This grant offered by the NIAID Department supports small business concerns (SBCs) in implementing investigator-initiated clinical trials focusing on NIAID’s research mission. The program encourages hypothesis-driven, milestone-driven clinical trials with a preference for high-risk studies involving non-routine interventions, unlicensed product administration, or licensed product usage for unapproved indications. Mechanistic studies are welcomed, but each application should propose only one clinical trial. While utilizing NIAID’s clinical study infrastructure is encouraged, dedicated resources outside of NIAID’s support are not eligible for funding. Closing date for applications is Jan 13, 2021.
Opportunity ID: 300503
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-632 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 06, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jan 13, 2021 |
| Current Closing Date for Applications: | Jan 13, 2021 |
| Archive Date: | Feb 18, 2021 |
| 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: | This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program. However, not more than one clinical trial should be proposed within each application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. Proposed clinical trials may use NIAIDs independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-632.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 |
|---|---|---|---|---|---|---|
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00238049 | Apr 14, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260209 | Apr 14, 2018 | Jan 13, 2021 | View |
Package 1
Mandatory forms
300503 RR_SF424_2_0-2.0.pdf
300503 PHS398_CoverPageSupplement_4_0-4.0.pdf
300503 RR_OtherProjectInfo_1_4-1.4.pdf
300503 PerformanceSite_2_0-2.0.pdf
300503 RR_KeyPersonExpanded_2_0-2.0.pdf
300503 RR_Budget_1_4-1.4.pdf
300503 PHS398_ResearchPlan_4_0-4.0.pdf
300503 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
300503 RR_SubawardBudget30_1_4-1.4.pdf
300503 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
300503 RR_SF424_2_0-2.0.pdf
300503 PHS398_CoverPageSupplement_5_0-5.0.pdf
300503 RR_OtherProjectInfo_1_4-1.4.pdf
300503 PerformanceSite_2_0-2.0.pdf
300503 RR_KeyPersonExpanded_2_0-2.0.pdf
300503 RR_Budget_1_4-1.4.pdf
300503 PHS398_ResearchPlan_4_0-4.0.pdf
300503 SBIR_STTR_Information_1_3-1.3.pdf
300503 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
300503 RR_SubawardBudget30_1_4-1.4.pdf
300503 PHS_AssignmentRequestForm_3_0-3.0.pdf
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