[Food and Drug Administration](https://www.fda.gov/)

Forecasted (no due date posted)

$250,000 (one award; cooperative agreement; typically 1 year)

Supports research to identify drug and formulation factors causing alcohol-induced rapid release (“dose dumping”) from modified-release oral drugs, to improve testing and regulatory guidance for safer generics.

Clinical trials are not allowed; opportunity is currently forecasted, not open.

--- ## Description This FDA grant opportunity seeks research to identify drug-related and formulation-related factors that contribute to alcohol dose dumping (ADD) in modified-release (MR) oral drug products. Alcohol dose dumping refers to the unintended, rapid release of a drug from an MR formulation when exposed to alcohol, which can lead to severe side effects or death. The project aims to: - Develop tools to facilitate the creation of MR generic drug products with low ADD potential. - Support regulatory decision-making for these products. - Provide evidence to help the FDA develop more specific recommendations for demonstrating low or comparative ADD risk in MR oral drugs containing high-risk active ingredients. The research is intended to address challenges in harmonizing ADD assessments globally, as current U.S. and European guidelines differ in alcohol concentrations used for testing, and in vitro results may not always predict in vivo behavior. --- ## Due Dates - This is a **forecasted opportunity**; no application due date has been posted yet. - Researchers should monitor [Grants.gov](https://www.grants.gov/search-results-detail/351128) for updates. --- ## Funding Amount - **Award Ceiling:** $250,000 - **Award Floor:** $250,000 - **Number of Awards:** 1 - **Funding Mechanism:** Cooperative Agreement - **Project Duration:** Typically 1 year No cost sharing or matching is required. --- ## Eligibility Eligible applicants include: - Public and private institutions of higher education - Nonprofits (with or without 501(c)(3) status) - State, county, city, township, and special district governments - Independent school districts - Native American tribal governments and organizations - Public housing authorities/Indian housing authorities - For-profit organizations (including small businesses) - Others, including unrestricted entities **Additional notes:** - Organizations may submit more than one application if each is scientifically distinct. - Duplicate or highly overlapping applications will not be accepted for review at the same time. --- ## Application Process - The opportunity is currently in the **forecasted** stage; application instructions and deadlines will be posted on [Grants.gov](https://www.grants.gov/search-results-detail/351128) when available. - Applications must be submitted electronically via Grants.gov. - Review the full funding announcement for detailed requirements once posted. --- ## Additional Information - **Clinical trials are not allowed** under this funding opportunity. - The research should focus on in vitro assessments and tool development, not on human or animal clinical studies. - The project is intended to inform regulatory science and generic drug development. --- ## External Links - [FDA Funder Page](https://www.fda.gov/) - [Official Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/351128) - [FDA Contact Page](https://www.fda.gov/about-fda/contact-fda) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|---------------------------------------|-----------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | (240) 402-7610 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888) 463-6332 |

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

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