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Grant Analysis

Purpose & Target

• Core objective: This grant aims to provide early-stage translational support for developing potential therapeutic candidates (small molecules, biologics, and combination products) to treat heart, lung, blood, and sleep (HLBS) diseases and disorders, progressing from target identification to preliminary product/lead series identification. • Target recipients: Researchers, higher education institutions, non-profits, for-profit organizations (including small businesses), and government entities engaged in therapeutic product definition and preclinical development. • SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on health and medical research, particularly within cardiology, pulmonology, hematology, and sleep medicine, with emphasis on therapeutic product development. • Geographic scope: Organizations based in the United States, including U.S. territories. Foreign organizations are not eligible. • Key filtering criteria: Focus on HLBS diseases and disorders, early-stage therapeutic development (pre-clinical, no clinical trials), and requirement for a phased (R61/R33) approach with defined milestones. • Grant frequency: Recurring, with multiple application deadlines through October 2027, as part of the broader NHLBI Catalyze innovation program.

Financial Structure

Total funding committed by NHLBI for the entire program: Up to $4,466,000 in FY 2026, $4,466,000 in FY 2027, and $4,466,000 in FY 2028.
Application budget limitations (direct costs): Must not exceed $400,000 per year during the R61 phase and must not exceed $400,000 per year during the R33 phase.
Cost matching requirement: For the R33 phase only, a minimum of a 0.25:1 non-Federal cash match of the Federal direct costs requested is expected. Proof of matching funds (letter of support) is required prior to the R61-to-R33 transition, not at application.
Annual reporting: The non-Federal cash match must be reported annually to NIH.
In-kind contributions: Encouraged, but do not count towards the cash matching expectation.
Ineligible matching fund sources: Costs borne by another Federal grant or sub-award, costs or contributions toward cost sharing on another Federal grant/contract, services or property financed by income earned by contractors, program income, patient incentives.
Eligible costs: Budget should include 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. Budget should also include appropriate project management support.
Budget flexibility: Annual project budgets should reflect the actual costs anticipated in each year.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (including Small Businesses and Other For-Profit)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized or Other))
Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
Other types: 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.

Geographic Requirements

Must be a domestic U.S. entity.
Non-domestic (non-U.S.) entities are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply.

Registration Requirements (Prior to application submission)

System for Award Management (SAM) registration (must be active and renewed at least annually). Includes Unique Entity Identifier (UEI).
eRA Commons registration (organizations need at least one Signing Official and one Program Director/Principal Investigator account).
Grants.gov registration (requires active SAM registration).
Foreign organizations, if eligible as a component of a U.S. organization, must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.

Investigator Requirements

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research can serve as Program Director(s)/Principal Investigator(s).

Clinical Trial Restriction

Projects proposing clinical trials are not allowed. Only applications that do not propose clinical trials will be accepted.

Non-Responsive Projects (Examples of Ineligible Activities)

Development of assays or probes solely to support basic understanding of disease or other basic research.
Development of devices or diagnostics (these are covered by companion NOFOs, RFA-HL-26-019 and RFA-HL-26-020).
Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers.
Investigational New Drug (IND) enabling studies.
Manufacture of therapeutic agents under good manufacturing practice for clinical use.
Clinical research and clinical trials.

Application Process

Application Submission Process

Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Applicants are encouraged to submit early to allow adequate time for error correction.
If the submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
Applicants are responsible for viewing their application in eRA Commons before the due date to ensure accurate and successful submission.

Key Dates and Deadlines

Posted Date: November 22, 2024
Open Date (Earliest Submission): January 11, 2025
Letter of Intent Due Date: 30 days prior to the application due date (encouraged, but not required or binding).
Latest Application Due Date: October 21, 2027, by 5:00 PM local time of the applicant organization (for New, Renewal, Resubmission, and Revision applications).
NOFO Expiration Date: December 24, 2027.

Required Documentation and Materials

Standard forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS Human Subjects and Clinical Trials Information, PHS Assignment Request Form.
PHS 398 Research Plan (with specific additions):
- Specific Aims: Must include separate headers for 'R61 Phase Specific Aims' and 'R33 Phase Specific Aims', detailing objectives and activities for each phase.
- Research Strategy: Must describe both the R61 and R33 phases, including biological/therapeutic rationale, unmet medical need, novelty, and project status. Must detail plans for identifying and characterizing therapeutic agents.
- Accelerator Partner: Describe how a potential Accelerator Partner's expertise might address anticipated development gaps.
- Milestones: Define specific, measurable, achievable, relevant, and time-bound milestones for both the R61 and R33 phases. Clear R61 milestones for successful R33 initiation are critical.
- Timeline: Provide a timeline with specific milestones for progression from the R61 phase to the R33 phase, ideally as a GANTT chart.
- Project Management: Describe plans for utilizing project management processes and identifying a team member responsible for project management.
- Rigor and Reproducibility: Address principles of study design and transparency.
Mandatory 'IP and Regulatory Strategies' Attachment: A PDF attachment named 'IP and Regulatory Strategies.pdf' is required, detailing preliminary IP and regulatory plans. Applications without this attachment will not be peer-reviewed.
Resource Sharing Plan and Data Management and Sharing Plan are required.
Appendix: Only limited materials are allowed (e.g., blank questionnaires, surveys; no publications).

Post-Submission Materials

Letters of support from manufacturers for new indications of re-purposed therapies (if applicable), confirming access to sufficient quantity of the not-yet-marketed technology for the proposed research. This must be submitted as post-submission material.

