Opportunity Information: Apply for RFA FD 24 024
The FDA funding opportunity titled "Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional" (RFA-FD-24-024) is designed to strengthen the evidence base needed to develop treatments for rare neurodegenerative diseases in both children and adults. The core idea is to fund well-structured studies that can map how these diseases progress over time (natural history), while also supporting projects that build or validate tools to measure disease status and change (clinical outcome assessments, or COAs) and/or identify measurable biological signals tied to disease mechanisms or progression (biomarkers). Because rare neurodegenerative disorders often have limited patient populations and fragmented datasets, the FDA is emphasizing efficient study designs and high-quality, interpretable data that can be used broadly by the field.
A key goal of the program is to close practical knowledge gaps that slow down product development. In many rare neurodegenerative conditions, developers and researchers struggle with basic questions such as what "typical" progression looks like across stages, which symptoms change reliably over time, which measurements are sensitive enough to detect meaningful change, and which biomarkers can support diagnosis, stratification, prognosis, or treatment-response monitoring. By investing in studies that generate rigorous and standardized evidence, FDA expects these projects to remove major barriers to running informative clinical studies, selecting endpoints, and interpreting results. The FOA also signals interest in work that can produce a significant and broad impact either within a single rare neurodegenerative disease or across multiple rare neurodegenerative diseases that share similar underlying biology or pathophysiology.
This opportunity uses a cooperative agreement mechanism (U01), meaning the FDA is likely to have substantial scientific or programmatic involvement compared with a typical grant. Projects funded under a cooperative agreement commonly involve coordination with the agency on milestones, data expectations, and study execution details, especially when the results are intended to be directly useful for regulatory science and future medical product development. Clinical trials are listed as optional, which generally means the program will consider proposals that are strictly observational (for example, longitudinal cohort studies and registries) as well as proposals that may include clinical trial elements when appropriate to the aims, such as validating an outcome assessment or biomarker within an interventional context. The main emphasis, however, is on generating reliable data resources and measurement frameworks that can support downstream therapeutic development.
The program is structured to support a limited number of relatively large awards. The listed award ceiling is $2,000,000, and the FDA anticipates making about three awards. This suggests the agency is looking for well-powered, carefully managed efforts with strong infrastructure for data collection, quality control, and analysis. The FOA language repeatedly stresses "high quality and interpretable data elements," which is a signal that FDA values clear definitions, consistent measurement protocols, standardized data formats where possible, and analytic plans that lead to results others can actually use. In practice, competitive applications typically demonstrate strong clinical and scientific leadership, access to the relevant patient population(s), thoughtful selection of measures and timepoints, strategies to minimize missing or biased data, and plans for data governance and sharing that maximize utility while protecting participants.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include public and private institutions of higher education (with explicit encouragement for institutions such as Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs), nonprofits with or without 501(c)(3) status, for-profit entities including small businesses, and multiple levels of government (state, county, city or township, special districts, and tribal governments). The FOA also lists other eligible entities such as independent school districts, public housing authorities/Indian housing authorities, tribal organizations that are not federally recognized governments, faith-based or community-based organizations, and regional organizations. Importantly, foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed under HHS grants policy, which supports international collaboration when patient populations and specialized expertise are distributed globally.
From an administrative standpoint, the opportunity is offered by the Food and Drug Administration under a discretionary funding category and uses the Cooperative Agreement funding instrument. The CFDA listing provided is 93.103, and the original application closing date shown is May 6, 2024, with the FOA created on December 11, 2023. Taken together, the structure and language of the announcement point to FDA's intent to fund projects that can quickly elevate the readiness of rare neurodegenerative disease communities for therapy development by clarifying disease trajectories, strengthening or validating outcome measures, and establishing biomarker evidence that can be relied upon in future clinical studies and regulatory interactions.Apply for RFA FD 24 024
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional" 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 2023-12-11.
- Applicants must submit their applications by 2024-05-06. (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 $2,000,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- 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, Others.
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| Funding Opportunity |
|---|
| Public Health Regulatory Systems Strengthening - U01 Clinical Trials Not Allowed Apply for RFA FD 24 015 Funding Number: RFA FD 24 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| National Project to Support and Promote Consistent Implementation of the Regulatory Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption and Produce Regulatory Standards (PRPS) (U2F) -Cooperative Agreements Apply for RFA FD 24 012 Funding Number: RFA FD 24 012 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Produce Safety Alliance-U01 Clinical Trials Not Allowed Apply for RFA FD 24 018 Funding Number: RFA FD 24 018 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed Apply for RFA FD 24 022 Funding Number: RFA FD 24 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed Apply for RFA FD 24 020 Funding Number: RFA FD 24 020 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 026 Funding Number: RFA FD 24 026 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 023 Funding Number: RFA FD 24 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) Apply for RFA FD 24 025 Funding Number: RFA FD 24 025 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Apply for RFA FD 24 029 Funding Number: RFA FD 24 029 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Critical Path Public Private Partnerships Clinical Trials Optional Apply for RFA FD 24 027 Funding Number: RFA FD 24 027 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $20,000,000 |
| Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed Apply for RFA FD 24 007 Funding Number: RFA FD 24 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional Apply for RFA FD 24 006 Funding Number: RFA FD 24 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) Apply for RFA FD 24 008 Funding Number: RFA FD 24 008 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 005 Funding Number: RFA FD 24 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011 Funding Number: RFA FD 24 011 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010 Funding Number: RFA FD 24 010 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038 Funding Number: RFA FD 24 038 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039 Funding Number: RFA FD 24 039 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $340,000 |
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