This grant from the FDA aims to research dissolution methods for the long-acting levonorgestrel intrauterine system. The study will focus on developing in vitro drug release assays to detect manufacturing variances, predict in vivo performance, and assess method robustness. Findings will assist the FDA in establishing bioequivalence standards for generic intrauterine systems. Application deadline: Apr 27, 2015.
Opportunity ID: 274611
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-006 |
| Funding Opportunity Title: | Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (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: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 17, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Apr 27, 2015 |
| Current Closing Date for Applications: | Apr 27, 2015 |
| Archive Date: | May 27, 2015 |
| Estimated Total Program Funding: | $125,000 |
| Award Ceiling: | $125,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Private institutions of higher education County governments Public and State controlled institutions of higher education State governments Small businesses 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 Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments Public housing authorities/Indian housing authorities |
| 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. – See more at: http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-006.html#sthash.60X4gtYR.dpuf |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for levonorgestrel intrauterine system (5-year application) and to analyze their capability of detecting manufacturing differences, predicting in vivo performance, and to evaluate method robustness. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic intrauterine systems. |
| Link to Additional Information: | Full Announcement of RFA-FD-15-006 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 274611 Other Supporting Documents-SF424 R&R VersionC Instructions 1 -> sf424_rr_guide_general_adobe_verc.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@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 | PKG00215029 | Feb 25, 2015 | Apr 27, 2015 | View |
Package 1
Mandatory forms
274611 RR_SF424_2_0-2.0.pdf
274611 PHS398_ResearchPlan_2_0-2.0.pdf
274611 PHS398_CoverPageSupplement_2_0-2.0.pdf
274611 RR_Budget_1_3-1.3.pdf
274611 RR_KeyPersonExpanded_2_0-2.0.pdf
274611 RR_OtherProjectInfo_1_3-1.3.pdf
274611 PerformanceSite_2_0-2.0.pdf
Optional forms
274611 PlannedReport-1.0.pdf
274611 PHS398_CumulativeInclusionReport-1.0.pdf
274611 RR_SubawardBudget30_1_3-1.3.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
