This NCATS Therapeutic Development Branch grant supports intramural-extramural collaborations for late-stage translational science, specifically therapeutic development of small molecules, biologics, or gene therapies. The UG3 phase provides funding for late-clinical work and trial planning at applicant institutions, aiming to enable an Investigational New Drug (IND) application. If UG3 milestones are met and IND cleared, the UH3 phase will support early-stage clinical trials conducted at applicant institutions. This grant facilitates a direct pathway for promising therapeutic candidates from advanced preclinical development to initial human trials.
Opportunity ID: 329109
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-20-301 |
| Funding Opportunity Title: | Drug Development Collaboratory (UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.350 — National Center for Advancing Translational Sciences |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 18, 2020 |
| Last Updated Date: | Sep 18, 2020 |
| Original Closing Date for Applications: | Jun 09, 2023 |
| Current Closing Date for Applications: | Jun 09, 2023 |
| Archive Date: | Jul 15, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | 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) Public and State controlled institutions of higher education For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) Private institutions of higher education Public housing authorities/Indian housing authorities County governments Independent school districts 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) Special district governments City or township governments Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to support intramural-extramural collaborations on late-stage translational science projects between NCATS Therapeutic Development Branch (TDB) and extramural researchers, for therapeutic development of small molecules, biologics, or gene therapies. The UG3 phase will provide support for late stage pre-clinical work and clinical trial planning that is conducted at applicant institutions. The goal of any collaboration with TDB is to enable an IND application by the end of the UG3 phase. If UG3 milestones are met and an IND is cleared, support may be provided for an early stage clinical trials in the UH3 phase that will be conducted at the applicant institutions. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-20-301.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 329109 Full Announcement-PAR-20-301 -> PAR-20-301-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00263451 | Jan 09, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270469 | Nov 18, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278421 | Nov 15, 2022 | Jun 09, 2023 | View |
Package 1
Mandatory forms
329109 RR_SF424_2_0-2.0.pdf
329109 PHS398_CoverPageSupplement_5_0-5.0.pdf
329109 RR_OtherProjectInfo_1_4-1.4.pdf
329109 PerformanceSite_2_0-2.0.pdf
329109 RR_KeyPersonExpanded_2_0-2.0.pdf
329109 RR_Budget10_1_4-1.4.pdf
329109 PHS398_ResearchPlan_4_0-4.0.pdf
329109 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
329109 RR_SubawardBudget10_30_1_4-1.4.pdf
329109 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
329109 RR_SF424_5_0-5.0.pdf
329109 PHS398_CoverPageSupplement_5_0-5.0.pdf
329109 RR_OtherProjectInfo_1_4-1.4.pdf
329109 PerformanceSite_4_0-4.0.pdf
329109 RR_KeyPersonExpanded_4_0-4.0.pdf
329109 RR_Budget10_3_0-3.0.pdf
329109 PHS398_ResearchPlan_4_0-4.0.pdf
329109 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
329109 RR_SubawardBudget10_30_3_0-3.0.pdf
329109 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
329109 RR_SF424_5_0-5.0.pdf
329109 PHS398_CoverPageSupplement_5_0-5.0.pdf
329109 RR_OtherProjectInfo_1_4-1.4.pdf
329109 PerformanceSite_4_0-4.0.pdf
329109 RR_KeyPersonExpanded_4_0-4.0.pdf
329109 RR_Budget10_3_0-3.0.pdf
329109 PHS398_ResearchPlan_5_0-5.0.pdf
329109 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
329109 RR_SubawardBudget10_30_3_0-3.0.pdf
329109 PHS_AssignmentRequestForm_3_0-3.0.pdf
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