Grants / Department of Health and Human Services / Food and Drug Administration

RFA-FD-24-010: 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

Closed Closed April 8, 2024 Opportunity RFA-FD-24-010 ☆ Save

This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2024.

• Award ceiling$250,000
• Total funding$250,000
• Expected awards1
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to any type of organization.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses, individuals.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $250,000 per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

What the grant funds

Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.

Category: Agriculture, Consumer Protection, Food and Nutrition.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.