This grant is for the critical purpose of advancing drug development tools within the qualification programs of FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). It specifically targets research initiatives involving tools that have already secured an accepted Letter of Intent (LOI) with either center. The funding aims to facilitate the continued development of these innovative tools. Upon successful qualification, these publicly available tools are intended to address significant unmet needs in the broader drug development landscape, fostering innovation and efficiency in bringing new therapies to patients. The initiative underscores a commitment to enhancing the regulatory science foundation.
Opportunity ID: 331601
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-178 |
| Funding Opportunity Title: | Drug Development Tools Research Grants (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 30 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Apr 29, 2022 |
| Original Closing Date for Applications: | May 25, 2021 Application Due Date(s)
May 25, 2021 by 11:59 PM Eastern Time May 3, 2022 by 11:59 PM Eastern Time May 3, 2023 by 11:59 PM Eastern Time |
| Current Closing Date for Applications: | May 03, 2023 Application Due Date(s)May 25, 2021 by 11:59 PM Eastern Time May 17, 2022 by 11:59 PM Eastern Time May 3, 2023 by 11:59 PM Eastern Time |
| Archive Date: | Jun 02, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Native American tribal governments (Federally recognized) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher education City or township governments State governments Public and State controlled institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. |
| Link to Additional Information: | PAR-21-178 – FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Extend Due Date for 2022 to May 17, 2022 | Apr 29, 2022 | |
| Correct Due date | Feb 18, 2021 | |
| Feb 18, 2021 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-178 |
| Funding Opportunity Title: | Drug Development Tools Research Grants (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 30 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Apr 29, 2022 |
| Original Closing Date for Applications: | May 25, 2021 Application Due Date(s)
May 25, 2021 by 11:59 PM Eastern Time May 3, 2022 by 11:59 PM Eastern Time May 3, 2023 by 11:59 PM Eastern Time |
| Current Closing Date for Applications: | May 03, 2023 Application Due Date(s)May 25, 2021 by 11:59 PM Eastern Time May 17, 2022 by 11:59 PM Eastern Time May 3, 2023 by 11:59 PM Eastern Time |
| Archive Date: | Jun 02, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Native American tribal governments (Federally recognized) Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher education City or township governments State governments Public and State controlled institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. |
| Link to Additional Information: | PAR-21-178 – FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-178 |
| Funding Opportunity Title: | Drug Development Tools Research Grants (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 30 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Feb 18, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 03, 2023 Application Due Date(s)May 25, 2021 by 11:59 PM Eastern Time May 3, 2022 by 11:59 PM Eastern TimeMay 3, 2023 by 11:59 PM Eastern Time |
| Archive Date: | Jun 02, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Independent school districts Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education State governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have 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) City or township governments Public and State controlled institutions of higher education County governments Small businesses Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. |
| Link to Additional Information: | PAR-21-178 – FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-178 |
| Funding Opportunity Title: | Drug Development Tools Research Grants (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 30 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Feb 18, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 25, 2021 Application Due Date(s)
May 25, 2021 by 11:59 PM Eastern Time May 3, 2022 by 11:59 PM Eastern Time May 3, 2023 by 11:59 PM Eastern Time |
| Archive Date: | Jun 24, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | $10,000 |
Eligibility
| Eligible Applicants: | Independent school districts Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education State governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have 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) City or township governments Public and State controlled institutions of higher education County governments Small businesses Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Hispanic-serving Institutions Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. |
| Link to Additional Information: | PAR-21-178 – FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@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 | PAR-21-178-FORMS-G | FORMS G – For due dates on or after January 25, 2022 | PKG00270076 | Nov 12, 2021 | Nov 24, 2022 | View |
| 93.103 | PAR-21-178-FORMS-H | FORMS H – For due dates on or after January 25, 2023 | PKG00278676 | Nov 24, 2022 | May 03, 2023 | View |
Package 1
Mandatory forms
331601 RR_SF424_5_0-5.0.pdf
331601 PHS398_CoverPageSupplement_5_0-5.0.pdf
331601 RR_OtherProjectInfo_1_4-1.4.pdf
331601 PerformanceSite_4_0-4.0.pdf
331601 RR_KeyPersonExpanded_4_0-4.0.pdf
331601 RR_Budget_3_0-3.0.pdf
331601 PHS398_ResearchPlan_4_0-4.0.pdf
331601 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
331601 RR_SubawardBudget30_3_0-3.0.pdf
331601 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
331601 RR_SF424_5_0-5.0.pdf
331601 PHS398_CoverPageSupplement_5_0-5.0.pdf
331601 RR_OtherProjectInfo_1_4-1.4.pdf
331601 PerformanceSite_4_0-4.0.pdf
331601 RR_KeyPersonExpanded_4_0-4.0.pdf
331601 RR_Budget_3_0-3.0.pdf
331601 PHS398_ResearchPlan_5_0-5.0.pdf
331601 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
331601 RR_SubawardBudget30_3_0-3.0.pdf
331601 PHS_AssignmentRequestForm_3_0-3.0.pdf
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