The CDER grant aims to investigate the in vivo performance of furosemide in healthy adults under conditions mimicking those in pediatric patients. The study will focus on the drug’s absorption phase when given with milk, baby formula, and Ensure Plus™. This research project builds on previous findings that showed higher solubility of furosemide in milk-based mediums. Closing Date: Jul 15, 2014
Opportunity ID: 257134
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-081 |
| Funding Opportunity Title: | Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (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: | Jun 10, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jul 15, 2014 |
| Current Closing Date for Applications: | Jul 15, 2014 |
| Archive Date: | Aug 14, 2014 |
| Estimated Total Program Funding: | $100,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education For profit organizations other than small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities 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: | Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium.
This research project will explore in vivo performance of furosemide in vivo in an environment similar to that seen in pediatric patients Furosemide will be given with milk, baby formula and Ensure Plus™ to healthy adults. The studies will be designed with emphasis on the absorption phase and the changes that may be detected during the first 4 to 6 hours after dosing. |
| Link to Additional Information: | Full Announcement RFA-FD-14-081 |
| 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 257134 Other Supporting Documents-SF424 RR Guide 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 | PKG00198625 | Jun 13, 2014 | Jul 15, 2014 | View |
Package 1
Mandatory forms
257134 RR_SF424_2_0-2.0.pdf
257134 PHS398_ResearchPlan_2_0-2.0.pdf
257134 PHS398_CoverPageSupplement_2_0-2.0.pdf
257134 RR_Budget_1_3-1.3.pdf
257134 RR_KeyPersonExpanded_2_0-2.0.pdf
257134 RR_OtherProjectInfo_1_3-1.3.pdf
257134 PerformanceSite_2_0-2.0.pdf
Optional forms
257134 PlannedReport-1.0.pdf
257134 PHS398_CumulativeInclusionReport-1.0.pdf
257134 RR_SubawardBudget30_1_3-1.3.pdf
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