Food and Drug Administration · Department of Health and Human Services
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
Key facts
- Deadline
- Opening date not announced
- Award size
- $250K – $500K
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Tribal organization, Public college or university, Larger business, Tribal government, State government, Anyone (unrestricted), Special district (utility, fire, etc.), County government, Nonprofit without 501(c)(3), Private college or university, Nonprofit with 501(c)(3), School district, City or town government, Small business, and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Opening soon: the funder has announced this grant, but you can't apply yet. Use the time to get ready and check whether it fits.
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Shelby County (nationwide program)
- No match required
- Past Tennessee awards on file: 42 — including your county
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/414f228f-fdfb-406d-bdf5-89bbb2bf9602 · Printed from grantme.click/grants/b4f7af9a-e7fe-445c-a40b-7763be931cb4
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About this grant
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, from the official notice
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).
Writing the need statement? Shelby County facts with citations.
Who in Tennessee has won this program
20 awards to Tennessee groups in 5 counties since 2016 · 1 in Shelby County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| University of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| State of Tennessee | Nashville | $2.7M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $2.4M | 2020 |
| University of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.9M | 2020 |
| University of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department of Health | Nashville, Davidson County | $1.3M | 2020 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2016 |
Source: USAspending.gov; Federal Audit Clearinghouse. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 22 pass-through grants on file · 2 in Shelby County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Combinedbrain, Inc | Brentwood | Duke University | $538K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Harvard Pilgrim Health Care | $241K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $75K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $69K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic Hospital | $51K spent that year | 2025 |
| Volumetrix Inc. | Nashville, Davidson County | The Children's Hospital of Philadelphia | $50K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Cumberland Pharmaceuticals Inc | $42K spent that year | 2025 |
| Loch & Key Productions, LLC | Knoxville, Knox County | Association of Public Health Laboratories, Inc. (THE) | $33K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The Queen's Medical Center | $32K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of California-San Francisco | $29K spent that year | 2025 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
Food and Drug Administration Research, also called “General Grant Funding”
Program number 93.103 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, Food and Drug Administration · Cooperative agreement (a grant with close agency involvement), project grant
How applications are judged
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.
Match
None required (federal program listing).