Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)

HHS-NIH11 PAR-25-050
Posted: Oct 02, 2024 12:00:00 AM EDT
Closes: 06/22/2026

Description

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). 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 and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

Synopsis

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). 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 and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

Eligibility

Eligible Applicants:
Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) For profit organizations other than small businesses State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education City or township governments Special district governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Independent school districts
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Funding Activity Categories

Health

CFDA Numbers

  • 93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

Contact Information

Agency: National Institutes of Health
Contact: National Institutes of Health
Phone: 301-402-2541
NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis
Opportunity Category: Discretionary
Version: 3
Last Updated: Jan 10, 2025 11:39:30 AM EST

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