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

FAQs: PHS 2019-02 Omnibus SBIR (PA-19-272)

What is PHS 2019-02 (PA-19-272)?

PHS 2019-02 is an omnibus (multi-agency) Small Business Innovation Research (SBIR) funding opportunity published as a Parent SBIR Funding Opportunity Announcement (FOA). It provides a broad, standing framework for eligible small businesses to propose health-related research and development projects that align with participating components of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), and that fit within the specific SBIR topic areas listed for this omnibus cycle.

Which agencies are involved in this opportunity?

This omnibus SBIR opportunity is issued jointly by NIH, CDC, and FDA, and is designed to support projects aligned with the missions and topic areas of participating components across those agencies.

What does it mean that this is a "Parent SBIR" FOA?

Being a Parent SBIR FOA means the announcement is broad and intended to be used by many agency components. Applicants are expected to align their proposals with the appropriate published SBIR topics included in the omnibus topic document for PHS 2019-2 (the SBIR/STTR Program Descriptions and Research Topics), rather than responding to a narrow, single-topic solicitation.

What is the main purpose of this grant opportunity?

The core purpose is to fund early-stage, high-impact innovation led by eligible U.S. small business concerns (SBCs). The government is seeking novel technologies and applied research concepts that can mature toward commercialization while also advancing federal public health, biomedical, regulatory science, and related priorities reflected in the participating NIH, CDC, and FDA missions and listed topic areas.

What kinds of projects are a good fit for this FOA?

Projects that propose innovative research and development leading toward products, tools, platforms, or services aligned with federal R&D needs and the published SBIR topics for NIH, CDC, and FDA under the PHS 2019-2 omnibus topic document. The opportunity is described as spanning a wide range of priorities across public health, biomedical science, regulatory science, and related areas such as health, food and nutrition, environment, and connected human services domains included under the funding activity categories.

What grant mechanisms are used (R43 and R44)?

This Parent SBIR announcement uses SBIR grant mechanisms R43 and R44. Generally, R43 corresponds to Phase I feasibility and early proof-of-concept work. R44 supports a combined Phase I and Phase II approach or a Phase II effort, depending on how the submission is structured and what the FOA and agency component allow.

Does this FOA allow clinical trials?

No. The FOA is explicitly labeled "Clinical Trial Not Allowed." Proposed work must be designed so it does not include a clinical trial as defined by NIH policy.

What does "Clinical Trial Not Allowed" mean in practical terms?

Applications should avoid proposing prospective human subject research that assigns participants to an intervention to evaluate effects on health-related biomedical or behavioral outcomes (i.e., a clinical trial under NIH policy). The proposed project must stay on the non-clinical-trial side of the boundary described in the opportunity summary.

If our long-term plan includes a clinical trial later, can we still apply?

The information provided indicates companies may still be able to apply if their overall roadmap includes eventual clinical evaluation, but the work proposed under this FOA must not include a clinical trial. The proposed scope should remain non-clinical-trial as described for this announcement.

What are examples of activities that may fit because they are non-clinical-trial work?

Examples mentioned in the opportunity description include preclinical validation, device prototyping and bench testing, software development, analytical validation, and certain usability studies or other human factors work that do not meet the clinical trial definition, depending on specifics and agency guidance.

Who is eligible to apply?

Eligibility is limited primarily to eligible United States small business concerns (SBCs) that meet SBIR program requirements, including U.S. ownership and control rules and applicable size standards.

Are foreign institutions eligible to apply?

No. Foreign institutions are explicitly not eligible to apply under this FOA.

Can a non-U.S. component of a U.S. organization apply?

No. Non-U.S. components of U.S. organizations are also not eligible to apply as applicants under this opportunity.

Are any foreign activities allowed at all?

The FOA notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowable in some cases. Based on the description provided, that typically means the applicant must still be a U.S. SBC, but certain well-justified elements of the project could be performed outside the U.S. if they are critical to the project and consistent with agency policy, with required justifications and approvals in place.

How do applicants choose the right topic area?

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). The intent is for proposed projects to fit within the participating component missions and the specific topic areas listed for this omnibus cycle.

What type of funding is this (grant vs. contract), and how is it categorized?

Administratively, the opportunity is categorized as discretionary funding and uses a grant instrument.

When was the FOA created and what was the closing date listed?

The FOA record indicates it was created on 2019-05-07, and it lists an original closing date of 2020-07-06.

Is there an award ceiling or expected number of awards stated in the excerpt?

No. The provided excerpt does not specify an award ceiling or an expected number of awards. The description notes this can be common for large parent announcements where award amounts and volumes vary by participating institute/center, topic area, and available appropriations.

Why are there many CFDA numbers associated with this FOA?

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). This reflects the breadth of potential mission alignments and funding streams under which awards might be made.

What is the overall goal for applicants and funded projects?

The overall goal is to help small companies move promising health-related innovations through feasibility and development stages toward practical use and commercialization, while also advancing federal public health and biomedical priorities within NIH, CDC, and FDA topic areas.