Frequently Asked Questions


FAQs are for informational purposes only and FOA language supersedes any content included herein. Please email catalyze_info@rti.org if you have any additional questions.

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Product Definition

Product Definition Informational Webinar

Applicants are encouraged to watch the Product Definition Informational presentation that was given by the Catalyze Scientific Program Director in February 2022. This 27-minute presentation covers information including the goals of the Catalyze Program, differences between the various funding announcements, tips for applicants, as well as information regarding what Catalyze applicants can look forward to if selected for an award.

View webinar Download slides

Application Checklists

Download a PDF Application Checklist to ensure your application includes the special requirements for the Catalyze RFAs.

HL23-010 - Enabling Technologies and Transformative Platforms R61/R33 - Product Definition phased applications R33 - Product Definition

General Information

The NHLBI Catalyze program provides a comprehensive suite of support and services to facilitate the translation of basic scientific discoveries into viable therapeutics, devices, and diagnostics ready for human testing.

The program has two main goals:

  • To drive development of new potential heart, lung, blood, and sleep (HLBS)-related therapies and cures —including drugs, devices, diagnostics, and biologics—by supporting early product definition studies and safety testing
  • To support development of novel, enabling platform technologies that catalyze next-generation predictive, diagnostic and therapeutic products. These products will specifically address HLBS-related disorders and diseases.
  • To train a diverse, globally competitive biomedical workforce that is well-versed in scientific research, technology development, and entrepreneurship

Currently, the Catalyze program supports five funding opportunities, and their funding mechanisms differ in their budget limits, cost sharing expectations, application materials, and project periods.

Catalyze has a coordinated and comprehensive array of activities and support services which are personalized to meet participants' individual needs. The Catalyze Coordinating Center works with investigators to develop individualized milestone-driven pathways to success

In addition to funding opportunities, Catalyze has a network of experts who share best practices, provide technical assistance, offer advisory services, and conduct entrepreneurial education and training. The Catalyze network includes experts in regulation, product development, toxicology, marketing, commercialization, and many other areas that help bring products to market. The program also creates opportunities for cohort-based learning so participants can benefit from the experiences of other participants.

This funding supports three overall categories of product development and preclinical research:

  • Therapeutics (small molecules and biologics)
  • Devices, diagnostics, and research tools
  • Enabling technologies and transformative platforms
This is a visual depiction of an overview of the Catalyze Program.  The image shows five boxes feeding into a box labeled Catalyze Program below. The first box is titled 'Funding' and says 'Leverages federal investment with matching commitments and flexibility to adjust to challenges'.  The second box is titled 'Coordinated Approach' and says 'Continuum of programs to advance research from validation to first-in-human trials'.  The third box is titled 'Individualized Support' and says 'Milestone-driven project management and support'.  The fourth box is titled 'Program Flexibility' and says 'Ability to adjust the program as needed and to share best practices'.  The fifth box is titled 'Network of Experts' and lists 'Access to key technical experts, Advisory services from NIH and mentoring network, Entrepreneurial education and training, and Cohort-based learning'. The five boxes feed into a final overarching box titled 'Catalyze Program' that says 'Provides a bridge from basic to clinical research across the entire Heart, Lung, Blood, and Sleep research spectrum/Trains a scientific workforce in product development and entrepreneurship'

This is a visual depiction of the early translational research supported by the Catalyze Program.

Currently, there are five funding opportunities: two that target therapeutics (dependent on early or late entry stage of development), two that target devices, diagnostics, and tools (dependent on early or late entry stage of development), and one that targets enabling technologies and transformative platforms. The five funding opportunities are summarized in the table below.

FOA # and Title

Funding Mechanism

Funding Purpose

RFA-HL-23-010

Enabling Technologies and Transformative Platforms

R33

(Direct to R33)

To develop enabling technologies and transformative platforms to catalyze next-generation predictive, diagnostic, and therapeutic products.

applications must offer the potential for projects to accelerate progress and/or transform current protocol in the areas of early detection and screening, model development, clinical diagnosis, treatment, control, prevention, or epidemiology

RFA-HL-23-011

Product Definition - Small Molecule and Biologic Target Identification and Validation, Assay Development, and Screening

R61/R33

phased award

To identify, validate, and screen compounds of interest and to identify a lead compound series to move into preclinical testing for optimization, safety, and efficacy

RFA-HL-23-012

Product Definition - Small Molecule and Biologic Lead Series Preliminary Product/Lead Series Identification

R33

(Direct to R33)

To develop and move a lead compound series forward to preclinical testing

For projects that have already identified, validated and screened compounds of interest and are therefore far enough along in development to skip R61 stage

RFA-HL-23-013

Product Definition - Device Prototype Design/Testing and Diagnostic Disease Target Identification and Assay Development, Research Tool Development

R61/R33

phased award

For initial development of prototypes through testing, identifying diagnostic disease targets and developing associated assays, and developing research tools

RFA-HL-23-014

Product Definition - Device prototype testing and Diagnostic disease assay development, and Research Tool Development

R33

(Direct to R33)

To develop and test existing device prototypes, explore assay components for diagnostics validation, and develop research tools

For projects that have already identified and tested initial prototype designs, that have identified a disease target and generated experimental design, or that identified, tested and piloted research tools, and are therefore far enough along in development to skip R61 stage

FOA Checklist

The table below contains all due dates for applications as well as the earliest start date for both AIDS and non-AIDS related funding opportunities.

Application Due DatesReview and Award Cycles
NewRenewal / Resubmission / Revision
(as allowed)
AIDSScientific Merit ReviewAdvisory Council ReviewEarliest Start Date
March 21, 2022March 21, 2022April 18, 2022July 1, 2022October 1, 2022December 1, 2022
July 21, 2022July 21, 2022August 18, 2022November 1, 2022January 1, 2023April 1, 2023
November 21, 2022November 21, 2022December 21, 2022March 1, 2023May 1, 2023July 1, 2023
February 21, 2023February 21, 2023April 18, 2023July 1, 2023October 1, 2023December 1, 2023
July 21, 2023July 21, 2023August 18, 2023November 1, 2023January 1, 2024April 1, 2024
November 21, 2023November 21, 2023December 21, 2023March 1, 2024May 1, 2024July 1, 2024
February 21, 2024February 21, 2024April 18, 2024July 1, 2024October 1, 2024December 1, 2024
July 22, 2024July 22, 2024August 19, 2024November 1, 2024January 1, 2025April 1, 2025
November 21, 2024November 21, 2024December 20, 2024March 1, 2025May 1, 2025July 1, 2025

Catalyze funding mechanism requirements (budget limits, cost sharing, Accelerator Partnerships, etc.) differ according to the type of technology under development, the stage of development, and the duration of the project. For therapeutic and device/diagnostic/tool development, both phased (R61/R33) and R33 awards are available. Researchers with projects that are earlier in development may apply for phased awards, while those with more advanced projects may apply directly for an R33 opportunity. In a phased award, transition from the R61 phase to the R33 phase is based on successful completion of the R61 phase and meeting additional R33 requirements.

This table summarizes the differences between the funding mechanisms.

FOA #

RFA-HL-23-010

RFA-HL-23-011

RFA-HL-23-012

RFA-HL-23-013

RFA-HL-23-014

Technology Type

Enabling Technologies & Transformative Platforms

Therapeutics

Therapeutics

Devices/Diagnostics/Tools

Devices/Diagnostics/Tools

FOA Name

Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)

Product Definition for Small Molecules and Biologics - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 – Clinical Trials Not Allowed)

Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)

Product Definition – Device Prototype Design and Testing, Diagnostic Disease Target Identification and Assay Development, and Research Tool Development (R61/R33

Clinical Trial Not Allowed)

Product Definition – Device Prototype Testing and Design Modification, Diagnostic Disease Target Assay Development and Design Characterization, and Research Tool Testing and

Validation (R33 - Clinical Trials Not Allowed)

Budget amounts

Maximum direct costs of $300,000 per year

Maximum direct costs of $350,000 per year in either the R61 or R33 phase

Maximum direct costs of $350,000 per year

Maximum direct costs of $250,000 per year in either the R61 or R33 phase

Maximum direct costs of $250,000 per year.

