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Grant Analysis

Purpose & Target

The core objective of this grant is to support the rigorous development and validation of Digital Health Technology (DHT) derived biomarkers and clinical outcome assessments (COAs) for remote monitoring. These are intended to fill defined unmet clinical endpoint needs for interventional clinical trials across multiple diseases.

Target Recipient Type and Size: Eligible organizations include a broad range of entities from Higher Education Institutions, Nonprofits, For-Profit Organizations (including Small Businesses), to various levels of Government entities and other community-based organizations. There are no explicit employee count restrictions, though small businesses are specifically noted as eligible for-profit entities.
This is a SECTOR-SPECIFIC grant.
Geographic Scope: Only U.S. organizations are eligible to apply. Foreign components (e.g., subcontractors, collaborators) are allowed, but the lead applicant must be a U.S. entity.
Key Filtering Criteria: Focus on developing and validating existing DHTs for remote monitoring as clinical trial endpoints in three or more disease areas, with required patient/community engagement.
Grant Frequency and Program Context: This is a Program Announcement (PAR-25-170) which typically implies a recurring funding opportunity, with multiple application due dates until June 2026, indicating it is active for several cycles.

Financial Structure

Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
Minimum/Maximum Grant Amount: No specific minimum or maximum grant amounts are stated. However, applicants requesting $500,000 or more in direct costs in any single year (excluding consortium F&A) must contact a Scientific/Research Contact at least 6 weeks prior to submission.
Currency: U.S. Dollars (USD), implied by funding organization (NIH, U.S. government).
Cost Sharing/Matching Funds: This funding opportunity does not require cost sharing or matching funds.
Eligible Costs: Pre-award costs are allowable as described in the NIH Grants Policy Statement. Otherwise, standard NIH cost principles apply.
Ineligible Costs: Not explicitly detailed, but generally costs not directly related to the proposed research or those not compliant with NIH cost principles.
Payment Schedule: Not explicitly detailed, but as a Cooperative Agreement, funding will likely be disbursed in phases tied to project progress and milestone achievement.
Financial Reporting Requirements: Recipients are required to submit annual Research Performance Progress Reports (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other For-Profit)
Local Governments (State, County, City/Township, Special District, Federally Recognized Indian/Native American Tribal Governments, Other Indian/Native American Tribal Governments)
Federal Government (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), Faith-based or Community-based Organizations, Regional Organizations)
Geographic Location Requirements:
Applicant organizations must be based in the U.S.
Non-domestic (non-U.S.) entities or non-domestic components of U.S. organizations are not eligible to apply as the lead applicant.
Foreign components (sub-awardees or collaborators) are allowed as defined by NIH policy.

Required Registrations and Certifications

Applicant Organizations: Must complete and maintain active registrations prior to application submission:
System for Award Management (SAM) with annual renewal.
Unique Entity Identifier (UEI) obtained through SAM.gov.
eRA Commons registration (requires identifying a Signing Official and at least one Program Director/Principal Investigator).
Grants.gov registration.
Program Directors/Principal Investigators (PDs/PIs):
Must have an eRA Commons account, affiliated with the applicant organization.

Project Specific Requirements

Partnership Requirements:
Partnerships with 'people with lived experience' (PWLE) and patient advocacy organizations are required to inform study design and endpoint selection.
Applicants are strongly encouraged to form multidisciplinary teams including clinical scientists, disease experts, statisticians, and regulatory experts.
Scope Requirements:
Proposed development and validation must be for DHTs used in three or more diseases or conditions.
The project must focus on developing and evaluating existing DHTs, not developing new devices or apps.
Applications must include a 'Contexts of Use' statement specifying how proposed endpoints will address an unmet need.
Projects must include a timeline and 'milestones' for 'go/no-go' decisions.

Application Process

Application Deadlines and Timeline

Application Due Dates:
February 21, 2025
June 20, 2025
February 20, 2026
June 22, 2026 (latest)
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Letter of Intent (LOI): Requested, but not required, 30 days before the application due date. It allows NIH staff to estimate review workload.
Project Period: The UG3 phase can be 1-2 years, and the UH3 phase can be 3-4 years, with the maximum combined project period being no more than 5 years.

Application Procedure and Submission

Submission Platform: Applications must be submitted electronically through Grants.gov using one of the following:
NIH ASSIST system
Institutional system-to-system (S2S) solution
Grants.gov Workspace
Early Submission Encouraged: Applicants are encouraged to submit early to allow time for corrections if errors are found during the submission process.
System Issues: If a system issue beyond the applicant's control threatens on-time submission, specific guidance for 'Dealing with System Issues' must be followed.

Required Documentation and Materials

Standard Forms: SF424(R&R) forms, PHS 398 forms, PHS Human Subjects and Clinical Trials Information form.
Project-Specific Attachments:
Timeline and Proposed Milestones (maximum 3 pages): Must describe project decision points with quantitative 'go/no-go' metrics for each phase and annual milestones. A Gantt chart is strongly encouraged.
Team Management Plan (maximum 2 pages): Describes workflow of the multidisciplinary team/key personnel, including organizational structure, roles, decision-making, resource sharing, and knowledge transfer.
Community Engagement Plan (maximum 2 pages): Outlines how community engagement strategies, input, and research will be incorporated. Must identify partners, their roles, and how they will be collaboratively engaged.
Intellectual Property (IP) Strategy (if applicable): Discusses IP landscape, constraints, and future filing plans. If using DHTs not owned by the applicant, a letter addressing 'freedom to operate' is required.
Data Management and Sharing Plan: Required for all applications generating scientific data.
Letters of Support: Required for community partners and potentially for IP freedom to operate.
Page Limitations: All specified page limitations in the 'How to Apply - Application Guide' and 'Table of Page Limits' must be followed.

Post-Award Requirements and Compliance

Reporting: Annual Research Performance Progress Reports (RPPRs) and financial statements are required.
ClinicalTrials.gov: If applicable, responsible party must register and submit results information for clinical trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Required for human biomedical and behavioral intervention studies.
IND/IDE Requirements: Clinical research involving investigational therapeutics/devices must be performed under FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) if applicable.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood of the project to have a sustained, powerful influence on the research field, considering the following factors: Significance

Addresses an important gap in knowledge, solves a critical problem, or creates a valuable conceptual/technical advance.
Rationale and scientific background justify the proposed study.
Specific to this NOFO: Likelihood of proposed DHT derived biomarkers/COAs being used in future clinical trials.
Added value of these candidate endpoints in reducing burden on participants/caregivers or improving clinical trial efficiency.
Assessment of whether benefits of implementing DHT derived biomarkers/COAs outweigh foreseen implementation issues.

Innovation

Application of novel concepts, methods, or technologies, or novel use of existing ones to enhance project impact.

Rigor and Feasibility (Approach)

Rigor: Potential to produce unbiased, reproducible, robust data, with appropriate experimental design, controls, and justified sample size.
Adequate plans for analysis, interpretation, and reporting results.
Plans to address relevant biological variables (e.g., sex, age).
For human subjects: Rigor of intervention, justified outcome variables, generalizability/relevance to subgroup, appropriate and diverse sample, adequate inclusion plans.
Feasibility: Sound and achievable proposed approach, with plans for addressing challenges.
For human subjects: Adequacy and feasibility of recruitment and retention plan for target population (age, race, ethnicity, sex).
For clinical trials: Feasible study timeline and milestones.
Specific to this NOFO:
Appropriateness of quantitative 'Go/No-Go' milestones and success criteria for UG3 to UH3 transition.
Clarity of milestones as indicators of feasibility and inclusion of performance metrics for DHT biomarker and detection methods.
Quality of the Community Engagement plan: clear roles, sufficient resources, description of benefits to community, dissemination of information, and feasibility of engagement.
Experimental design effectively tests if DHT can be used as proposed for the 'Contexts of Use'.

