Opportunity Information: Apply for RFA FD 24 010
This FDA grant opportunity focuses on a long-standing safety concern with modified release (MR) oral drug products: alcohol dose dumping (ADD). MR products often contain a relatively large total amount of drug because the dose is meant to be released gradually over many hours. If alcohol disrupts the formulation, that carefully controlled release can fail and a large fraction of the drug can be released much faster than intended. The consequence can be dangerously high drug exposure in a short period of time, with severe adverse effects and, in worst cases, death. The overall goal of the opportunity is to generate practical, science-based tools and evidence that make it easier to design safer MR generic products, help regulators evaluate these products more confidently, and ultimately support clearer, more efficient FDA recommendations on how to demonstrate a low or comparable risk of alcohol dose dumping, especially for higher-risk drugs.
A central issue highlighted in the funding description is that current approaches to ADD testing are not harmonized across regions. The FDA generally recommends in vitro dissolution testing in multiple alcohol concentrations (0%, 5%, 20%, and 40% alcohol in the dissolution media) for prospective generic MR products, while the European Medicines Agency has recommended testing only up to 20% alcohol. That difference matters because formulators developing products for multiple markets may have to meet different expectations, and because MR formulations do not always respond to increasing alcohol concentration in a simple, linear way. In other words, a product might look acceptable at 20% alcohol but behave unexpectedly at 40%, or show non-monotonic changes where release speeds up at one alcohol level and not another. The announcement also notes a limitation of the current in vitro assessments: even when they reveal changes in dissolution behavior, it can be difficult to interpret what those findings mean for real-world (in vivo) performance and patient risk. This funding call is therefore aimed at identifying the drug-related and formulation-related factors that drive ADD and at building tools or frameworks that connect in vitro results to meaningful safety and regulatory decisions.
The award mechanism is a U01 cooperative agreement, which typically means the FDA expects substantial scientific interaction with the funded team during the project rather than a purely hands-off grant. The opportunity is explicitly labeled “Clinical Trial Not Allowed,” indicating the work should be non-clinical in nature, such as laboratory-based dissolution and formulation studies, mechanistic investigations, computational modeling, method development, and similar activities that do not involve prospective assignment of human subjects to interventions. The intent is to strengthen the premarket evaluation toolkit for MR generics by improving how alcohol-related risks are studied and predicted without relying on clinical trials.
From an administrative standpoint, this is a discretionary funding opportunity (RFA-FD-24-010) offered by the Food and Drug Administration under CFDA number 93.103. The program is listed under the broad activity area of Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA’s public health and consumer protection role. The expected number of awards is one, with an award ceiling of $250,000, signaling a single, focused project rather than a large multi-award program. Eligibility is broad and includes federal, state, and local government entities; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); tribal governments and tribal organizations; public housing authorities/Indian housing authorities; and for-profit organizations including small businesses. The original application due date was April 8, 2024, and the opportunity was created January 15, 2024.
In practical terms, a competitive project under this announcement would likely aim to pinpoint which characteristics of MR formulations (for example, polymer type and grade, coating composition and thickness, matrix design, pore formers, plasticizers, excipient choices, manufacturing variables, and drug-polymer interactions) and which characteristics of the active drug substance (such as solubility, ionization behavior, partitioning, alcohol affinity, dose strength, and physicochemical stability) make a product more or less vulnerable to alcohol-triggered rapid release. It would also be aligned with developing improved testing strategies or decision tools that reduce uncertainty when comparing a generic to a reference product, help interpret non-linear dissolution behavior across alcohol concentrations, and support more efficient regulatory expectations that still protect patients. The endpoint is not just more data, but actionable methods and evidence that allow developers to build MR generic products with demonstrably low ADD potential and allow FDA reviewers to assess that risk with greater confidence and consistency.Apply for RFA FD 24 010
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "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" 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 2024-01-15.
- Applicants must submit their applications by 2024-04-08. (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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 1 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, Unrestricted.
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| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
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| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
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| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required) Apply for RFA FD 19 024 Funding Number: RFA FD 19 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
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| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 24 216 Funding Number: PAR 24 216 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U18) - Clinical Trials Not Allowed Apply for RFA FD 24 017 Funding Number: RFA FD 24 017 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
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