This grant is for developing a comprehensive workflow to design and execute reliable virtual bioequivalence studies. This department aims to leverage validated physiologically-based pharmacokinetic (PBPK) models to accurately detect formulation differences between reference standard and prospective generic drug products. The funded work will explore essential considerations and establish reasonable assumptions for conducting virtual bioequivalence assessments using complex mechanistic modeling and simulation tools. This initiative seeks to advance the precision and efficiency of drug development, providing a standardized and high-confidence approach to virtual bioequivalence, supporting regulatory evaluation.
Opportunity ID: 344255
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-23-016 |
| Funding Opportunity Title: | Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 01, 2022 |
| Last Updated Date: | Dec 01, 2022 |
| Original Closing Date for Applications: | Feb 15, 2023 |
| Current Closing Date for Applications: | Feb 15, 2023 |
| Archive Date: | Mar 17, 2023 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | State governments Small businesses Public housing authorities/Indian housing authorities Private institutions of higher education Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments City or township governments Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Eligible 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 Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard product and a prospective generic drug product. The workflow will explore considerations and reasonable assumptions related to performing a virtual bioequivalence assessment using mechanistic modeling and simulation tools of increased complexity, such as PBPK models. |
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 344255 Full Announcement-NOFO -> FINAL- RFA-FD-23-016.pdf
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-23-016 | FORMS H | PKG00278709 | Nov 29, 2022 | Feb 15, 2023 | View |
Package 1
Mandatory forms
344255 RR_SF424_5_0-5.0.pdf
344255 PHS398_CoverPageSupplement_5_0-5.0.pdf
344255 RR_OtherProjectInfo_1_4-1.4.pdf
344255 PerformanceSite_4_0-4.0.pdf
344255 RR_KeyPersonExpanded_4_0-4.0.pdf
344255 RR_Budget_3_0-3.0.pdf
344255 PHS398_ResearchPlan_5_0-5.0.pdf
344255 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
344255 RR_SubawardBudget30_3_0-3.0.pdf
344255 PHS_AssignmentRequestForm_3_0-3.0.pdf
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