Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

This grant, PAR-24-098, aims to support the rigorous analytical validation of methods used for measuring biomarkers relevant to neurological and neuromuscular disorders. The goal is to prepare these biomarkers for use in clinical trials or clinical practice.

Target Recipient Type and Size: SME (small business concerns, generally with less than 500 employees).
SECTOR-SPECIFIC: Healthcare, specifically neurological and neuromuscular disorders.
Geographic Scope: Applicants must be U.S.-based organizations.
Key Filtering Criteria: Focus on analytical validation of biomarkers for neurological/neuromuscular disorders, U.S. small business, and experience in biomarker research.
Grant Frequency and Program Context: This is a recurring funding opportunity (reissue of PAR-21-057) under the NIH Small Business Innovation Research (SBIR) program, designed to bridge the gap between biomarker discovery and clinical application.

Financial Structure

Award Budget (Phase I): Up to $700,000 total costs per year.
Award Budget (Phase II): Up to $1,500,000 total costs per year.
Project Period (Phase I): Up to 2 years.
Project Period (Phase II): Up to 3 years.
Maximum Project Period (total): 4 years.
Matching Fund Requirements: No cost sharing or matching funds are required.
Eligible Costs: Costs associated with analytical validation activities, optimization and standardization of detection methods, multi-site studies, data sharing, BioSEND sample sharing, and commercialization planning are implied as eligible.
Indirect Cost Policies: Included within the 'total costs' budget limits.
Payment Schedule/Mechanisms: Funds are released based on progress towards milestones and overall project goals, assessed by NIH program staff. This is a Cooperative Agreement, implying active financial oversight by the funder.

Eligibility Requirements

Organization Type & Size

Eligible organizations are United States small business concerns (SBCs).
Must be organized for profit, with a place of business in the U.S., operating primarily within the U.S. or contributing significantly to the U.S. economy.
Legal forms include: individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative.
Joint ventures must have less than 50% participation by foreign business entities.
Ownership: Must be more than 50% directly owned and controlled by U.S. citizens/permanent resident aliens, other eligible U.S. business concerns, Indian tribes, Alaska Native Corporations (ANCs), Native Hawaiian Organizations (NHOs), or a combination.
Alternatively, for SBIR-only, more than 50% owned by multiple U.S.-based venture capital operating companies, hedge funds, or private equity firms (with no single one owning more than 50% unless that single entity qualifies as an SBC).
Employee Count: Must have, including affiliates, not more than 500 employees.

Geographic Requirements

United States-based organizations only. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. Foreign components (sub-contracting work) may be allowed.

Performance Benchmarks (for experienced applicants)

Phase I to Phase II Transition Rate: For companies with more than 20 Phase I awards in the past 5 fiscal years (excluding most recent), a minimum transition rate of 0.25 (or 0.5 for >50 Phase I awards) is required to be eligible for new Phase I, Fast-Track, or Direct Phase II awards.
Phase II to Commercialization Benchmark: For companies with more than 15 Phase II awards in the past 10 fiscal years (excluding two most recent), an average of at least $100,000 in revenues/investments per Phase II award OR at least 0.15 patents per Phase II award is required (higher thresholds for companies with >50 or >100 Phase II awards). Failure to meet this benchmark results in ineligibility for new Phase I, Fast-Track, or Direct Phase II awards for one year.

Principal Investigator (PD/PI) Requirements

Primary employment of the PD/PI must be with the small business concern at the time of award and throughout the project. For multiple PD/PIs, at least one must meet this requirement.
Each PD/PI must commit a minimum of 10% effort to the project.

Contractual/Consortium Arrangements

Phase I: Normally, at least two-thirds (67%) of the research effort must be carried out by the small business concern. Consultant/contractual arrangements to third parties generally not more than 33%.
Phase II: Normally, at least one-half (50%) of the research effort must be carried out by the small business concern. Consultant/contractual arrangements to third parties generally not more than 50%.
Subcontracting to Federal laboratories is allowed within these limits.

Exclusion Criteria

Organizations that do not meet the definition of a 'small business concern' as outlined.
Foreign organizations or foreign components of U.S. organizations (as primary applicant).
SBIR-only applicants that are more than 50% owned by multiple venture capital operating companies, hedge funds, or private equity firms are NOT eligible to apply to the NIH STTR program (this grant is SBIR).
Duplicate or highly overlapping applications under review at the same time will not be accepted.

Application Process

Application Deadlines

Applications are due by 5:00 PM local time of applicant organization on the following dates:
February 21, 2025
June 20, 2025
February 20, 2026
June 22, 2026 (latest deadline)
Letters of Intent are due 30 days prior to the application due date.
Applicants are encouraged to apply early to allow time for corrections.

