The Health Department is offering a grant to develop and implement an optimization algorithm to enable population-based statistical analysis in physiologically-based pharmacokinetic (PBPK) models. This research aims to derive parameter distributions in specific populations, supporting bioequivalence assessments and regulatory decisions for generic drug development.
Opportunity ID: 282331
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-026 |
| Funding Opportunity Title: | Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 18, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 16, 2016 |
| Current Closing Date for Applications: | May 16, 2016 |
| Archive Date: | Jun 15, 2016 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this project is to develop and implement a robust optimization algorithm that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models so that knowledge of parameter distributions in the population(s) of interest can be derived. The models developed will be used to generate predictions that can inform bioequivalence assessments and regulatory decisions relating to generic drug development. |
| Link to Additional Information: | Full Announcement of RFA-FD-16-026 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Eric Bozoian
Grants Management Specialist Phone 2404027623 Email:eric.bozoian@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Eric Bozoian Grants Management Specialist Phone 2404027623 Email: eric.bozoian@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 | PKG00221728 | Mar 17, 2016 | May 16, 2016 | View |
Package 1
Mandatory forms
282331 RR_SF424_2_0-2.0.pdf
282331 PHS398_CoverPageSupplement_3_0-3.0.pdf
282331 RR_OtherProjectInfo_1_3-1.3.pdf
282331 PerformanceSite_2_0-2.0.pdf
282331 RR_KeyPersonExpanded_2_0-2.0.pdf
282331 RR_Budget_1_3-1.3.pdf
282331 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282331 RR_SubawardBudget30_1_3-1.3.pdf
282331 PHS_Inclusion_Enrollment_Report-1.0.pdf
282331 PHS_AssignmentRequestForm-1.0.pdf
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