Investigator(s) and Environment

Investigator(s): Demonstrated background, training, and expertise. For Multiple Principal Investigator (MPI) applications, quality of the leadership plan for coordination and collaboration.
Environment: Appropriate institutional resources for successful execution of the proposed work.

Additional Review Criteria (No Criterion Scores)

Intellectual Property (IP) Strategy: Assessment of any significant concerns with the IP strategy or landscape that could hinder translational success and adoption.
Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, data and safety monitoring.
Vertebrate Animals: Description of procedures, justification for animal use, interventions to minimize discomfort, justification for euthanasia method.
Biohazards: Evaluation of hazardous materials/procedures and proposed protections.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.

Compliance & Special Requirements

Regulatory Compliance Requirements

General: Compliance with all applicable federal regulations, including those outlined in the Public Health Service Act and 2 CFR Part 200.
Clinical Research:
Adherence to Good Clinical Practices (GCP).
Compliance with FDA's Drug Development Tools qualification programs guidance.
Consideration of Centers for Medicare & Medicaid Services (CMS) policies (e.g., Coverage with Evidence Development).
Health Information Technology:
If implementing, acquiring, or upgrading health IT, use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B.
For eligible clinicians in ambulatory settings or hospitals, use ONC Health IT Certified Technology if available.

Data Protection and Security

Data Management and Sharing (DMS):
Compliance with the 2023 NIH Policy for Data Management and Sharing. A DMS Plan must be submitted and adhered to.
Data and biospecimens are expected to be shared through broad-sharing repositories.
Cybersecurity: If recipients have ongoing access to HHS information or operational technology systems, or handle PII/PHI from HHS, they must develop plans and procedures modeled after the NIST Cybersecurity Framework.

Ethical Standards

Human Subjects Protection: Adherence to 45 CFR Part 46 regulations for research involving human subjects, including justification for involvement, protection against risks, and data/safety monitoring.
Responsible Conduct: Mandatory disclosure of any violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award (2 CFR 200.113).

Intellectual Property (IP) Policies

Ownership: Recipients retain custody of and primary rights to data and software developed under these awards, subject to Government rights of access.
Strategy: Applications should include an IP strategy if commercialization is intended, addressing the IP landscape, known constraints, and future filing plans.
Freedom to Operate: If using DHTs whose IP is not owned by the applicant's institution, a letter addressing freedom to operate is required.

Special Considerations

Phased Approach: The UG3/UH3 mechanism is a phased award (UG3 for 1-2 years, UH3 for 3-4 years) with a maximum combined duration of 5 years. Transition to the UH3 phase is contingent on achieving milestones from the UG3 phase.
Substantial Funder Involvement: This is a Cooperative Agreement, meaning NIH staff will have substantial programmatic involvement, assisting, guiding, and coordinating project activities. NIH Program Officers will negotiate and monitor milestones.
Patient and Community Engagement: Required partnership with 'people with lived experience' (PWLE) and patient advocacy organizations. A robust Community Engagement Plan is critical, demonstrating how communities will be meaningfully involved and how research results will be disseminated back to them.
Multidisciplinary Team: Strongly encouraged to ensure comprehensive expertise in clinical science, disease biology, statistics (especially clinical trial design), and regulatory affairs.
Focus on Existing DHTs: The grant supports validation of existing DHTs, not the development of new devices or applications.
Multiple Disease Areas: Projects must propose development and validation of DHTs in three or more diseases or conditions to promote standardization and collaboration.
Non-Responsive Applications: Studies will be administratively withdrawn without review if they fall outside the specific scope (e.g., focused on therapeutic agent development, preclinical research, or if they lack a 'Contexts of Use' statement or milestones).

Grant Details