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Grant Details

https://www.grants.gov/search-results-detail/357337

Grant Analysis

Purpose & Target

  • This grant aims to provide early stage translational support to identify lead compound series for potential therapeutic agents to treat heart, lung, blood, and sleep (HLBS) diseases and disorders. The goal is to advance projects to a stage suitable for preclinical optimization and development, or to attract independent development support.
  • Target recipients are primarily research institutions, non-profits, and for-profit organizations engaged in biomedical research.
  • This grant is SECTOR-SPECIFIC to the biomedical/healthcare sector, focusing on therapeutics for HLBS diseases.
  • Geographic scope requires the applicant organization to be based in the United States. While foreign components of U.S. organizations are allowed, non-U.S. entities cannot apply directly.
  • Key filtering criteria include a focus on small molecules, biologics, and combination products, preliminary product/lead series identification, and the exclusion of clinical trials.
  • This is a recurring grant opportunity, reissued from a previous RFA, and is part of the larger NIH Catalyze innovation grants suite, supporting multiple application cycles until its expiration in December 2027.

Financial Structure

  • Maximum direct costs are $400,000 per year per application.
  • The maximum project period is up to two years, implying a potential total maximum direct cost of $800,000 per project.
  • A minimum 0.25:1 non-Federal cash match of the Federal direct costs requested is expected.
  • Eligible costs include budget support for the PD/PI to participate in a 1.5-day NHLBI-held innovation meeting or workshop in the Washington, DC/Metropolitan area once each budget year.
  • Appropriate project management support should be budgeted.
  • Ineligible sources for matching funds include: costs from other Federal grants/sub awards, cost-sharing on other Federal awards/contracts, costs of services/property financed by income earned by contractors, and patient incentives.
  • Financial reporting requires annual submission of the Research Performance Progress Report (RPPR) and financial statements.
  • A total project budget justification (Federal and non-Federal matching) must be provided, documenting any cost-matching contributions.
  • Cost matching funds are subject to audit.
  • If third-party support is proposed, it will be incorporated as a Term and Condition of Award; if it ceases and makes the program untenable, a close-out plan may be requested.

Eligibility Requirements

Organizational Type and Status
  • Eligible organization types include:
    • Higher Education Institutions (Public/State Controlled, Private)
    • Nonprofits (with or without 501(c)(3) IRS Status)
    • For-Profit Organizations (Small Businesses, Other than Small Businesses)
    • Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal Governments)
    • Federal Governments (Eligible Agencies)
    • Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply directly.
  • Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply, and foreign components (subcontractors) are allowed.
Registration Requirements
  • Applicant organizations must be registered and maintain active status in:
    • System for Award Management (SAM) (requires annual renewal)
    • NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations in lieu of CAGE code, to register in SAM)
    • Unique Entity Identifier (UEI) (issued via SAM.gov, must be consistent across all registrations)
    • eRA Commons (organization must identify a Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account)
    • Grants.gov
Project and Research Requirements
  • Projects must not involve clinical trials (explicitly stated as 'Clinical Trial Not Allowed').
  • Applicants must have identified and validated a compound series, tested constituent components of combination products, and completed in-vitro testing of combination product prototypes.
  • Preliminary IP (Intellectual Property) and regulatory strategies are required to be submitted with the application.
  • A committed Accelerator Partner is required, and a letter of support from this partner must be included in the application. Failure to include this letter will result in the application not being peer-reviewed.
  • Applicants are expected to provide a minimum of a 0.25:1 non-Federal cash match of the Federal direct costs requested. This is an expectation of cost matching.
Exclusion Criteria
  • Projects focused on target identification and development are non-responsive (see companion NOFO RFA-HL-26-017).
  • Projects for the development of assays or probes for basic disease understanding or other basic research are non-responsive.
  • Projects for the development of devices, diagnostics, or tools are non-responsive (see companion NOFOs RFA-HL-26-019 and RFA-HL-26-020).
  • Projects for the development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers are non-responsive.
  • Projects for Investigational New Drug (IND) enabling studies are non-responsive.
  • Projects for the manufacture of therapeutic agents under good manufacturing practice for clinical use are non-responsive.
  • Projects for clinical research and clinical trials are non-responsive.

