This grant is for the purpose of demonstrating the bioequivalence between generic and brand-name bupropion HCl modified release products at steady state in patients. The study will also evaluate if patients perceive differences in release patterns and experience lack of efficacy or increased adverse events after switching between treatments. Outcomes will address critical concerns regarding the quality, bioequivalence, and therapeutic equivalence of bupropion hydrochloride modified release generic products. This research contributes to ensuring patient safety and confidence in generic medications. The closing date for applications was May 31, 2013.
Opportunity ID: 228859
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-021 |
| Funding Opportunity Title: | Bioequivalence of Generic Bupropion (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: | Apr 02, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 31, 2013 |
| Current Closing Date for Applications: | May 31, 2013 |
| Archive Date: | Jun 30, 2013 |
| Estimated Total Program Funding: | $800,000 |
| Award Ceiling: | $800,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Small businesses Private institutions of higher education For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities County governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 the study is to (1) demonstrate bioequivalence between generic and brand name bupropion HCl modified release products with different release patterns at steady state in patients, and (2) evaluate whether patients can perceive the difference in release pattern and experience lack of efficacy or increased adverse events after they are switched between each treatment. The outcome of this study will help address concerns on quality, bioequivalence, and therapeutic equivalence of bupropion hydrochloride modified release generic products. |
| Link to Additional Information: | Link to Full Announcement of RFA-FD-13-021 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
There are no related documents on this grant.
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 | PKG00172077 | Apr 15, 2013 | May 31, 2013 | View |
Package 1
Mandatory forms
228859 RR_SF424_1_2-1.2.pdf
228859 PerformanceSite_1_4-1.4.pdf
228859 RR_OtherProjectInfo_1_3-1.3.pdf
228859 RR_KeyPersonExpanded_1_2-1.2.pdf
228859 RR_Budget-1.1.pdf
228859 PHS398_CoverPageSupplement_1_4-1.4.pdf
228859 PHS398_ResearchPlan_1_3-1.3.pdf
228859 PHS398_Checklist_1_3-1.3.pdf
Optional forms
228859 RR_SubawardBudget30-1.2.pdf
228859 PHS_CoverLetter_1_2-1.2.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
