Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)

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Funding Opportunity ID: 312819
Opportunity Number: RFA-FD-19-010
Opportunity Title: Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
CFDA Number(s): 93.103
Eligible Applicants: State governments
County governments
City or township governments
Special district governments
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 text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Higher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions)
Agency Code: HHS-FDA
Agency Name: Department of Health and Human Services
Food and Drug Administration
Posted Date: Feb 11, 2019
Close Date: Apr 11, 2019
Last Updated Date: Feb 11, 2019
Award Ceiling: $1,500,000
Award Floor: $500,000
Estimated Total Program Funding:
Expected Number of Awards: 1
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. 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 and dermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
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