PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) | PA 18 575

Frequently Asked Questions (FAQs): PHS 2018-02 / PA 18-575 (NIH Parent STTR R41/R42, No Clinical Trials)

1) What is PHS 2018-02 / PA 18-575?

PHS 2018-02 (opportunity number PA 18-575) is an omnibus "Parent" Small Business Technology Transfer (STTR) funding opportunity led by the National Institutes of Health (NIH). It sits within the broader NIH/CDC/FDA SBIR/STTR ecosystem and is designed to support early-stage, high-impact research and development (R&D) projects that can move innovative science toward practical products, tools, or services aligned with the missions of participating NIH awarding components.

2) What does it mean that this is a "Parent" STTR opportunity?

"Parent" means the solicitation is broad and intended to be used across many biomedical and public health topic areas, rather than being limited to a single disease area, technology type, or one institute-specific initiative. Applicants are expected to align their proposal with the participating NIH components by using the referenced SBIR/STTR Program Descriptions and Research Topics for NIH in PHS 2018-2.

3) What program mechanism and activity codes are used?

This opportunity uses the STTR program mechanism with the R41/R42 activity codes.

4) How do Phase I (R41) and Phase II (R42) differ?

Phase I (R41) generally supports feasibility and proof-of-concept work. Phase II (R42) generally supports more advanced R&D to further develop the technology, reduce technical risk, and position the project for later-stage commercialization or deployment.

5) What is the core purpose of the STTR collaboration requirement?

The purpose is to fund projects where a U.S. small business formally collaborates with a nonprofit research institution to advance innovative science toward real-world application. A key premise of STTR is that the small business and research institution work together in a structured way to develop the underlying innovation.

6) Who is eligible to apply?

Eligibility is focused on U.S. small business concerns. The applicant organization must qualify as a small business under applicable STTR rules and must be based in the United States.

7) Can a foreign organization apply as the applicant?

No. Foreign institutions are not eligible to apply as the applicant organization under this opportunity.

8) Can a non-U.S. component of a U.S. organization apply as the applicant entity?

No. Non-U.S. components of U.S. organizations are not eligible to serve as the applicant entity.

9) Are any foreign components allowed at all?

Potentially, yes. Foreign components (as defined in the NIH Grants Policy Statement) may be allowed in some cases. If included, the application would need to follow NIH policy and clearly justify why the foreign component is necessary and how it benefits the project in a way that cannot be readily achieved domestically.

10) Are clinical trials allowed under this FOA?

No. A key restriction in this announcement is that clinical trials are not allowed. Applicants must structure their aims so they do not propose a study that meets NIH's definition of a clinical trial.

11) What is an example of what NIH considers a clinical trial (as described here)?

An example given is the prospective assignment of human participants to an intervention to evaluate effects on health-related outcomes. Projects that meet this kind of definition would not be allowed under this FOA.

12) If clinical trials are not allowed, what kinds of work are still appropriate?

Projects may include non-clinical development and testing common in biomedical innovation, such as laboratory validation, benchtop prototyping, assay development, preclinical studies, computational modeling, device engineering, software development, data infrastructure work, or other R&D activities, as long as they do not cross into clinical trial territory.

13) What should applicants do if their project requires a clinical trial?

Applicants who need to run a clinical trial would generally need to look for a different funding opportunity announcement (FOA) that explicitly allows or solicits clinical trials.

14) How should an applicant choose a topic area or NIH component for alignment?

Applications are expected to fit within the research topics and guidance referenced in the PHS 2018-2 SBIR/STTR Program Descriptions and Research Topics for NIH. Applicants use those descriptions to align proposed work with the priorities and interests of the NIH components participating under this umbrella.

15) What types of innovations is this solicitation meant to advance?

The solicitation is meant to advance innovative science toward practical products, tools, or services that align with the missions of participating NIH awarding components. It supports biomedical and health-related technologies, including enabling technologies and research tools, so long as the project fits within the referenced program descriptions and topics and does not include a clinical trial.

16) What is the funding type?

This opportunity is categorized as discretionary grant funding.

17) What public service domains does this opportunity span?

The activity spans multiple public service domains, including health, environment, food and nutrition, education, and social services, reflecting that NIH-supported innovations can cut across clinical medicine, population health, research tools, and enabling technologies.

18) What do the many CFDA (Assistance Listing) numbers imply?

The large set of CFDA numbers (now commonly referred to as Assistance Listings) signals that many NIH institutes and centers may make awards under their relevant authorities, depending on topic alignment and application quality.

19) What are the key dates provided for this opportunity?

The creation date shown is 2018-01-16. An original closing date is listed as 2019-04-05.

20) Does the excerpt state an award ceiling or expected number of awards?

No. The excerpt does not specify an award ceiling or the expected number of awards.

21) How are awards typically made under STTR, based on the information provided?

STTR awards are typically made competitively based on scientific and technical merit, programmatic fit with the participating NIH component, and the credibility of the project plan for advancing the technology toward commercialization.

22) What qualities are highlighted as common in strong STTR applications?

Strong applications usually show a clear technical need, a convincing innovation story, a feasible and well-structured work plan appropriate to the phase being requested, and a realistic path to downstream use, adoption, or commercialization, while maintaining the required collaboration between the small business and the partner research institution.

23) Is this opportunity limited to a single disease or technology area?

No. It is designed to be broadly applicable across many biomedical and public health topic areas rather than being limited to a single disease, technology, or institute-specific initiative.

24) What is the overall summary of what this FOA funds?

This FOA funds U.S. small businesses working with nonprofit research institution partners to develop biomedical and health-related technologies through the STTR R41/R42 pathway, with the explicit condition that proposed research must not include clinical trials and with eligibility limits that generally exclude non-U.S. applicant entities while allowing certain foreign components under NIH policy when appropriately justified.