RFA-HL-26-020: Catalyze: Product Definition – Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)

RFA-HL-26-020: Catalyze: Product Definition – Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) is sponsored by National Heart, Lung, and Blood Institute (NHLBI). Supports the optimization of medical device prototypes, focusing on product definition and development.

RFA-HL-26-020: Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) 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: Product Definition – Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed) R33 Exploratory/Developmental Grants Phase II. January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 . 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) Companion Funding Opportunity Exploratory/Developmental Grants Phase II Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II Exploratory/Developmental Grants Phase II Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 837, 93. 233, 93.

838, 93. 839 Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) will provide the early stage translational support needed for prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders.

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 Preclinical program or attract independent development support from other federal or private partners for preclinical product optimization and characterization.

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.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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 Catalyze Product Definition: Medical Device Prototype Optimization The NHLBI Catalyze 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 Product Definition NOFO will provide the early stage translational support needed for prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of HLBS diseases and disorders.

Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. A companion NOFO ( RFA-HL-26-019 ) is available for earlier stage projects (initial prototype design/testing).

For innovators developing small molecule and biologics, Catalyze has companion initiatives that support therapeutic development ( RFA-HL-26-017 and RFA-HL-26-018 ), and an initiative to support enabling technologies and transformative platforms for HLBS ( RFA-HL-26-016 ). See website for additional information. Novelty: This NOFO seeks applications that propose to apply new knowledge around novel devices, diagnostics and research tools.

Projects should aim to develop potential products that are significant improvements over existing solutions for HLBS diseases and disorders. It is expected that proposed projects will provide evidence of the unmet gaps and needs to support proposed activities.

Biological rationale and preliminary data: This NOFO will fund projects that have a strong biological rationale for the intended approach, which have preliminary data that reflect well-designed experiments (either from the literature, data from other sources, or, when available, from investigator-generated data).

Relevance for development: Projects that propose to develop novel therapeutic agents that can be advanced towards development of NHLBI mission-relevant therapies and cures and fulfill the clinical gaps and needs are of high programmatic interest.

Applicants will be expected to have completed the following: Tested key components testing (electronics, control and feedback system, sensing element, stent deployment, fluid handling, purification/separation efficiency, etc) Performed computational modeling to inform design features of the device or diagnostic Achieved first prototype or bench-top unit and assess for anatomical fit and ease of implantation Conducted In-vitro testing Conducted acute in-vivo testing Conducted small animal model testing Conducted limited biocompatibility, hemocompatibility, histopathology testing Completed preclinical testing or training with limited human samples Treated/analyzed spiked samples Generated experimental design, have a working prototype and preclinical testing and have a working prototype Optimized or scaled-up synthesis of a novel imaging agent Performed in-vitro cytotoxicity and mutagenesis assays for a novel imaging agent Incorporated a new assay or multiple assays onto an existing sensing platform Identified a disease target Designed and evaluated algorithms for HLBS disease detection Designed and built a smartphone user interface and conduct limited user testing Conducted pilot studies to establish feasibility of larger trial to assess tool effectiveness in changing user behavior Conducted focus group studies for initial usability testing Assessed response to reference compounds, for tissue-based high-throughput drug screening tools Have an initial design of a computer-aided system to import patient electronic health record data and prescribe the best regimen of medications All projects funded through this NOFO will be expected to provide preliminary or advanced intellectual property and regulatory strategies (depending on project stage), evidence of an Accelerator Partner and secured non-federal matching funds to support project development.

For Devices , the R33 allows prototype development and testing, in addition to modifying design features and user feedback.

Examples of activities for the R33 phase may include, but are not limited to: Complete system integration Engineering optimization to reduce size, weight, cost or improve system performance, reliability, repeatability, power consumption, durability Design for manufacturing, transition to contract manufacturer Parametric investigation for component or system optimization Performance comparison against gold standard, competitive devices In-vivo evaluation for reduction in procedure time by a panel of independent surgeons Verification and validation testing according to ASTM standards Demonstrate safety and reliability in chronic in-vivo testing Large animal model testing Bicompatibility, hemocompatibility, histopathology testing per accepted standards Pre-submission meeting with FDA For Diagnostics , the R33 award allows product generation, exploration of assay components and characterization of a load design.

