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Grant Analysis

Purpose & Target

GRANT PURPOSE AND TARGET: - Support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. - Explicit identification of target recipient type and size: The grant targets a wide range of U.S.-based organizations, including higher education institutions, nonprofits, for-profit businesses (small and other), and various government entities. There are no explicit size restrictions, but applicants must have the capacity and expertise for complex research. - SECTOR-SPECIFIC: Healthcare (Neurology, Neuromuscular Disorders) and Technology (Biomarker Analytical Methods). - Geographic scope: Organizations must be based in the United States. Foreign components are allowed within a U.S. application, but foreign entities cannot be the primary applicant. - Key filtering criteria: Focus on analytical validation of biomarkers, not early discovery or clinical efficacy trials. Must address neurological or neuromuscular disorders. Must have preliminary data supporting biomarker utility and a developed detection method. Must specify context(s) of use and include milestones. - Grant frequency and program context: This is a reissue of PAR-24-095, indicating a recurring funding opportunity within the National Institute of Neurological Disorders and Stroke (NINDS) program to advance biomarker development for clinical readiness.

Financial Structure

FINANCIAL STRUCTURE: - Budget range and limitations: Application budgets are not limited but should reflect the actual needs of the proposed project. There are no specified minimum or maximum award amounts. - Matching fund requirements: This funding opportunity does not require cost sharing. - Co-financing requirements: None explicitly stated. - Financial reporting requirements: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for award closeout. - Eligible costs: Budgets should reflect costs associated with Data Management and Sharing efforts. Costs for collection of biofluid samples from prospectively enrolled participants, if shared through BioSEND, are not included as a component of the BioSEND repository award and thus must be covered by the grant application's budget. - Indirect cost policies: Not explicitly detailed within the text, but general NIH policies apply. For applications requesting $500,000 or more in direct costs in any year, consortium F&A costs are excluded when calculating this threshold.

Eligibility Requirements

ELIGIBILITY REQUIREMENTS: Organization Types

Higher Education Institutions: Public/State Controlled, Private
Nonprofits: With or Without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations: Small Businesses, Other than Small Businesses
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and Other)
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

Geographic Location

Applicant organization must be based in the United States.
Non-domestic (non-U.S.) Entities are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components (e.g., specific collaborators or resources) are allowed within a U.S. based application.

Registrations & Certifications

Active System for Award Management (SAM) registration (requires annual renewal).
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations/components, if applicable).
Unique Entity Identifier (UEI) obtained through SAM.gov registration.
eRA Commons registration for both the organization and all Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)).
Grants.gov registration.

Technical & Project Specifics

The project must focus on rigorous analytical validation of detection method(s) for biomarkers.
Biomarkers must be for neurological or neuromuscular disorders.
Premise for biomarker utility should include evidence of preliminary testing in an appropriate clinical population (prospective or retrospective data/samples) showing sufficient clinical sensitivity/specificity or association with the biological concept of interest.
The detection method for the biomarker must already be developed and have undergone initial evaluation of precision and analytical sensitivity.
Applications must specify one or two 'context(s) of use' for the biomarker(s).
Applications must include project 'milestones'.
The proposed research must be within the mission of the National Institute of Neurological Disorders and Stroke (NINDS).

Exclusion Criteria

Clinical trials or clinical research primarily intended to develop therapeutic agents or devices.
Clinical trials or clinical research evaluating a therapeutic agent or device's clinical safety, efficacy, effectiveness, and/or clinical management.
Pre-clinical research using animal models.
Applications where the primary intent is to validate clinical outcome assessments (COA) rather than biomarkers.
Applications that do not include a statement specifying the context(s) of use.
Applications that do not include milestones.
Applications that are not within the NINDS mission.

Application Process

APPLICATION PRACTICAL INFORMATION: Key Dates

Posted Date: October 02, 2024
Open Date (Earliest Submission): January 21, 2025
Letter of Intent Due Date(s): 30 days prior to the application due date.
Application Due Dates:
- February 21, 2025
- June 20, 2025
- February 20, 2026
- June 22, 2026
All applications are due by 5:00 PM local time of the applicant organization.
Latest Expiration Date: June 23, 2026 (the final application deadline is June 22, 2026).

