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

The summary for the Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
Federal Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	PAR-25-050
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.853
CFDA Descriptions:	Information not provided
Current Application Deadline:	June 22nd, 2026
Original Application Deadline:	June 22nd, 2026
Posted Date:	October 2nd, 2024
Creation Date:	October 2nd, 2024
Archive Date:	July 28th, 2026
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:	No
Last Updated:	October 2nd, 2024

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information 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.
Link to Full Grant Announcement: https://grants.nih.gov/grants/guide/pa-files/PAR-25-050.html
Grant Announcement Contact: NIH Grants Information
[email protected]
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
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