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Grant Analysis

Purpose & Target

This grant supports pilot studies that generate essential information for planning future Phase II-IV clinical trials focused on heart, lung, blood, or sleep disorders. - Explicit identification of target recipient type and size: Organizations involved in clinical research. A wide range of organization types are eligible, including higher education, nonprofits, for-profits (small and large), and various government entities. Size is not explicitly limited, but capacity to conduct clinical trials is implied. - MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC - Geographic scope and any location requirements: Organizations must be U.S.-based. Non-domestic components of U.S. organizations and foreign components are allowed, but foreign entities cannot apply directly. - Key filtering criteria for initial grant screening: Focus on specific medical disorders, pilot study for future clinical trials (Phase II-IV), U.S. organization. - Grant frequency and program context: Recurring opportunity (multiple deadlines annually until Jan 2027) as a reissuance, part of NHLBI's clinical trial optimization initiative.

Financial Structure

Total funding amount: Up to $450,000 in direct costs.
Duration: Over a three-year period.
Annual direct cost limit: Up to $225,000 in direct costs in any single year.
Minimum grant amount: Not specified, but implied by total limits.
Maximum grant amount: $450,000 direct costs over three years.
Currency: Not explicitly stated, but as a US federal grant, it's implied to be USD.
Funding rate: Not explicitly stated as a percentage, but 'grant' implies full funding of approved eligible costs within limits.
Matching fund requirements: Not required.
Co-financing requirements: Not required.
Eligible costs: Not exhaustively listed, but subject to NIH Grants Policy Statement and related cost principles. Pre-award costs are allowable as described in NIH Grants Policy Statement Section 7.9.1.
Ineligible costs: Not exhaustively listed, but subject to NIH Grants Policy Statement.
Payment schedule: Not specified, standard NIH grant payment.
Financial reporting: Annual Research Performance Progress Report (RPPR) and financial statements required. Final RPPR and expenditure data for closeout. Reporting subawards over the threshold to FSRS (www.fsrs.gov).
Audit requirements: Subject to 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Financial guarantees: Not specified.

Eligibility Requirements

Organizational Type and Legal Structure

Eligible:
Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: 501(c)(3) IRS Status, Other.
For-Profit Organizations: Small Businesses, Other For-Profit.
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized or Other).
Federal Governments: Eligible Agencies, U.S. Territory or Possession.
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.
Ineligible:
Non-domestic (non-U.S.) Entities (Foreign Organizations).

Geographic and Regulatory Requirements

Applicants must be U.S.-based organizations.
Required Registrations (must be active and completed before submission):
System for Award Management (SAM)
Unique Entity Identifier (UEI) (assigned via SAM.gov)
eRA Commons (for organization and PD/PI)
Grants.gov
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
If involving FDA regulated products, must secure IND authorization or IDE approval and provide documentation to NHLBI before a funding decision.

Project Scope and Focus Requirements

Proposed research must be within NHLBI's mission (heart, lung, blood, or sleep disorders).
Purpose: To generate information scientifically necessary and sufficient to inform the planning of a Phase II-IV clinical trial.
Exclusions:
Not for first-in-human studies.
Not for writing protocols or manuals.
Not for developing infrastructure.
Not for implementing an already fully designed trial.
Not for purely mechanistic studies.
Not for animal studies.
Research addressing prevention or treatment of malignancies is not eligible.

Investigator Qualifications

Any individual(s) with the knowledge, skills, and resources to carry out the proposed research may serve as PD(s)/PI(s).
PD(s)/PI(s) must have an eRA Commons account.
Investigators should provide evidence of knowledge, skills, and experience to conduct a clinical trial in biosketches.
Appropriate biostatistical support for the R34 award is required.

Application Process

Application Deadlines and Submission

Letter of Intent Due Date: 30 days before application due date (optional).
Application Due Dates (latest): October 16, 2026 (5:00 PM local time of applicant organization).
Open Date (Earliest Submission Date): January 16, 2025.
Expiration Date for this Funding Opportunity: January 08, 2027.
Submission platform: Grants.gov (via NIH ASSIST, institutional system-to-system (S2S), or Grants.gov Workspace).
Electronic submission only; paper applications are not accepted.

