The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Enabling Technologies and Transformative Platforms initiative will support needed to rigorously validate transformative, multi-use platforms or technologies that can enable. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.

RFA-HL-26-016: Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)

March 31, 2025

This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s) National Institutes of Health (NIH)

Components of Participating Organizations National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)

Activity Code R33 - Exploratory/Developmental Grants Phase II.

Announcement Type Reissue of RFA-HL-23-010

Related Notices

• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON) RFA-HL-26-016

Companion Funding Opportunity

• RFA-HL-26-017, R61/R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II
• RFA-HL-26-018, R33 Exploratory/Developmental Grants Phase II
• RFA-HL-26-019, R61/R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II
• RFA-HL-26-020, R33 Exploratory/Developmental Grants Phase II

Number of Applications See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.837, 93.838, 93.839, 93.233

Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) solicits grant applications to further develop enabling technologies and transformative platforms to catalyze next-generation predictive, diagnostic and therapeutic products to address heart, lung, blood, and sleep (HLBS)-related disorders and diseases. This NOFO solicits R33 applications where major feasibility gaps for the enabling technology or transformative platform have already been overcome, as demonstrated with supportive preliminary data, but still requires further development and rigorous validation to encourage downstream demonstration, utilization and adoption. Well-suited applications must offer the potential to accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention or epidemiology, while addressing issues associated with HLBS-related diseases and disorders. Projects proposing application of existing technologies where the novelty resides in the biological or clinical target/question being pursued are not appropriate for this solicitation. Applications considered nonresponsive to the NOFO will not be reviewed.

This NOFO is part of a suite of Catalyze innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Product Definition or Preclinical NOFOs.

Funding Opportunity Goal(s)

• 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.
• The Division of Lung Diseases supports research and research training on the causes, diagnosis, prevention, and treatment of lung diseases and sleep disorders. Research is funded through investigator-initiated and Institute-initiated grant programs and through contract programs in areas including asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis, respiratory neurobiology, sleep and circadian biology, sleep-disordered breathing, critical care and acute lung injury, developmental biology and pediatric pulmonary diseases, immunologic and fibrotic pulmonary disease, rare lung disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis. The Division is responsible for monitoring the latest research developments in the extramural scientific community as well as identifying research gaps and needs, obtaining advice from experts in the field, and implementing programs to address new opportunities.
• The Division of Blood Diseases and Resources supports research and research training on the pathophysiology, diagnosis, treatment, and prevention of non-malignant blood diseases, including anemias, sickle cell disease, thalassemia; leukocyte biology, pre-malignant processes such as myelodysplasia and myeloproliferative disorders; hemophilia and other abnormalities of hemostasis and thrombosis; and immune dysfunction. Funding encompasses a broad spectrum of hematologic inquiry, ranging from stem cell biology to medical management of blood diseases and to assuring the adequacy and safety of the nation's blood supply. Programs also support the development of novel cell-based therapies to bring the expertise of transfusion medicine and stem cell technology to the repair and regeneration of human tissues and organs.
• The National Center on Sleep Disorders Research (NCSDR) supports research and research training related to sleep disordered breathing, and the fundamental functions of sleep and circadian rhythms. The center also stewards several forums that facilitate the coordination of sleep research across NIH, other federal agencies and outside organizations, including the Sleep Disorders Research Advisory Board and an NIH-wide Sleep Research Coordinating Committee. The center also participates in the translation of new sleep research findings for dissemination to health care professionals and the public.