Examples of activities for the R33 phase may include, but are not limited to: Validation in a large panel of human samples or large clinical datasets Improvements in sensitivity, repeatability, precision, accuracy, stability Identify misuse modalities Performance comparison against gold standard, international standards or competitive devices Pre-submission meeting with FDA Assess pharmacokinetics and biodistribution of a novel imaging agent in an animal model Evaluate multiplex assay, interfering analytes and miniaturized geometry For Research Tools , the R33 will allow product improvement, large trial testing and data integration.

For research tools, activities for the R33 Phase may include, but are not limited to: Improve smartphone user interface based on large population testing Large human trial to assess tool usability/comfort, and effectiveness in changing user behavior vs standard medical guidance Wireless data integration with electronic health records Extend smartphone app and associated systems to iOS or Android platform Use AI and large numbers/concentrations of compounds to train the prediction system and evaluate its performance, for tissue-based high-throughput drug screening tools Multi-site clinical study of a computer-aided system to compare computer-recommended prescriptions vs standard medical therapy Applications considered nonresponsive to the NOFO will not be reviewed.

Examples of activities that are not appropriate for this NOFO include, but are not limited to: Activities geared toward therapeutic agent development (See companion NOFOs RFA-HL-26-017 and RFA-HL-26-018 ) Early stage device and diagnostic development activities, including initial prototype and diagnostic disease target identification (See companion NOFO RFA-HL-26-016 ) Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers Clinical research and clinical trials Special Requirements for this NOFO The NHLBI recognizes that early stage product development requires access to unique expertise, including regulatory, reimbursement, business, legal, partner engagement, and project management.

The NHLBI will work with recipients to provide guidance and support in these unique areas of expertise, if needed, to enable advancement of devices, diagnostics and tools towards preclinical testing and development. 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.

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. 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 has been made or that a Specific Aim has been completed. The project Specific Aims and milestones should be laid out as a timeline or GANNT chart as a part of the application. Specific Aims or a list of activities planned for each year are not considered milestones because they do not provide decision-making goals.

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. Cost matching is expected for applicants responding to this NOFO . It is recommended that recipients provide a minimum of a 0.

25:1 non-Federal cash match of the Federal direct costs requested. Institutions must be able to document their actual contributions to the project and provide assurances that the organization(s) are committed to providing the funds and resources for their share of the project. Federal funds may not be used as a source of matching funds.

To be considered responsive to this NOFO, applicants are expected to provide sufficient information regarding the use of any third party support to demonstrate a substantial value-added contribution toward the development of the technology.

Generally, cost matching may not be met from the following sources: Costs borne by another Federal grant or sub award Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient) If the application proposes cost matching, then a letter of support from any non-Federal source(s) of cost matching must be included.

At least one Accelerator Partner is required for this award. Accelerator Partners are commercialization experts working as development partners with innovators whose projects are funded through the Catalyze program. Accelerator Partners help innovator-researchers achieve the necessary multidisciplinary approach for developing technologies.

Accelerator Partners provide skills development and mentoring to enable innovator-researchers to assess the medical and commercial potential of their projects. They also help advance the proposed projects to a stage suitable to continue product development in the private sector or to apply for support through other NHLBI translational programs.

Accelerator Partners may do this by connecting innovator-researchers with individuals such as: Experienced entrepreneurs and scientists, including those who can facilitate interactions with businesses, industries, sources of private capital, and research-performing institutions Experts such as clinicians and biostatisticians who are familiar with how the desired product should look to meet vested shared interests Potential partners who have complementary development expertise and resources for successful project development Potential licensing and commercialization partners who can offer advice soon after the researcher gets an award Ecosystem partners, such as those from biotechnology or pharmaceutical companies, who are knowledgeable about the process for developing therapeutics, devices, and diagnostics Accelerator partners are encouraged to provide access to expertise and mentoring related to: product development stages, business development and commercialization strategy, market analysis, preparation of regulatory submissions, intellectual property protection, and reimbursement strategy.

Recipients are highly encouraged to use Accelerator Partners for this kind of career development, as these experts can facilitate exposure to the myriad processes required to translate discoveries into therapies. Applicants are expected to consider how they will identify and foster relationships with Accelerator Partners. It is acceptable for an Accelerator partner to provide the matching funds, but not required.