Application Procedure & Submission

Applications must be submitted electronically via one of these options:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Required registrations must be completed prior to submission: System for Award Management (SAM), Unique Entity Identifier (UEI), SBA Company Registry, eRA Commons, Grants.gov.
All PD/PIs must have an eRA Commons account.
Letter of Intent is encouraged but not required.

Required Documentation & Materials

Follow SBIR/STTR (B) Instructions in the 'How to Apply – Application Guide' and program-specific instructions in this NOFO.
Page Limitations: Adhere to limits in the 'How to Apply – Application Guide' and 'Table of Page Limits'.
Mandatory Attachments (under SF424(R&R) Other Project Information):
Timeline and Proposed Milestones (max 3 pages): Describe project decision points with quantitative go/no-go metrics and a Gantt chart. Includes progress and performance metrics, and plans for regulatory interactions.
Team Management Plan (max 3 pages): Describes workflow of team/key personnel, multidisciplinary approach, organizational structure, roles, resource sharing, and communication.
Associated Clinical Trial Protocols and Consent Forms (if applicable, no page limit): For projects leveraging existing clinical trials, include protocols and consent forms.
Intellectual Property Plan (max 1 page): Describe constraints on commercialization, IP landscape, future filing plans, and IP sharing among parties.
Letters of Support (if applicable, no page limits): From consultants, contractors, collaborators, BioSEND (if using), technology transfer officials, and institutions if multi-institutional.
SBIR Application Certification for majority VCOC-owned small businesses (if applicable, specific PDF file name required).
PHS 398 Research Plan: Includes Context of Use (max 2 contexts of use) and Specific Aims.
Research Strategy section must include:
Clinical Context and Unmet Need.
Premise, Biological Rationale and Technical Readiness.
Approach and Statistical Analysis Plan.
Resource Sharing Plans: Required; specifically encouraged for biofluid samples via BioSEND.
Data Management and Sharing Plan: Required for all applicants.
Appendix: Limited items allowed; protocols for biomarker measurement encouraged; FDA communication summaries encouraged.

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR), Final Invention Statement and Certification, Annual Invention Utilization Reports, Federal Financial Report (FFR), SBIR.gov reports. Timely submission is critical.
Compliance: Adherence to all terms and conditions outlined in the Notice of Award (NoA) and NIH Grants Policy Statement.
Clinical Trial Oversight (if applicable): Registration and results reporting on ClinicalTrials.gov, IRB/IEC approval, Data and Safety Monitoring, IND/IDE requirements.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood of the project to have a sustained, powerful influence on the research field(s). Scored Review Criteria

Significance:
Does the project address an important problem, critical barrier, or unmet need in neurological/neuromuscular disorders?
Rigor of prior research supporting the project.
How will successful completion improve scientific knowledge, technical capability, clinical practice?
Commercial potential (product, target customers, unmet need).
Likelihood of biomarker(s) and detection method(s) being used in future clinical trials or practice.
Degree of improvement over existing tools.
Feasibility of broad implementation (considering technical limitations, time, cost, burden).
Rigor of prior research (minimizing bias, robust experimental designs, transparent reporting).
Investigator(s):
Appropriateness of PD/PI(s), collaborators, and other researchers, and their commitment.
Experience and training of PD/PI(s); track record of accomplishments.
Complementary and integrated expertise in collaborative/multi-PD/PI projects.
Expertise for commercializing technology/service/product.
Appropriateness of multidisciplinary team (clinical scientists, disease/biology experts, statisticians, regulatory experts).
Clearly defined roles in the team management plan and budget justification.
Innovation:
Does the proposed product/service offer an innovative approach to an important problem?
Will it shift current research/clinical practice paradigms?
Significant advantages over existing approaches or those in development.
For Phase II/Fast-Track: Plan to create a 'temporal barrier' (e.g., IP protection) against competitors.
Specific to this NOFO: How innovative are elements such as study design, detection method, or proposed clinical context of use (innovation is not required but contributes).
Approach:
Appropriateness of research aims for the development stage.
Soundness of overall strategy, methodology, and analyses.
Plans to address weaknesses in rigor of prior research.
Strategies for robust and unbiased approach.
Management of potential problems, alternative strategies, benchmarks for success.
Feasibility establishment and risky aspects management for early-stage projects.
Clear, appropriate, measurable milestones for Phase I to Phase II progression.
Plans to address relevant biological variables (sex, etc.).
Specific to this NOFO: Appropriateness of experimental design and statistical analysis plans for optimizing detection method performance and evaluating analytical validity.
Plans for evaluating and minimizing pre-analytic variables.
Plans for evaluating Accuracy, Precision, Analytical sensitivity/specificity, Reportable range, Reference intervals, inter/intra variability, and other performance characteristics.
Validation plans for algorithms/machine learning (training, testing, avoiding overfitting, stability, reliability).
Justification for single-site analytical validation (if applicable).
Environment:
Contribution of the scientific and business environment to success and commercialization.
Adequacy of small business support, equipment, and physical resources.
Benefit from unique features of environment, subject populations, or collaborations.
Business expertise and resources for commercialization (Phase I) or access to experts (Phase II/Fast-Track).

