The U.S. Food and Drug Administration (FDA) has forecasted a grant opportunity titled "Studies Addressing Rare Neurodegenerative Diseases including ALS" under opportunity number FOR-FD-25-006. This funding aims to support research studies that advance the development of medical products designed to prevent, diagnose, treat, or potentially cure Amyotrophic Lateral Sclerosis (ALS) and other rare neurodegenerative diseases affecting both adults and children. By addressing critical knowledge gaps, these studies are expected to significantly contribute to the understanding and treatment of such diseases, potentially leading to advancements in medical product development.

The primary purpose of this funding opportunity is to encourage research that focuses on innovative interventions for rare neurodegenerative diseases. ALS, a progressive and fatal neurological disorder, has been a key focus, but the scope also includes other under-researched neurodegenerative conditions. The studies supported by this grant are expected to inform the development of medical products that could range from diagnostics and preventative measures to therapeutic treatments. The overarching goal is to improve outcomes for patients affected by these devastating conditions, while also contributing to the broader knowledge base that supports future drug or treatment approvals.

The program is expected to provide approximately 10 awards, though the total available funding and the exact award ceiling and floor have not yet been specified. There is no requirement for cost-sharing or matching funds, allowing organizations to pursue this funding opportunity without the need for supplementary financial commitments. The specific timeline for application submissions and award dates has not yet been announced, but interested parties should expect further details by the end of 2024 or early 2025.

Eligible applicants for this funding include a wide range of entities, such as state and local governments, nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, independent school districts, Native American tribal organizations, public housing authorities, and various for-profit organizations. This broad eligibility allows a diverse array of stakeholders, from academic researchers to government and industry groups, to apply if they can contribute to the goals of the program.

As this is a discretionary grant, applications will be judged based on the quality and relevance of the proposed studies, with a particular focus on their potential to impact the treatment or understanding of rare neurodegenerative diseases. Interested applicants are encouraged to align their projects with the FDA’s goals of addressing critical gaps in knowledge and supporting the development of novel medical products that could have long-term benefits for individuals suffering from ALS and similar conditions.

Further details on submission requirements, evaluation criteria, and deadlines will be available closer to the estimated post date. For more information or questions, applicants can contact the FDA’s grantor representative, Terrin Brown, at (240) 402-7610 or via email at terrin.brown@fda.hhs.gov. This grant represents a significant opportunity for researchers and organizations committed to combating ALS and other rare neurodegenerative diseases to secure support for pioneering studies that could make a substantial difference in the field.