Bioequivalence of Generic Bupropion (U01)

The summary for the Bioequivalence of Generic Bupropion (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

Bioequivalence of Generic Bupropion (U01): 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.

Federal Grant Title:	Bioequivalence of Generic Bupropion (U01)
Federal Agency Name:	Food and Drug Administration
Grant Categories:	Consumer Protection Food and Nutrition Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-13-021
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	May 31, 2013
Original Application Deadline:	May 31, 2013
Posted Date:	Apr 02, 2013
Creation Date:	Apr 02, 2013
Archive Date:	Jun 30, 2013
Total Program Funding:	$800,000
Maximum Federal Grant Award:	$800,000
Minimum Federal Grant Award:
Expected Number of Awards:	1
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification)
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.
Grant Announcement Contact: Lisa Ko Grants Management Specialist

[email protected] [[email protected]]
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