Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
View forecast on Grants.gov →Forecasted — not yet open · no update since it was posted
- 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 FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $213M
- FY2026 obligated
- $215.3M
- FY2027 (to date) obligated
- $0
- Awards in window
- 849
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
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
- County governments
- Public and State controlled institutions of higher education
- Public housing authorities/Indian housing authorities
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- City or township governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Independent school districts
- For profit organizations other than small businesses
- Small businesses
- Native American tribal organizations (other than Federally recognized tribal governments)
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- State governments
- Special district governments
- Private institutions of higher education
- Native American tribal governments (Federally recognized)
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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