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

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name

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

Issuing agency

Food and Drug Administration (Department of Health and Human Services)

Opportunity number

FOR-FD-24-004

Funding type

Cooperative Agreement

Funding purpose

Agriculture, Food and Nutrition, Consumer Protection

Status

Forecasted

Application deadline

Forecasted · no application dates yet

Published award range

Up to $250,000

Expected number of awards

1

Cost sharing or match required

No

Eligible applicants (official categories)

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities/Indian housing authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Private institutions of higher education
• For profit organizations other than small businesses
• Small businesses
• Others (see Additional Information on Eligibility)
• Unrestricted (open to any type of entity, subject to any clarification in Additional Information on Eligibility)

Relevant to

Businesses and NonprofitsHow we determined this: Grants.gov lists eligibility as Unrestricted. Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.

Geographic restrictions

None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.

Assistance Listing (CFDA)

93.103

Official source

View on Grants.gov ↗

Application URL

www.grants.gov/search-results-detail/351126 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.

Source identifier

Grants.gov opportunity ID 351126 · Funding opportunity number FOR-FD-24-004

Posted

November 24, 2023 · Source last updated November 24, 2023

Last verified

October 29, 2026 (against Grants.gov)

Data completeness

92% of key fields published by the sourceNot published: application dates.

Record confidence

mediumforecast — dates and amounts are agency estimates.

Eligibility details (from the agency)

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).

Description (from the official listing)

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.

Agency contact

Terrin Brown Grantor
terrin.brown@fda.hhs.gov