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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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