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Grant Analysis

Purpose & Target

The PAR-25-055 grant aims to support the rigorous clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. - The core objective is to establish the clinical sensitivity and specificity of biomarker measurements within the clinical population of interest, consistent with FDA guidelines. - Target recipients include a wide range of organizations, including higher education institutions, nonprofits, for-profit organizations (both small businesses and other), and various government entities. - This grant is SECTOR-SPECIFIC, focusing exclusively on neurological and neuromuscular disorders. - Geographic scope is primarily the United States, as foreign entities are not eligible to apply directly, but foreign components (collaborators) of U.S. organizations are permitted. - Key filtering criteria: applicants must already have an identified candidate biomarker, a developed and analytically validated detection method, and a clear research/clinical need and context of use. - This is a recurring grant, reissued from PAR-24-097, indicating ongoing support for biomarker validation.

Financial Structure

Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
Eligible Costs: No specific list of eligible/ineligible costs provided, but costs associated with data sharing efforts should be reflected in the budget.
Matching Fund Requirements: This NOFO does not require cost sharing.
Payment Schedule: Not explicitly detailed, but NIH awards are typically subject to standard federal payment mechanisms.
Financial Reporting: Recipients must submit Research Performance Progress Report (RPPR) annually and financial statements as required.
Audit Requirements: Standard federal audit requirements apply (2 CFR Part 200).
Indirect Cost Policies: Not specified in detail, but implied to follow standard NIH guidelines.
Financial Guarantees: Not explicitly required.

Eligibility Requirements

Eligible Organization Types

Higher Education Institutions: Public/State Controlled and Private Institutions of Higher Education
Nonprofits: With or without 501(c)(3) IRS Status
For-Profit Organizations: Small Businesses and other For-Profit Organizations
Local Governments: State, County, City or Township, Special District Governments
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 Requirements

Organizations must be based in the United States.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are allowed (meaning U.S. applicants can collaborate internationally).

Registration Requirements

Applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM) (requires annual renewal).
- Unique Entity Identifier (UEI) (issued as part of SAM.gov registration).
- eRA Commons (for organizations, must identify at least one Signing Official and one Program Director/Principal Investigator).
- Grants.gov.
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account, affiliated with the applicant organization.

Project Specific Qualifications

Must focus on clinical validation of a candidate biomarker for neurological or neuromuscular disorders.
The candidate biomarker must have already been identified.
The detection method technology must have already been developed and analytically validated.
The research and/or clinical need and potential context of use (COU) must have been identified.
Applications not responsive to this NOFO (and will be administratively withdrawn) include:
- Clinical trials or research primarily intended to develop therapeutic agents or devices.
- Clinical trials or 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 rather than biomarkers.
- Applications that do not include a context of use statement.
- Applications that do not include milestones.
- Applications not within the NINDS mission.

Number of Applications

Applicant organizations may submit more than one application, provided each is scientifically distinct.

Application Process

Application Deadlines and Submission

Open Date (Earliest Submission Date): January 21, 2025
Letter of Intent Due Date: 30 days prior to the application due date (not required, not binding).
Application Due Dates: Multiple deadlines, the latest being June 22, 2026, by 5:00 PM local time of applicant organization.
Applications are submitted electronically via NIH ASSIST, institutional system-to-system, or Grants.gov Workspace.
Applicants are encouraged to apply early to allow time for error correction.
If a submission date falls on a weekend or Federal holiday, the deadline is extended to the next business day.

Required Documentation and Materials

Standard Forms: SF424(R&R) Cover, SF424(R&R) Project/Performance Site Locations, SF424(R&R) Other Project Information.
Timeline and Proposed Milestones: Required (max 3 pages). Must include quantitative annual milestones for go/no-go decision making, progress metrics (e.g., enrollment goals, sample collection), performance metrics (e.g., sensitivity/specificity thresholds), and planned interactions with regulatory agencies (if applicable).
Team Management Plan: Required (max 3 pages). Describes team/key personnel workflow, organizational structure, roles, resource sharing, coordination, and communication.
Associated Clinical Trial Protocols and Consent Forms: Required if applicable (no page limit), especially if leveraging existing trials/samples.
Intellectual Property Plan: If applicable (max 1 page). Describes constraints on commercialization and how issues will be addressed. If IP is owned by another entity, a letter of support is needed.
Letters of Support: If applicable (no page limits). From consultants, collaborators, subcontractors, BioSEND (if using), technology transfer officials, and private entities involved.
Resource Sharing Plan: Required. Especially for biofluid samples, encouraging sharing through BioSEND.
Data Management and Sharing Plan: Required for all applications, regardless of direct costs, in compliance with the 2023 NIH Policy.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved.

Application Procedure

Access the application package through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', with program-specific deviations noted in this NOFO.
Ensure all required registrations (SAM, UEI, eRA Commons, Grants.gov) are complete before submission.
PD/PIs must include their eRA Commons ID.
Applications requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submitting.

Review and Selection Process

Applications are evaluated for scientific and technical merit by NIH peer review.
Reviewed by a Scientific Review Group (SRG) convened by NINDS.
Receive a written critique (Summary Statement) via eRA Commons.
Applications deemed to have the highest scientific and technical merit (generally top half) will be discussed and scored.
Funding decisions consider scientific merit, availability of funds, and relevance to program priorities (e.g., addressing unmet medical need, strong biological rationale, clear performance evaluation plan, standardization).

