PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required | PA 19 273

Opportunity Information: Apply for PA 19 273

The PHS 2019-02 Omnibus Solicitation (PA 19-273) is a federal SBIR grant opportunity run jointly by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). It is designed to fund U.S. small business concerns that can develop innovative products, processes, or technologies that support the research and development missions of these agencies. In practical terms, the solicitation acts as a broad "parent" umbrella: instead of being limited to one narrow disease area or technology, applicants propose projects that align with the scientific priorities of one or more participating NIH Institutes and Centers (and relevant CDC or FDA components) and respond to the topic areas laid out in the companion PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics document.

This specific parent announcement is the SBIR R43/R44 pathway and is labeled "Clinical Trial Required," which is a major defining feature. That means the application must include at least one clinical trial as part of the proposed work. The expectation is not just preclinical development or bench research, but a plan that advances into human subjects research where an intervention is prospectively assigned and outcomes are evaluated. The clinical trial requirement signals that the agencies want to support small businesses that are ready to test safety, feasibility, performance, or early efficacy in people, typically as part of moving a product toward commercialization and eventual public health impact.

Eligibility is restricted to U.S. small business concerns. Foreign institutions cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply as the applicant entity. However, the announcement notes that "foreign components," as defined under the NIH Grants Policy Statement, may be allowed in some cases, which typically means a discrete element of the project can be performed outside the U.S. if it is well justified and consistent with federal policy. The core applicant, though, must be a qualifying U.S. small business with the capability to carry out the proposed R and D and manage the compliance responsibilities that come with clinical research.

As an SBIR grant mechanism, the opportunity supports small business-led innovation intended to translate into real-world use. While the solicitation text provided does not list a specific award ceiling or expected number of awards, SBIR funding generally follows a phased structure under the R43/R44 program: Phase I is commonly used to establish feasibility and early proof of concept, and Phase II is used to expand development and further validate the innovation, often including more robust clinical evaluation and steps toward regulatory and commercialization milestones. Because this parent FOA requires a clinical trial, applicants should be prepared for the operational and regulatory realities of human research, such as study design, participant protections, data and safety monitoring, and any applicable FDA regulatory considerations depending on whether the product is a drug, biologic, device, diagnostic, or digital health tool.

The funding instrument type is a grant, and the opportunity is categorized as discretionary federal funding. The activity categories tied to the CFDA listings span a wide set of health-related programs, reflecting the broad missions of NIH, CDC, and FDA. The long list of CFDA numbers indicates that many institutes and programs may participate and make awards under this umbrella, which reinforces that fit with an institute or center mission is central. Applicants are expected to align their project with the programmatic interests of one or more participating components, meaning the scientific rationale and the clinical trial should clearly map to the public health, biomedical, or regulatory science priorities of the funding organization most relevant to the work.

Key dates included in the source data show the opportunity was created on May 7, 2019, with an original closing date of July 6, 2020. Even though those dates indicate the historical window for that particular posting, the main takeaway is what the program was offering: a route for U.S. small businesses to obtain SBIR support, under NIH/CDC/FDA, for projects that are mature enough to include at least one clinical trial and that are directly tied to the mission needs and research topic areas identified in the omnibus solicitation materials.

• The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.061, 93.068, 93.073, 93.084, 93.103, 93.113, 93.136, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.307, 93.316, 93.326, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867.
• 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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