Grant Details

Grant Source URL https://www.grants.gov/search-results-detail/351914

General Overview

Grant Name and Funding Organization

Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

National Institutes of Health (NIH)

Total Funding Amount and Duration

Up to $700,000 for Phase I and $1,500,000 for Phase II

Maximum project period of 4 years

Primary Objective and Mission Statement

To support rigorous analytical validation of biomarkers for neurological and neuromuscular disorders.

Key Stakeholders and Beneficiaries

Small business concerns (SBCs) in the United States

Patients with neurological and neuromuscular disorders

Grant Program Context and History

Reissue of PAR-21-057

Aligned with agency priorities to improve public health

Funding Source and Type

NIH funding through the SBIR program

Cooperative agreements

Significance within Funding Landscape

Addresses critical gaps in biomarker validation for clinical trials

Grant Frequency

Recurring grant opportunity with multiple application deadlines

Organizational Aspects

Eligible Organization Types

Only United States small business concerns (SBCs)

Specific Qualifications and Certifications Needed

Must meet SBIR eligibility criteria

Organizational Size and Capacity Requirements

Must have not more than 500 employees

Geographic Location Requirements

Must be located in the United States

Track Record and Experience Requirements

Previous experience in biomarker research is beneficial

Partnership or Consortium Requirements

Multi-site applications are expected but not required

Inclusivity and Diversity Considerations

Not specified

Previous Relationship with Funder Considerations

Not specified

Organizational Maturity Requirements

Not specified

Scope and Focus

Primary Focus Areas and Priorities

Analytical validation of biomarkers for neurological and neuromuscular disorders

Target Sectors and Themes

Healthcare, biotechnology

Target Beneficiaries and Stakeholders

Patients with neurological and neuromuscular disorders

Geographic Coverage Requirements

United States

Scope Limitations and Exclusions

Not specified

Expected Outcomes and Deliverables

Validated biomarkers for use in clinical trials

Alignment Requirements with Funder Priorities

Must address unmet medical needs

Impact Expectations

Improvement in public health through better biomarker validation

Project Scale Requirements

Phase I and Phase II projects

Sustainability Expectations

Not specified

Technical Details

Technical Expertise Requirements

Expertise in biomarker research and validation

Infrastructure Requirements

Access to clinical laboratories for validation

Team Composition and Qualification Requirements

Multi-disciplinary teams encouraged

Research Methodology Requirements

Rigorous design and execution of studies

Quality Standards and Expectations

Must meet FDA guidance standards

Technical Documentation Requirements

Detailed project timeline and milestones required

Risk Management Expectations

Not specified

Intellectual Property Policies

Consult with tech transfer office if commercialization is planned

Technology Specifications

Not specified

Technical Partnerships Expectations

Encouraged to collaborate with FDA qualification experts

Security and Data Protection Requirements

Not specified

Technical Compliance Standards

Must comply with NIH and FDA standards

Financial Structure

Budget Range and Limitations

Up to $700,000 for Phase I and $1,500,000 for Phase II

Eligible and Ineligible Costs

Not specified

Matching Fund Requirements and Percentages

Not specified

Co-Financing Requirements

Not specified

Payment Schedule and Mechanisms

Not specified

Financial Reporting Requirements

Must comply with NIH financial reporting standards

Audit Requirements

Not specified

Financial Sustainability Expectations

Not specified

Cost-Sharing Structures

Not specified

Indirect Cost Policies

Not specified

Budget Flexibility Parameters

Not specified

Financial Guarantees Required

Not specified

Timeline and Implementation

Application Deadlines and Submission Windows

Latest application due date: February 20, 2026

Grant Duration Parameters

Maximum project period of 4 years

Implementation Timeline Expectations

Annual milestones required

Reporting Schedule and Frequency

Regular progress reports required

Key Milestones and Deliverables Timeline

Milestones must be included in the application

Monitoring and Evaluation Requirements

NIH Program Staff will monitor project progress

Implementation Phases Requirements

Not specified

Extension Possibilities

Not specified

Project Planning Requirements

Must include a detailed project timeline

Progress Tracking Mechanisms

NIH Program Official will track progress

Post-Grant Period Expectations

Not specified

Compliance and Requirements

Regulatory Compliance Requirements

Must comply with NIH and FDA regulations

Required Permits and Authorizations

Not specified

Data Protection and Privacy Regulations

Not specified

Environmental Compliance Requirements

Not specified

Ethical Standards and Requirements

Not specified

International Collaboration Regulations

Not specified

Industry-Specific Regulatory Compliance

Not specified

Labor Standards Compliance

Not specified

Tax Implications and Requirements

Not specified

Reporting Compliance Requirements

Must comply with NIH reporting standards

Accessibility and Inclusion Standards

Not specified

Legal Framework Compliance

Not specified

Application Process

Required Documentation and Materials

Must follow SBIR/STTR application instructions

Application Procedure and Steps

Submit through Grants.gov or NIH ASSIST

Evaluation Criteria and Scoring System

Applications will be evaluated for scientific and technical merit

Review Process and Timeline

Applications will undergo peer review

Selection Criteria and Priorities

Priority for applications addressing unmet medical needs

Pre-Application Requirements

Consultation with NINDS Program Staff encouraged

Submission Format and Platform

Use Grants.gov or NIH ASSIST for submission

Supporting Materials Required

Include a project timeline and milestones

Interview or Presentation Requirements

Not specified

Application Assistance Availability

eRA Service Desk available for support

Resubmission Policies

Resubmission allowed as per NIH guidelines

Special Considerations

Unique Aspects or Requirements

Not specified

Potential Challenges or Limitations

Not specified

Strategic Alignment Opportunities

Not specified

Competitive Advantages Factors

Not specified

Cross-Cutting Themes

Not specified

Innovation Requirements or Preferences

Not specified

Research Component Requirements

Not specified

Risk Tolerance and Mitigation Expectations

Not specified

Cultural and Contextual Considerations

Not specified

Knowledge Sharing Expectations

Not specified

Previous Funding Patterns

Historical Grant Recipients Profile

Not specified

Success Rate Statistics

Not specified

Grant Size Trends

Not specified

Recurring Grantee Patterns

Not specified

Geographic Distribution Patterns

Not specified

Sector Concentration Patterns

Not specified

Emerging Priority Areas

Not specified

Changes in Funding Criteria Over Time

Not specified

Success Stories and Case Studies

Not specified

Lessons Learned from Previous Cycles

Not specified