This grant from the National Institute of Allergy and Infectious Diseases supports Small Business Innovation Research (SBIR) projects for investigator-initiated clinical trials. It encourages high-risk clinical studies with unique features, such as non-routine interventions or use of unlicensed products. Mechanistic studies are also welcomed. Only one clinical trial proposal per application is allowed. The NIAID offers resources for conducting clinical trials but does not support studies using dedicated resources from NIAID clinical trial networks. Applicants must include a Commercialization Plan outlining strategies for promoting the intervention’s commercialization and establishing partnerships with investors and partners. Closing date for applications is 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:: | |
| Category of Funding Activity:: | Health |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | |
| Competition ID: | ADOBE-FORMS-B2 |
| Competition Title: | Adobe-Forms-B2 |
| Opportunity Package ID: | PKG00179847 |
| Opening Date: | Aug 11, 2013 |
| Closing Date: | Sep 07, 2014 |
| Agency Contact Information:: | eRA Commons Help Desk |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] SBIR/STTR_Information [V1.1] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2] |
Package No: 2
| Assistance Listings: | |
| Competition ID: | FORMS-C |
| Competition Title: | FORMS-C |
| Opportunity Package ID: | PKG00204243 |
| Opening Date: | Aug 25, 2014 |
| Closing Date: | May 13, 2016 |
| Agency Contact Information:: | eRA Commons Help Desk |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V2.0] PHS 398 Research Plan [V2.0] SBIR/STTR_Information [V1.1] Research and Related Senior/Key Person Profile (Expanded) [V2.0] Research And Related Other Project Information [V1.3] Research & Related Budget [V1.3] Project/Performance Site Location(s) [V2.0] PHS 398 Cover Page Supplement [V2.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3] Planned Enrollment Report [V1.0] PHS 398 Cumulative Inclusion Enrollment Report [V1.0] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| ADOBE-FORMS-B2 | Adobe-Forms-B2 | PKG00179847 | Aug 11, 2013 | Sep 07, 2014 | View | eRA Commons Help Desk | Organization Applicants |
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| FORMS-C | FORMS-C | PKG00204243 | Aug 25, 2014 | May 13, 2016 | View | eRA Commons Help Desk | Organization Applicants |