PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) | PA 20 262

Opportunity Information: Apply for PA 20 262

The PHS 2020-2 Omnibus Solicitation (PA 20 262) 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 and test innovations aligned with the research and development missions of these agencies. In practical terms, this announcement serves as a broad "parent" pathway for small companies to propose technology-driven biomedical and public health projects that fit within the scientific interests of specific participating NIH Institutes and Centers (and relevant CDC/FDA components), rather than being limited to a single narrow disease area or a one-off program topic.

A defining requirement of this specific parent SBIR announcement is that the application must propose at least one clinical trial. That means the work plan needs to include a prospective study in human participants designed to evaluate an intervention or to test health-related outcomes, consistent with NIH clinical trial definitions. This clinical trial requirement is central to the solicitation: companies should not treat the clinical trial as a distant future activity or a vague possibility, but as a concrete part of the proposed project. The project still needs to be squarely tied to the programmatic priorities of one or more participating NIH Institutes and Centers based on their scientific missions, and applicants are expected to align their proposal to the appropriate research areas described in the SBIR/STTR program topic materials referenced by the FOA (the PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA).

The eligible applicant pool is restricted to U.S. small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to serve as the applicant entity. However, the announcement notes that "foreign components" (as defined under the NIH Grants Policy Statement) may be allowed in some circumstances, which typically means limited, well-justified portions of the project could be conducted outside the U.S. if there is a strong scientific or practical reason and the arrangement complies with NIH policy. Even when foreign components are permitted, the applicant organization itself must remain a qualifying U.S. small business concern.

From a funding mechanism perspective, this is an SBIR grant announcement using the R43/R44 structure. R43 generally corresponds to SBIR Phase I (early feasibility, proof of concept, and foundational data), while R44 corresponds to SBIR Phase II (more extensive development, validation, and steps toward commercialization). Applicants may propose a Phase I, a Phase II, or in many SBIR contexts a Fast-Track approach that transitions from Phase I to Phase II, depending on the details allowed under the parent announcement and the readiness of the technology. The overall intent is to support research with a clear development pathway and a credible plan for translating the innovation toward real-world use, whether as a therapeutic, diagnostic, medical device, digital health tool, vaccine-related product, public health intervention, or another health-related technology consistent with NIH/CDC/FDA missions.

Administratively, the opportunity is categorized as a discretionary grant, and it spans a wide range of health- and human services-related program areas (reflected in the broad funding activity categories and many listed CFDA numbers). The opportunity was created on July 13, 2020, and the original closing date listed in the provided data is April 5, 2021. The source data does not specify an award ceiling or the expected number of awards, which is common for omnibus solicitations where award size and volume vary substantially by institute, topic area, and the scale of the proposed project. In these cases, actual budgets and award counts depend on the participating component, the availability of funds, and the scientific and technical merit of the applications received.

Overall, this FOA is best viewed as a wide-entry SBIR clinical-trial-required doorway into NIH/CDC/FDA funding for U.S. small businesses that are ready to move beyond preclinical or purely technical development and into human testing. Strong applications typically make a clear case that the product or service addresses an important health need, fits an identified agency mission area, has a well-designed clinical trial with appropriate oversight and protections for participants, and has a realistic development and commercialization plan that explains how the work funded by the grant will advance the technology toward adoption and impact.

• 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, 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): 93.068, 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 20 262

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