This Health Department grant aims to demonstrate bioequivalence between generic and brand name bupropion HCl modified release products in patients. The study will evaluate patient perception of release patterns, efficacy, and adverse events. Results will address concerns regarding the quality and therapeutic equivalence of generic bupropion hydrochloride products. Closing date: 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:: | |
| Category of Funding Activity:: | Consumer Protection |
| Category Explanation:: | |
| Expected Number of Awards:: | 1 |
| Assistance Listings Number(s):: | 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:: | Special district governments |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | |
| Competition Title: | |
| Opportunity Package ID: | PKG00172077 |
| Opening Date: | Apr 15, 2013 |
| Closing Date: | May 31, 2013 |
| Agency Contact Information:: | Lisa Ko |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | PKG00172077 | Apr 15, 2013 | May 31, 2013 | View | Lisa Ko | Organization Applicants |