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Forecasted

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

Federal funding opportunity FOR-FD-24-004 from Food and Drug Administration.

View forecast on Grants.gov →Forecasted — not yet open

Posted
November 24, 2023
Closes
See announcement
Award ceiling
$250,000
Award floor
$250,000
Expected awards
1
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
$15M
Awards in window
911

Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, The Medical Device Innovation Consortium, Duke University

Source: USAspending.gov · refreshed July 2026

Synopsis

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. 

Who can apply

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

Applications go through the official government listing. Grants Radar links you straight to the source.

View on Grants.gov

Agency contact: Terrin Brown Grantor · terrin.brown@fda.hhs.gov · 2403387494

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