The National Institutes of Health (NIH) is offering this grant to fund preclinical proof of concept studies for rare diseases. This grant aims to support efficacy studies in established rare disease models to demonstrate that therapeutic agents, including small molecules, biologics, or biotechnology-derived products, warrant further development. This funding also covers accompanying pharmacodynamic and pharmacokinetic studies. This grant is for the purpose of spurring therapeutic development for various rare diseases, advancing projects to a stage where they can attract subsequent investment. The ultimate goal is to facilitate full Investigational New Drug (IND) application development or progression to clinical trials, especially for repurposing or repositioning existing treatments.
Opportunity ID: 353369
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-TR-24-023 |
| Funding Opportunity Title: | Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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 2 |
| Posted Date: | Apr 03, 2024 |
| Last Updated Date: | Dec 06, 2024 |
| Original Closing Date for Applications: | Jun 02, 2026 |
| Current Closing Date for Applications: | Dec 05, 2024 |
| Archive Date: | Jan 04, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities 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 Native American tribal governments (Federally recognized) Small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments City or township governments Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments |
| 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 Organizations) 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: |
This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-24-023.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close date per reissued NOFO RFA-TR-25-002. | Dec 06, 2024 | |
| Apr 03, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-TR-24-023 |
| Funding Opportunity Title: | Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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 2 |
| Posted Date: | Apr 03, 2024 |
| Last Updated Date: | Dec 06, 2024 |
| Original Closing Date for Applications: | Jun 02, 2026 |
| Current Closing Date for Applications: | Dec 05, 2024 |
| Archive Date: | Jan 04, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities 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 Native American tribal governments (Federally recognized) Small businesses Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments City or township governments Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments |
| 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 Organizations) 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: |
This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-24-023.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-TR-24-023 |
| Funding Opportunity Title: | Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | Apr 03, 2024 |
| Last Updated Date: | Apr 03, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 02, 2026 |
| Archive Date: | Jul 08, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Native American tribal governments (Federally recognized) Private institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments |
| 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 Organizations) 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: | This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-24-023.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00285856 | May 03, 2024 | Dec 07, 2024 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288927 | Nov 08, 2024 | Dec 07, 2024 | View |
Package 1
Mandatory forms
353369 RR_SF424_5_0-5.0.pdf
353369 PHS398_CoverPageSupplement_5_0-5.0.pdf
353369 RR_OtherProjectInfo_1_4-1.4.pdf
353369 PerformanceSite_4_0-4.0.pdf
353369 RR_KeyPersonExpanded_4_0-4.0.pdf
353369 PHS398_ResearchPlan_5_0-5.0.pdf
353369 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353369 RR_Budget_3_0-3.0.pdf
353369 RR_SubawardBudget30_3_0-3.0.pdf
353369 PHS398_ModularBudget_1_2-1.2.pdf
353369 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
353369 RR_SF424_5_0-5.0.pdf
353369 PHS398_CoverPageSupplement_5_0-5.0.pdf
353369 RR_OtherProjectInfo_1_4-1.4.pdf
353369 PerformanceSite_4_0-4.0.pdf
353369 RR_KeyPersonExpanded_4_0-4.0.pdf
353369 PHS398_ResearchPlan_5_0-5.0.pdf
353369 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353369 RR_Budget_3_0-3.0.pdf
353369 RR_SubawardBudget30_3_0-3.0.pdf
353369 PHS398_ModularBudget_1_2-1.2.pdf
353369 PHS_AssignmentRequestForm_4_0-4.0.pdf
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