Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
View forecast on Grants.gov →Forecasted — not yet open
- Posted
- November 24, 2023
- Closes
- See announcement
- Award ceiling
- $500,000
- Award floor
- $250,000
- Expected awards
- 2
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
Program funding history
Awards made under Assistance Listing 93.103 across FY2024–FY2026, from public federal spending records.
- FY2024 obligated
- $250.8M
- FY2025 obligated
- $213M
- FY2026 (to date) obligated
- $65.5M
- Awards in window
- 920
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, The Medical Device Innovation Consortium, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed August 2026
Synopsis
The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products.
Who can apply
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- City or township governments
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Special district governments
- Small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- For profit organizations other than small businesses
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal organizations (other than Federally recognized tribal governments)
- Private institutions of higher education
- State governments
- Public housing authorities/Indian housing authorities
- Public and State controlled institutions of higher education
- County governments
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
How to apply
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