Cost sharing expectations

No cost sharing required

For the R33 portion ONLY: minimum 0.25:1 non-federal cash match of the federal direct costs recommended

Minimum of 0.25:1 non-federal cash match of the federal direct costs recommended

For the R33 portion ONLY: minimum 0.25:1 non-federal cash match of the federal direct costs recommended

Minimum of 0.25:1 non-federal cash match of the federal direct costs recommended

Letter of support for cost sharing funds

No cost sharing required

Required to transition from R61 to R33 phase

Required at time of application

Required to transition from R61 to R33

Required at time of application

Project period

Maximum: 2 years

Maximum combined R61 and R33: 3 years

Up to 2 years in either R61 or R33 allowed

R61 and R33 awards not allowed in same fiscal year

Maximum: 2 years

Maximum combined R61 and R33: 3 years

Up to 2 years in either R61 or R33 allowed

R61 and R33 awards not allowed in same fiscal year

Maximum: 2 years

Letter of support from Accelerator Partner

Not required

Required to transition from R61 to R33

Required at time of application

Required to transition from R61 to R33

Required at time of application

To transition from the R61 to R33 phase, awardees must do the following:

Progress and achievement of these requirements will be evaluated by an NHLBI committee tasked with making advancement decisions.

For phased awards, evidence of having secured the cash match and the Accelerator Partner is not required at the time of application, but will be needed at the time of R61 milestone review to transition to an R33 award.

Matching Funds

Proof of matching funds is not required at the time of application and onset of the R61 phase of these awards, but will be expected as part of the transition process to the R33 award. As the R61 phase nears its end, evidence of matching funds must be provided to NIH in the form of a letter of support prior to the meeting of the NHLBI committee that makes the advancement decisions. To be considered responsive to these FOAs, applicants are expected to include a description in the Budget Justification of how the matching funds will be used for the R33 phase of the award. Evidence of the cash match is expected prior to release of R33 federal funds.

The Enabling Technologies and Transformative Platforms for HLBS Research RFA (RFA-HL-23-010) does not have a cost sharing component.

The non-phased applications must include a letter of support from the non-federal source(s) of cash matching. Applications that do not include this letter will be considered unresponsive and will not be peer reviewed. Evidence of the cash match is required prior to release of R33 federal funds. This requirement is not negotiable.

The Enabling Technologies and Transformative Platforms for HLBS Research RFA (RFA-HL-23-010) does not have a cost sharing component.

Sources of non-federal funding could include, but are not necessarily limited to, foundations, participating institutions, a state or local governmental body, angel investors, venture capital firms, individual benefactors, or any combination of the above.

In-kind contributions are encouraged, but do NOT apply to the cash matching requirements and do not need to be reported to the NIH. 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.

Generally, cost matching requirements 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)
  • Program income
  • Patient incentives

Accelerator Partners

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 the NHLBI Catalyze Preclinical or other translational programs.

Accelerator Partners may do this by connecting innovator-researchers with people such as:

  • experienced entrepreneurs and scientists, including those who can facilitate interactions with businesses, industries, sources of private capital, and research-performing institutions
  • 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
  • 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

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. Awardees 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. At least one Accelerator Partner is required for the R33 portion of the phased awards and the R33 only awards. An Accelerator Partner is not required for RFA-HL-23-010.

For phased awards, awardees will be expected to search for an Accelerator Partner early in the R61 phase. For phased awards, proof of an Accelerator partner is not required at the time of application; however, evidence that an Accelerator Partner has been identified must be provided to NIH in the form of a letter of support prior to the meeting of the NHLBI committee that will decide whether an awardee will transition from the R61 to the R33 award. Transition from R61 to R33 is contingent on procurement of an Accelerator Partner. For R33 only awards, the Accelerator Partner must be identified at the time of application.

Yes. It is acceptable for an Accelerator Partner to provide cash matching funds for the R33 stage, but it is not required.

Milestones

Milestones are an event or moment in time in a project that indicates 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 GANTT 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. Applicants are expected to propose activities and milestones, with an associated timeline, to be completed during the proposed duration of award. Successful awardees 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 will be peer reviewed as well as programmatically reviewed and if needed will be negotiated with the awardee 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.

Milestones are required for all RFAs (RFA-HL-23-010, 011, 012, 013, and 014).

Phased awards (RFA-HL-23-011 and RFA-HL-23-013). To be responsive to this FOA, applicants must meet the entry criteria to be eligible for the award and propose two separate sets of clear, quantifiable milestones with timelines (one set each for the R61 and R33 phases) to be completed sequentially within a three-year period, but with no more than two years in either stage.