Application Submission Process

Applications must be submitted electronically through one of the following:
- NIH ASSIST system
- An institutional system-to-system (S2S) solution
- Grants.gov Workspace
Required registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed and active before application submission.
PD(s)/PI(s) must have an eRA Commons account and ID.
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 submitting the application.
Early submission is encouraged to allow time for corrections.
Applicants are responsible for viewing their application in eRA Commons to ensure successful submission.

Required Documentation and Materials

Standard SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget/Subaward Budget).
PHS 398 Cover Page Supplement.
Timeline and Proposed Milestones (maximum 3 pages): Must describe quantitative 'go/no-go' decision points, progress metrics (e.g., enrollment goals, sample/data collection), performance metrics (e.g., target sensitivity, specificity, precision), and planned interactions with regulatory agencies. A Gantt chart is required.
Team Management Plan (maximum 3 pages): Describe workflow, organizational structure, team composition, roles, contributions, resource sharing, and credit assignment for multidisciplinary teams.
Associated clinical trial protocols and consent forms (if applicable, no page limit): For applications leveraging samples/data from previous clinical trials.
Intellectual Property Plan (if applicable, maximum 1 page): Developed in consultation with institutional technology transfer officials, addressing constraints, previous IP filings, patents, and management across institutions.
Letters of Support (if applicable, no page limits): From consultants, contractors, collaborators, BioSEND (if using biospecimens), technology transfer officials, other institutions (if multi-institutional), and private entities (if collaborating).
PHS 398 Research Plan, including:
- Clinical Context and Unmet Need: Explain the biomarker's intended use, clinical population, and justification for its advancement.
- Premise, Biological Rationale and Technical Readiness: Provide rigorous supporting literature/preliminary data, evidence of initial testing, and describe detection method readiness.
- Approach and Statistical Analysis Plan: Detail experimental design, statistical analysis (SAP), sample size justification, handling of missing data, and evaluation of performance characteristics (accuracy, precision, sensitivity, specificity, etc.). Justification is required if proposing a single-site analytical validation.
Resource Sharing Plan (e.g., for BioSEND).
Data Management and Sharing Plan (required for all applications generating scientific data).
Appendix: Only blank questionnaires or surveys are allowed. May include standardized biomarker measurement protocols and summary/documentation of FDA communications.
PHS Human Subjects and Clinical Trials Information (if human subjects are involved).
PHS Assignment Request Form.

Application Assistance

eRA Service Desk: For ASSIST, eRA Commons, application errors, system issues.
General Grants Information: For application instructions, processes, NIH grant resources.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues.
Scientific/Research Contact: Dr. Carol Taylor-Burds (NINDS), for inquiries about the funding opportunity scope.
Peer Review Contact: Chief, Scientific Review Branch (NINDS).
Financial/Grants Management Contact: Chief Grants Management Officer (NINDS).

Evaluation Criteria

EVALUATION CRITERIA: Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field, considering the following scored factors and additional criteria.

Importance of the Research (Scored Factor 1)

Significance:
- Addresses an important gap in knowledge, solves a critical problem, or creates a valuable conceptual or technical advance.
- Rationale for the study and rigor of its scientific background (preliminary data, prior literature) justify the proposed work.
- If successful, how likely the proposed biomarker(s) will be used in future clinical trials or clinical practice.
- If successful, whether the benefits of implementing the biomarker(s) significantly outweigh potential implementation costs (technical requirements, feasibility, time, cost, patient/clinician burden).
Innovation:
- Applies novel concepts, methods, or technologies, or uses existing ones in novel ways, to enhance the overall project impact.

Rigor and Feasibility (Scored Factor 2)

Approach:
- Potential to produce unbiased, reproducible, robust data.
- Rigor of experimental design and appropriateness of controls.
- Sample size is sufficient and well-justified.
- Quality of plans for analysis, interpretation, and reporting of results.
- Adequate plans to address relevant biological variables (e.g., sex, age).
- For human subjects/vertebrate animals: rigor of intervention, justification of outcome variables, generalizability/relevance, and appropriate/diverse sample.
Feasibility:
- Proposed approach is sound and achievable, with plans to address emergent problems.
- For human subjects, adequacy and feasibility of participant recruitment and retention plans.
- Study timeline and milestones are feasible.
- Milestones clearly describe critical quantitative 'go/no-go' decision points.
- If leveraging an ongoing clinical trial: assess if the biomarker validation study adds significant burden to participants, and if there is sufficient time for data/sample collection.
- Team management plan clearly describes the workflow, organizational structure, team composition, roles, contributions, resource sharing, and credit assignment.

