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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FAQs: FDA Grant RFA-FD-24-024 (U01) - Rare Neurodegenerative Diseases
What is the title and number of this FDA funding opportunity?
The opportunity is titled "Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional" and the FOA number is RFA-FD-24-024.
What is the main purpose of this grant program?
The program is designed to strengthen the evidence base needed to develop treatments for rare neurodegenerative diseases in both children and adults. It focuses on generating rigorous, standardized data and measurement approaches that can be broadly useful for future therapeutic development.
What types of diseases does this opportunity focus on?
It focuses on rare neurodegenerative diseases. The intent is to support work relevant to pediatric and adult populations.
What kinds of studies does FDA want to fund under this FOA?
The FOA emphasizes well-structured studies that (1) map disease progression over time (natural history), (2) build or validate tools to measure disease status and change (clinical outcome assessments, or COAs), and/or (3) identify measurable biological signals tied to disease mechanisms or progression (biomarkers).
What is meant by a "natural history" study in this context?
Within the description provided, natural history refers to studies that map how rare neurodegenerative diseases progress over time, often across stages and in a way that clarifies what typical progression looks like.
What are clinical outcome assessments (COAs) as described in this opportunity?
COAs are tools used to measure disease status and change over time. The FOA supports projects that build or validate COAs so that disease-related changes can be captured reliably and interpreted in future studies.
What are biomarkers in the context of this FOA?
Biomarkers are measurable biological signals tied to disease mechanisms or progression. The FOA highlights biomarker work that could support diagnosis, stratification, prognosis, or monitoring treatment response.
Why is FDA emphasizing "high-quality and interpretable data elements"?
Because rare neurodegenerative disorders often have limited patient populations and fragmented datasets, the FDA is emphasizing efficient study designs and data that are rigorous, standardized, and clearly defined so results are usable by the broader field and can support downstream product development.
What practical gaps is FDA trying to close with this program?
The FOA highlights gaps that slow product development, such as uncertainty about typical disease progression, which symptoms change reliably, which measures are sensitive enough to detect meaningful change, and which biomarkers are suitable for different uses (for example diagnosis or monitoring).
Is the funding intended to support therapeutic development directly?
Based on the description provided, the main emphasis is on generating reliable data resources, natural history knowledge, outcome measures, and biomarker evidence that can support downstream therapeutic development and future clinical studies.
What does "Clinical Trials Optional" mean for applicants?
It means the program will consider proposals that are strictly observational (such as longitudinal cohort studies and registries) as well as proposals that include clinical trial elements when appropriate to the aims, such as validating an outcome assessment or biomarker within an interventional context.
Does FDA prefer observational studies over clinical trials?
The description indicates that clinical trials are optional, and the main emphasis is on generating reliable data resources and measurement frameworks. Observational designs (like longitudinal cohorts and registries) are explicitly within scope.
What funding mechanism is used for this opportunity?
This opportunity uses a cooperative agreement mechanism (U01).
What does a U01 cooperative agreement imply about FDA involvement?
A U01 indicates substantial scientific or programmatic involvement by FDA compared with a typical grant. Projects commonly involve coordination with the agency on milestones, data expectations, and study execution details, especially when outputs are meant to be directly useful for regulatory science and product development.
How many awards does FDA expect to make?
FDA anticipates making about three awards.
What is the maximum award amount mentioned in the opportunity description?
The listed award ceiling is $2,000,000.
What does the combination of a high ceiling and few awards suggest?
It suggests FDA is looking for a limited number of relatively large, carefully managed efforts with strong infrastructure for data collection, quality control, and analysis.
Does the FOA encourage projects with impact beyond a single disease?
Yes. The description 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.
What qualities are implied to be important for competitive applications?
Based on the description, competitive applications typically demonstrate strong clinical and scientific leadership, access to the relevant patient population(s), careful 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.
Who is eligible to apply?
Eligibility is broad and includes domestic and non-domestic organizations, including: public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit entities (including small businesses); and various levels of government (state, county, city or township, special districts, tribal governments), along with several other entity types listed in the FOA description.
Are minority-serving institutions specifically encouraged?
Yes. The FOA explicitly encourages applications from institutions such as Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.
Are for-profit companies eligible to apply?
Yes. The eligible applicant types include for-profit entities, including small businesses.
Are foreign institutions eligible to apply?
Yes. 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.
Does the opportunity support international collaboration?
Yes. The eligibility language allowing foreign institutions and foreign components supports international collaboration, which can be important when patient populations and specialized expertise are globally distributed.
Which federal agency is offering this grant opportunity?
The opportunity is offered by the Food and Drug Administration (FDA).
What is the funding instrument type?
The funding instrument is a Cooperative Agreement.
What CFDA number is associated with this opportunity?
The CFDA listing provided is 93.103.
What are the key dates mentioned for this FOA?
The FOA was created on December 11, 2023, and the original application closing date shown is May 6, 2024.
What is FDA ultimately trying to enable by funding these projects?
The description points to FDA's intent to elevate readiness 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.
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