NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
ID: 353331Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/353331

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-173.html
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for the NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for heart, lung, blood, and sleep (HLBS) disorders, under the funding opportunity number PAR-24-173. This grant program aims to support investigator-initiated Phase I clinical trials (R61/R33 mechanism) that focus on developing new diagnostic and therapeutic interventions for both adults and children, facilitating trial preparation, implementation, and necessary preclinical activities. The initiative is crucial for advancing public health outcomes by accelerating the development of effective interventions for HLBS disorders. Applications are due starting May 4, 2024, with no cost-sharing requirements, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For more details, visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-24-173.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-173-Full-Announcement.html
    PAR-24-173.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), seeks applications for the NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for heart, lung, blood, and sleep (HLBS) disorders through a reissued funding opportunity number PAR-24-173. The program supports investigator-initiated Phase I clinical trials (R61/R33 mechanism) focused on developing new diagnostic and therapeutic interventions. Grants funding will assist in trial preparation, implementation, and final preclinical activities necessary for clinical trials involving both adults and children. The application should align with scientific rigor and efficiency, maintaining detailed project management plans with defined milestones for each award phase. Eligible organizations include higher education institutions, nonprofits, and state or local government agencies, with applications due at various intervals starting May 4, 2024. Rigorous review criteria assess the significance and innovation of the proposed trials, the qualifications of the investigators, the appropriateness of the methodology, and the potential impact on clinical practices. Applications must address key considerations such as recruitment strategies and ethical protections for human subjects. The comprehensive approach aims to facilitate accelerated development of interventions for HLBS disorders, thereby enhancing public health outcomes.
    Similar Opportunities
    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 Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for R34 Clinical Trial Pilot Studies aimed at supporting research that informs the planning of Phase II-IV clinical trials focused on heart, lung, blood, and sleep disorders. Applicants are required to demonstrate that their proposed studies are essential for the design of future trials and must include a Plan for Enhancing Diverse Perspectives (PEDP) to promote diversity within research teams. This initiative is critical for advancing clinical practice and understanding in these vital health areas, with awards of up to $450,000 available over three years. Interested applicants should submit their proposals by January 7, 2027, and can find additional information at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
    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 for Single-Site Investigator-Initiated Clinical Trials (R61/R33), aimed at supporting applications for clinical trials that test therapeutic, behavioral, or prevention strategies relevant to NHLBI's mission. This funding mechanism involves a bi-phasic award structure, with an initial R61 phase focused on protocol development followed by an R33 phase for trial execution, emphasizing comprehensive project management, subject recruitment, and community engagement. The initiative is particularly significant for advancing clinical research while promoting diversity among study participants and project teams. Interested applicants can find more details and submit proposals by September 12, 2025, and should direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.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) is inviting applications for the "Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research" grant, aimed at advancing technologies that address heart, lung, blood, and sleep (HLBS) disorders. This funding opportunity specifically seeks R33 exploratory/developmental grant applications that focus on mid-stage developments requiring further validation and refinement, with an emphasis on demonstrating novelty and substantial improvement over existing methods. The initiative is crucial for facilitating transformations in HLBS-related research and clinical practices, promoting the swift adoption of breakthrough technologies. Interested applicants can apply for funding of up to $1.86 million annually, with a submission deadline of December 20, 2024. For further inquiries, applicants may contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NHLBI Program Project Applications (P01 Clinical Trials Optional)
    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 for Program Project (P01) grant applications aimed at advancing research in heart, lung, and blood diseases. Applicants are required to submit proposals that include a minimum of three interrelated research projects focused on a common biomedical theme, with the option to incorporate clinical trials. This initiative is designed to foster collaborative research efforts and encourage innovative scientific directions, particularly supporting projects led by Early Stage Investigators (ESIs). The maximum funding for awarded projects is capped at $1.515 million annually, or $1.765 million if an ESI-led project is included, with a project duration of up to five years. Interested applicants can find more information and submit their proposals electronically via Grants.gov, with a closing date for applications set for September 25, 2026. For further inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    Catalyze: Product Definition Device Prototype Design and Testing, Diagnostic Disease Target Identification and Assay Development, and Research Tool Development (R61/R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Catalyze: Product Definition Device Prototype Design and Testing," aimed at providing early-stage translational support for the development of devices, diagnostic targets, and research tools addressing heart, lung, blood, and sleep (HLBS) disorders. This initiative includes two phases: the R61 phase focuses on initial prototype design and testing, while the R33 phase emphasizes further development and validation, requiring a non-Federal cash match for the latter. The program is critical for advancing innovative solutions in public health, with anticipated awards totaling up to $6,277,500 annually for up to 13 projects per year. Interested applicants must submit their proposals by December 20, 2024, and can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries.
    Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 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 for exploratory R21 grant applications focused on secondary analyses of existing human datasets related to heart, lung, blood diseases, and sleep disorders. The objective of this grant is to stimulate innovative research by utilizing existing datasets to explore novel scientific ideas and develop impactful biomedical tools and technologies, without the need for new primary data collection. This initiative is crucial for advancing public health research aligned with NHLBI priorities, with an annual funding commitment of up to $2,187,000 over three years, supporting approximately eighteen new awards each year, with a maximum of $75,000 in direct costs per application for a two-year project period. Interested applicants can find more information and application guidelines at NIH Grants, and should note that the application deadline is January 7, 2026.
    Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)" aimed at supporting early-stage translational research for developing therapeutic agents targeting heart, lung, blood, and sleep disorders. This initiative seeks to identify lead compound series and bridge the gap between basic science discoveries and preclinical testing, emphasizing innovation through novel therapeutic approaches and strong biological rationale. The grant offers a maximum funding amount of $350,000 over a two-year period, with no cost-sharing requirement, and applications are due by December 20, 2024. For further inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-012.html.
    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)
    Active
    National Institutes of Health
    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.
    Catalyze: 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)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Catalyze: Product Definition Device Prototype Testing and Design Modification, Diagnostic Disease Target Assay Development and Design Characterization, and Research Tool Testing and Validation" (RFA-HL-23-014). This grant aims to support early-stage translational research focused on developing devices, diagnostics, and research tools for heart, lung, blood, and sleep (HLBS) diseases, with an emphasis on prototype testing, user feedback, and regulatory strategies. The total funding available is up to $6.3 million per year, and applicants are required to provide substantial evidence of unmet medical needs and preliminary data, along with a minimum cash match of 25% from non-federal sources. Applications are due by December 20, 2024, and further inquiries can be directed to the NIH OER Webmaster at OERWebmaster03@od.nih.gov. More details can be found at the provided link: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-014.html.