Application Process

Application Deadlines and Timeline
  • Letter of Intent Due Date: 30 days prior to the application due date (not required, but encouraged).
  • Application Due Dates (all by 5:00 PM local time of applicant organization):
    • February 11, 2025
    • June 18, 2025
    • October 21, 2025
    • February 11, 2026
    • June 18, 2026
    • October 21, 2026
    • February 11, 2027
    • June 17, 2027
    • Latest Application Due Date: October 21, 2027.
  • Expiration Date for the funding opportunity: December 24, 2027.
  • The earliest start date for projects submitting on the latest due date (Oct 21, 2027) is July 2028.
  • Project period is a maximum of two years.
Application Procedure and Submission
  • Applications must be submitted electronically via:
    • NIH ASSIST system
    • Institutional system-to-system (S2S) solution
    • Grants.gov Workspace
  • Applicants are encouraged to submit early to allow time for corrections.
  • System for Award Management (SAM), UEI, eRA Commons, and Grants.gov registrations must be active prior to submission.
Required Documentation and Materials
  • Standard SF424(R&R) forms and instructions from the 'How to Apply - Application Guide' must be followed.
  • Required Attachments:
    • Preliminary IP (Intellectual Property) and Regulatory Strategies.pdf: This attachment is mandatory. For early-stage projects, a brief description of the current stage and potential strategies is acceptable. For more advanced projects, detailed IP and regulatory plans, including known constraints, third-party IP, patent details, and regulatory path steps, are expected. Consultation with institutional technology transfer officials is encouraged.
    • Letter of Support from the Accelerator Partner: This is a critical requirement. Applications without this letter will be considered incomplete and will not be peer-reviewed.
  • PHS 398 Research Plan must include:
    • Specific Aims: Clear objectives and activities for lead series identification, with at least one milestone per aim.
    • Research Strategy: Background outlining biological/therapeutic rationale, unmet medical need, novelty, project status, and experimental design rationale.
    • Accelerator Partner: Description of how their expertise fills development gaps.
    • Milestones: Specific, measurable, achievable, relevant, and time-bound milestones with an associated timeline (GANTT chart recommended).
    • Project Management Plan: Describe processes for continuous assessment of progress and strategic decisions; identify a team member responsible for project management.
    • Rigor and Reproducibility: Plans to ensure high-quality and reproducible results.
    • Letters of Support: For cost matching (non-Federal sources) and the Accelerator Partner.
  • Data Management and Sharing Plan: Required for all applications, regardless of direct costs requested.
  • Human Subjects and Clinical Trials Information: If human subjects are involved, complete the PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Post-Award Requirements and Reporting
  • Quarterly meetings: Recipients will meet quarterly with NHLBI staff to monitor progress against proposed milestones.
  • Annual Reporting: Submission of Research Performance Progress Reports (RPPR) and financial statements annually.
  • Milestone Achievement: Non-competing award decisions are made annually based on achieving milestones.
  • Final Reporting: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for closeout.

Evaluation Criteria

Overall Impact
  • Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved.
Scored Review Criteria
  • Factor 1: Importance of the Research (Significance and Innovation)
    • Novelty: Focus on applying new knowledge around novel targets, mechanisms, and pathways.
    • Aim for significant improvements over existing HLBS therapeutics.
    • Evidence of unmet gaps and needs to support proposed activities.
  • Factor 2: Rigor and Feasibility (Approach)
    • Strong biological rationale for the intended approach.
    • Well-designed preliminary data (from literature, other sources, or investigator-generated).
    • Clear rationale for experimental design, showing a path for optimization of preliminary therapeutic agents.
    • Quality and reproducibility of experimental results.
  • Factor 3: Expertise and Resources (Investigator(s) and Environment)
    • Qualifications and experience of the Program Director(s)/Principal Investigator(s) and key personnel.
    • Adequacy of the environment and resources to conduct the proposed research.
    • Description of how a potential Accelerator Partner's expertise fills anticipated development gaps.
Additional Review Criteria (Not Scored, but Considered in Overall Impact)
  • Protections for Human Subjects (if applicable)
  • Vertebrate Animals (if applicable)
  • Biohazards: Evaluation of safety measures for hazardous materials/procedures.
  • Resubmissions: Evaluation of the full application as presented.
  • Renewals: Evaluation of progress made in the last funding period.
Additional Review Considerations (Not Scored, Not Used for Overall Impact Score)
  • Authentication of Key Biological and/or Chemical Resources.
  • Budget and Period of Support: Justification and reasonableness relative to proposed research.
  • Intellectual Property (IP) and Regulatory Strategy:
    • Assessment of IP strategy relative to the stage of technology development.
    • Understanding of known constraints and viable solutions for therapeutic discovery/development.
    • Clarity on limitations of required third-party IP.
    • Adequacy of regulatory considerations for market access.
    • Understanding of relevant FDA Center and Review Division.
    • Proposed market access pathway (e.g., IND leading to BLA, NDA, or 510(b)(2)).
    • Evidence of discussions with consultants or FDA interactions (if applicable).

