Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01)

The summary for the Pharmacokinetics Studies of Tacrolimus in Transplant Patients (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.

Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01): The goal of this proposal is to compare the pharmacokinetics of two sources of generic tacrolimus capsules to Prograf in stable transplant patients. Patients will be switched between both brand and generic. The outcome of this study can help address the public concerns regarding the quality of generic tacrolimus and improve review practices of generic tacrolimus if necessary.

Federal Grant Title:	Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01)
Federal Agency Name:	Food and Drug Administration
Grant Categories:	Consumer Protection Health Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-12-021
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jun 08, 2012
Original Application Deadline:	May 31, 2012
Posted Date:	Apr 27, 2012
Creation Date:	May 10, 2012
Archive Date:	Jun 30, 2012
Total Program Funding:	$2,700,000
Maximum Federal Grant Award:	$700,000
Minimum Federal Grant Award:	$0
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 FDA Grants Policy Statement, are allowed.
Grant Announcement Contact: Lisa Ko Grants Management Specialist

[email protected] [[email protected]]
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