This grant is for the critical purpose of advancing bioequivalence (BE) assessment for Orally Inhaled Drug Products (OIDPs). Currently, establishing BE for locally acting OIDPs, particularly those where comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies lack sensitivity to detect formulation differences, presents significant challenges. This funding opportunity aims to support innovative research that leverages modeling and simulation techniques. The goal is to investigate the feasibility of utilizing systemic pharmacokinetic (PK) concentration data to accurately assess formulation differences in regional lung exposure. Such research is vital for establishing robust BE criteria for OIDPs with diverse drug and product properties, ultimately streamlining drug development and approval processes.
Opportunity ID: 344257
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-23-017 |
| Funding Opportunity Title: | Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed |
| 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: | – |
| 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 28, 2023 |
| Current Closing Date for Applications: | Feb 28, 2023 |
| Archive Date: | Mar 30, 2023 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | State governments Public housing authorities/Indian housing authorities Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Public and State controlled institutions of higher education For profit organizations other than small businesses Special district governments |
| 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 OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products. To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies; along with formulation sameness and device similarity. For some OIDPs, both CCEP and PD studies can pose a challenge due to a lack of sensitivity to detect formulation differences. The purpose of this funding opportunity is to support research that will use modeling and simulation to investigate the feasibility of assessing formulation differences in regional lung exposure based on systemic PK concentration data to establish BE for OIDPs with different drug and product properties. |
| 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 344257 Full Announcement-NOFO -> FINAL -RFA-FD-23-017.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 |
|---|---|---|---|---|---|---|
| RFA-FD-23-017 | FORMS H | PKG00278731 | Nov 30, 2022 | Feb 28, 2023 | View |
Package 1
Mandatory forms
344257 RR_SF424_5_0-5.0.pdf
344257 PHS398_CoverPageSupplement_5_0-5.0.pdf
344257 RR_OtherProjectInfo_1_4-1.4.pdf
344257 PerformanceSite_4_0-4.0.pdf
344257 RR_KeyPersonExpanded_4_0-4.0.pdf
344257 RR_Budget10_3_0-3.0.pdf
344257 PHS398_ResearchPlan_5_0-5.0.pdf
344257 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
344257 RR_SubawardBudget10_30_3_0-3.0.pdf
344257 PHS_AssignmentRequestForm_3_0-3.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
