The Department of Health is offering a grant to integrate in vivo supersaturation-precipitation mechanisms into mechanism-based oral absorption models for poorly water-soluble drugs. The project aims to predict the in vivo performance of associated formulations and establish an in vitro-in vivo correlation for these drug products. Apply before Jun 03, 2016 12:00:00 AM EDT.
Opportunity ID: 282696
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-025 |
| Funding Opportunity Title: | Integrating Supersaturation-precipitation Mechanisms in Mechanistic Oral Absorption Models for Predicting In- vivo Performance of Associated Formulations (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: | 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: | $500,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities State governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education County governments Special district governments Small businesses |
| 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 objectives of this project are to: 1) integrate in vivo supersaturation-precipitation mechanisms into mechanism-based oral absorption models for poorly water-soluble drugs formulated into supersaturable systems, and 2) to establish a mechanism-based in vitro-in vivo correlation (IVIVC) for these drug products. |
| Link to Additional Information: | Full Announcement of RFA-FD-16-021 |
| 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 | PKG00222284 | Apr 04, 2016 | Jun 03, 2016 | View |
Package 1
Mandatory forms
282696 RR_SF424_2_0-2.0.pdf
282696 PHS398_CoverPageSupplement_3_0-3.0.pdf
282696 RR_OtherProjectInfo_1_3-1.3.pdf
282696 PerformanceSite_2_0-2.0.pdf
282696 RR_KeyPersonExpanded_2_0-2.0.pdf
282696 RR_Budget_1_3-1.3.pdf
282696 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282696 RR_SubawardBudget30_1_3-1.3.pdf
282696 PHS_Inclusion_Enrollment_Report-1.0.pdf
282696 PHS_AssignmentRequestForm-1.0.pdf
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