Key Dates

• Posted Date: November 22, 2024
• Open Date (Earliest Submission Date): January 11, 2025
• Application Due Dates:
  • February 11, 2025
  • June 18, 2025
  • October 21, 2025
  • February 11, 2026
  • June 18, 2026
  • October 21, 2026
  • February 11, 2027
  • June 17, 2027
  • October 21, 2027
• Review and Award Cycles:
  • New:
    • Scientific Merit Review: April 21, 2025; August 21, 2025; December 22, 2025; April 21, 2026; August 21, 2026; December 23, 2026; April 23, 2027; August 23, 2027; December 23, 2027
    • Advisory Council Review: July 2025; November 2025; March 2026; July 2026; November 2026; March 2027; July 2027; November 2027; March 2028
    • Earliest Start Date: June 18, 2025; October 21, 2025; February 11, 2026; June 18, 2026; October 21, 2026; February 11, 2027; June 17, 2027; October 21, 2027; February 11, 2028
  • Renewal / Resubmission / Revision (as allowed):
    • Scientific Merit Review: April 21, 2025; August 21, 2025; December 22, 2025; April 21, 2026; August 21, 2026; December 23, 2026; April 23, 2027; August 23, 2027; December 23, 2027
    • Advisory Council Review: July 2025; November 2025; March 2026; July 2026; November 2026; March 2027; July 2027; November 2027; March 2028
    • Earliest Start Date: June 18, 2025; October 21, 2025; February 11, 2026; June 18, 2026; October 21, 2026; February 11, 2027; June 17, 2027; October 21, 2027; February 11, 2028
  • AIDS - New/Renewal/Resubmission/Revision, as allowed:
    • Scientific Merit Review: April 21, 2025; August 21, 2025; December 22, 2025; April 21, 2026; August 21, 2026; December 23, 2026; April 23, 2027; August 23, 2027; December 23, 2027
    • Advisory Council Review: July 2025; November 2025; March 2026; July 2026; November 2026; March 2027; July 2027; November 2027; March 2028
    • Earliest Start Date: June 18, 2025; October 21, 2025; February 11, 2026; June 18, 2026; October 21, 2026; February 11, 2027; June 17, 2027; October 21, 2027; February 11, 2028

All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date December 24, 2027

Due Dates for E.O. 12372 Not Applicable

Required Application Instructions 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.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research

The NHLBI Catalyze innovation program is designed to provide a suite of comprehensive support and services to facilitate the transition of basic science discoveries into new treatments for diseases and disorders that fall under the NHLBI mission. The Catalyze Program initiatives support product development (supporting product definition studies and pre-clinical research and development) and enabling technologies and transformative platforms. Catalyze is coordinated by the Catalyze Coordinating Center, which provides program administration and evaluation, milestone-driven project management, communications and outreach, as well as development guidance for projects in the Catalyze portfolio. The Catalyze program aims to create cultural and systemic changes to more rapidly move breakthrough innovations to products that will have health, economic, and societal impact. Information on the Catalyze programs can be found on the Catalyze website.

This specific Catalyze Notice of Funding Opportunity (NOFO) solicits grant applications to rigorously validate transformative, multi-use platforms or technologies that can enable the next generation of predictive, diagnostic and therapeutic products or model systems relevant to heart, lung, blood and/or sleep (HLBS)-related diseases or disorders. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.

NOFO Emphasis:

The NOFO is suitable for projects in which major feasibility gaps for the technology or platform have already been overcome, as demonstrated with supportive preliminary data, but still requires further development and rigorous validation to establish repeatable, reliable performance in an HLBS-relevant context. Recipients projects should be between a mid- stage Technology Readiness Level (TRL) 3 and TRL4. For more information about technical readiness please refer to the Technology Readiness Guidelines.

Projects where the novelty resides in the application of the technology to a single biological issue or clinical need, or involves an efficacy demonstration for a specific disease or condition, are not appropriate for this NOFO. Applications considered nonresponsive to this NOFO will not be reviewed. However, such applications may be appropriate for other Catalyze NOFOs.

Objectives

The proposed projects must be focused on development and validation of an enabling or platform technology in a representative biologically or clinically relevant system. In addition, all projects proposed in response to this NOFO must involve the following general attributes:

• Offers novel capabilities that may be judged by appropriate experts as potentially transformative in laboratory and/or clinical settings, and beyond providing incremental improvements to existing capabilities.
• Rigorous study design with a verifiable approach, based on well-defined, performance measures (see below for description of performance measures). An application lacking performance measures will not be reviewed. For details on addressing these requirements, see [Section IV. Application and Submission Information](Section IV. Application and Submission Information).

