Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)
ID: 356539Type: Forecasted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $4M

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/356539
Timeline
    Description

    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) for the NHLBI SBIR Phase IIB Small Market Awards aimed at accelerating the commercialization of technologies for heart, lung, blood, and sleep disorders. This funding opportunity is designed to support small businesses in advancing promising biomedical projects that have previously received SBIR or STTR Phase II funding, specifically targeting products that address rare diseases or pediatric populations. With an estimated total program funding of $21 million and an award ceiling of $3.5 million, the anticipated application due date is February 25, 2025, with awards expected to be made by December 1, 2025. Interested applicants are encouraged to prepare their proposals in advance to meet the requirements integral to this initiative.

    Point(s) of Contact
    No information provided.
    Files
    No associated files provided.
    Similar Opportunities
    Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is forecasting a funding opportunity for the Small Business Innovation Research (SBIR) Phase IIB Bridge Awards aimed at accelerating the commercialization of technologies related to heart, lung, blood, and sleep disorders. This initiative seeks to support small businesses in advancing promising biomedical projects that have previously received SBIR or STTR Phase II funding, addressing the critical funding gap that often hinders the transition to commercialization and regulatory approval. The program is designed to foster partnerships between SBIR Phase II awardees and third-party investors, with a total estimated funding of $52.5 million and individual awards capped at $3.5 million. Interested applicants should prepare to submit proposals by February 25, 2025, with the anticipated award date set for December 1, 2025.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity aimed at supporting Phase I clinical trials for therapeutic and diagnostic interventions related to heart, lung, blood, and sleep (HLBS) disorders. This initiative seeks to accelerate the development of clinical interventions by funding investigator-initiated studies that demonstrate potential advancements in HLBS health, with a focus on ensuring that applicants are prepared to initiate trials promptly after receiving funding. The funding is capped at $1.5 million per year for a project period of up to three years, contingent on satisfactory progress and milestone completion, with applications opening on January 3, 2025, and the first due date set for February 3, 2025. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries and are encouraged to review the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-25-025.html.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity (FON: PAR-24-173) aimed at supporting Phase I clinical trials for therapeutics and diagnostics related to heart, lung, blood, and sleep (HLBS) disorders in both adults and children. This initiative utilizes a bi-phasic R61/R33 award mechanism, where the R61 phase focuses on preparatory activities such as finalizing trial protocols and gathering preclinical data, while the R33 phase is dedicated to executing the clinical trial. The funding limits include up to $250,000 annually for the R61 phase and $1,515,000 for the R33 phase, with total support available for a maximum of five years. Interested applicants must adhere to NIH guidelines and submit their proposals by January 7, 2027, to be considered for this opportunity. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the NHLBI Early Phase Clinical Trials (R33), aimed at supporting investigator-initiated Phase I clinical trials for therapeutic and diagnostic interventions targeting heart, lung, blood, and sleep (HLBS) disorders. Applicants are required to be prepared to initiate their clinical trials within the first quarter of the project period and must demonstrate readiness in obtaining necessary regulatory approvals, including FDA and IRB, prior to the award. This funding is crucial for addressing unmet medical needs through innovative research, with a maximum budget of $1.515 million per year and a project duration of up to three years, contingent upon achieving specific milestones. Interested applicants should note the application deadline of June 4, 2024, and can direct inquiries to NIH Grants Information at grantsinfo@nih.gov for further details.
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders," aimed at supporting investigator-initiated Phase I clinical trials for heart, lung, blood, and sleep (HLBS) disorders in both adults and children. This grant (R61/R33) facilitates funding for essential preclinical activities and the execution of clinical trials, structured in two phases: the R61 phase focuses on preparatory tasks, while the R33 phase involves the actual trial conduct, guided by specific milestones. This initiative is crucial for advancing research that addresses significant health challenges associated with HLBS disorders. Interested applicants can submit proposals starting January 3, 2025, with a maximum project period of five years, and should direct inquiries to grantsinfo@nih.gov. For more details, visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-026.html.
    Catalyze: Product Definition for Small Molecules, Biologics and Combination Products - Target Identification and Validation, and Preliminary Product/Lead Series Identification (R61/R33 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products," aimed at supporting early-stage translational research for heart, lung, blood, and sleep disorders. This initiative employs a phased approach (R61/R33), where the R61 phase focuses on identifying and validating therapeutic candidates, while the R33 phase involves lead series identification for preclinical testing, emphasizing innovation and addressing therapeutic gaps. The total funding commitment is approximately $4.47 million per fiscal year from 2026 to 2028, with a maximum budget of $400,000 per year for each phase, and applications are due by December 23, 2027. Interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity titled "Catalyze Product Definition," aimed at supporting the development of medical device prototypes, diagnostic targets, and related research tools for heart, lung, blood, and sleep (HLBS) diseases. This initiative adopts a phased approach (R61/R33) to assist early-stage projects, focusing on preliminary prototype testing in the R61 phase and advancing to extensive development activities in the R33 phase, with a requirement for applicants to demonstrate novelty and a strong biological rationale supported by preliminary data. The program anticipates funding approximately $4.4 million annually from FY 2026 to FY 2028, with up to 24 awards available, and requires applicants to engage with an Accelerator Partner to enhance commercialization expertise. Interested parties can find more information and application guidelines at the NIH grants website, with a submission deadline of December 23, 2027.
    Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), is offering a funding opportunity titled "Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products." This initiative aims to support early-stage translational research focused on identifying lead compounds for therapeutic agents targeting heart, lung, blood, and sleep (HLBS) diseases, facilitating their transition into preclinical testing. Eligible applicants include a diverse range of entities such as higher education institutions, nonprofits, and government bodies, with a requirement for a non-federal cash match of at least 25% of the federal direct costs. The total anticipated funding over three years is approximately $13.4 million, with project budgets capped at $400,000 per year and a maximum project period of two years. Applications must be submitted by December 23, 2027, and further inquiries can be directed to NIH Grants Information at grantsinfo@nih.gov.
    Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), is offering a funding opportunity titled "Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)." This grant aims to support the development and validation of innovative technologies that address significant gaps in heart, lung, blood, and sleep (HLBS) research, focusing on advancing diagnostic and therapeutic solutions with promising preliminary data. Eligible applicants include a wide range of institutions and organizations, with a budget ceiling of $350,000 in direct costs per year, and total funding commitments expected to reach $2,156,000 annually for the next three fiscal years. The application deadline is set for January 11, 2025, and further details can be found on the NIH grants website or by contacting NIH Grants Information at grantsinfo@nih.gov.
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) to support pre-clinical research aimed at bridging funding gaps that impede the commercialization of medical biotechnology products. This funding opportunity specifically targets previously funded SBIR or STTR Phase II projects, with the objective of advancing products or technologies that require federal regulatory approval, while fostering partnerships between small businesses and external investors to enhance commercialization prospects. Applicants are encouraged to secure independent third-party funding that equals or exceeds one-third of the requested NINDS funds, and must include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in the research environment. The application deadline is April 5, 2027, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. More details can be found in the full announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-24-222.html.