PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) | PA 22 179

Opportunity Information: Apply for PA 22 179

The PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications, also referred to as the Parent STTR (R41/R42) Clinical Trial Required announcement (Funding Opportunity Number PA-22-179), is a discretionary NIH grant opportunity designed specifically for eligible US small businesses that want to develop and translate biomedical or behavioral innovations in partnership with a research institution. It falls under the STTR program, which is built around formal collaboration between a small business concern and a nonprofit research partner (such as a university, medical center, or research institute). The intent is to move promising technologies toward real-world use while strengthening the commercialization pipeline for federally supported R and D.

A defining feature of this particular parent announcement is that it requires at least one clinical trial to be proposed as part of the application. In other words, applicants are expected to include a clinical study component that meets NIH's definition of a clinical trial, rather than limiting the project to only preclinical development, lab validation, or feasibility work. The clinical trial requirement signals that NIH is looking for projects that are ready to be evaluated in human participants in a structured way, such as early feasibility, pilot, or other clinical testing aligned with the maturity of the technology. The exact trial design, endpoints, and scope would need to match both the development stage of the product and the expectations of the participating NIH Institute or Center (IC) that is most aligned with the topic area.

This is an omnibus or "parent" solicitation, meaning it is broad and intended to cover a wide range of scientific and technology areas rather than a single narrow disease or product category. Applicants are expected to propose projects that fit within the programmatic interests of one or more participating NIH Institutes and Centers, based on their scientific missions. In practice, that means the innovation should map clearly to an NIH priority area and to one of the identified topics listed in the PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA, which acts as the topic guide for what the agencies are seeking. The list of CFDA numbers associated with the announcement (including many within the 93.xxx series) reflects that multiple NIH components and research domains are covered, spanning health and related public service areas.

The eligible applicant pool is limited to small businesses, and the eligibility rules are strict about foreign involvement. Non-domestic (non-US) entities (foreign institutions) are not eligible to apply, and non-domestic components of US organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowed in some situations, which generally means that certain discrete project activities may be performed outside the US if they are justified, clearly described, and consistent with NIH policy and the specific IC's guidelines. Even when foreign components are allowable, the applicant organization itself must still be an eligible US small business meeting STTR program requirements.

From a mechanism standpoint, the opportunity uses the STTR grant activity codes R41 and R42. These generally correspond to a phased development pathway, with Phase I (R41) supporting early-stage feasibility and proof-of-concept work and Phase II (R42) supporting more advanced R and D aimed at moving the technology closer to commercialization. Applicants typically choose the phase that matches the maturity of their technology and their development plan, and they must structure the work so that it is appropriate for a small business-led translational project executed jointly with a research institution partner. The STTR structure also implies expectations around a formal collaboration agreement, defined roles for the small business and research institution, and a credible path to commercial impact.

Key administrative details included in the source information are that the sponsoring agency is the National Institutes of Health (NIH), the funding instrument type is a grant, and the opportunity category is discretionary. The opportunity was created on 2022-06-02, and the original closing date listed is 2023-04-05. The award ceiling shown in the provided data is 275,766, which should be treated as a referenced cap in the listing rather than a universal guarantee of what every applicant can request, since STTR budgets and limits can vary by phase, IC-specific guidance, and any applicable hard caps or exceptions described in the full FOA. The listing does not specify an expected number of awards in the provided field, so prospective applicants typically would look to the full solicitation and to NIH IC funding patterns to gauge competitiveness.

Overall, this FOA is best understood as a broad NIH STTR entry point for US small businesses that are ready to run at least one clinical trial as part of developing a health-related technology, product, or service, and that can justify why the project fits an NIH mission area and an identified PHS 2022-2 topic. It is oriented toward translation and commercialization, with a clear expectation that the proposed clinical work will generate evidence needed to advance the innovation toward broader adoption, regulatory pathways when relevant, and eventual market deployment.

• The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "PHS 2022-2 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, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.286, 93.307, 93.361, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 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.

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