Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed

The summary for the Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed: The purpose of this funding opportunity is to elucidate how pharmacokinetic principles and concepts (e.g., dose, fraction of drug absorbed, apparent volume of distribution, Cmax, AUCinfinity) should be applied or adapted when evaluating the rate and extent to which a topically applied compound becomes available in the dermis, at or near a site of action within the skin, and to evaluate the relative sensitivity of in vivo dermal pharmacokinetic methods to discriminate differences in drug concentrations in the skin. The expectation is that the funded work will establish appropriate designs and analyses for in vivo dermal microdialysis (dMD) or dermal open flow microperfusion (dOFM) studies to evaluate topical bioavailability and bioequivalence based upon appropriate dermal pharmacokinetic endpoints.
Federal Grant Title: Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed
Federal Agency Name: Food and Drug Administration (HHS-FDA)
Grant Categories: Agriculture Consumer Protection Food and Nutrition
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-20-019
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Information not provided
Current Application Deadline: February 27th, 2020
Original Application Deadline: February 27th, 2020
Posted Date: December 19th, 2019
Creation Date: December 19th, 2019
Archive Date: March 28th, 2020
Total Program Funding: $1,000,000
Maximum Federal Grant Award: $1,000,000
Minimum Federal Grant Award: $250,000
Expected Number of Awards: 5
Cost Sharing or Matching: No
Last Updated: December 19th, 2019
Applicants Eligible for this Grant
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 - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility
Eligible Organizations Higher Education Institutions Public/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: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits 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 Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State 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 Other Independent 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)
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