This grant is designed to support clinical projects addressing crucial needs for clinical trial readiness in rare diseases, disorders, and syndromes. Its primary purpose is to facilitate groundbreaking rare diseases research by streamlining the advancement of candidate therapeutics or diagnostics towards clinical trials. The initiative aims to significantly increase the success rate of these trials through the development and testing of robust biomarkers and comprehensive clinical outcome assessment measures. Additionally, funding will support efforts to precisely define the presentation and natural course of rare diseases, which is essential for enabling the effective and efficient design of upcoming clinical trials. This ensures a more strategic and informed approach to bringing new treatments to patients with rare conditions.
Opportunity ID: 347499
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-23-159 |
| Funding Opportunity Title: | Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health Income Security and Social Services |
| 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 13, 2023 |
| Last Updated Date: | Apr 13, 2023 |
| Original Closing Date for Applications: | Oct 17, 2024 |
| Current Closing Date for Applications: | Oct 17, 2024 |
| Archive Date: | Nov 22, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $275,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities County governments Public and State controlled institutions of higher education For profit organizations other than small businesses Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Native American tribal governments (Federally recognized) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education |
| 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 Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials, and to increase their likelihood of success through development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-23-159.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 |
|---|---|---|
Related Documents
Folder 347499 Full Announcement-PAR-23-159 -> PAR-23-159-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 | PKG00281143 | Apr 15, 2023 | Oct 17, 2024 | View |
Package 1
Mandatory forms
347499 RR_SF424_5_0-5.0.pdf
347499 PHS398_CoverPageSupplement_5_0-5.0.pdf
347499 RR_OtherProjectInfo_1_4-1.4.pdf
347499 PerformanceSite_4_0-4.0.pdf
347499 RR_KeyPersonExpanded_4_0-4.0.pdf
347499 PHS398_ResearchPlan_5_0-5.0.pdf
347499 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
347499 RR_Budget_3_0-3.0.pdf
347499 RR_SubawardBudget30_3_0-3.0.pdf
347499 PHS398_ModularBudget_1_2-1.2.pdf
347499 PHS_AssignmentRequestForm_3_0-3.0.pdf
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