This grant is for small businesses to accelerate the commercialization of innovative biomedical technologies addressing public health challenges, particularly those targeting small commercial markets like rare diseases or young pediatric populations (aged 0-12 years). It specifically provides SBIR Phase IIB funding to bridge the significant funding gap between prior SBIR/STTR Phase II awards and the commercialization stage. The National Heart, Lung, and Blood Institute (NHLBI) seeks to support later-stage research and development for promising projects. The objective is to advance products towards Federal regulatory approval and commercialization by fostering partnerships between small business awardees and third-party investors or strategic partners. Eligible projects must align with the NHLBI mission and ultimately require regulatory clearance.
Opportunity ID: 357231
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-26-015 |
| Funding Opportunity Title: | NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 19, 2024 |
| Last Updated Date: | Nov 19, 2024 |
| Original Closing Date for Applications: | Feb 26, 2027 |
| Current Closing Date for Applications: | Feb 26, 2027 |
| Archive Date: | Apr 03, 2027 |
| 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 Organizations) 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 Small Business Innovation Research (SBIR) Program is an important National Institutes of Health (NIH) funding mechanism used to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. This gap is increased by the barriers associated with technologies under development for small commercial markets, such as those focused on rare diseases or young pediatric populations. This Notice of Funding Opportunity (NOFO) invites small businesses to submit SBIR grant applications to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR (Small Business Technology Transfer) Phase II awards that address rare diseases or young pediatric populations (aged 0-12 years and defined in Section IV, part 7), and will require eventual Federal regulatory approval/clearance. The goal of this NOFO and the resulting Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between small business awardees and third-party investors and/or strategic partners, including patient advocacy organizations. Proposed projects MUST be relevant to the NHLBImission(see B. Scientific/Technical Scope) and require ultimate approval/clearance by a Federal regulatory agency. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-26-015.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
Folder 357231 Full Announcement-RFA-HL-26-015 -> RFA-HL-26-015-Full-Announcement.pdf
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-I | Use for due dates on or after January 25, 2025 | PKG00288814 | Jan 26, 2025 | Feb 26, 2027 | View |
Package 1
Mandatory forms
357231 RR_SF424_5_0-5.0.pdf
357231 PHS398_CoverPageSupplement_5_0-5.0.pdf
357231 RR_OtherProjectInfo_1_4-1.4.pdf
357231 PerformanceSite_4_0-4.0.pdf
357231 RR_KeyPersonExpanded_4_0-4.0.pdf
357231 RR_Budget_3_0-3.0.pdf
357231 PHS398_ResearchPlan_5_0-5.0.pdf
357231 SBIR_STTR_Information_3_0-3.0.pdf
357231 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357231 RR_SubawardBudget30_3_0-3.0.pdf
357231 PHS_AssignmentRequestForm_4_0-4.0.pdf
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