The FDA is offering a grant to evaluate and compare quantitative methods for identifying aberrant observations in bioequivalence studies, aiming to improve the assessment of residual variability and within-subject variability. This study will enhance regulatory science by enhancing detection of aberrant observations and assisting generic companies in assessing the quality of their products’ in vivo performance.
Opportunity ID: 282697
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-018 |
| Funding Opportunity Title: | Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (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: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 03, 2016 |
| Current Closing Date for Applications: | Jun 03, 2016 |
| Archive Date: | Jul 03, 2016 |
| Estimated Total Program Funding: | $600,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Public housing authorities/Indian housing authorities Special district governments For profit organizations other than small businesses Private institutions of higher education 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: | Aberrant observations in a bioequivalence study with pharmacokinetic endpoints may impact the estimation of residual variability, within-subject variability of the test and reference products, and potentially the bioequivalence conclusion. The purpose of this study is to evaluate and compare different quantitative methods for their capability in defining aberrant observations in bioequivalence studies with different study design features. Study results will advance regulatory science by improving the detection and understanding of aberrant observations and may help generic companies to evaluate the quality and in vivo performance of their proposed products. |
| Link to Additional Information: | Full Announcement of RFA-FD-16-018 |
| 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 | PKG00222285 | Apr 04, 2016 | Jun 03, 2016 | View |
Package 1
Mandatory forms
282697 RR_SF424_2_0-2.0.pdf
282697 PHS398_CoverPageSupplement_3_0-3.0.pdf
282697 RR_OtherProjectInfo_1_3-1.3.pdf
282697 PerformanceSite_2_0-2.0.pdf
282697 RR_KeyPersonExpanded_2_0-2.0.pdf
282697 RR_Budget_1_3-1.3.pdf
282697 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282697 RR_SubawardBudget30_1_3-1.3.pdf
282697 PHS_Inclusion_Enrollment_Report-1.0.pdf
282697 PHS_AssignmentRequestForm-1.0.pdf
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