Compliance & Special Requirements

Regulatory and Ethical Compliance
  • Adherence to all terms and conditions outlined in the NIH Grants Policy Statement.
  • Compliance with 2 CFR Part 200, 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'.
  • Compliance with all applicable nondiscrimination laws, including submitting an 'Assurance of Compliance (HHS-690)'.
  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for human subjects protocols, and NIH must receive copies of major changes.
  • Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.
Data Management and Security
  • Compliance with the 2023 NIH Policy for Data Management and Sharing; a Data Management and Sharing Plan must be implemented.
  • If applicable, health IT used must meet standards in 45 CFR part 170, Subpart B, or be ONC Health IT Certified.
  • Plans and procedures modeled after the NIST Cybersecurity framework are required for recipients/subrecipients with ongoing access to HHS information/operational technology systems or PII/PHI obtained from HHS.
Intellectual Property (IP) and Regulatory Considerations
  • A preliminary IP and regulatory strategy is a mandatory application component. Applications without this attachment are considered incomplete and will not be peer-reviewed.
  • The strategy should address how known IP constraints will be managed and should reflect consultation with institutional technology transfer officials.
  • For projects repurposing currently marketed or under-development therapies, a letter of support from the manufacturer for the new indication is required at the time of application or as post-submission material.
Special Programmatic Requirements
  • Accelerator Partner Requirement: Applicants must secure and include a letter of support from an 'Accelerator Partner'. This partner provides essential expertise and mentoring in areas like product development, commercialization, market analysis, regulatory submissions, IP protection, and reimbursement strategy. This partner can contribute to the required matching funds but is not obligated to.
  • Cost Matching Expectation: A minimum of a 0.25:1 non-Federal cash match of the Federal direct costs requested is expected. Institutions must document actual contributions.
  • Project Management: Applicants are expected to utilize formal project management processes and identify a team member responsible for this function. The Catalyze Coordinating Center offers resources and support for project management.
  • Milestone-Driven Progress: Proposed activities must be organized with specific, measurable, achievable, relevant, and time-bound (SMART) milestones. Progress will be rigorously monitored against these milestones, influencing annual non-competing award decisions.
  • Clinical Trial Exclusion: This NOFO explicitly states 'Clinical Trial Not Allowed', meaning projects proposing clinical trials will be considered non-responsive.
Unique Aspects
  • The grant encourages strategic alignment by requiring a strong biological rationale and preliminary data, coupled with a focus on novel targets and significant improvements over existing therapies.
  • Emphasizes the translation of basic science discoveries into treatments for HLBS diseases, bridging the gap between early research and preclinical development.

Grant Details

healthcare biomedical research therapeutics small molecules biologics combination products drug discovery preclinical development heart diseases lung diseases blood diseases sleep disorders translational research product definition innovation research and development nih nhlbi r33 grant federal funding grant
Catalyze: Product Definition for Small Molecules, Biologics, and Combination Products - Preliminary Product/Lead Series Identification and Combination Product Prototype (R33 - Clinical Trial Not Allowed)
RFA-HL-26-018
NIH Catalyze Program
UNIVERSITY NGO SME ENTERPRISE PUBLIC OTHER
US
HEALTHCARE TECHNOLOGY
DEVELOPMENT PILOT_PROJECTS
OTHER
SDG3
FUNDING RESEARCH_DEVELOPMENT MENTORSHIP CAPACITY_BUILDING INNOVATION_COMMERCIALIZATION
13398000.00
100000.00
800000.00
USD
25.00
Oct. 21, 2027, 10 p.m.
March 2028 - May 2028