Responsive Technologies and Scientific Scope

Responsive technologies include relevant novel or hybrid materials, chemical reagents, instrumentation, devices, and associated methods and models.

These technologies may be intended for molecular, cellular and/or organ-level analyses in-vitro, in-situ, and/or in-vivo (with some exceptions listed below), and may target basic, diagnostic, translational, epidemiological, and/or clinical gaps. It must be clear that proposed projects are focused on the development of platforms and technologies to enable development in certain areas (e.g., clinical detection, drug development, biomarker discovery and validation, or epidemiology), and NOT on pursuing specific discoveries (e.g., discovery of a novel biomarker or demonstrating efficacy for a novel therapeutic agent) or specific applications (e.g. detection of a known biomarker) in those areas.

Technology development projects that are HLBS-relevant are encouraged provided that the technology proposed meets the requirements stated above, including transformative potential.

Technologies may target atomic, molecular, sub-cellular, cellular and/or organ-level features.

At the core of any project must be a novel analysis or targeting capability (encompassing novel devices, materials, or chemical/biochemical approaches) with an accompanying validation plan. General areas of interest include, but are not limited to, the following:

• Drug discovery platforms for identification of molecules that stimulate endogenous repair mechanisms
• In vitro and in vivo models that enable clinically-relevant safety and efficacy testing of therapeutics
• Gene delivery and gene therapy technologies that minimize cost-of-goods and maximize safety (including reduced risk of insertional mutagenesis and ability to control expression levels and/or killing of cells with inappropriate expression)
• Technologies, including materials and devices, to deliver pharmaceutical or cell-based therapeutics
• Technologies for non-invasive, clinically relevant diagnosis and monitoring
• Cell expansion technologies that maintain adult stem cell self-renewal without concomitant increases in risk of transformation
• Tools to discover clinically-relevant biomarkers
• Novel tools or approaches for producing and improving animal models
• Technologies that can facilitate and/or enhance molecular analyses in HLBS disease epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of data)
• Point-of-care technologies (POCTs) to facilitate the collection of relevant biological data for examining the factors contributing to health disparities (e.g., for HLBS disease sub-types and differences across individuals with a variety of backgrounds)
• New approaches for stem cell authentication and standards
• Strategies for tracking and monitoring of stem cell therapies in vivo

IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this NOFO are encouraged to contact the Scientific/Research Contact(s) listed in Section VII.

Non-Responsive Projects

Applications considered non-responsive to the NOFO will not be reviewed. Focus on the following will be considered non-responsive:

• Biomarker discovery or biomarker validation. Pursuit of a biological or clinical hypothesis for which the novelty of the project resides in the biological or clinical question (i.e., traditional biological hypothesis-driven research) and NOT in the novel technical capability being developed;
• Development of specific contrast agents (though generalizable contrast agents are allowed);
• Development of drugs or therapies only intended to treat a specific disease or condition
• Development of devices only intended to treat a specific disease or condition
• Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods.
• Projects which are earlier in development, without first-generation prototypes and/or where major feasibility gaps for the enabling technology or transformative platform have not already been overcome are not responsive to this announcement, but should consider applying for support under NOT-HL-21-024 "Notice of Special Interest (NOSI): Bold New Bioengineering Research for Heart, Lung, Blood and Sleep Disorders and Diseases (Reissue)" and its reissues.
• Projects which are later in development, that have already developed a prototype of an enabling technology or transformative platform of proven feasibility, that has also satisfied rigorous performance measures, should consider applying for support from the Catalyze Product Definition NOFOs listed on the NHLBI Catalyze website.

Special Requirements for this NOFO

Project Management

Each project is expected to use project management processes that guide the studies to successful completion of the established milestones. While it may not be possible to have a full-time project manager, each project is expected to identify a team member who will hold this responsibility as a part of their project management plan. The Catalyze Coordinating Center may support the local project management through resources, educational materials, and regular communications. The project manager will support the development of milestones, timelines, and identification of risks and mitigation strategies and will work closely with the Program Officer and with the support of the Catalyze Coordinating Center to update and refine these upon notice of award and as needed through the project.

