This NIDDK grant is for the purpose of advancing new therapies for diseases within its mission through lead optimization and preclinical development. It is structured in two phases. Phase I supports preliminary steps in therapeutic development. Phase II supports advanced lead optimization and preclinical development of candidates, aiming for an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application submission to the FDA by the project’s end. Projects must demonstrate significant progress towards this goal. Applications require defined milestones and timelines, incorporating key Go/No Go decision points, to ensure clear progression.
Opportunity ID: 249654
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PA-14-054 |
| Funding Opportunity Title: | Lead Optimization and Pre-Clinical Development of Therapeutic Candidates for Diseases of Interest to NIDDK (STTR (R41/R42)) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 02, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jan 07, 2017 |
| Current Closing Date for Applications: | Jan 07, 2017 |
| Archive Date: | Feb 07, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: 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, may be allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The goal of this Funding Opportunity Announcement (FOA) is to support lead optimization and preclinical development of new therapies for diseases within the mission of the NIDDK. Phase I supports preliminary steps in the process for lead optimization or preclinical development of therapeutics. Phase II supports lead optimization and preclinical development of lead candidates and projects must be sufficiently advanced such that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) can be submitted by the end of a Phase II or IIB project. Applications are expected to have defined Milestones and Timelines detailing how the project will move forward with identified key Go/No Go decision points. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PA-14-054.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
There are no related documents on this grant.
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 |
|---|---|---|---|---|---|---|
| 93.847 | ADOBE-FORMS-B2 | Adobe-Forms-B2 | PKG00191470 | Mar 05, 2014 | Sep 07, 2014 | View |
| FORMS-C | Use for due dates on or after August 5, 2014 | PKG00196573 | Mar 05, 2014 | Jun 08, 2016 | View | |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00224045 | Aug 05, 2016 | Jan 07, 2017 | View |
Package 1
Mandatory forms
249654 RR_SF424_1_2-1.2.pdf
249654 PerformanceSite_1_4-1.4.pdf
249654 RR_OtherProjectInfo_1_3-1.3.pdf
249654 RR_KeyPersonExpanded_1_2-1.2.pdf
249654 RR_Budget-1.1.pdf
249654 RR_SubawardBudget30-1.2.pdf
249654 PHS398_CoverPageSupplement_1_4-1.4.pdf
249654 PHS398_ResearchPlan_1_3-1.3.pdf
249654 PHS398_Checklist_1_3-1.3.pdf
249654 SBIR_STTR_Information_1_1-1.1.pdf
Optional forms
249654 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
249654 RR_SF424_2_0-2.0.pdf
249654 SBIR_STTR_Information_1_1-1.1.pdf
249654 RR_KeyPersonExpanded_2_0-2.0.pdf
249654 RR_OtherProjectInfo_1_3-1.3.pdf
249654 RR_Budget_1_3-1.3.pdf
249654 RR_SubawardBudget30_1_3-1.3.pdf
249654 PerformanceSite_2_0-2.0.pdf
249654 PHS398_ResearchPlan_2_0-2.0.pdf
249654 PHS398_CoverPageSupplement_2_0-2.0.pdf
Optional forms
249654 PlannedReport-1.0.pdf
249654 PHS398_CumulativeInclusionReport-1.0.pdf
Package 3
Mandatory forms
249654 RR_SF424_2_0-2.0.pdf
249654 PHS398_CoverPageSupplement_3_0-3.0.pdf
249654 RR_OtherProjectInfo_1_3-1.3.pdf
249654 PerformanceSite_2_0-2.0.pdf
249654 RR_KeyPersonExpanded_2_0-2.0.pdf
249654 RR_Budget_1_3-1.3.pdf
249654 RR_SubawardBudget30_1_3-1.3.pdf
249654 PHS398_ResearchPlan_3_0-3.0.pdf
249654 SBIR_STTR_Information_1_1-1.1.pdf
Optional forms
249654 PHS_Inclusion_Enrollment_Report-1.0.pdf
249654 PHS_AssignmentRequestForm-1.0.pdf
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