PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required | PA 19 271

Opportunity Information: Apply for PA 19 271

The PHS 2019-02 Omnibus Solicitation (Parent STTR R41/R42) Clinical Trial Required funding opportunity, listed as PA 19-271, is a National Institutes of Health (NIH) grant program designed to support U.S. small business concerns that want to move biomedical and behavioral health innovations toward real-world use through research and development that includes human clinical testing. It sits under the Small Business Technology Transfer (STTR) program, which is specifically built around a formal partnership between a small business and a nonprofit research institution (such as a university, hospital, or research institute). The central goal is to help small businesses translate promising science into products, services, or technologies that align with NIH public health missions, while leveraging academic or nonprofit research strengths to strengthen the project and speed development.

A defining feature of this particular Parent announcement is that it is “Clinical Trial Required,” meaning applicants must propose at least one clinical trial as part of the project. In practical terms, this points to projects that have progressed beyond early concept work and are ready to be evaluated in humans, whether to test safety, feasibility, early efficacy, clinical performance, or other predefined outcomes depending on the trial design and stage of development. The trial requirement also means the application needs to be structured to meet NIH expectations for clinical research oversight and planning, such as having clear endpoints, appropriate study design, recruitment plans, data and safety monitoring where applicable, and the ability to meet regulatory and ethical requirements. The clinical trial component is not optional under this FOA, so proposals that do not include a qualifying clinical trial would not be responsive.

The opportunity is described as an omnibus solicitation, which means it is a broad, multi-institute “parent” mechanism rather than a narrow, single-topic call. Applicants are expected to align their proposal with the programmatic interests of one or more participating NIH Institutes and Centers (ICs). NIH publishes topic and mission guidance for this omnibus solicitation through the associated PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics document, and applicants typically use that to identify which IC is the best fit for the science area, disease or condition focus, population, or technology type. Because NIH has many different components with different scientific missions, this parent structure provides a common application pathway while still requiring that each project clearly match an IC’s priorities.

Eligibility is focused on U.S. small businesses. The FOA makes it clear that non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, it notes that “foreign components,” as defined in the NIH Grants Policy Statement, may be allowed in some cases. That distinction matters: it generally means the applicant organization must be a U.S.-based small business meeting SBA and NIH requirements, but certain limited portions of the work might be carried out abroad if they meet NIH rules, are well-justified, and are allowable under policy. Applicants considering any foreign component typically need to address why the foreign element is necessary and how oversight and compliance will be handled.

The funding instrument is a grant under the STTR phased structure, using R41 (Phase I) and R42 (Phase II). Phase I is usually used to establish feasibility and the scientific and technical merit of the approach, while Phase II generally supports more advanced development, validation, and steps toward commercialization. Because this specific parent announcement requires a clinical trial, the work proposed in one or both phases must include at least one clinical trial, which often implies a relatively advanced development plan and readiness for human testing. Applicants are expected to present a coherent, milestone-driven R and D plan and to frame the work in a way that shows a path toward product development and eventual impact in healthcare.

The NIH is the issuing agency, and the opportunity appears in a broad set of program areas reflected by the listed funding activity categories (including health, environment, food and nutrition, education, and social services) and the multiple CFDA numbers provided, which correspond to NIH institutes and programs that may participate. The posting indicates an original closing date of 2020-07-06 for that cycle. The award ceiling and expected number of awards are not specified in the provided source data, which typically means applicants would need to consult the FOA text and NIH budget guidelines for STTR to understand standard budget limits, caps, and any IC-specific variations.

Overall, this FOA is meant for U.S. small businesses that are ready to collaborate with a research institution to run at least one clinical trial tied to a technology or intervention with commercial potential and strong alignment to NIH institute missions. It is especially relevant for companies developing therapeutics, diagnostics, devices, digital health tools, or other clinical innovations that have reached a point where human testing is appropriate and necessary to advance the product toward regulatory acceptance, adoption, and real patient or public health benefit.

• 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 2019-02 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): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879.
• This funding opportunity was created on 2019-05-07.
• Applicants must submit their applications by 2020-07-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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