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

ID: PAR-25-055 • Type: Posted

Description

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Overview

Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 10/2/24 the National Institutes of Health posted grant opportunity PAR-25-055 for Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional). The grant will be issued under grant program 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.

Timing

Posted Date
Oct. 2, 2024, 12:00 a.m. EDT
Closing Date
June 22, 2026, 12:00 a.m. EDT Due in 554 Days
Last Updated
Oct. 2, 2024, 1:11 p.m. EDT
Version
1
Archive Date
July 28, 2026

Eligibility

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

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html

Documents

Posted documents for PAR-25-055

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