The NIAID is offering this Small Business Innovation Research (SBIR) Phase II grant to support small business concerns (SBCs) in implementing investigator-initiated clinical trials. This grant, utilizing a U44 cooperative agreement, is specifically for hypothesis-driven, milestone-driven studies related to NIAID’s research mission. While standard trials are eligible, this program particularly encourages high-risk clinical studies, defined by features like non-routine interventions or the use of unlicensed/unapproved licensed products. Mechanistic studies are also welcomed, with only one clinical trial permitted per application. Applicants may leverage NIAID’s independent clinical study infrastructure but cannot use resources from existing NIAID-supported trial networks. A Commercialization Plan detailing future product/technology advancement and partnerships is required. The closing date for this opportunity was May 13, 2016.
Opportunity ID: 236728
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-250 |
| Funding Opportunity Title: | NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) |
| 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, Immunology and Transplantation Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 24, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 13, 2016 |
| Current Closing Date for Applications: | May 13, 2016 |
| Archive Date: | Jun 13, 2016 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | – |
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 will utilize the cooperative agreement mechanism (U44) to enable 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 grant application. The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants 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. A Commercialization Plan must be included that details plans for promoting further commercialization of the intervention/product/technology to be derived from or associated with the proposed clinical trial, including plans for promoting and establishing partnerships between the SBIR Phase II awardee and third-party investors and/or strategic partners. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-13-250.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 |
|---|---|---|---|---|---|---|
| ADOBE-FORMS-B2 | Adobe-Forms-B2 | PKG00179847 | Aug 11, 2013 | Sep 07, 2014 | View | |
| FORMS-C | FORMS-C | PKG00204243 | Aug 25, 2014 | May 13, 2016 | View |
Package 1
Mandatory forms
236728 RR_SF424_1_2-1.2.pdf
236728 PerformanceSite_1_4-1.4.pdf
236728 RR_OtherProjectInfo_1_3-1.3.pdf
236728 RR_KeyPersonExpanded_1_2-1.2.pdf
236728 RR_Budget-1.1.pdf
236728 PHS398_CoverPageSupplement_1_4-1.4.pdf
236728 PHS398_ResearchPlan_1_3-1.3.pdf
236728 PHS398_Checklist_1_3-1.3.pdf
236728 SBIR_STTR_Information_1_1-1.1.pdf
Optional forms
236728 RR_SubawardBudget30-1.2.pdf
236728 PHS_CoverLetter_1_2-1.2.pdf
Package 2
Mandatory forms
236728 RR_SF424_2_0-2.0.pdf
236728 PHS398_ResearchPlan_2_0-2.0.pdf
236728 SBIR_STTR_Information_1_1-1.1.pdf
236728 RR_KeyPersonExpanded_2_0-2.0.pdf
236728 RR_OtherProjectInfo_1_3-1.3.pdf
236728 RR_Budget_1_3-1.3.pdf
236728 PerformanceSite_2_0-2.0.pdf
236728 PHS398_CoverPageSupplement_2_0-2.0.pdf
Optional forms
236728 RR_SubawardBudget30_1_3-1.3.pdf
236728 PlannedReport-1.0.pdf
236728 PHS398_CumulativeInclusionReport-1.0.pdf
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