Milestones for the R61 and R33 activities must be submitted at the time of application and will be reviewed simultaneously; however, receipt of funding for the R33 component of phased awards is contingent on achieving pre-specified milestones during the R61 component. Completion of milestones will ensure sufficient progress during the R61 phase to provide the feasibility and scientific rationale to conduct the product definition activities proposed in the R33.

Non-phased R33 awards (RFA-HL-23-010, RFA-HL-23-012 and RFA-HL-23-014). To be considered responsive to the FOA, applicants must meet the entry criteria to be eligible for the award and propose milestones to be completed during the duration of award. These milestones will ensure that projects are sufficiently progressing to be in a position to for further development, including entering into preclinical programs following completion of the award.

Milestones must be identified in the application and may be negotiated, pre-award, by the NHLBI team based on comments from the peer review panel. NHLBI emphasizes the importance of the robustness and reproducibility of experimental results in evaluating progress. For the phased awards, investigators must exhibit successful completion of milestones for consideration of transition to the R33 phase.

Intellectual Property, Regulatory and Project Management Requirement

Applicants are required to submit their IP and regulatory strategies in their applications. Projects that are appropriate for these FOAs must be at the stage of development where IP and regulatory strategies are being considered. For phased awards, continued development of IP and regulatory strategies will be required and considered for a transition from the R61 phase to the R33 phase of the award.

While IP and regulatory strategy are not required for the Enabling Technologies and Transformative Platforms funding opportunity (RFA-HL-23-010), funded awardees will be expected to develop IP and regulatory strategy as the technology develops.

Each project is expected to use a robust, milestone-driven project management processes that make it possible to assess progress on a continuous basis, relative to established milestones. Applicants should describe their project management strategies and name the individual(s) who will be responsible for implementing them. For more information about developing project management strategies prior to application submission, please contact the NHLBI Catalyze team at catalyze_info@rti.org.

The Enabling Technologies and Transformative Platforms funding opportunity requires a separate attachment that describes the milestones, timeline and project management plan. In addition, within the Research Section applicants are required to include a subsection to describe performance measures.

FAQ pages are for informational purposes only and FOA language supersedes any content included herein.

Preclinical

EOI Submission Questions

Information on the Catalyze Preclinical Services Program can be found on our Preclinical Services Program page.

A webinar and slides focusing on the Catalyze Preclinical Services Program can be found on our Preclinical Services Program Webinar page.

The Catalyze Preclinical Services Program focuses on services not typically part of the Catalyze Product Definition R61/R33 awards. The Catalyze Preclinical Services Program supports activities for technology development of products that are at end-stage proof-of-concept through preclinical development and US regulatory approval. Additional information can be found within the preclinical webinar presentation slides.

Applicants must be U.S.-based, and the technology must support NHLBI initiatives (Heart, Lung, Blood, and Sleep). Additional criteria for preclinical services, including the appropriate technology stage, are described in slides 7-11 of the preclinical webinar presentation slides.

While the Catalyze Program does not enforce a fixed budget cap on applications, in general, the program does not support projects above $1,000,000/year.

To apply, an applicant completes an Expression of Interest (EOI) form, which is subsequently reviewed by NHLBI. If selected, applicants are invited to complete a full online application through a secure Catalyze website, which has an open period of 4 weeks for applicants to submit their requested services.

Applications are completed through an online portal. Applicants are encouraged to utilize the PDF / Word copy of the Catalyze Application on the public website to gather information needed for submission. The applicant may draft responses on the Word version and use it as a template to copy/paste into the Catalyze website. The application can take between 4-6 hours to complete. After the submission period ends, the Catalyze Coordinating Center (RTI) may contact the applicant by email if there are questions about the application. Applicants will be notified of the final decision by email within 6 months.

While not a requirement, applicants are encouraged to have an accelerator partner. NHLBI expects applicants to pursue fundraising to increase the likelihood that the technologies will advance to the marketplace.

Either academic PIs or accelerator partners may apply, but the applicant must ensure the support of a specific suitable development team to support the technology.

Procurement of non-federal funding demonstrates market demand for a product and indicates the potential for success in commercializing the technology. NHLBI recognizes, however, that some rare diseases or specific technologies of interest to NHLBI may be less likely to receive external funding. NHLBI has developed a broad-spectrum approach to ensure the portfolio aligns within NHLBI's divisions.

