PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) | PA 18 576

Opportunity Information: Apply for PA 18 576

The PHS 2018-02 Omnibus Solicitation (PA 18-576) is a federal grant opportunity from the National Institutes of Health (NIH) under the Small Business Technology Transfer (STTR) program. It is designed to fund U.S. small business concerns that want to develop and translate health-related technologies in partnership with a nonprofit research institution, using the STTR R41/R42 phased award structure. The core idea is to push early-stage innovations toward real-world clinical use by supporting both feasibility work (Phase I, R41) and more advanced development (Phase II, R42), while staying aligned with the research and development missions of participating NIH Institutes and Centers. Although the title references NIH, CDC, and FDA as part of the broader omnibus solicitation ecosystem, this specific announcement is framed and administered through NIH and expects applicants to match their proposal to the scientific priorities of one or more participating NIH components and the topics published under the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics.

A key defining feature of this parent STTR announcement is that it is "Clinical Trial Required." That means an application must include at least one clinical trial as part of the proposed project, not as an optional future step. In practical terms, applicants need to be ready to describe a clinical trial that is appropriately designed for the stage of development and the technology being studied, and to address the operational expectations that come with human subjects research. This emphasis signals that NIH is looking for small business-led translational efforts that are far enough along to justify testing in people, whether that is a first-in-human study, a pilot clinical evaluation, or another well-justified clinical trial aligned with NIH definitions and policies.

Eligibility is narrowly focused on U.S. small businesses, consistent with STTR rules, and the work must be relevant to the programmatic interests of at least one participating NIH Institute or Center. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the announcement notes that "foreign components" may be permitted as defined by the NIH Grants Policy Statement, which generally refers to discrete project elements performed outside the United States that are justified by unique expertise, populations, resources, or other compelling scientific reasons. Applicants considering any foreign component typically need to be careful to justify why that element must occur abroad and how it fits NIH policy, while keeping the applicant organization itself and the primary eligibility squarely within the United States.

Administratively, the opportunity is categorized as discretionary funding and uses the grant instrument type. It sits within broad funding activity areas that include education and health, and it is associated with multiple CFDA numbers (now often referenced through Assistance Listings), reflecting the many NIH awarding components and program areas that can use this parent mechanism. The solicitation was created on January 16, 2018, and an original closing date listed in the source data is April 5, 2019. The record does not provide an award ceiling or expected number of awards in the extracted fields, which is common for large omnibus parent announcements where award levels and counts can vary widely depending on institute budgets, application volume, scientific merit, and topic alignment.

Overall, this FOA is best understood as an entry point for U.S. small businesses that have a clinical-stage innovation and a qualified research institution partner, and that can propose at least one clinical trial directly within the STTR project. Competitive applications typically hinge on strong fit with an NIH Institute or Center mission, a clear commercialization and translational rationale consistent with STTR goals, and a clinical trial plan that is feasible, ethically and scientifically sound, and appropriately matched to the maturity of the technology and the intended health impact.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA 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): 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.307, 93.361, 93.393, 93.394, 93.395, 93.399, 93.837, 93.838, 93.839, 93.840, 93.859, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2018-01-16.
• Applicants must submit their applications by 2019-04-05. (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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