Additional Review Criteria (Not Scored)

Study Timeline: Detailed, feasible, and justified timeline, incorporating efficiencies, addressing challenges.
Milestones and Timeline: Clarity and quantitativeness of go/no-go decision points, appropriateness of performance metrics, feasibility of timeline.
Team Management Plan: Description of team/key personnel workflow, organizational structure, roles, resource sharing, etc.
Associated Clinical Trial Protocols and Consent Forms: Adequacy of consent for proposed studies, feasibility.
Intellectual Property (IP) Plan: Appropriateness and sufficiency of IP plan for commercialization, outline of IP landscape, protection strategy, details of filed patents, IP sharing among institutions/investigators.
Commercialization (Phase II and Fast-Track Only):
Market opportunity understanding and addressing barriers (regulatory, reimbursement, competition).
Post-SBIR product development and commercialization milestones.
Plan for funding development and commercialization (including letters of interest/commitment).
Suitability of management team and business experts.
Sound strategy for product adoption and revenue generation.
Protections for Human Subjects: Justification for involvement, protection against risks, benefits, importance of knowledge, data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Justification for use, description of procedures, methods to limit discomfort.
Biohazards: Assessment of potential hazards and proposed protection.
Resubmissions: Evaluation of responses to previous comments and changes made.
Intellectual Property: Constraints, IP landscape, protection strategy, patent details, IP sharing plans.

Compliance & Special Requirements

Regulatory Compliance Requirements

Projects should consider data package needed for FDA’s Biomarker Qualification Submission or submission to FDA’s Center for Devices and Radiological Health.
Milestones should include planned interactions with regulatory agencies (e.g., filing for Medical Device Development Tool qualification, Letter of Intent for Biomarker Qualification, CLIA certification, FDA Q-Submission meeting).
If involving human subjects, compliance with 45 CFR Part 46 regarding protection of human subjects, and inclusion policies for women, racial/ethnic minorities, and individuals across the lifespan.
If clinical trial optional is exercised, adherence to ClinicalTrials.gov registration and reporting, IRB/IEC approval, Data and Safety Monitoring, and Investigational New Drug (IND)/Investigational Device Exemption (IDE) requirements.

Data Protection and Privacy

Compliance with the 2023 NIH Policy for Data Management and Sharing for scientific data generated.
SBIR/STTR recipients may retain data rights for up to 20 years after award date.

Intellectual Property (IP) Policies

An Intellectual Property Plan is required (max 1 page) to describe potential commercialization impediments, the IP landscape of the detection method, future filing plans, and how IP will be shared among multiple investigators/institutions.
Applicants are encouraged to consult their tech transfer office.

Risk Management and Security Requirements

Foreign Disclosure Requirements: Required for owners and covered individuals (senior key personnel) regarding funded and unfunded relationships with foreign countries.
Awards may be denied if ties to 'foreign countries of concern' (e.g., People’s Republic of China) pose a security risk (e.g., interfere with activities, create duplication, conflicts of interest, undeclared, violate law, national security risk).
Repayment of Funds: Required if material misstatement or significant change in ownership/structure determined to pose a national security risk.

Cooperative Agreement (Substantial Funder Involvement)

This is a Cooperative Agreement (U44), meaning there will be substantial Federal scientific or programmatic involvement from NIH (NINDS).
NIH program staff will assist, guide, coordinate, and participate in project activities.
Recipients primarily define objectives and approaches, conduct research, and own data, but NIH staff provide input on milestones, assess progress, may recommend critical experiments, and participate in regulatory meetings.
Funding continuation is tied to meeting milestones and overall progress.
A Dispute Resolution process is in place for scientific/programmatic disagreements between recipients and NIH.

Other Special Requirements

Multi-site Studies: Expected for analytical validation; strong justification needed for single-site applications.
Leveraging Existing Resources: Encouraged to use resources like NINDS Human Biospecimen and Data Repository (BioSEND) and ongoing clinical trials/studies.
Project Milestones: Mandatory annual quantitative milestones for go/no-go decision making.
Rigor and Reproducibility: Strong emphasis on rigorous experimental design, minimization of bias, transparent reporting, and data sharing (code/scripts, analytic tools, protocols, metadata).

Grant Details