This National Institutes of Health grant is for the purpose of meticulously comparing the pharmacokinetics of generic tacrolimus capsules against the brand-name drug, Prograf, in stable transplant patients. The study involves switching patients between both generic and brand sources to gather comprehensive data. This research aims to directly address prevalent public concerns regarding the quality and efficacy of generic tacrolimus. Ultimately, the findings will be crucial in improving current review practices for generic tacrolimus, ensuring patient safety and effective treatment outcomes in transplant recipients. This grant seeks to provide evidence-based insights to support better drug regulation and patient care.
Opportunity ID: 168034
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 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: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Private institutions of higher education Special district governments City or township governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts For profit organizations other than 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: | Full Announcement RFA-FD-12-021 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Correction to Application Due Date, Expiration Date, Available Funds and Award Budget. | May 10, 2012 | |
| Edits to Funding Opportunity Text Description. | May 10, 2012 | |
| Edits to FOA text description. | Apr 27, 2012 | |
| Apr 27, 2012 |
DISPLAYING: Synopsis 4
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 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: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Private institutions of higher education Special district governments City or township governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts For profit organizations other than 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: | Full Announcement RFA-FD-12-021 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 3
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | May 10, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 31, 2012 |
| Archive Date: | Jun 30, 2012 |
| Estimated Total Program Funding: | $1,500,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities State governments Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) 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 City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Small businesses For profit organizations other than 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: | Full Announcement RFA-FD-12-021 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 2
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 27, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 31, 2012 |
| Archive Date: | Jun 30, 2012 |
| Estimated Total Program Funding: | $1,500,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Small businesses For profit organizations other than 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: | Full Announcement RFA-FD-12-021 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 1
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 27, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 31, 2012 |
| Archive Date: | Jun 30, 2012 |
| Estimated Total Program Funding: | $1,500,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Small businesses For profit organizations other than 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 and generic and brand. 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: | Full Announcement RFA-FD-12-021 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Related Documents
Folder 168034 Other Supporting Documents-SF424 R&R Guide General Adobe Version B 1 -> sf424_rr_guide_general_adobe_verb.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00119391 | May 01, 2012 | Jun 08, 2012 | View |
Package 1
Mandatory forms
168034 RR_SF424_1_2-1.2.pdf
168034 PerformanceSite_1_4-1.4.pdf
168034 RR_OtherProjectInfo_1_3-1.3.pdf
168034 RR_KeyPersonExpanded_1_2-1.2.pdf
168034 RR_Budget-1.1.pdf
168034 PHS398_CoverPageSupplement_1_4-1.4.pdf
168034 PHS398_ResearchPlan_1_3-1.3.pdf
168034 PHS398_Checklist_1_3-1.3.pdf
Optional forms
168034 RR_SubawardBudget30-1.2.pdf
168034 PHS_CoverLetter_1_2-1.2.pdf
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