We encourage small businesses to apply for SBIR funding instead of Catalyze Preclinical Services Program. Those with existing or prior SBIR support may be considered if the applicants need assistance to complete studies not otherwise funded but are needed to progress to SBIR Phase II or Phase IIB support. For more information about applying to the SBIR/STTR programs, click here.

Those applying for Catalyze Preclinical Services Program support should be able to provide efficacy data in an animal model and demonstrate feasibility, depending on the technology type.

Focus on gap filling studies to accelerate promising technology toward traditional funding mechanisms or 3rd-party investment.

Prior funding through Catalyze is not a requirement for the preclinical services program. Existing NHLBI support will not disqualify applicants from receiving a Catalyze award, and neither prior nor current Catalyze Program support is a requirement for preclinical services.

If the applicant is part of an academic institution, the Grants Management Office must be consulted. No funds will be transferred to the institution, the services are provided by the Catalyze Coordinating Center (RTI) on behalf of the applicant.

Other organizations should follow up with their legal team.

Within 4-6 weeks of submitting an EOI, applicants will receive notification of rejection or an invitation to submit a full application.

Future submission dates for EOIs are not yet determined but will be announced and posted on the website when finalized. A downloadable version of the EOI and full application are accessible on the Preclinical Services Program page. NHLBI anticipates 1-2 submission cycles for fiscal years 2023 and 2024.

Funds will not be awarded to the applicant. The Catalyze Coordinating Center (RTI) will select CROs/CMOs that will provide preclinical services. The Catalyze Coordinating Center will manage the services and work with the investigators to ensure that work is being correctly completed at the CROs/CMOs. Additional commercialization milestones will be required of the investigator.

Applicants are expected to provide cost estimates for services requested from the Catalyze Program as part of their full application. It is recommended that quotes are requested from CROs/CMOs shortly after EOI submission.

Following selection, the Catalyze Coordinating Center (RTI) will verify cost estimates and qualify the CRO/CMOs prior to the initiation of the studies.

Applicants will be notified of the final decision by email within 6 months.

Studies leading to the acquisition of in vitro or in vivo (animal) data demonstrating efficacy and/or mechanism of action would be more appropriate for the Catalyze Product Definition grant applications that the Catalyze Preclinical Services Program.

The Catalyze Program will not support any GLP/GMP requests before a pre-IND meeting. Applicants may request regulatory support for a pre-IND meeting.

Contract Research Organizations/Contract Manufacturing Organization Questions

In a situation where an applicant was accepted into the program and had previously worked with a CRO/CMO it may be more cost/time efficient to continue working with that vendor although other costs estimates may be obtained from other vendors for comparison. If the project has not yet worked with a CRO/CMO, then the Catalyze Coordinating Center (RTI) will obtain bids from several vendors in compliance with federal procurement regulations to identify the most appropriate vendor.

The Catalyze Coordinating Center (RTI) will perform a qualification for all vendors to ensure that the vendor meets the appropriate requirements and has experience providing reports and documentation sufficient for regulatory submission.

Catalyze does not have a list of approved/preferred CRO/CMOs but the Catalyze Coordinating Center (RTI) can provide assistance identifying potential vendors.

The Catalyze Coordinating Center (RTI) can share Request for Proposal (RFP) templates that investigators can use to request quotes. The Catalyze Coordinating Center team has expertise in toxicology, manufacturing, and regulatory strategy/regulatory submissions. Applicants are welcome to contact NHLBI_catalyze@mail.nih.gov to request assistance identifying potential CROs or CMOs.

The application should demonstrate an understanding of the necessary steps to advance the technology from its current stage to FDA clearance, as well as the steps to advance from FDA clearance to commercialization. If the goal is market approval, applicants may request several services but in general, the program does not support projects above $1,000,000/year. NHLBI will work with applicants to adjust which services can be supported by Catalyze. Other funding sources may be required.

CMOs/CROs located outside of the US would need to comply with U.S. State Department regulations as well as NIH policies.

Services provided by CROs can range from preclinical efficacy studies, dose range finding studies (i.e., early toxicology studies), GLP toxicology studies, or in vivo animal studies for devices. Please note that the Catalyze Program will not support any GLP/GMP requests before a pre-IND meeting. The applicant may request regulatory support for pre-IND meeting.