This grant is for advancing therapeutic development for rare diseases. It provides funding for efficacy studies using established preclinical models to demonstrate that a proposed therapeutic agent warrants further development. Support also covers accompanying pharmacodynamic and pharmacokinetic studies. Eligible therapeutic agents include small molecules, biologics, or biotechnology-derived products. The primary purpose is to advance promising projects to a stage where they can attract subsequent investment, facilitating full Investigational New Drug (IND) application development or progression to clinical trials, especially for drug repurposing or repositioning initiatives. This aims to accelerate the translation of research into potential treatments for rare conditions.
Opportunity ID: 349107
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-TR-23-016 |
| 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: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jul 05, 2023 |
| Last Updated Date: | Mar 25, 2024 |
| Original Closing Date for Applications: | Jun 02, 2025 |
| Current Closing Date for Applications: | Mar 25, 2024 |
| Archive Date: | Apr 24, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Native American tribal governments (Federally recognized) 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: |
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 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-23-016.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 |
|---|---|---|
| updated close date | Mar 25, 2024 | |
| Jul 05, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-TR-23-016 |
| 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: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jul 05, 2023 |
| Last Updated Date: | Mar 25, 2024 |
| Original Closing Date for Applications: | Jun 02, 2025 |
| Current Closing Date for Applications: | Mar 25, 2024 |
| Archive Date: | Apr 24, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Native American tribal governments (Federally recognized) 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: |
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 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-23-016.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-23-016 |
| 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: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 05, 2023 |
| Last Updated Date: | Jul 05, 2023 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 02, 2025 |
| Archive Date: | Jul 08, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education City or township governments Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education For profit organizations other than 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: | 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 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-23-016.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
Folder 349107 Full Announcement-RFA-TR-23-016 -> RFA-TR-23-016-Full-Announcement.pdf
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 after January 25, 2023 | PKG00282441 | Sep 01, 2023 | Mar 26, 2024 | View |
Package 1
Mandatory forms
349107 RR_SF424_5_0-5.0.pdf
349107 PHS398_CoverPageSupplement_5_0-5.0.pdf
349107 RR_OtherProjectInfo_1_4-1.4.pdf
349107 PerformanceSite_4_0-4.0.pdf
349107 RR_KeyPersonExpanded_4_0-4.0.pdf
349107 PHS398_ResearchPlan_5_0-5.0.pdf
349107 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
349107 RR_Budget_3_0-3.0.pdf
349107 RR_SubawardBudget30_3_0-3.0.pdf
349107 PHS398_ModularBudget_1_2-1.2.pdf
349107 PHS_AssignmentRequestForm_3_0-3.0.pdf
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