Studies Addressing Rare Neurodegenerative Diseases including ALS
🏛 Food and Drug Administration (HHS-FDA)
✓ Free, no account · Source: Grants.gov · Last verified Oct 19, 2026
Can you apply?
This grant is for researchers and research institutions seeking to support studies addressing rare neurodegenerative diseases, including ALS (amyotrophic lateral sclerosis). The grant welcomes applications from academic medical centers, research universities, nonprofit research institutions, and eligible for-profit entities. It supports basic, translational, and clinical research that advances understanding of disease mechanisms, identifies biomarkers, develops diagnostic tools, or evaluates potential therapeutics. Geographic scope is nationwide. Activities supported include laboratory research, clinical trials, epidemiological studies, and data analysis projects that contribute to FDA's regulatory science mission and improve outcomes for patients with rare neurodegenerative conditions.
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Program description
The purpose of this funding opportunity announcement (FOA) is to support studies that advance medical product development of interventions intended to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in adults and children. Through the support of these studies, FDA expects to address critical knowledge gaps, exert a significant impact on rare neurodegenerative diseases, and to inform current or future product development.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- NIH Form 424 (SF-424) or agency-specific application form
- Project narrative (typically 15-25 pages) with research aims, background, methods, and significance
- Specific Aims page (1-2 pages)
- Budget and budget narrative (itemized costs with justification)
- Biosketches of key personnel (2-page NIH format or equivalent)
- Facilities and resources documentation
- Letters of institutional support and commitment
- Conflict of interest disclosures
- Compliance certifications (human subjects, animal care, etc. as applicable)
- References cited in the proposal
Program contact
- 👤 Terrin Brown Grantor
- 📧 terrin.brown@fda.hhs.gov
- 📞 2404027610
Funding track record
Recent awards under CFDA 93.103 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$137,050,554
-
$76,105,626
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$53,144,194
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$52,672,417
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$38,251,997
-
$36,000,000
-
$35,391,995
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$32,562,281
-
$30,732,300
-
$25,132,999
Top States by Funding
- AZ 4 awards $149.9M
- CA 9 awards $114.6M
- MD 7 awards $112.8M
- VA 7 awards $104.5M
- PA 11 awards $86.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.103). How funding has trended year over year.
| 2016 | $170,482,435 | |
| 2017 est. | $208,900,832 | |
| 2018 | $173,077,408 | |
| 2019 | $198,507,896 | |
| 2020 | $212,448,590 | |
| 2021 | $218,918,739 | |
| 2022 est. | $255,910,458 | |
| 2023 est. | $246,894,600 |
FAQ
Who is eligible to apply for this FDA research grant?
Typically, domestic research institutions including universities, medical centers, nonprofit organizations, government agencies, and for-profit entities can apply. Federal employees may have restrictions. Check the specific grant solicitation for eligibility details and any required qualifications.
What types of research does this grant support?
The grant supports studies of rare neurodegenerative diseases with emphasis on ALS research. Funded projects may include basic science investigations, translational research, clinical trials, biomarker development, diagnostic tool development, and regulatory science studies.
What is the typical funding amount and project duration?
Federal research grants of this type commonly range from $100,000 to several million dollars annually, depending on project scope. Project periods are typically 3-5 years, though specific terms should be confirmed in the active solicitation.
How competitive is this grant?
This is moderately to highly competitive. Applicants should expect rigorous peer review of scientific merit, feasibility, team qualifications, and the significance of the research to FDA's regulatory mission and patient populations.
What is the application timeline?
The application period opened August 14, 2024. Exact submission deadlines are typically posted in the full solicitation. Plan 8-12 weeks lead time from your organization's internal deadline to the federal deadline.
💡 Tips for applicants
- Align your research question directly with FDA's regulatory science priorities and the specific neurodegenerative disease focus; explain how findings will inform drug development, approval, or post-market monitoring.
- Build a multidisciplinary team including neurologists, basic scientists, biostatisticians, and clinical research coordinators; FDA values collaboration across institutional and disciplinary boundaries.
- Provide strong preliminary data demonstrating feasibility; include published results, pilot study outcomes, or preliminary analyses that support your proposed methodology.
- Clearly articulate patient impact and how your research addresses an unmet clinical need in rare neurodegenerative disease; include letters of support from patient advocacy organizations if applicable.
- Budget conservatively and justify all costs; federal reviewers scrutinize indirect costs and look for efficient use of taxpayer resources in line with your institution's negotiated rates.
⚠️ Common mistakes
Applicants frequently fail to adequately connect their research to FDA's regulatory science mission and approval pathways, resulting in lower scores for significance. Another common issue is submitting weak preliminary data or insufficient evidence of team expertise in neurodegenerative disease research, particularly ALS. Additionally, poorly justified budgets or failure to address the specific rare disease focus (rather than generic neurological research) can lead to rejection or reduced funding.
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