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

US · US National Institutes of Health (NIH) grant open #PAR-25-024
Response due Jan 07, 2028 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting research applications under a Phased Innovation Award (R61/R33) mechanism to support the development of biomarkers or composite biomarkers for neurological and neuromuscular disorders. The R61 phase is expected to focus on milestone-driven exploratory/developmental work, with the R33 phase providing expanded support contingent on meeting R61 milestones. Clinical trials are optional under this funding opportunity announcement (FOA). The opportunity is open on a recurring basis through early 2028, suggesting multiple submission cycles.

What they want

Applicants must propose research to identify, develop, validate, or refine biomarkers or composite biomarkers applicable to neurological and/or neuromuscular disorders. The work follows a two-phase structure: (1) R61 phase — exploratory/developmental research with defined milestones; (2) R33 phase — expanded research contingent on successful completion of R61 milestones. Clinical trial components are permitted but not required. Projects must be relevant to the mission of NIH and its participating institutes/centers.
Technical requirements
  • Two-phase R61/R33 award structure with milestone-driven progression
  • R61 phase must include defined, measurable milestones
  • R33 phase contingent on successful R61 milestone completion
  • Clinical trial component is optional but permissible
  • Research must focus on neurological and/or neuromuscular disorders

How they evaluate

  • Scientific and technical merit (peer review)
  • Milestone feasibility and clarity
  • Relevance to NIH mission and participating institute priorities
  • Innovation and significance of biomarker approach
Submission: Grants.gov electronic submission (federal grants portal); full application package per NIH standard requirements under FOA PAR-25-024

Risks & flags

  • No dollar value or award ceiling stated — budget competitiveness is opaque
  • Multi-year open window (Oct 2024 – Jan 2028) with rolling submissions may obscure actual review cycles and deadlines
  • Minimal details provided in source text — full FOA (PAR-25-024) must be reviewed for complete requirements, specific institute interests, and submission deadlines

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Development of Biomarkers or Composite Bio…
Due Jan 07
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