PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) | PA 22 177

Opportunity Information: Apply for PA 22 177

The PHS 2022-2 Omnibus Solicitation (PA 22-177) is a federal SBIR grant opportunity run by the National Institutes of Health (NIH) in partnership with the Centers for Disease Control and Prevention (CDC). It is designed to fund U.S. small businesses that can develop and commercialize innovative technologies that support the research and development missions of participating NIH Institutes and Centers and relevant CDC components. This is a broad, "parent" solicitation, meaning it is not limited to one narrow disease area or one specific product type; instead, companies are expected to align their proposed work with one or more of the many participating program areas and topic priorities described in the companion topic document (the PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA).

A defining requirement of this particular parent announcement is that it is the "Clinical Trial Required" version of the SBIR mechanism. That means an application submitted under this FOA must propose at least one clinical trial as part of the project. In practical terms, the work plan needs to include human subjects research that meets NIH's definition of a clinical trial, such as prospectively assigning people to an intervention to evaluate effects on health-related biomedical or behavioral outcomes. This makes the opportunity especially relevant for small companies developing therapeutics, vaccines, diagnostics, medical devices, digital health tools, or behavioral interventions that have reached a stage where clinical evaluation is appropriate and can be responsibly executed within the project period.

The funding instrument is a grant under the SBIR program using the R43/R44 mechanisms, which generally correspond to SBIR Phase I (R43) and Phase II (R44). Phase I typically supports early feasibility and proof-of-concept work, while Phase II supports more advanced R and D efforts aimed at development, validation, and readiness for commercialization. Because this is an omnibus solicitation, the exact scientific fit, expectations, and in some cases budget or project period details may vary by participating NIH Institute/Center or CDC component, so applicants are expected to tailor the proposal to the mission and interests of the target awarding component and to follow any component-specific guidance included in the topic listings.

Eligibility is limited to United States small businesses that meet SBIR requirements and have the expertise and capacity to perform the proposed R and D. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. At the same time, the announcement notes that "foreign components" as defined in the NIH Grants Policy Statement may be allowable in some cases, which typically means certain discrete elements of the work may be performed outside the U.S. if they are well justified, carefully described, and approved under NIH policy, but the applicant organization itself must be an eligible U.S. small business.

This opportunity sits within a discretionary funding category and spans a wide range of public service areas reflected in the activity categories listed (education, environment, food and nutrition, health, income security and social services). The long list of CFDA numbers signals that multiple NIH and CDC programs can support awards through this solicitation, reinforcing that applicants should focus on mission alignment and topic fit when choosing where the application best belongs. The posting lists an award ceiling of $275,766, though in NIH SBIR programs the allowable budgets are often governed by SBIR policy caps and any waivers or institute-specific limits, so applicants typically verify current budget guidance in the FOA and the SBIR policy framework when planning the request.

Key administrative details included in the source information are the opportunity number (PA 22-177), the title indicating it is part of the PHS 2022-2 omnibus cycle, and an original closing date of 2023-04-05. The overall message of the solicitation is that NIH and CDC are seeking clinically oriented SBIR proposals from U.S. small businesses, tied to the specific R and D priorities listed for the participating components, with the explicit expectation that the project includes at least one clinical trial and is positioned to advance innovations with real-world health impact and commercialization potential.

• 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 2022-2 Omnibus Solicitation of the NIH and CDC 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, 93.083, 93.084, 93.113, 93.136, 93.142, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.286, 93.307, 93.326, 93.361, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.847, 93.859, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2022-06-02.
• Applicants must submit their applications by 2023-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $275,766.00 in funding.
• Eligible applicants include: Small businesses.

Apply for PA 22 177

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