This Notice of Funding Opportunity (NOFO) aims to support clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions.

The goal is to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines.

This NOFO assumes that a candidate biomarker has already been identified, a detection method technology has been developed and analytically validated, and the research and/or clinical need and potential context of use have been identified.

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

Scope of Work

This NOFO supports research to conduct clinical validation of a biomarker or biomarker signature or composite biomarker for one or two specified context(s) of use. The premise for the utility of the biomarker(s) should include evidence that the biomarker(s) has undergone preliminary testing in an appropriate clinical population, using either prospective or retrospective data or samples, and shows sufficient clinical sensitivity and specificity to predict or measure the relevant clinical or biological concept of interest to warrant additional investment.

Applications to this NOFO should include evidence that the detection method for the biomarker has already been developed and analytically validated with sufficiently reliable performance for the proposed context of use.

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.

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 need to reflect the actual needs of the proposed project.

The maximum project period is 5 years.

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

Additional Information

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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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