Closed · RFA-FD-24-010 · CFDA 93.103 · Discretionary
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
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- up to $250K
- Award range
- Closed
- Status
- April 8, 2024
- Close date
- 1
- Expected awards
The verdict
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 is a closed discretionary listing from Food and Drug Administration that offered Up to $250,000 across 1 expected award. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.
- up to $250K
- award range
- Closed
- application status
- 1
- expected award
- 93.103
- CFDA program
Archived opportunity record
Identification of Drug-related and Formulatio… is closed (last close April 8, 2024). The parent program page for CFDA 93.103 is the reliable place to catch re-announcements. Food and Drug Administration still indexes 481 other opportunities here.
According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.
Deadline tracker
Application window closed
Closed April 8, 2024
Est. Total Funding
$250,000
Expected Awards
1
Instrument
Cooperative Agreement
Description
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.
Wide-open applicant board · 15 Grants.gov doors
Identification of Drug-related and Formulatio… prints 15 distinct Grants.gov eligibility doors (State governments; County governments; City or township governments; Special district governments; +11 more). Filter fit before reading award size as demand — most applicant classes appear on the row. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity codes span Agriculture · Consumer Protection · Food and Nutrition (AG;CP;FN). Only 11 other Food and Drug Administration listings share this exact eligibility-code string (2% of 482).
- Code 00
- State governments
- Code 01
- County governments
- Code 02
- City or township governments
- Code 04
- Special district governments
- Code 05
- Independent school districts
- Code 06
- Public / state-controlled institutions of higher education
- Code 07
- Federally recognized tribal governments
- Code 08
- Public / Indian housing authorities
- Code 11
- Native American tribal organizations (other than Federally recognized tribal governments)
- Code 12
- Nonprofits with 501(c)(3) status (other than IHEs)
- Code 13
- Nonprofits without 501(c)(3) status (other than IHEs)
- Code 20
- Private institutions of higher education
- Code 22
- For-profit organizations other than small businesses
- Code 23
- Small businesses
- Code 99
- Unrestricted / see official listing
Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Terrin Brown Grantor
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What to do next
Identification of Drug-related and Formulatio… is closed; use the parent program and agency catalog for the next funding cycle.
- Parent CFDA 93.103 may publish future NOFOs under the same assistance listing. Open program
- Food and Drug Administration Research indexes 42 Grants.gov listings in this extract. Program profile
- Food and Drug Administration lists 481 other indexed opportunities on PlainGrants. Agency catalog
Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.
Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
Read our methodology - how this data is sourced, computed, and verified.
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |