This Notice of Funding Opportunity (NOFO) aims to support the rigorous analytical validation of methods used for measuring biomarkers for neurological and neuromuscular disorders.

The focus is on biomarkers that can be used in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and specify one or two contexts of use.

Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators.

Multi-site applications are expected but not required.

Scope of Work

This NOFO supports research to conduct analytical validation of the detection method for a biomarker or biomarker signature or composite biomarker for one or two specified contexts of use.

The research should include analytical validation in multiple testing sites.

If a single site is proposed, a scientific justification should be included.

The project should include analytical validation in multiple testing sites.

If a single site is proposed, a scientific justification should be included.

Eligibility

Eligible applicants include Higher Education Institutions, Nonprofits, For-Profit Organizations, Local Governments, State Governments, Federal Government, U.S. Territory or Possession, and other organizations.

Foreign organizations are not eligible to apply.

All applicant organizations must complete and maintain the following registrations: System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code, Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account.

Budget and Duration

Application budgets are not limited but should reflect the actual needs of the proposed project.

The maximum project period is 4 years.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Additional Information

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP).

Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment.

Key Dates

• Posted Date: October 02, 2024

• Open Date (Earliest Submission Date): January 21, 2025

• Letter of Intent Due Date(s): 30 days prior to the application due date.

• Expiration Date: June 23, 2026

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