Required Documentation and Materials

Standard NIH application forms (SF424(R&R) series, PHS 398 series).
Budget (R&R or Modular) and Subaward Budget forms.
PHS Human Subjects and Clinical Trials Information form (if applicable).
Research Strategy section: Describe how proposed research informs future trial decisions and how R34 data are necessary and sufficient.
Data Management and Sharing Plan.
Appendix: Limited to blank questionnaires or surveys (no publications or other material).
Specific Attachments:
'Future Clinical Trial Description.pdf': Required, max 3 pages, provides context for the future clinical trial.
'FDA Approval.pdf': If applicable, documents status of FDA requirements for R34.
'Supporting Documents.pdf': Single file for contracts, MOUs, or agreements (if applicable).

Post-Award Requirements

Annual Research Performance Progress Report (RPPR) and financial statements.
Final RPPR, invention statement, and expenditure data for closeout.
Registration and results reporting for clinical trials on ClinicalTrials.gov (if applicable).
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required.
Compliance with Data and Safety Monitoring requirements for human studies.
Compliance with Federal Funding Accountability and Transparency Act (FFATA) for subawards over threshold (fsrs.gov).
Mandatory disclosures for violations of federal criminal law involving fraud, bribery, or gratuity.
Integrity and performance reporting in SAM.gov for awards over $10,000,000 cumulative value.

Application Support

Contacts available for eRA Service Desk, General Grants Information, Grants.gov Customer Support, Scientific/Research, Peer Review, and Financial/Grants Management inquiries.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood for the project to exert a sustained, powerful influence on the research field.

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluates the importance and novelty of the proposed research.
Rigor and Feasibility (Approach): Assesses the soundness of the proposed methodology and the likelihood of success. This includes how the proposed research will lead to decisions that inform future clinical trials and how the data collected will be necessary and sufficient for final decisions about the subsequent trial.
Expertise and Resources (Investigator(s) and Environment): Examines the qualifications of the investigator(s) and the appropriateness of the research environment (lead institution and collaborating sites, capacity to recruit subjects).

Additional Review Criteria (Considered, but not scored)

Protections for Human Subjects: Evaluation of ethical considerations and safety measures for human participants.
Vertebrate Animals: If applicable.
Biohazards: Evaluation of hazards and proposed protections.
Resubmissions/Renewals/Revisions: Evaluation of progress or appropriateness of proposed expansion.

Additional Review Considerations (Considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Brief plans for validating resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration.
Inclusion: Reviewers will not consider race, ethnicity, age, or sex of a researcher in funding recommendations.

Compliance & Special Requirements

Regulatory and Ethical Compliance

FDA Requirements: For studies using FDA regulated products, IND authorization or IDE approval is required before a funding decision is made. Applicants must describe the plan for FDA approval if not yet granted.
Human Subjects Protections: Applications involving human subjects must comply with protections, and protocol changes must be provided to NIH.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board or Independent Ethics Committee.
Data Management and Sharing: All applications must include a Data Management and Sharing Plan, and recipients must implement the approved plan.
ClinicalTrials.gov: If the award supports clinical trials, registration and results reporting are expected, and legally required for 'applicable clinical trials'.
Nondiscrimination: Compliance with all applicable nondiscrimination laws (e.g., HHS-690 Assurance of Compliance).
Biohazards: Evaluation of potential hazards and proposed protections for research personnel and environment.

Scope Limitations and Exclusions

Research must be within NHLBI's mission (heart, lung, blood, or sleep disorders); research on malignancies is excluded.
Not intended for 'first-in-human' studies, writing protocols, infrastructure development, implementing already designed trials, purely mechanistic studies, or animal studies.

Unique Aspects

This R34 grant is specifically designed for 'pilot studies' that provide new information to answer scientific or operational questions for the final development of a future Phase II-IV clinical trial.
The results of the R34 must be 'sufficient' to inform the future trial without requiring further studies before the main trial.
Support for the proposed future clinical trial will require a new application, regardless of R34 results.

Risk Management

NIH reviews an applicant's federal award history in SAM.gov for sound business practices and integrity.
Potential termination of awards for noncompliance or other reasons.

Grant Details