SBIR Technology Transfer (R43/R44 Clinical Trial Not Allowed) | PA 18 705

Opportunity Information: Apply for PA 18 705

The SBIR Technology Transfer (R43/R44 Clinical Trial Not Allowed) opportunity (Funding Opportunity Number PA 18-705) is a National Institutes of Health (NIH) discretionary grant program designed to move inventions created inside NIH intramural research laboratories into the private sector for commercial development. The core purpose is technology transfer: NIH is looking for Small Business Concerns (SBCs) that can take NIH-owned or NIH-controlled technologies and turn them into real-world products that ultimately benefit public health. In practical terms, this FOA supports early-stage R&D activities that help a small business de-risk, validate, and advance an NIH intramural invention toward market readiness, but it does so within the SBIR framework and specifically excludes clinical trials.

A defining feature of this FOA is the licensing arrangement tied to award selection. If an SBC is selected for SBIR funding under this announcement, NIH will provide the company a royalty-free, non-exclusive patent license agreement for internal research use. That license is limited to the term of the SBIR award and restricted to the field of use of the award, meaning the company can use the NIH-held intellectual property to perform the research and development proposed in the funded project, but the rights are not necessarily broad commercial exclusivity by default. The intent behind this structure is to lower barriers for small businesses to begin developing NIH intramural inventions quickly, while still aligning the license scope with the SBIR-supported research plan and timeframe.

The grant mechanism is SBIR, using the R43 and R44 activity codes, which correspond to the phased SBIR structure (generally, Phase I for feasibility and proof-of-concept and Phase II for further development). The announcement is explicitly labeled "Clinical Trial Not Allowed," which means applicants must propose work that does not include conducting a clinical trial. Projects can still be clinically relevant and aimed at eventual medical or health applications, but the funded activities must stop short of a clinical trial as defined by NIH policy. This typically steers applicants toward preclinical development, prototyping, assay development, software or device refinement (without clinical trial testing), manufacturing process development, analytical validation, or other translational steps that prepare a technology for later-stage testing and commercialization.

Eligibility is focused on U.S. small businesses. The FOA states that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some cases, which generally means limited, well-justified elements of the work could potentially be performed outside the U.S. if they meet NIH policy requirements and are specifically permitted, but the applicant organization itself must be an eligible U.S. small business meeting SBIR rules.

From an administrative standpoint, the agency is NIH, the funding instrument type is a grant, and the activity categories span education and health, reflecting NIHs biomedical and behavioral research mission. The associated CFDA numbers listed (including 93.121, 93.273, 93.279, 93.361, and several others) indicate that multiple NIH institutes, centers, or program areas may participate under this umbrella, so relevant topics can cover a broad range of biomedical, behavioral, and health-related technologies originating from NIH intramural labs. The source data indicates the FOA was created on 2018-03-06 and lists an original closing date of 2021-09-05, which matters for applicants assessing whether the announcement is still active or has been superseded by a newer reissue or parent announcement.

Overall, this opportunity is best understood as a bridge between NIH intramural innovation and private-sector commercialization: NIH supplies the underlying invention and a defined, research-focused license to use it during the award, while the small business supplies the commercialization drive, development plan, and technical execution needed to move the technology closer to a product. The program emphasizes translation and commercialization readiness, but within the constraint that no clinical trials can be part of the proposed scope under this specific FOA.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "SBIR Technology Transfer (R43/R44 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.273, 93.279, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.853, 93.867.
• This funding opportunity was created on 2018-03-06.
• Applicants must submit their applications by 2021-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 18 705

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