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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FAQs: FDA Grant RFA-FD-24-010 (Alcohol Dose Dumping and Modified Release Oral Drug Products)
1) What safety problem is this FDA funding opportunity trying to address?
This opportunity targets alcohol dose dumping (ADD) in modified release (MR) oral drug products. ADD refers to a failure of the controlled-release mechanism when alcohol is present, which can cause a larger-than-intended amount of drug to be released in a short time. Because MR products often contain a relatively large total drug amount (intended to be released over many hours), rapid release can lead to dangerously high exposure, severe adverse effects, and in worst cases, death.
2) What are modified release (MR) oral drug products, and why are they higher risk in this context?
MR oral products are designed to release drug gradually over an extended period. To accomplish that, they may include release-controlling polymers, coatings, or matrix systems and often contain more total drug than an immediate-release product. If alcohol disrupts the formulation, the controlled-release design can fail, increasing the risk of rapid drug release and high short-term exposure.
3) What is the overall goal of the grant?
The overall goal is to generate practical, science-based tools and evidence to support safer MR generic product design and more confident regulatory evaluation. The work is meant to help FDA develop clearer, more efficient recommendations for demonstrating a low or comparable risk of alcohol dose dumping, especially for higher-risk drugs.
4) What types of outputs does FDA appear to be seeking from the funded project?
Based on the description, FDA is looking for actionable methods, tools, or frameworks that (a) identify drug-related and formulation-related factors that drive ADD, and (b) better connect in vitro dissolution findings to meaningful safety and regulatory decisions. The emphasis is on practical utility for developers and regulators, not just generating additional data.
5) Why is harmonization of ADD testing approaches a central issue in this opportunity?
The funding description highlights that current ADD testing approaches are not harmonized across regions. FDA generally recommends in vitro dissolution testing at multiple alcohol concentrations (0%, 5%, 20%, and 40%), while the European Medicines Agency has recommended testing only up to 20%. Different expectations can complicate development for multiple markets and may miss behaviors that only appear at higher alcohol concentrations.
6) What alcohol concentrations are specifically mentioned for in vitro dissolution testing?
The FDA approach described includes in vitro dissolution testing at 0%, 5%, 20%, and 40% alcohol in the dissolution media. The European Medicines Agency approach referenced includes testing only up to 20% alcohol.
7) Why does the difference between testing up to 20% vs. 40% alcohol matter?
The announcement notes that MR formulations do not always respond to increasing alcohol concentration in a simple, linear way. A product could appear acceptable at 20% alcohol but behave unexpectedly at 40%, or show non-monotonic behavior where release speeds up at one concentration and not another. This means higher-alcohol testing could reveal risks not visible at lower levels.
8) What does "non-monotonic" dissolution behavior mean in the context of this grant?
Non-monotonic behavior means the dissolution or release rate does not consistently increase or decrease as alcohol concentration rises. Instead, the release profile may change in unexpected ways across 0%, 5%, 20%, and 40% alcohol, which complicates interpretation and risk assessment.
9) What limitation of current in vitro ADD assessments is identified in the opportunity?
Even when in vitro testing shows changes in dissolution behavior in the presence of alcohol, it can be difficult to interpret what those changes mean for real-world (in vivo) performance and patient risk. A major aim of this call is to develop tools or frameworks that help translate in vitro findings into meaningful safety and regulatory conclusions.
10) Is the work expected to be clinical or non-clinical?
The opportunity is labeled "Clinical Trial Not Allowed," and it is described as non-clinical in nature. The examples given include laboratory-based dissolution and formulation studies, mechanistic investigations, computational modeling, and method development, rather than prospective assignment of human subjects to interventions.
11) What funding mechanism is being used, and what does it imply?
The mechanism is a U01 cooperative agreement. This typically implies substantial scientific interaction between FDA and the funded team during the project, rather than a purely hands-off relationship.
12) What kinds of research activities fit the intent of this opportunity?
The description suggests activities such as in vitro dissolution testing across alcohol concentrations, mechanistic studies of how alcohol interacts with MR formulations, formulation and manufacturing variable investigations, computational or predictive modeling, and development of improved testing strategies or decision tools that support regulatory evaluation without clinical trials.
13) What formulation factors are specifically mentioned as potentially important for alcohol dose dumping risk?
The opportunity notes several MR formulation characteristics that could influence vulnerability to ADD, including polymer type and grade, coating composition and thickness, matrix design, pore formers, plasticizers, excipient choices, manufacturing variables, and drug-polymer interactions.
14) What drug substance (API) characteristics are specifically mentioned as potentially important?
The description identifies active drug characteristics that may drive ADD risk, such as solubility, ionization behavior, partitioning, alcohol affinity, dose strength, and physicochemical stability.
15) Who is the intended beneficiary of the tools and evidence developed under this grant?
The stated intent is to help generic drug developers design safer MR generic products and to help regulators evaluate these products more confidently and consistently. The ultimate public health goal is reducing alcohol-related rapid release risk for patients.
16) How does this opportunity relate specifically to generic MR products?
The announcement repeatedly emphasizes MR generic products and the need to strengthen the premarket evaluation toolkit for MR generics. It also highlights improving the ability to compare a generic to a reference product and reducing uncertainty in regulatory decision-making around alcohol-related risks.
17) What is the anticipated scope of the program in terms of number of awards and budget?
The expected number of awards is one. The award ceiling is $250,000. This points to a single, focused project rather than a large multi-award program.
18) What is the opportunity number and the administering agency?
The opportunity is RFA-FD-24-010 and it is offered by the Food and Drug Administration (FDA).
19) What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.103.
20) What activity area is this program listed under?
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.
21) Who is eligible to apply based on the description provided?
Eligibility is described as 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.
22) What were the key dates mentioned in the opportunity summary?
The opportunity was created on January 15, 2024. The original application due date was April 8, 2024.
23) What does "discretionary" mean in the context of this funding opportunity?
The summary states it is a discretionary funding opportunity. The description does not provide additional detail beyond that label, but it indicates this is a specific FDA-administered funding announcement rather than an entitlement-style program.
24) What kind of decision-support or evaluation improvements does the announcement hint at?
The call emphasizes 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 while still protecting patients.
25) What does success look like according to the opportunity description?
Success is described as more than generating data. The endpoint is actionable methods and evidence that help developers build MR generic products with demonstrably low ADD potential and help FDA reviewers assess alcohol-related risk with greater confidence and consistency, supporting clearer and more efficient FDA recommendations.
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