PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) | PA 18 573

Opportunity Information: Apply for PA 18 573

PHS 2018-02 is an omnibus, or broad, SBIR parent solicitation jointly issued 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 bring U.S. small businesses into the federal health and biomedical research pipeline by funding research and development projects that align with the scientific and public health missions of participating NIH Institutes and Centers and relevant CDC/FDA components. The opportunity is structured as a grant mechanism (SBIR) rather than a contract, meaning applicants propose investigator-initiated projects that fit within the agencies' stated topic areas and program priorities rather than responding to a single narrowly defined procurement need.

This particular parent announcement is the SBIR R43/R44 track and is labeled "Clinical Trial Required," which is the central distinguishing feature of the opportunity. In practical terms, applicants must propose at least one clinical trial as part of the project. That requirement signals that the proposed technology or intervention is expected to be mature enough to be tested in humans during the project period, and the application should be built around clinical study aims, clinical endpoints, participant considerations, and operational planning appropriate for a clinical trial. The work still needs to be innovative and R and D-focused, but the solicitation is explicitly aimed at small businesses prepared to take the step into clinical evaluation rather than stopping at preclinical development only.

Eligibility is limited to U.S. small business concerns (SBCs) that meet the SBIR program requirements, and the announcement explicitly notes that non-U.S. entities (foreign institutions) cannot apply. It also states that non-domestic components of U.S. organizations are not eligible to apply, which generally means the applicant organization cannot propose that substantial parts of the work will be performed by an affiliated entity located outside the United States. At the same time, the notice leaves room for "foreign components" as defined by the NIH Grants Policy Statement, which can sometimes be permitted when there is a strong scientific justification and the arrangement complies with NIH policy. The key takeaway is that the applicant must be a qualifying U.S. small business, and any involvement of foreign performance sites or collaborators must be carefully evaluated against the rules and justified under NIH policy if allowed.

As an omnibus solicitation, the FOA is meant to cover a wide range of biomedical, behavioral, clinical, public health, and regulatory science topics that fit the missions of NIH, CDC, and FDA, rather than being confined to a single disease area. The announcement points applicants to the companion topic list (the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA), which is where applicants identify which participating component and topic area their proposed clinical trial-enabled innovation best matches. A competitive application, therefore, is not only about proposing a sound clinical trial, but also about clearly aligning the proposed product, platform, or service with the interests of the specific NIH Institute/Center or CDC/FDA program that would be most appropriate to support it.

From the source details provided, the funding opportunity number is PA-18-573, categorized as discretionary funding and using the grant funding instrument. The activity category is listed broadly under Education, Health, Income Security and Social Services, reflecting the federal classification rather than a narrow technical scope. Multiple CFDA numbers are associated with the opportunity, which is typical for omnibus NIH/CDC/FDA announcements because awards can be made under different statutory program authorities depending on which component funds a given application. The posting (creation) date is January 16, 2018, and the original closing date listed is April 5, 2019, indicating the solicitation was open for submissions through that window (and, in many NIH parent announcements, often through multiple standard receipt dates within the active period, depending on the specific FOA structure and NIH submission cycles).

Overall, this FOA can be understood as a pathway for eligible U.S. small businesses to secure non-dilutive federal R and D funding to advance health-related innovations into human testing. The defining requirement is that at least one clinical trial must be included, so the solicitation is geared toward companies ready to demonstrate clinical feasibility, safety, preliminary efficacy, or other clinically meaningful performance characteristics, in a way that advances NIH/CDC/FDA mission goals and supports eventual commercialization and public 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 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): 93.121, 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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