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

Frequently Asked Questions (FAQs)

What is the PHS 2018-02 Omnibus Solicitation (PA 18-576)?

PHS 2018-02 Omnibus Solicitation (PA 18-576) is a federal grant opportunity administered by the National Institutes of Health (NIH) under the Small Business Technology Transfer (STTR) program. It supports U.S. small business concerns that want to develop and translate health-related technologies in partnership with a nonprofit research institution, using the STTR phased award structure.

Which program does this funding opportunity fall under?

This opportunity is offered through the NIH STTR program and uses the STTR R41/R42 phased award structure (Phase I and Phase II).

What does the R41/R42 phased award structure mean?

The opportunity supports a two-phase pathway:

• Phase I (R41): Feasibility work intended to establish early evidence that the technology and approach are workable.
• Phase II (R42): More advanced research and development to further develop the technology and move it toward real-world clinical use.

What is the main purpose of this STTR parent announcement?

The core goal is to push early-stage health innovations toward real-world clinical use by funding small business-led translational development done in partnership with a nonprofit research institution. Projects are expected to align with the research and development missions of participating NIH Institutes and Centers.

Is this opportunity administered by NIH, CDC, or FDA?

This specific announcement is framed and administered through NIH. While the broader omnibus solicitation ecosystem references NIH, CDC, and FDA, applicants are expected to match their proposal to the scientific priorities of one or more participating NIH Institutes and Centers and the topics published under the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics.

What does "Clinical Trial Required" mean for this opportunity?

"Clinical Trial Required" means the application must include at least one clinical trial as part of the proposed project. A clinical trial cannot be presented only as a possible future step; it must be built into the proposed work for the STTR project.

Does the clinical trial have to be a specific type (for example, first-in-human)?

The information provided indicates that the clinical trial should be appropriately designed for the stage of development and the technology being studied. Examples mentioned include a first-in-human study, a pilot clinical evaluation, or another well-justified clinical trial aligned with NIH definitions and policies.

What is NIH looking for in the clinical trial portion of the application?

Applicants should be prepared to describe a clinical trial that is feasible and appropriately designed, and to address operational expectations that come with human subjects research. The emphasis suggests NIH is looking for translational efforts that are far enough along to justify testing in people.

Who is eligible to apply?

Eligibility is narrowly focused on U.S. small business concerns, consistent with STTR rules. The project must also be relevant to the programmatic interests of at least one participating NIH Institute or Center.

Are foreign institutions eligible to apply?

No. Foreign institutions are not eligible to apply under this opportunity.

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.

Are any foreign activities allowed at all?

The announcement notes that "foreign components" may be permitted as defined by the NIH Grants Policy Statement. In general terms, a foreign component refers to discrete project elements performed outside the United States that are justified by unique expertise, populations, resources, or other compelling scientific reasons.

If a project includes a foreign component, what is expected?

Based on the information provided, applicants typically need to justify why the work must occur abroad and how it fits NIH policy, while keeping the applicant organization and primary eligibility within the United States.

What kind of partner is expected under STTR for this opportunity?

The opportunity is designed for U.S. small businesses working in partnership with a nonprofit research institution. The partnership is a defining element of the STTR approach described in the opportunity summary.

What kinds of topics or scientific areas does this opportunity cover?

The solicitation functions as a parent STTR announcement and expects applicants to align proposals with the scientific priorities of participating NIH Institutes and Centers and with the topics published under the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics. The opportunity is broadly health-related and translational in nature.

What type of funding is this (grant, contract, or something else)?

This opportunity uses the grant instrument type and is categorized as discretionary funding.

What are the general funding activity areas associated with this opportunity?

The funding activity areas include education and health, as described in the opportunity summary.

Is there a stated award ceiling or expected number of awards?

The extracted record does not provide an award ceiling or an expected number of awards. This is described as common for large omnibus parent announcements where award levels and counts can vary depending on institute budgets, application volume, scientific merit, and alignment with topics and priorities.

When was this solicitation created?

The solicitation record indicates it was created on January 16, 2018.

What is the closing date listed for this opportunity?

The source data lists an original closing date of April 5, 2019.

What does it mean that applicants must match NIH Institute or Center priorities?

It means the proposed project should be aligned with the research and development mission and programmatic interests of at least one participating NIH Institute or Center, and it should fit within the topics described under the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics.

What makes an application competitive based on the description provided?

Based on the opportunity summary, competitive applications commonly hinge on:

• Strong fit with an NIH Institute or Center mission and priorities
• A clear translational and commercialization rationale consistent with STTR goals
• A clinical trial plan that is feasible, ethically and scientifically sound, and appropriately matched to the maturity of the technology and intended health impact

What stage of technology development is this opportunity geared toward?

The description emphasizes translational efforts that are far enough along to justify testing in people, since at least one clinical trial must be included in the proposed project.

Is this opportunity best suited for early-stage or clinical-stage innovations?

As described, it is best understood as an entry point for U.S. small businesses that have a clinical-stage innovation, a qualified research institution partner, and a plan to conduct at least one clinical trial within the STTR project.