Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 – Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for developing biomarkers and composite biomarkers for neurological and neuromuscular disorders. Eligible applicants include research institutions, universities, and organizations with strong research capacity. The program uses a phased approach (R61/R33) where early-stage research receives support before advancing to later clinical validation. Projects focused on discovering and validating biomarkers for conditions like Parkinson's disease, ALS, myasthenia gravis, and other neurological/neuromuscular disorders are supported.
Clinical trials are optional. Applicants must have demonstrated research expertise in biomarker development or neurology. Both domestic and international researchers can apply through U.S. institutions. The NIH evaluates applications based on scientific merit, innovation, and feasibility of the proposed research.
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Program description
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.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Federal Application for Federal Assistance)
- Project Narrative/Research Strategy
- Budget and Budget Justification
- Biographical Sketches (key personnel)
- Letters of Support/Collaboration
- Preliminary Data and Literature Review
- Specific Aims
- Protection of Human Subjects (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$56,144,651
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$40,959,789
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$35,655,349
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$35,655,116
-
$35,335,145
-
$34,183,297
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$32,294,153
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$32,234,840
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$31,739,294
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$27,282,286
Top States by Funding
- MA 5 awards $123.9M
- OH 4 awards $112.5M
- CA 4 awards $101.3M
- FL 3 awards $100.3M
- MI 3 awards $85.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this grant?
Research institutions, universities, and research-focused nonprofits with biomarker research capacity. Individual researchers must be affiliated with eligible institutions.
When is the deadline?
The fixed deadline is January 7, 2028. Applications typically open 6 months before the deadline. Check NIH Grants.gov for submission portals and exact times.
What types of biomarker research are supported?
Projects developing biomarkers for neurological and neuromuscular disorders like Parkinson's, ALS, and epilepsy. Both basic and translational research focused on discovery and validation are eligible.
Is this a competitive grant?
Yes. Applications are peer-reviewed by scientific experts. Strong preliminary data and clear innovation significantly improve competitiveness.
What is the typical funding range?
Varies by phase. R61 phase typically supports $200K-$300K annually. R33 phase scales up based on project needs. Check the most recent RFP for exact amounts.
💡 Tips for applicants
- Start with strong preliminary data showing feasibility of your biomarker approach and relevance to a specific disorder.
- Clearly articulate how your biomarkers will advance diagnosis, prognosis, or treatment monitoring for the target disease.
- Use the phased R61/R33 structure strategically: R61 proves concept, R33 validates and scales up.
- Assemble a team with expertise in both biomarker science and the target neurological disorder.
- Build clear go/no-go decision points between R61 and R33 phases to demonstrate project management rigor.
⚠️ Common mistakes
Applications lack sufficient preliminary data or clear clinical relevance for the proposed biomarkers. Teams overlook the importance of demonstrating disease specificity and utility over existing diagnostic methods. Poor planning of the transition between R61 and R33 phases undermines credibility.
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