Application Assistance

Applicants are strongly encouraged to contact the Scientific/Research Staff listed in Section VII of the NOFO to discuss potential research projects prior to submission.
eRA Service Desk for system-related questions (web ticket, phone: 301-402-7469 or 866-504-9552).
General Grants Information for application instructions and processes (email: [email protected], phone: 301-480-7075).
Grants.gov Customer Support for registration and Workspace issues (phone: 800-518-4726, email: [email protected]).

Evaluation Criteria

Applications are evaluated for scientific and technical merit through NIH's peer review system. Reviewers will provide an overall impact score. Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria (These receive separate factor scores)

Importance of the Research (Significance and Innovation): Evaluates the novelty of the proposed new knowledge around targets, mechanisms, and pathways. Projects should aim to develop therapeutics that are significant improvements over existing options for HLBS diseases.
Rigor and Feasibility (Approach): Assesses the strong biological rationale for the intended approach, the quality of preliminary data (well-designed experiments from literature, other sources, or investigator-generated data), and the overall experimental design for identifying and characterizing proposed preliminary therapeutic agents. Includes how data obtained in the R33 phase will provide a path for optimization.
Expertise and Resources (Investigator(s) and Environment): Evaluates the skills, knowledge, and resources of the PD(s)/PI(s), and the adequacy of the institutional and project environment to support the proposed work.

Additional Review Criteria (Considered, but not separately scored)

Protections for Human Subjects: If applicable, evaluate the involvement of human subjects.
Vertebrate Animals: If applicable, evaluate proposed procedures, justifications for use, interventions to minimize discomfort, and euthanasia methods.
Biohazards: If applicable, evaluate whether specific materials or procedures are significantly hazardous and if adequate protection is proposed.
Resubmissions: Evaluate the full application as presented.
Renewals: Evaluate the progress made in the last funding period.

Additional Review Considerations (Considered, but not separately scored)

Authentication of Key Biological and/or Chemical Resources: Evaluate brief plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Intellectual Property and Regulatory Strategy: Evaluate the IP strategy relative to the stage of technology development. Assess the applicant's understanding of known constraints and viable solutions, adequacy of third-party IP description, and understanding of regulatory requirements for market access (e.g., FDA Center/Review Division, proposed market access pathway). Also, evaluate discussions with consultants or FDA interactions, if applicable.

Compliance & Special Requirements

Regulatory Compliance and Intellectual Property (IP)

IP and Regulatory Strategies: A mandatory attachment detailing preliminary IP and regulatory plans is required. For more advanced projects, applicants should describe their understanding of regulatory and IP requirements. If too early, indicate why and provide a brief description of the current stage and potential strategies.
- For IP: Describe known constraints (e.g., restrictions, existing patent protection) and how they will be addressed. Identify required third-party IP (with a letter if applicable). Provide details of pertinent patent filings.
- For Regulatory: Describe steps to refine and align the project with regulatory requirements. For drug/biologic development, describe data to be collected to support an Investigational New Drug (IND) filing. Provide evidence of prior communications with IRB or FDA, if any. Describe the expected regulatory pathway, foreseeable risks, or accelerated programs.
Health IT Compliance: If the award involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets standards in 45 CFR part 170, Subpart B, and, if applicable to clinicians in ambulatory settings or hospitals, health IT certified under the ONC Health IT Certification Program.

Data Management and Sharing

Compliance with the 2023 NIH Policy for Data Management and Sharing is required. All applications must include a Data Management and Sharing Plan.

Ethical and Safety Standards

Human Subjects Protection: Compliance with instructions for human subjects research, if applicable.
Vertebrate Animals: Compliance with guidelines for procedures, justifications, and welfare, if applicable.
Biohazards: Evaluation of hazardous materials/procedures and proposed protection.

Cybersecurity and Data Protection

If recipients have consistent access to HHS owned/operated information/operational technology systems, or handle Personal Identifiable Information (PII)/Personal Health Information (PHI) from the awarding agency, they must develop plans and procedures modeled after the NIST Cybersecurity Framework.

Legal and Administrative Compliance

Adherence to all applicable nondiscrimination laws.
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (as per 2 CFR 200.113 and NIH Grants Policy Statement 4.1.35).
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and the NIH Grants Policy Statement.

Special Award Structure and Requirements

Phased Award (R61/R33): This NOFO utilizes a bi-phasic grant mechanism.
- R61 Phase: Supports target identification and validation, and development of individual components for combination products (max 2 years).
- R33 Phase: Supports identification of a lead series for pre-clinical testing and development, and testing/optimization of combination product prototypes (max 2 years).
- Transition from R61 to R33: Contingent upon three factors:
  1. Acceptable progress and achievement of pre-specified R61 milestones.
  2. Ability to secure third-party investment (evidence of the 0.25:1 non-Federal cash match).
  3. Securing an Accelerator Partner.
Accelerator Partner: A commercialization expert partner is required for the R33 phase of the award. This partner provides skills development, mentoring, and connections to advance the project towards private sector development or further funding.
Project Management: Each project is expected to use formal project management processes and identify a team member responsible for project management. The Catalyze Coordinating Center offers resources and guidance.
Innovation Focus: Projects should propose new knowledge around novel targets, mechanisms, and pathways, aiming for significant improvements over existing therapeutics for HLBS diseases and disorders.

Grant Details