Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)

---

Description

This funding opportunity supports the late-stage translation of biomedical and behavioral research results in arthritis, musculoskeletal, and skin diseases from academic or non-profit laboratories to the commercial marketplace. The program is administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the NIH and uses the Small Business Innovation Research (SBIR) grant mechanism (R43/R44). The focus is on advancing promising technologies, diagnostics, or therapies toward regulatory approval or practical clinical use, but clinical trials are not permitted under this announcement.

Projects must involve close collaboration between the original academic/non-profit developers and the small business concern (SBC), with a technology transfer agreement in place. The initiative is designed to help bridge the gap between academic innovation and commercial product development, supporting activities such as pre-clinical validation, regulatory studies, and optimization for clinical application.

---

Due Dates

• April 5, 2025: New, Renewal, Resubmission, and Revision applications
• September 5, 2025: New, Renewal, Resubmission, and Revision applications

All applications are due by 5:00 PM local time of the applicant organization. No letter of intent is required.

---

Funding Amount

• Phase I: Up to $300,000 total costs for up to 1 year
• Phase II: Up to $2,000,000 total costs for up to 3 years

Budgets must include all direct, indirect, and fee costs. The number of awards is contingent on NIH appropriations and the submission of a sufficient number of meritorious applications.

---

Eligibility

• Eligible Applicants: Only United States small business concerns (SBCs) are eligible to apply.
  • Must be organized for profit, have a place of business in the U.S., and have no more than 500 employees.
  • Must be majority-owned by U.S. individuals or qualifying entities.
  • Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible.
  • Foreign components may be allowed if justified.
• Collaboration Requirement: Must involve a technology transfer agreement and collaboration with the original academic or non-profit lab where the technology originated.
• SBIR Policy: The majority of the research must be performed by the small business, with limits on subcontracting to the academic/non-profit partner (typically ≤33% of Phase I, ≤50% of Phase II).
• Performance Benchmarks: Applicants with significant prior SBIR/STTR funding must meet NIH transition and commercialization benchmarks.

---

Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required Registrations: SAM, SBA Company Registry, eRA Commons, and Grants.gov.
• Application Guide: Follow the SF424 (R&R) SBIR/STTR Application Guide.
• Attachments:
  • Technology transfer agreement between the research institution and the SBC.
  • SBIR Application Certification (if majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms).
• Review Criteria: Applications are evaluated for significance, innovation, approach, investigator(s), environment, and the strength of the academic/non-profit collaboration and technology transfer.

---

Additional Information

• Scope: Supports late-stage pre-clinical studies, regulatory studies, and activities to make lab technologies practical for clinical use. Human subjects research is allowed, but clinical trials are not.
• Milestones: Applications must include clear, quantitative milestones and a project timeline (Gantt chart).
• Non-Responsive Applications: Projects not originating from academic/non-profit labs or proposing intervention studies will be returned without review.
• Data Management: A Data Management and Sharing Plan is required.
• Reporting: Annual and final progress, invention, and financial reports are required.

---

External Links

• NIH Funding Opportunity Announcement (PAR-23-032)
• Grants.gov Opportunity Listing
• NIAMS (Institute home)
• NIH SBIR/STTR Application Guide

---

Contact Information

---