PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed | PA 19 272

Opportunity Information: Apply for PA 19 272

PHS 2019-02 is an omnibus (multi-agency) Small Business Innovation Research (SBIR) grant opportunity issued 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 published as a Parent SBIR Funding Opportunity Announcement (FOA), meaning it provides a broad, standing framework for small businesses to propose research and development projects that fit within the participating NIH, CDC, and FDA components missions and the specific SBIR topic areas listed for this omnibus cycle. The FOA is identified as PA-19-272 and supports proposals that advance health-related science and technology across a wide range of public health, biomedical, regulatory science, and related priorities reflected in its many CFDA program listings.

The core purpose of the opportunity is to fund early-stage, high-impact innovation led by eligible United States small business concerns (SBCs) that can translate technical expertise into products, tools, platforms, or services aligned with federal R and D needs. Applicants are expected to select and respond to the appropriate published SBIR topics for NIH, CDC, and FDA under the PHS 2019-2 omnibus topic document (the SBIR/STTR Program Descriptions and Research Topics). In practical terms, the government is signaling that it wants small businesses to bring forward novel technologies and applied research concepts that can mature toward commercialization while also supporting agency missions in areas such as health, food and nutrition, environment, and other connected human services domains included under the funding activity categories.

This Parent SBIR announcement uses the SBIR grant mechanisms R43 and R44. Generally, R43 corresponds to Phase I feasibility work and early proof-of-concept, while R44 supports a combined Phase I and Phase II approach or a Phase II effort depending on how the applicant structures the submission and what the FOA and agency component allow. The FOA is specifically labeled "Clinical Trial Not Allowed," which is an important boundary condition: projects must be designed so they do not include a clinical trial as defined by NIH policy. That typically means the application should avoid proposing prospective human subject research that assigns participants to an intervention to evaluate effects on health-related biomedical or behavioral outcomes. Companies whose roadmap includes eventual clinical evaluation may still be able to apply, but the work proposed under this FOA must stay on the non-clinical-trial side (for example, preclinical validation, device prototyping and bench testing, software development, analytical validation, usability studies that do not meet the clinical trial definition, or other non-trial human factors work, depending on the specifics and agency guidance).

Eligibility is limited primarily to U.S. small businesses that meet SBIR program requirements (including U.S. ownership and control rules and size standards). Foreign institutions are explicitly not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply as applicants. However, the FOA notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowable in some cases. That usually means that while the applicant organization must be a U.S. SBC, certain well-justified elements of the project can be performed outside the U.S. if they are critical to the project and consistent with agency policy, and if all required justifications and approvals are in place.

Administratively, the opportunity is categorized as discretionary funding and uses a grant instrument. The FOA record indicates an original closing date of 2020-07-06, with the FOA created on 2019-05-07. The listing does not specify an award ceiling or expected number of awards in the provided excerpt, which is common for large parent announcements where award amounts and volumes vary by participating institute/center, topic area, and available appropriations. Because this is an omnibus parent FOA spanning many NIH, CDC, and FDA components, it is associated with a long list of CFDA numbers (for example, 93.061, 93.068, 93.073, and many others), reflecting the breadth of potential mission alignments and funding streams under which awards might be made.

In summary, PA-19-272 (PHS 2019-02 Omnibus Solicitation) is a broad SBIR funding pathway for U.S. small businesses to propose innovative R and D projects that fit specified NIH, CDC, and FDA topic areas, with the explicit restriction that proposed research cannot include a clinical trial. It is intended to help small companies move promising health-related innovations through feasibility and development stages toward practical use and commercialization, while advancing federal public health and biomedical priorities.

• 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, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [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): 93.061, 93.068, 93.073, 93.084, 93.103, 93.113, 93.121, 93.136, 93.143, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.286, 93.307, 93.316, 93.326, 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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