PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) | PA 20 261

Opportunity Information: Apply for PA 20 261

The PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR R41/R42, Clinical Trial Required), funding opportunity number PA-20-261, is a National Institutes of Health (NIH) grant announcement designed specifically for eligible U.S. small business concerns that want to develop and move biomedical or health-related technologies toward real-world use through a formal collaboration with a research institution. It uses the STTR mechanism, which is built around the idea that small businesses are often the best vehicle for commercializing innovations, while universities and other research organizations frequently have deep scientific expertise and specialized infrastructure that can accelerate development. This parent omnibus solicitation is broad, meaning it can support a wide range of disease areas, technologies, and product types, as long as the proposal fits within the missions and current program interests of one or more participating NIH Institutes and Centers.

A defining feature of this specific parent FOA is that it is the “Clinical Trial Required” version. That requirement is not a minor detail: applicants must propose at least one clinical trial as part of the project. In practical terms, the research plan needs to include human subjects research that meets NIH’s definition of a clinical trial, typically involving prospective assignment to an intervention and assessing effects on health-related biomedical or behavioral outcomes. Projects that are strictly preclinical or that do not include a qualifying clinical trial would not be appropriate for this announcement and would generally need to look to a different parent solicitation that is “clinical trial not allowed” or “clinical trial optional,” depending on the fit.

The opportunity supports the STTR phased award structure, meaning applicants may seek Phase I (R41) funding to establish feasibility and generate early proof-of-concept data, and then Phase II (R42) funding to expand development, continue clinical testing, and move the product or service closer to commercialization or broader implementation. The core purpose is research and development with a commercialization trajectory, so the proposal is expected to have a clear path toward a marketable product, platform, or service that addresses an unmet need in health or healthcare. While this announcement is an omnibus solicitation, it points applicants to the broader set of NIH, CDC, and FDA SBIR/STTR program descriptions and topic areas (referenced as PHS 2019-2 topics) so companies can align their proposed work with the most relevant participating components and better understand what kinds of projects are being prioritized.

Eligibility is focused on U.S. small business concerns, consistent with SBIR/STTR requirements. Foreign institutions cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply as the primary applicant entity. However, the FOA notes that “foreign components,” as defined in the NIH Grants Policy Statement, may be allowed in certain circumstances. This usually means that limited, well-justified elements of the work can occur outside the United States if they are essential and cannot be done domestically, but the applicant organization remains a qualifying U.S. small business and the application must meet NIH policy requirements for any foreign involvement. In general, the expectation is that the main leadership, performance, and benefit of the project remain anchored in the U.S. small business and its eligible partner research institution.

From an administrative standpoint, the opportunity is categorized as a discretionary grant program administered by NIH, with an original closing date listed as April 5, 2021, and a creation date of July 13, 2020. It is associated with a large set of CFDA numbers (now commonly referred to under Assistance Listings) that reflect the many NIH Institutes and Centers that may participate and fund awards under this broad solicitation. The funding activity categories listed span multiple public-purpose areas, including health and related social domains, reflecting the NIH’s wide-ranging biomedical mission and the cross-cutting nature of technologies that can impact prevention, diagnosis, treatment, disease management, and healthcare delivery.

At a high level, the best fit applicants are small businesses that already have a well-defined innovation and a credible plan to test it in humans, and that can form or already have a strong partnership with a U.S. research institution to execute the clinical trial and supporting development work. Competitive projects typically show a strong scientific rationale, a realistic and well-controlled clinical trial design, a capable team with both technical and clinical operations expertise, and a thoughtful commercialization strategy that explains who will use the product, what problem it solves, why it is meaningfully better than existing alternatives, and how the company will navigate development milestones, regulatory expectations, and adoption barriers.

• The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.068, 93.070, 93.073, 93.084, 93.103, 93.113, 93.136, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.307, 93.316, 93.326, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.847, 93.859, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2020-07-13.
• Applicants must submit their applications by 2021-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 20 261

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