Milestones

Applicants are expected to propose activities and milestones, with an associated timeline, to be completed during the proposed duration of award.

Recipients will develop specific, measurable, achievable, relevant, and time-bound Specific Aims for their project. Specific Aims or a list of activities planned for each year are not considered milestones because they do not provide decision-making goals. Each Specific Aim should have at least one milestone associated with it. Milestones are an event or moment in time in a project that indicate progress toward a Specific Aim or a Specific Aim has been met. The project Specific Aims and milestones should be laid out as a timeline or GANNT chart as a part of the application.

Milestones will be peer reviewed as well as programmatically reviewed and if needed will be negotiated with the recipient before they are included in the terms of the award. NHLBI staff will monitor program progress against proposed milestones through quarterly meetings and make non-competing award decisions annually based on achieving milestones. NHLBI emphasizes the importance of the robustness and reproducibility of experimental results in evaluating progress.

Additional Considerations

• Applicants are strongly encouraged to contact Scientific/Research Staff listed in Section VII to discuss potential research projects prior to submitting an application.
• Prior to funding an application, NHLBI Program staff may contact the applicant to discuss the proposed performance measures, milestones, and any changes suggested by the NHLBI review panel or Program staff. A final set of approved performance measures and milestones will be specified in the Notice of Award.
• See [Section VIII. Other Information](Section VIII. Other Information) for award authorities and regulations.

Section II. Award Information

Funding Instrument Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

• New
• Resubmission

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.

Clinical Trial? Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? See NIH Guidance.

Funds Available and Anticipated Number of Awards NHLBI intends to commit total costs of up to $2,156,000 in FY 2026, $2,156,000 in FY 2027, and $2,156,000 in FY 2028. NHLBI expects to fund up to 4 new awards in FY 2026, 4 new awards in FY 2027, and 4 new awards in FY 2028, for a total of up to 12 new awards.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

• Application budgets must not exceed $350,000 direct costs per year.
• The total budget must reflect the actual needs of the proposed project and annual project budgets must reflect the actual costs anticipated in each year.

Award Project Period The maximum project period is two years. The scope of the project should determine the project period.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Foreign 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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the 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).