Post-Award Requirements

Compliance with NIH Grants Policy Statement terms and conditions.
Registration and results reporting for clinical trials on ClinicalTrials.gov (if applicable).
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
Data and safety monitoring for human biomedical and behavioral intervention studies.
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements (if applicable).
Annual submission of Research Performance Progress Reports (RPPR) and financial statements.
Submission of a final RPPR, invention statement, and expenditure data for closeout.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood for the project to have a sustained, powerful influence on the research field, considering: Importance of the Research (Factor 1)

Significance: Does the research address an important knowledge gap, solve a critical problem, or create a valuable conceptual/technical advance?
Rationale: Is the rationale sound? Does the scientific background (literature/preliminary data) justify the study?
Innovation: Does the work apply novel concepts, methods, technologies, or use existing ones in novel ways to enhance impact?
NOFO-Specific: Assess the likelihood of the proposed biomarker(s) being used in future clinical trials or clinical practice.
NOFO-Specific: Do the benefits of implementing the biomarker(s) significantly outweigh potential implementation costs (technical requirements, time, cost, burden on patients/clinicians)?

Rigor and Feasibility (Factor 2)

Rigor: Will the project produce unbiased, reproducible, robust data? Are experimental design, controls, sample size, and analysis plans appropriate?
Biological Variables: Are plans to address biological variables (e.g., sex, age) adequate?
Human Subjects/Vertebrate Animals: Is the rigor of intervention/study manipulation appropriate? Are outcome variables justified? Will results be generalizable/relevant? Is the sample appropriate and diverse?
Feasibility: Is the approach sound and achievable? Are plans for problems/challenges adequate?
Human Subjects: Is the plan to recruit/retain diverse participants adequate and feasible?
NOFO-Specific: Milestones and Timeline: Do milestones clearly describe quantitative go/no-go decision points? Are performance metrics (consistency, sensitivity/specificity thresholds, standardization) appropriate? Is the timeline efficient and feasible?
NOFO-Specific: Team Management Plan: Does the plan effectively describe workflow, organizational structure, roles, resource sharing, and coordination?

Expertise and Resources (Factor 3)

Investigator(s): Do the investigators have the necessary background, training, and expertise?
Environment: Are institutional resources sufficient for successful execution?

Additional Review Criteria (Not Scored Separately)

Associated clinical trial protocols and consent forms: Are consent forms adequate for proposed biomarker studies? If not, can concerns be addressed?
Intellectual Property (IP) Plan: If commercialization is intended, is the IP plan appropriate, considering the IP landscape and any constraints? Does it address IP handling among institutions/investigators?
Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, knowledge gained, data and safety monitoring.
Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, justification for euthanasia method.
Biohazards: Are specific materials/procedures hazardous, and is adequate protection proposed?

Resubmissions/Revisions

Resubmissions: Evaluated based on present application, considering responses to previous comments and changes.
Revisions: Appropriateness of scope expansion. If related to previously unapproved investigation, adequacy of responses to comments and evident changes.

Compliance & Special Requirements

Regulatory Compliance Requirements

FDA Guidelines: Clinical validation should align with FDA guidance standards appropriate for the Context of Use.
NIH Policies: All awards subject to NIH Grants Policy Statement, including terms and conditions, cost principles, and public policy requirements.
Federal Regulations: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Non-discrimination Laws: Recipients must comply with all applicable non-discrimination laws, as agreed upon during SAM.gov registration.

Data Protection and Privacy Regulations

Data Management and Sharing Plan: Required for all projects, adhering to the 2023 NIH Policy. Recipients must implement the approved plan.
Confidentiality Agreements: Necessary for independent consultants/specialists advising NIH staff to protect intellectual property.

Ethical Standards and Requirements

Human Subjects Protections: For research involving human subjects, evaluation of justification, protection against risks, benefits, knowledge gained, and data/safety monitoring.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their IRB or IEC.

Intellectual Property Policies

Ownership: Recipients retain custody of and primary rights to data and software developed under awards, subject to Government rights of access.
Patent Protection: Recipients are responsible for pursuing patent protection, consistent with award terms and program goals.
IP Plan: Required if commercialization is intended, addressing potential constraints, existing patents, and inter-institutional IP management.

Risk Management and Security Requirements

Rigour and Reproducibility: Strong emphasis on rigorous and transparent research design, execution, and reporting to minimize bias and ensure validity.
Data Quality: Approaches for monitoring data quality, including auditing data completeness and variations from protocol.
Milestone-Driven: Cooperative agreement is milestone-driven, with NIH staff assessing progress against milestones for continued funding.

Special Considerations / Unique Aspects

Cooperative Agreement (U01): Implies substantial Federal scientific or programmatic involvement. NIH staff actively assist, guide, coordinate, or participate in project activities, going beyond normal stewardship.
Team Composition: Strong encouragement for multidisciplinary teams including clinical scientists, disease/biology experts, statisticians (especially in clinical trial design), and regulatory expertise.
Leveraging Existing Resources: Encouragement to use resources like the NINDS Human Biospecimen and Data Repository (BioSEND) or other existing biospecimen/data repositories.
Pre-Application Consultation: Applicants are strongly encouraged to consult with NINDS Program Staff early to discuss scope, timeline, milestones, and budget exceeding $500,000 direct costs.
Priority Funding: Within meritorious range, priority may be given to applications addressing critical program gaps and biomarkers that:
1. Address an unmet medical need.
2. Are supported by strong biological rationale.
3. Include a carefully designed performance evaluation plan.
4. Include a plan for standardization of samples and data collection.
5. Provide strong justification for utility in clinical setting or trial design.
Clinical Trial Optional: The grant accepts applications that either propose or do not propose clinical trials, but the validation itself is clinical.

Grant Details