Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)

Funding Agency:
National Institutes of Health

The purpose of this Funding Opportunity Announcement (FOA) is to promote the development of fit-for-purpose candidate biomarkers and biomarker signatures that enable more efficient clinical trials to advance therapeutic development or be used in clinical practice to help guide clinical care decisions. Specifically, the goal of this phased funding mechanism is to first identify or confirm candidate biomarkers or biomarker signatures using human samples and/or data, followed by an independent retrospective or prospective clinical study to conduct initial clinical validation of the biomarker/signature’s clinical utility for a defined Context of Use(s). In the first phase, applicants are expected to demonstrate that the biomarker acceptably identifies or predicts the concept of interest and may include optimization of the detection method using carefully standardized human samples or datasets. The overarching purpose of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.


  • Letter of Intent Due Date(s): 30 days prior to the application due date
  • Application Due Date(s): June 22, 2022; Feb 22, 2023; June 22, 2023; Feb 22, 2024; June 22, 2024; Feb 21, 2025
  • AIDS Application Due Date(s): September 7, 2022; May 7, 2023; Sep 7, 2023; May 7, 2024; Sep 7, 2024; May 7, 2025

PAR-22-089 Expiration Date May 08, 2025

Agency Website

Amount Description


Funding Type





Environmental & Life Sciences
Medical - Basic Science
Medical - Clinical Science

External Deadline

June 22, 2024