Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)
About
The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and/or early evaluation of strong candidate biomarkers and biomarker signatures that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Although research supported by this FOA can include animal studies, it must also include preliminary human evaluation using carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.
The Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional) grant is designed for researchers and organizations seeking to identify and evaluate candidate biomarkers and biomarker signatures that can advance the clinical development of neurological and neuromuscular therapeutics. This grant is ideal for research institutions, universities, and eligible organizations committed to discovering biomarkers that facilitate drug development and improve clinical practice. The program supports the discovery and early-stage evaluation of strong biomarker candidates through rigorous biological, analytical, and clinical assessment. While animal studies are permitted, applicants must include preliminary human evaluation using standardized human samples or datasets. The ultimate goal is to develop candidate biomarkers ready for definitive validation studies. Researchers in neurology, neuromuscular medicine, and translational neuroscience should apply to advance innovative biomarker research that could transform treatment approaches for neurological disorders. This funding opportunity encourages collaboration between academic institutions, including HBCUs, Hispanic-serving institutions, and community-based organizations, to accelerate the path from discovery to clinical application.
Funding Facts
● Applications openDeadline
January 7, 2028
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by funding cycle
Deadline
2028-01-07
Grant Type
federal
Application Cycle
Annual with deadline January 7, 2028
Best For
Research institutions, universities, HBCUs, Hispanic-serving institutions, and community-based organizations conducting biomarker research for neurological and neuromuscular disorders
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 Govern
Frequently Asked Questions
Who is eligible for Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)?
Eligible applicants include research institutions, universities, and organizations such as HBCUs, Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, eligible Federal agencies, faith-based or community-based organizations, and Indian/Native American Tribal Governments. For comprehensive and current eligibility requirements, applicants should consult the official NIH Funding Opportunity Announcement.
How much funding does Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional) provide?
Specific funding amounts vary and are determined through individual funding cycles. Applicants should visit the official NIH website or contact the sponsoring institute for current budget information and funding range details for the specific cycle in which they plan to apply.
How do I apply for Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)?
Applications are submitted through the NIH electronic submission system (eRA Commons/ASSIST). Applicants must follow the specific instructions outlined in the Funding Opportunity Announcement, including proposal format, required sections, and submission deadlines. Visit the official NIH FOA page for detailed application guidelines, instructions, and the submission portal.
What can Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional) funding be used for?
Funding supports the discovery and early evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Permitted uses include animal studies combined with preliminary human evaluation using standardized samples or datasets, biological assessment, analytical validation, and initial clinical evaluation. The aim is to develop candidate biomarkers ready for definitive validation studies. Clinical trials are optional under this mechanism.
Last updated: July 5, 2026