Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional

The summary for the Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional 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.

Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional: The purpose of this funding opportunity is to develop and validate an enhanced mechanistic PBPK model to reliably describe the skin permeation of active pharmaceutical ingredients in topical drug products applied on the skin surface of virtual subjects by accounting for the drug product quality attributes and the metamorphosis these products undergo post application. The goal is to develop an in silico tool and to assess its capability to predict skin absorption for reference listed drug and test drug products considering their potentially different formulation compositions and quality attributes and the dynamic changes they undergo post application. This in silico tool (validated using appropriate datasets) is intended to identify parameters that may impact therapeutic equivalence between a reference listed drug and a test drug product applied on the skin and to inform decisions on generic drug development for these products.

Federal Grant Title:	Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Consumer Protection Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-23-015
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	March 21st, 2023
Original Application Deadline:	March 21st, 2023
Posted Date:	January 5th, 2023
Creation Date:	January 5th, 2023
Archive Date:	April 19th, 2023
Total Program Funding:	$1,000,000
Maximum Federal Grant Award:	$750,000
Minimum Federal Grant Award:	$50,000
Expected Number of Awards:	2
Cost Sharing or Matching:	No
Last Updated:	January 5th, 2023

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - 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: ligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian 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 BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)
Link to Full Grant Announcement: FULL ANNOUNCEMENT
Grant Announcement Contact: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected]
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