Partnerships for Development of Clinically Useful Diagnostics for Antimicrobial-Resistant Bacteria (R01) | RFA AI 17 014

FAQs: Partnerships for Development of Clinically Useful Diagnostics for Antimicrobial-Resistant Bacteria (R01) (RFA-AI-17-014)

What is this NIH funding opportunity?

This is an NIH R01 funding opportunity titled "Partnerships for Development of Clinically Useful Diagnostics for Antimicrobial-Resistant Bacteria (R01)" with the identifier RFA-AI-17-014. It supports projects aimed at developing clinically useful diagnostics for antimicrobial-resistant (AMR) bacteria.

What is the main goal of the program?

The main goal is to push AMR diagnostic platforms toward real clinical use. The emphasis is on development that leads to tools clinicians can use to make better and faster treatment decisions, improve patient outcomes, and support antibiotic stewardship by reducing unnecessary or ineffective antibiotic use.

Is this opportunity focused on basic research or on development?

It is focused on product-oriented, milestone-driven development rather than basic discovery. Applications are expected to resemble a development pipeline with measurable milestones and deliverables, not an open-ended research plan.

What kinds of diagnostic capabilities are expected?

The supported diagnostic platforms are expected to identify selected antibiotic-resistant bacterial pathogens and provide clinically meaningful antimicrobial susceptibility information, such as whether the pathogen is sensitive or resistant to particular antibiotics.

Why does the opportunity emphasize antimicrobial susceptibility information?

The program highlights susceptibility information because it directly supports clinical decision-making. Knowing whether a pathogen is susceptible or resistant to specific antibiotics can help clinicians choose effective treatment faster and avoid antibiotics that are unnecessary or unlikely to work.

What does “clinically useful” mean in the context of this opportunity?

Based on the description provided, "clinically useful" aligns with diagnostics that can realistically be validated, integrated into clinical workflows, adopted in clinical settings, and used to inform treatment decisions. The program is oriented toward real-world clinical implementation rather than purely laboratory demonstration.

What is meant by “milestone-driven” development?

Milestone-driven development means the project plan should be organized around clear, measurable milestones and concrete deliverables. Progress against these milestones is central to project management and evaluation under this opportunity.

What is a Product Development Strategy, and is it required?

A Product Development Strategy is required. It is a key element reviewers will use to assess whether the proposed diagnostic can plausibly move from development into clinical validation, manufacturing, adoption, and routine clinical use.

What topics should the Product Development Strategy address?

The opportunity indicates the Product Development Strategy typically implies attention to topics such as intended use and use environment (for example, hospital laboratory versus point-of-care), sample types, workflow integration, performance targets (such as sensitivity, specificity, time-to-result, and limits of detection), analytical and clinical validation planning, regulatory considerations, and pathways for scaling and commercialization.

Are partnerships required, and what kind of partner is expected?

Yes. A defining requirement is partnership with industry in a meaningful way. The solicitation requires substantive investment by at least one industrial participant, indicating the industrial partner should contribute real resources, expertise, and commitment to advancing the technology toward clinical implementation.

What does “substantive investment” by industry imply?

It implies the industrial participant must be more than a nominal collaborator. While the investment can take different forms depending on the partnership model, the expectation is that the partner contributes materially to de-risking and advancing the diagnostic toward validation and real-world adoption.

What funding mechanism is used for this opportunity?

The funding mechanism is an R01 grant.

What is the funding instrument type?

The funding instrument type is a grant.

Which agency is offering this opportunity?

The opportunity is offered under the NIH (National Institutes of Health).

What is the activity category?

The activity category is health-focused (as described in the opportunity summary provided).

Is the award amount (ceiling) specified?

No specific award ceiling number is provided in the supplied information. The listing shows an award ceiling field without a specified number.

Is the expected number of awards provided?

No. The supplied information does not provide an expected awards count.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.855 and 93.856.

Who is eligible to apply?

Eligibility is broad and includes many organization types across government, academia, nonprofit, and industry. The provided information lists eligible applicants including state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; and Native American tribal organizations other than federally recognized tribal governments.

Are nonprofits eligible (including 501(c)(3) organizations)?

Yes. The opportunity is open to nonprofits, including both 501(c)(3) and non-501(c)(3) entities.

Are for-profit organizations eligible?

Yes. The opportunity includes for-profit organizations other than small businesses, and it also includes small businesses among eligible applicants.

Are small businesses eligible?

Yes. Small businesses are explicitly included among eligible applicants.

Are tribal entities eligible?

Yes. The information provided includes federally recognized Native American tribal governments and also includes Native American tribal organizations other than federally recognized tribal governments. It further highlights tribally controlled colleges and universities and tribal governments other than federally recognized as other eligible applicants.

Are minority-serving institutions highlighted as eligible?

Yes. The opportunity explicitly highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, and Tribally Controlled Colleges and Universities as other eligible applicants.

Are federal government agencies eligible?

Yes. The information provided includes eligible agencies of the federal government among other eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly included in the list of other eligible applicants.

Are non-U.S. (foreign) entities eligible to apply?

Yes. Non-U.S. (foreign) entities are explicitly included among other eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly included among other eligible applicants.

When was this opportunity created and when did it close?

The opportunity was created on 2017-06-01, and the original closing date provided is 2017-10-04.

What is the overall intent of the program?

The overall intent is to accelerate development of clinically useful AMR diagnostics by combining structured milestones, a concrete product development plan, and genuine industry participation, increasing the likelihood that supported technologies can move beyond the lab and into routine clinical care.

What kinds of clinical settings or use environments are contemplated?

The provided information references intended use and use environment examples such as hospital laboratories and point-of-care settings, implying the program expects applicants to define where and how the diagnostic would be used.

What types of performance targets are relevant to this opportunity?

The opportunity description calls out performance targets such as sensitivity, specificity, time-to-result, and limits of detection as examples of the kinds of measurable targets that may be relevant to a development-oriented diagnostic plan.

Does the opportunity expect planning for validation and regulatory considerations?

Yes. The description indicates that a credible Product Development Strategy typically implies planning for analytical and clinical validation as well as regulatory considerations.

Does the opportunity encourage commercialization and scaling plans?

Yes. The description indicates that reviewers will look for a credible plan for scaling and commercialization as part of a realistic pathway to adoption in clinical settings.

Why is industry participation emphasized?

Industry participation is emphasized to encourage public-private collaboration and reduce the risk that promising prototypes stall before reaching clinical implementation. The requirement for substantive investment signals preference for projects with real development traction and a plausible route to deployment.