Expertise and Resources (Scored Factor 3)

Investigator(s): Demonstrated background, training, and expertise suitable for the proposed work.
Environment: Institutional resources are appropriate for successful project execution.

Additional Review Criteria (Not scored separately, but influence overall impact)

Associated clinical trial protocols and consent forms (if applicable): Assess if original consent forms permit proposed biomarker studies, and if inadequacies can be addressed.
Intellectual Property (IP) Plan (if applicable): Appropriateness and sufficiency of the IP plan, considering the IP landscape, constraints, and how IP will be handled across institutions.
Protections for Human Subjects: Justification for involvement, proposed protections against risks, potential benefits, importance of knowledge, and data/safety monitoring.
Vertebrate Animals (if applicable): Description of procedures, justification for use, interventions to minimize discomfort, and justification for euthanasia method.
Biohazards (if applicable): Evaluation of specific hazardous materials/procedures and proposed protections.

Compliance & Special Requirements

COMPLIANCE AND SPECIAL REQUIREMENTS: Regulatory Compliance

Adherence to all terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Compliance with all applicable non-discrimination laws, including submission of an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance, as highlighted in the NIH Grants Policy Statement Section 4.
If a clinical study, compliance with Good Clinical Practices (GCP) and NIH/NINDS data and safety monitoring guidelines.
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Required Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval for human subjects research.
Registration and results submission on ClinicalTrials.gov for applicable clinical trials.

Data Management & Sharing

A mandatory Data Management and Sharing Plan is required for all applications that generate scientific data, regardless of direct costs requested.
Recipients are required to implement the approved Data Management and Sharing Plan.
Investigators are generally expected to share code/scripts, analytic tools/statistical models, protocols/processes, and metadata before the end of the project period.
Applicants collecting biofluid samples from prospectively enrolled participants are encouraged to share them through the NINDS biomarker repository, BioSEND.
Recipients retain primary rights to data and software developed under the award, subject to Government access rights.

Intellectual Property

An Intellectual Property Plan (max 1 page) is required if applicable, and applicants are encouraged to consult their institutional technology transfer officials.
The plan should describe any constraints that could impede commercialization and how these will be addressed.
NIH expects recipients to pursue patent protection as appropriate and consistent with award goals.

Cooperative Agreement Specifics (Substantial NIH Involvement)

This award mechanism involves substantial NIH programmatic involvement, meaning NIH staff will actively assist, guide, coordinate, or participate in project activities.
NIH Program Staff will provide input on and recommend finalization of proposed milestones.
The NIH Program Officer will assess progress against milestones and recommend further fund release.
NIH Subject Matter Experts may advise the Program Officer on scientific matters.
NIH may, in rare, well-justified cases, add critical experiments as additional milestones (potentially with additional funding).
NIH Program Officers and Subject Matter Experts may participate in meetings with regulatory agencies (e.g., FDA) related to the funded project.
Funding decisions are based on progress towards milestones, overall data package robustness, NIH portfolio balance, program priorities, competitive landscape, and fund availability.
Funding may be discontinued if milestones are not met.

Special Considerations

The grant is specifically for analytical validation of biomarkers; it is not intended for early-stage biomarker discovery or final clinical validation where the detection method is already extensively validated.
Multi-site applications are expected, though a strong scientific justification can be provided for single-site analytical validation.
Priority will be given to applications that fill critical program gaps, address an unmet medical need, have a strong biological rationale, include a carefully designed plan for performance evaluation, plan for standardization of samples and data collection, and provide strong justification for the biomarker's utility in clinical settings or trials.
Emphasis on multidisciplinary collaboration among scientific investigators, developers, clinicians, statisticians, and regulatory experts.

Grant Details