Pharmacokinetics Studies Grant by Department of Health

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This Department of Health grant aims to conduct pharmacokinetics studies comparing generic tacrolimus capsules to Prograf in stable transplant patients. The study involves switching patients between brand and generic versions to address concerns about generic tacrolimus quality and potentially enhance review practices. Deadline for proposal submission is Jun 08, 2012.

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Opportunity ID: 168034

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General Information

Document Type:: Grants Notice
Funding Opportunity Number:: RFA-FD-12-021
Funding Opportunity Title:: Pharmacokinetics Studies of Tacrolimus in Transplant Patients (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 4
Posted Date:: Apr 27, 2012
Last Updated Date:: May 10, 2012
Original Closing Date for Applications:: May 31, 2012
Current Closing Date for Applications:: Jun 08, 2012
Archive Date:: Jun 30, 2012
Estimated Total Program Funding:: $ 2,700,000
Award Ceiling:: $700,000
Award Floor:: $0

Eligibility

Eligible Applicants:: 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 FDA Grants Policy Statement, are allowed.

Additional Information

Agency Name:: Food and Drug Administration
Description:: 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.
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 4 Correction to Application Due Date, Expiration Date, Available Funds and Award Budget. May 10, 2012
Synopsis 3 Edits to Funding Opportunity Text Description.
Synopsis 2 Edits to FOA text description.
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: PKG00119391
Opening Date: May 01, 2012
Closing Date: Jun 08, 2012
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]

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Packages

Assistance Listings Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions Who Can Apply:
93.103 PKG00119391 May 01, 2012 Jun 08, 2012 View Lisa Ko Organization Applicants

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