This grant is for the purpose of supporting clinical projects crucial for preparing rare diseases for clinical trials. It aims to accelerate rare disease research by streamlining the progression of potential therapeutics or diagnostics towards human trials. Key objectives include enhancing the success rate of future trials by focusing on the development and rigorous testing of essential biomarkers and clinical outcome assessment measures. Furthermore, the grant supports comprehensive efforts to characterize the natural history and presentation of rare diseases, providing foundational knowledge vital for designing effective and well-informed clinical trials. This initiative is designed to overcome critical challenges in rare disease research by fostering a robust environment for clinical trial development.
Opportunity ID: 337811
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-100 |
| Funding Opportunity Title: | Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 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 2 |
| Posted Date: | Feb 03, 2022 |
| Last Updated Date: | Apr 13, 2023 |
| Original Closing Date for Applications: | Oct 17, 2024 |
| Current Closing Date for Applications: | Apr 13, 2023 |
| Archive Date: | May 13, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts |
| 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-100.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Closing early due to issuance of PAR-23-160 | Apr 13, 2023 | |
| Feb 03, 2022 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-100 |
| Funding Opportunity Title: | Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 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 2 |
| Posted Date: | Feb 03, 2022 |
| Last Updated Date: | Apr 13, 2023 |
| Original Closing Date for Applications: | Oct 17, 2024 |
| Current Closing Date for Applications: | Apr 13, 2023 |
| Archive Date: | May 13, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts |
| 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-100.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-100 |
| Funding Opportunity Title: | Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 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: | Feb 03, 2022 |
| Last Updated Date: | Feb 03, 2022 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 17, 2024 |
| Archive Date: | Nov 22, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Public and State controlled institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities Small businesses 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) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education State governments Independent school districts Native American tribal governments (Federally recognized) |
| 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-100.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00271885 | May 17, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278230 | Nov 09, 2022 | Apr 14, 2023 | View |
Package 1
Mandatory forms
337811 RR_SF424_5_0-5.0.pdf
337811 PHS398_CoverPageSupplement_5_0-5.0.pdf
337811 RR_OtherProjectInfo_1_4-1.4.pdf
337811 PerformanceSite_4_0-4.0.pdf
337811 RR_KeyPersonExpanded_4_0-4.0.pdf
337811 PHS398_ResearchPlan_4_0-4.0.pdf
337811 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337811 RR_Budget_3_0-3.0.pdf
337811 RR_SubawardBudget30_3_0-3.0.pdf
337811 PHS398_ModularBudget_1_2-1.2.pdf
337811 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
337811 RR_SF424_5_0-5.0.pdf
337811 PHS398_CoverPageSupplement_5_0-5.0.pdf
337811 RR_OtherProjectInfo_1_4-1.4.pdf
337811 PerformanceSite_4_0-4.0.pdf
337811 RR_KeyPersonExpanded_4_0-4.0.pdf
337811 PHS398_ResearchPlan_5_0-5.0.pdf
337811 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
337811 RR_Budget_3_0-3.0.pdf
337811 RR_SubawardBudget30_3_0-3.0.pdf
337811 PHS398_ModularBudget_1_2-1.2.pdf
337811 PHS_AssignmentRequestForm_3_0-3.0.pdf
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