Food and Drug Administration · Department of Health and Human Services
Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
Key facts
- Deadline
- Forecast — no date yet
- Award size
- Up to $250K
- Cost share / match ?
- Not required
- Who can apply
- Tribal organization, Special district (utility, fire, etc.), Larger business, Anyone (unrestricted), School district, Tribal government, County government, Other (see eligibility), State government, Private college or university, City or town government, Small business, Nonprofit with 501(c)(3), Public college or university, Nonprofit without 501(c)(3)
- Where
- Anywhere in the U.S., including Tennessee
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. Grant-ready checklist
How this fits you
- Available in Tennessee (nationwide program)
- No cost share required
- Tennessee recipients since 2023: 18
Tell us who you are to see whether you're eligible.
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Official notice: https://simpler.grants.gov/opportunity/a16a8998-c3d8-45c8-ab49-7ee05622e4d1 · Printed from grantme.click/grants/0fcf5190-1657-4b33-bbed-72e2df680d78
Read the official notice View on Grants.gov Sign in to save
About this grant
The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
Eligibility (from the 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).
Who in Tennessee has won this program
18 awards to Tennessee recipients in 5 counties since federal FY2023. Largest shown:
| Recipient | Where | Amount | FY |
|---|---|---|---|
| University Of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $2.4M | 2020 |
| University Of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.9M | 2020 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| University Of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department Of Health | Nashville, Davidson County | $1.3M | 2020 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2016 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.2M | 2025 |
Source: USAspending.gov. Past awards show who this program funds; they don't guarantee future awards.
About the program (93.103)
Food and Drug Administration Research — General Grant Funding
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.
Matching requirements
This program has no statutory formula.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Examples of funded projects
Not Applicable.