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

National Institutes of Health

PAR-25-050

HHS-NIH11

General Information

N/a
Est. Program Funding:
June 22, 2026
Closing Date:
N/a
Expected No. of Awards
N/a
Award Ceiling

Opportunity Number:
PAR-25-050

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

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.

Response Date Jun 22, 2026 12:00:00 AM EDT
Posting Date Oct 02, 2024 12:00:00 AM EDT
Archive Date Jul 22, 2026 12:00:00 AM EDT
Award Ceiling N/a
Award Floor N/a
Cost Sharing No

Eligibility

Eligible Applicants Small businesses, County governments, Independent school districts, Native American tribal organizations (other than Federally recognized tribal governments), Public and State controlled institutions of higher education, Private institutions of higher education, City or township governments, State governments, Special district governments, Public housing authorities/Indian housing authorities, Others (see text field entitled "Additional Information on Eligibility" for clarification), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal governments (Federally recognized), For profit organizations other than small businesses, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Info on Eligibility: 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.

Additional Information

Agency Name National Institutes of Health
Link to Additional Information: https://grants.nih.gov/grants/guide/pa-files/PAR-25-050.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk
Phone: 301-402-2541

CFDA Program(s)

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

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