other NIH grants, if necessary, to permit the required effort on the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment must reduce those other commitments to accommodate the OIA time and effort.

8. There must be continued evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support, access to resources, protected time, space, etc.) for the duration of the award.

9. The NHLBI will not consider funding future individual or multiple PD/PI research grants from an OIA recipient during the OIA project period, except for applications included under the list of exempted awards in Part 2, Section I of this NOFO.

10. Transfer of an OIA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval; however, OIA funds may not be used to support this component.

7. Other Submission Requirements and Information

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 NHLBI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In an NHLBI OIA application, applicants should not propose research that fits appropriately within the mission of other NIH Institutes and Centers (ICs). PD/PIs are encouraged to contact NHLBI Scientific/Research staff prior to submission of an NHLBI OIA application to discuss whether their application is relevant to the NHLBI mission and whether it overlaps with awards from other NIH ICs or independent funding entities.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

The OIA is meant to support a research program focused on HLBS research within the scope of the NHLBI mission for an individual PD/PI.

The OIA is intended to promote scientific productivity and innovation by providing stable and flexible funding. Applicants are expected to provide an overview of the research program, the scientific questions they currently plan to address, and a general description of possible strategies. Experimental details and preliminary data are not expected, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published.

Accordingly, in addition to the criteria below, reviewers will emphasize the following:

1. Evidence of important previous contributions made by the PD/PI to their field (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; professional service; etc.) based on their current career stage;

2. Evidence that the PD/PI has demonstrated outstanding HLBS research productivity of the highest quality;

3. Potential that the PD/PI will continue to impact and influence HLBS research at the same high caliber level in the future.

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.

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 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 to the NHLBI. 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 National Heart, Lung, and Blood Advisory Council. Final award decisions will be based on a variety of criteria relevant to scientific merit, program balance, and NHLBI strategic priorities including:

• Scientific and technical merit of the proposed program as determined by scientific peer review
• National Heart, Lung, and Blood Advisory Council (NHLBAC) recommendations
• Relevance to NHLBI’s strategic research priorities
• Overall programmatic portfolio balance and need (e.g., scientific gaps and needs, areas of interest to the NHLBI, poorly represented areas in Institute’s portfolio, overlap with existing programs, etc.)
• Potential for high scientific or public health impact (e.g., highly innovative research, research relevant to special populations that are disproportionately affected or understudied [women, medically underserved populations, pediatric populations, patients with rare diseases], etc.)

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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 institutions 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).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. 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 addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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.

Not Applicable

3. Data Management and Sharing

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.

4. Reporting

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.

The instructions are hereby amended as follows:

a) Under Section 6.2 B.1 What are the major goals of the project? Note that the goals of the program of research supported by the OIA are broader than the specific aims of a single project and should be appropriately described. If the goals of the OIA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and further contributions to the field, and an explanation of how the research continues to fit within NHLBI mission interests.

b) Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.

c) Under section D.2.c. additional information, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the OIA.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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. 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.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Division of Cardiovascular Sciences
Narasimhan Danthi, Ph.D.
Telephone: 301-451-5170
Email: [email protected]
 

Division of Lung Diseases
Lisa Postow, Ph.D.
Telephone: 301-827-7843
Email: [email protected]

Division of Blood Diseases and Resources
Andrei Kindzelski, M.D., Ph.D.
Telephone: 301-827-8275
Email: [email protected]
 

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI) 
Telephone: 301-435-0270
Email: [email protected]

Jasmine Johnson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8177
Email: [email protected]

Section VIII. Other Information

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.