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 Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Instructions for Application Submission 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.
• Other Attachments
  • Statement of Potential Impact (Required) The filename "Statement of Potential Impact.pdf" should be used. The attachment may not exceed one page. Provide a description of the expected potential of the proposed technology to transform HLBS-research and clinical practice. Address the following questions:
    • How is the new capability provided by the proposed technology potentially transformative and why may it be expected to produce an unusually high impact on biomedical research and medicine (i.e., describe the potentially transformative outcomes that might be realized should this technology be successfully developed)?
    • If applicable, how will the proposed technology overcome limitations for currently available technologies or alternative approaches (i.e., provide evidence to substantiate the claim of innovativeness beyond currently available technologies)?
    • What are the next steps for the transformative capabilities to be transferred and/or demonstrated in a prototype product? Is there a track-record of such development, or are partnerships and collaborations in place?
• SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.
• R&R Budget All instructions in the How to Apply- Application Guide must be followed.
  • Applicants should include budget support for the PD/PI to participate in a 1.5-day NHLBI-held innovation meeting or workshop once each budget year in the Washington, DC/Metropolitan area.
  • Applicants should budget for an appropriate amount of project management 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:
  • Research Strategy: Applicants must address all of the following required aspects:
    • Advanced Development and Validation of HLBS-relevant Technology. Applications must focus on further development of a novel technology beyond the early-stage proof of concept demonstration and engage a rigorous validation of the novel capability in an HLBS-relevant biological context of use that targets the needs of basic, preventative, diagnostic, translational, epidemiological, and/or clinical research. Applications must provide appropriate background/preliminary data to justify that the proposed technology has passed the pilot developmental stage and shows promise. Describe the strategy and specific research steps to evaluate and rigorously validate the proposed technology within the context of its intended use (see performance measures, below).
    • Substantial Improvement and/or New Capabilities. All proposed technologies must offer the potential for substantial improvements over conventional approaches and/or add qualitatively new research capabilities not provided by existing technologies and approaches.
    • Transformative Potential. Define clearly the unmet technical need from the community being targeted by the technology and describe its anticipated use in laboratory research and/or clinical settings. Claimed potential impact is expected to be substantiated by specific performance measures (next bullet).
    • Performance measures. Propose explicit performance measures that are objectively assessable measures for determining targeted performance capabilities. They should be carefully justified and selected, and precisely defined, and must clearly detail the expected advantages of the proposed technology relative to existing technologies/approaches. Appropriately targeted performance measures require that the underlying experimental results have been subjected to appropriate statistical analysis, yielding a reasonable level of certainty that the targeted level of performance has been achieved.
    • Milestones: Define milestones that are specific, measurable, achievable, relevant, and time-bound. The milestones should allow program staff to assess progress during the period of the award. Specific aims or a list of activities are not considered milestones. Describe the milestones that need to be reached in the R33 phase to address the specific aims and ensure the successful completion of the entire project.
    • Timeline: Provide a detailed timeline with specific milestones for the work proposed in each year of the award. The timeline, specific goals and feasibility milestones should be clear and complete. Indicate when it is anticipated that essential components of the project will be completed. The proposed timeline with specific milestones should be clearly delineated and should be referenced in the Research Strategy Section.
    • Project Management: Describe specific plans for utilizing project management processes to enable continuous assessment of the progress of the project relative to the established milestones and how the progress assessments will be used to make strategic decisions regarding the proposed project. While it may not be possible to have a full-time project manager, each project is expected to identify a team member who will hold this responsibility as a part of their project management plan. The Catalyze Coordinating Center may support the local project management through resources, educational materials, and regular communications.
  • Rigor and Reproducibility High-quality and reproducible product definition studies are an essential cornerstone of the translational research enterprise. Attention to principles of study design and transparency is essential to enable stakeholders to assess the quality of the experimental design and scientific findings. In support of this important goal, investigators must follow instructions to address Rigor and Reproducibility.
  • Additional Information on Performance Measures Within Research Strategy there must be a dedicated subsection labeled "Performance Measures". Performance measures should be well-described, quantifiable, and scientifically justified. Critical components for proposed measures include the numerically described target of performance as well as the means by which it will be assessed. Proposed performance measures will be a means of supporting success for the validation of the technology. Performance measures should include the relevant statistical context for the targeted parameter. Whenever appropriate, present the proposed measures in the context of current technologies to substantiate the anticipated transformative potential. All performance measures should be described within the context in which they would be assessed, statistical strength of the resulting measures, and the approach by which they will be determined. Specific aims may not be regarded as performance measures. The specific aims describe the goals and intended path of the research. Performance measures provide the means for objectively assessing progress against those aims and substantiate the potential impact the technology might have on HLBS research or clinical use. The project will be evaluated for success based on the completion of the performance measure(s) proposed. For some specific aims, it may be sufficient to define a single performance measure. For others, multiple performance measures may be more appropriate. An example of a properly described performance measure could be achieving a detection limit of 1 femtogram of a targeted analyte per microliter of sample or less with a p value < 0.05 under conditions a, b and c, and with 95% confidence limits +/- 0.2 fg for a 2 fg reading over a concentration range of g to h. Other types of performance measures might include:
    • Detection of a single mutated cell out of 109 differentiated therapeutic cells, with false positive detection rate <2%;
    • Demonstration that the measured analyte is highly correlated (Pearson correlation coefficient r >0.95) for a given human serum sample when analyzed on different days. This should include mean, standard deviation, and relative standard deviation for repeatability targets superior to next best approach (if applicable);
    • Reduction of sequence read errors to one in 5,000,000 base pairs; and/or
    • Demonstration that the technology can be n-fold faster, or n-fold more sensitive, or n-fold more specific, etc, than the current "gold standard" technology. Please note these additional performance measure examples should still be properly described in an experimental context as demonstrated in the example above.
  • 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:
    • 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.
• 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.

