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

Agency: Food and Drug Administration

Assistance Listings: 93.103 -- Food and Drug Administration Research

Last Updated: November 24, 2023

Description

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

Eligible applicants

Nonprofit

  • Other Native American tribal organizations
  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)

Government

  • Special district governments
  • Federally recognized Native American tribal governments
  • County governments
  • Public and Indian housing authorities
  • State governments
  • City or township governments

Business

  • For-profit organizations other than small businesses
  • Small businesses

Miscellaneous

  • Unrestricted
  • Other

Education

  • Independent school districts
  • Private institutions of higher education
  • Public and state institutions of higher education

Additional information

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).

Grantor contact information

Description

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Email

terrin.brown@fda.hhs.gov

terrin.brown@fda.hhs.gov

Documents

No documents are currently available.

Link to additional information

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Forecasted

Estimated Post Date:

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Estimated Application Due Date:

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Estimated Due Date Description:

Not available

Estimated Award Date:

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Estimated Project Start Date:

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Fiscal Year:

2024

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

1

Expected awards

$250,000

Award Minimum

$250,000

Award Maximum

Funding opportunity number:

FOR-FD-24-004

Cost sharing or matching requirement:

No

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

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Category of Funding Activity:

Consumer protection

Food and nutrition

Agriculture

Category Explanation:

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History

Version:

3

Forecast posted date:

November 24, 2023

Archive date:

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