Opportunity Information: Apply for RFA FD 25 001
The grant opportunity titled "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required" (Funding Opportunity Number RFA-FD-25-001) is a discretionary grant program offered by the U.S. Food and Drug Administration (FDA). Its central aim is to support clinical trials that generate evidence on a product's safety and/or efficacy, specifically to help justify a new indication or a change in labeling. In practical terms, the FDA is looking to fund trials that can move a therapy closer to regulatory action by producing data that directly supports how the product should be used, for whom, and under what conditions, with a clear focus on rare neurodegenerative diseases affecting both children and adults.
This NOFO is designed around the idea that rare neurodegenerative diseases often have major unmet medical needs: few or no approved therapies, limited natural history data, small patient populations that make traditional trial designs difficult, and high burdens on patients and caregivers. The FDA is explicitly encouraging clinical trials that are collaborative, efficient, and/or innovative. That can include multi-site coordination, creative recruitment and retention strategies for small populations, and trial approaches that reduce cost or participant burden while still producing rigorous, interpretable evidence. The broader goal is not only to advance individual products, but to increase the overall number of approved treatments in this space and create a positive ripple effect across rare disease drug development by demonstrating workable trial models and generating high-quality datasets.
The funding instrument is an R01 grant, and the opportunity is categorized under the broad funding activity area of Agriculture, Consumer Protection, Food and Nutrition, associated with CFDA number 93.103. While that category may look unusual to applicants focused on neurology, it reflects the FDA's grant cataloging rather than the scientific scope; the substance of the program is squarely about clinical trials in rare neurodegenerative conditions and the evidence needed to support labeling decisions. The opportunity is "Clinical Trials Required," meaning applications are expected to propose actual interventional clinical studies rather than purely observational work, tool development, or preclinical research. The emphasis on efficacy and/or safety "in support of" an indication or labeling change signals that the study should be designed with regulatory relevance in mind, including endpoints, analysis plans, and operational controls appropriate for a potential FDA review context.
Eligibility is broad, which is consistent with the FDA's interest in enabling strong trial teams regardless of sector. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and unrestricted applicants. This breadth allows academic medical centers, hospitals, nonprofit research organizations, patient-focused foundations, biotech and pharma sponsors, and hybrid collaborations to apply, which aligns with the program's stated preference for collaborative and efficient trial execution.
Key administrative details include an original closing date of October 21, 2025, and an award ceiling of $650,000. The opportunity record lists the agency as the FDA and shows a creation date of August 23, 2024. The number of expected awards is not specified in the provided source data, so applicants should not assume a particular success rate and should treat competitiveness as potentially high, especially given the specialized topic area and the FDA's interest in actionable clinical evidence. The $650,000 ceiling suggests proposals will need to be tightly scoped and operationally realistic, potentially favoring designs that maximize information gained per participant and per dollar, such as adaptive designs, efficient endpoint selection, strong use of existing infrastructure, and multi-stakeholder coordination that avoids duplicative effort.
Overall, this NOFO is best understood as an FDA-driven push to accelerate clinically meaningful studies in rare neurodegenerative diseases that can directly support regulatory decision-making. The FDA is signaling that it wants studies that are not just scientifically interesting, but structured to answer the specific questions needed to expand access to treatments through new indications or labeling updates. Applicants that can show a clear unmet need, a feasible recruitment plan for a rare population, a rigorous and interpretable trial design, and a credible path from study results to labeling impact will be most aligned with the stated purpose of the opportunity.Apply for RFA FD 25 001
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on 2024-08-23.
- Applicants must submit their applications by 2025-10-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $650,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Unrestricted.
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| Funding Opportunity |
|---|
| Laboratory Flexible Funding Model (LFFM) Apply for RFA FD 25 007 Funding Number: RFA FD 25 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| A Research Study of Contaminants in School Meals (U18) Apply for RFA FD 25 024 Funding Number: RFA FD 25 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed Apply for PAR 25 003 Funding Number: PAR 25 003 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Food Safety Capacity and Infrastructure Building (U2F) Apply for RFA FD 25 019 Funding Number: RFA FD 25 019 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Conformance with the Egg Regulatory Program Standards Apply for RFA FD 25 021 Funding Number: RFA FD 25 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $47,000 |
| Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) Apply for RFA FD 25 017 Funding Number: RFA FD 25 017 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens Apply for PAR 25 014 Funding Number: PAR 25 014 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) Apply for RFA FD 25 020 Funding Number: RFA FD 25 020 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $900,000 |
| Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities Apply for RFA FD 25 023 Funding Number: RFA FD 25 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| FDA's Integrated Food Safety System Training Delivery and Development Apply for RFA FD 25 016 Funding Number: RFA FD 25 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Establishing the Integrated Food Safety System (IFSS) Regulatory and Laboratory Training System (RLTS) National Coordination Center (NCC) and Learning Management System (LMS) Apply for RFA FD 25 005 Funding Number: RFA FD 25 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,750,000 |
| Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional Apply for RFA FD 25 015 Funding Number: RFA FD 25 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs Apply for RFA FD 25 022 Funding Number: RFA FD 25 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
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