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

Mandatory Disclosure 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 oig.hotline@hhs.gov.

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.

Overall Impact 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.

Scored Review Criteria 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.

Factor 1. Importance of the Research (Significance and Innovation)

• Significance Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance. Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.
• Innovation Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
• Specific to this NOFO:
  • Assess how well the feasibility gaps for the technology or platform have been overcome, based on the preliminary data.
  • Evaluate the likeliness that the proposed technology will be widely adopted by the relevant research and development community.
  • Evaluate the potential transformative impact and transformative outcomes of the proposed technology to biomedical research and medicine.

Factor 2. Rigor and Feasibility (Approach)

• Approach Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).
  • Rigor:
    • Evaluate the potential to produce unbiased, reproducible, robust data.
    • Evaluate the rigor of experimental design and whether appropriate controls are in place.
    • Evaluate whether the sample size is sufficient and well-justified.
    • Assess the quality of the plans for analysis, interpretation, and reporting of results.
    • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
    • For applications involving human subjects or vertebrate animals, also evaluate:
      • the rigor of the intervention or study manipulation (if applicable to the study design).
      • whether outcome variables are justified.
      • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
      • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
    • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.
  • Feasibility:
    • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
    • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex.
    • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.
• Specific to this NOFO:
  • Evaluate the milestones for each phase for appropriateness, measurability, achievability, and how well-suited they are for achieving the goals of the project.
  • Evaluate how realistic, achievable, and non-duplicative the proposed timelines are.
  • Evaluate how well-described, quantifiable, and scientifically justified the performance measures are.
  • Assess how well the proposed performance measures provide a means of supporting the success for the validation of the technology.

Factor 3. Expertise and Resources (Investigator(s) and Environment)

• 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 to this NOFO:
  • Evaluate the project management structure for its likeliness to be efficient and effective in keeping the proposed activities on schedule according to the proposed timeline.

Additional Review Criteria 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.

• Protections for Human Subjects 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.
• Vertebrate Animals 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.
• Biohazards 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.
• Resubmissions As applicable, evaluate the full application as now presented.
• Renewals As applicable, evaluate the progress made in the last funding period.
• Revisions Not Applicable

Additional Review Considerations 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.

• Authentication of Key Biological and/or Chemical Resources For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
• Budget and Period of Support Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Heart, Lung and Blood Institute 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with data management and resource sharing policies.

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.

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

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](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.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• 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.
• 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:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award. 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.

Cooperative Agreement Terms and Conditions of Award 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 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

• 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@od.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

Scientific/Research Contact(s)

• General Questions
  • Mike Pieck, Ph.D.
  • Telephone: 301-827-7986
  • Email: mike.pieck@nih.gov
• Division of Blood Diseases and Research
  • Nitin Agrawal, Ph.D.
  • National Heart, Lung and Blood Institute (NHLBI)
  • Telephone: 301-435-7768
  • Email: nitin.agrawal@nih.gov
• Division of Cardiovascular Sciences
  • Rahul Thakar, Ph.D.
  • National Heart, Lung and Blood Institute (NHLBI)
  • Telephone: 301-827-8151
  • Email: rahul.thakar@nih.gov
• National Center on Sleep Disorders Research
  • Alfonso Alfini, Ph.D.
  • National Heart, Lung and Blood Institute (NHLBI)
  • Telephone: 301-435-0199
  • Email: alfonso.alfini@nih.gov
• Division of Lung Diseases
  • Sidd Shenoy, Ph.D.
  • National Heart, Lung and Blood Institute (NHLBI)
  • Telephone: 301-435-0202
  • Email: sidd.shenoy@nih.gov

Peer Review Contact(s)

• Director, Office of Scientific Review
• National Heart, Lung, and Blood Institute (NHLBI)
• Email: nhlbi_asr@nhlbi.nih.gov

Financial/Grants Management Contact(s)

• Ron Caulder
• National Heart, Lung, and Blood Institute (NHLBI)
• Telephone: 301-827-8020
• Email: ronald.caulder@nih.gov

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.

Authority and Regulations 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.

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