Evidence of an Accelerator Partner is required and applicants must include a letter of support from the Accelerator Partner in their application. Applications that do not include the letter of support from the Accelerator Partner are incomplete for this NOFO and will not be peer-reviewed .

Intellectual Property and Regulatory Considerations Projects at the stage of development supported through this NOFO are expected to be developed to the point where initial IP and regulatory strategies are being developed. This NOFO requires that applicants submit their IP and regulatory strategies in their applications, even if the plans are not yet fully developed.

See Section IV, Application and Submission Information, SF424(R&R) Other Project Information for details. 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 for award authorities and regulations. Section II. Award Information 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 The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NHLBI intends to commit total costs of up to $4,466,000 in FY 2026, $4,466,000 in FY 2027, and $4,466,000 in FY 2028.

NHLBI expects to fund up to 8 new awards in FY 2026, 8 new awards in FY 2027, and 8 new awards in FY 2028, for a total of up to 24 new awards for projects submitted to this NOFO and three companion funding opportunity announcements (RFA-HL-26-017, RFA-HL-26-018, RFA-HL-26-019). The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets must not exceed direct costs of $300,000 per year. The total budget (Federal award and non-Federal matching contributions) should reflect the actual needs of the overall proposed project. Annual project budgets should reflect the actual costs anticipated in each year.

Cost Matching Funds : The recipient is expected to provide at least a 0. 25:1 non-Federal match of the Federal direct costs requested. 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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. 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. This NOFO has an expectation of cost matching as defined in the NIH Grants Policy Statement. More information on the cost matching expectation is in Section IV.

2 R&R or Modular Budget. 3. Additional Information on Eligibility 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&nnbsp; 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. 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.

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.

IP and Regulatory Strategies (Required) Preliminary IP and regulatory plans must be described in an attachment using the filename "IP and Regulatory Strategies. pdf". Applications that do not include this attachment are incomplete for this NOFO and will not be peer-reviewed.

NHLBI recognizes that applications submitted in response to this NOFO may detail projects at different stages of development. Applications should include a detailed description of Intellectual property (IP) and regulatory strategies for more advanced projects.

If the project is too early for a well-defined strategy, the applicant should indicate so and provide a brief description of the current stage and potential IP and regulatory strategies. For more advanced projects, applicants should address their current understanding of regulatory and IP requirements for the proposed product, even if the plans are not fully complete.

For IP, applicants should describe any known constraints that could impede product development (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar products that are under patent protection and/or on the market, etc.) and how these issues could be addressed with achieving the goals of this program.

If any third-party IP is required, identify whether there are any limitations on its use and include a letter from the third-party appended as part of this attachment. If patents pertinent to the product being developed under this application have been filed, the applicant should indicate the details of filing dates, what type of patents are filed, and application status, and associated USPTO links, if applicable.

Describe plans for working closely with institutional technology transfer officials to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project.

Applicants are strongly encouraged to prepare the IP section of this application in consultation with their institution's technology transfer officials. For the regulatory path, applicants should describe the steps they will take to refine and align their project to align with regulatory requirements either during the currently requested award period or in the future.

If a device or diagnostic is being developed, describe the data that will be collected during the project period to support a pre-submission meeting, a 510(k) filing, or an Investigational Device Exemption filing.

If the development team has already interacted with their local IRB or FDA regarding regulatory oversight of their proposed product, provide evidence of prior communications (letters/emails) appended as part of this attachment.

If there is hypertext in communication with FDA (e.g., hyperlinks and URLs), these should either be removed or disabled by the applicants before submission in accordance with NIH policy on the use of hypertext ( https://grants. nih. gov/grants/guide/notice-files/NOT-OD-20-174.

html ). Applicants are also strongly encouraged to contact the appropriate NIH Scientific/Research contact listed in Section VII for questions regarding application expectations for IP and regulatory prior to submission. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

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. A total project budget justification (i.e., the requested budget plus the cost-matching budget) must be provided and must document any cost-matching (non-Federal) component and the Federal (non-cost matching) component.

Any costs and contributions used to provide cost matching must be documented by the recipient prior to release of the R33 award and are subject to audit. The amount, type, and source of funding/contributions from sources other than NIH must be presented in detail in the budget justification. Third Party support of the proposed research activity (if approved) will be incorporated as a Term and Condition of Award.

If the Third Party support ceases and the program is no longer tenable without the Third Party support, a close-out