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Federal Forecasted GRANTS-GOV-351126

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

Food and Drug Administration (HHS) · Competitive grant · Science & Technology

At a glance

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) is a federal competitive grant from Food and Drug Administration for the science & technology sector. Funding is up to $250K. Eligible applicants: Small businesses; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Private institutions of higher education; County governments; Native American tribal g. Applications are accepted on a rolling basis. Apply via the official listing at www.grants.gov.

Amount
Up to $250K
Deadline
Rolling
Type
Competitive
Status
Forecasted

About this program

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

Small businesses; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Private institutions of higher education; County governments; Native American tribal governments (Federally recognized); Others (see text field entitled "Additional Information on Eligibility" for clarification); 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; Special district governments; Public housing authorities/Indian housing authorities; Independent school districts; State governments; City or township governments; Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"; Native American tribal organizations (other than Federally recognized tribal governments). 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

Apply through Grants.gov using funding opportunity number FOR-FD-24-004. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source