The NIH National Center for Advancing Translational Sciences (NCATS) and the FDA are offering this grant through SBIR cooperative agreements. This funding supports the development, regulatory qualification, and commercialization of alternative approaches for botulinum toxin potency testing. This grant is for establishing the “Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh)” as a vital Drug Development Tool. The primary purpose is to replace the current mouse lethality bioassay (MLB) with innovative neuromuscular junction Tissue Chips platforms. Collaborations between award recipients, NCATS, and FDA will ensure BoT PATCh is positioned as a validated, stand-alone alternative test method, driving its regulatory acceptance and commercialization.
Opportunity ID: 343630
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-TR-22-032 |
| Funding Opportunity Title: | Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) (U43/U44 – Clinical Trail Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.350 — National Center for Advancing Translational Sciences |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 19, 2022 |
| Last Updated Date: | Sep 19, 2022 |
| Original Closing Date for Applications: | Aug 21, 2023 |
| Current Closing Date for Applications: | Aug 21, 2023 |
| Archive Date: | Sep 26, 2023 |
| 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- are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This FOA provides support using the SBIR cooperative agreement mechanisms for the development, regulatory qualification and commercialization of alternative approaches methods (NAMs) that specifically utilizes the neuromuscular junction Tissue Chips (TC) platforms that will replace the LD50 assay (mouse lethality bioassay (MLB) as a potency assay for botulinum toxin. The NIH NCATS and FDA are partners in this FOA and will collaborate and coordinate efforts with award recipients. The goal of this collaboration is to establish the Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) as a Drug Development Tool (DDT). A main objective for this funding opportunity would be to position BoT PATCh as an alternative test method that can be utilized as a stand-alone replacement for MLB. As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH and FDA staff to develop and implement the final validation plan for the proposed alternative test method. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-22-032.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@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 | PKG00276870 | Oct 21, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278483 | Nov 15, 2022 | Aug 21, 2023 | View |
Package 1
Mandatory forms
343630 RR_SF424_5_0-5.0.pdf
343630 PHS398_CoverPageSupplement_5_0-5.0.pdf
343630 RR_OtherProjectInfo_1_4-1.4.pdf
343630 PerformanceSite_4_0-4.0.pdf
343630 RR_KeyPersonExpanded_4_0-4.0.pdf
343630 RR_Budget_3_0-3.0.pdf
343630 PHS398_ResearchPlan_4_0-4.0.pdf
343630 SBIR_STTR_Information_3_0-3.0.pdf
343630 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
343630 RR_SubawardBudget30_3_0-3.0.pdf
343630 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
343630 RR_SF424_5_0-5.0.pdf
343630 PHS398_CoverPageSupplement_5_0-5.0.pdf
343630 RR_OtherProjectInfo_1_4-1.4.pdf
343630 PerformanceSite_4_0-4.0.pdf
343630 RR_KeyPersonExpanded_4_0-4.0.pdf
343630 RR_Budget_3_0-3.0.pdf
343630 PHS398_ResearchPlan_5_0-5.0.pdf
343630 SBIR_STTR_Information_3_0-3.0.pdf
343630 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
343630 RR_SubawardBudget30_3_0-3.0.pdf
343630 PHS_AssignmentRequestForm_3_0-3.0.pdf
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