Opportunity Information: Apply for RFA AI 14 019
Apply for RFA AI 14 019
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Partnerships for Diagnostics to Address Antimicrobial Resistance of Select Bacterial Pathogens (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Mar 12, 2014 and posted on Mar 11, 2014.
- Applicants must submit their applications by Jun 19, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $12,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Independent school districts Special district governments State governments Private institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity titled "Partnerships for Diagnostics to Address Antimicrobial Resistance of Select Bacterial Pathogens (R01)" (Funding Opportunity Number RFA-AI-14-019) was designed to support research projects that move beyond basic discovery and into practical diagnostic development aimed at urgent clinical needs in antimicrobial resistance. The central goal is to drive the development and/or production of diagnostic tools that can detect high-priority antimicrobial-resistant Gram-negative bacteria quickly and accurately without relying on traditional culture methods. In practical terms, the FOA is looking for diagnostics that are rapid, sensitive, and specific, and that can identify resistant pathogens directly from patient samples or relevant clinical materials, shortening the time from suspicion of infection to actionable results.
The FOA targets a specific group of healthcare-associated bacterial threats where resistance has increasingly undermined available treatment options. The pathogens explicitly highlighted are Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species, and extraintestinal pathogenic Escherichia coli. These organisms are common causes of serious hospital and healthcare-associated infections, and they are notorious for acquiring and spreading resistance mechanisms that can make empiric therapy unreliable. The thrust of the opportunity is therefore tied to real-world decision-making: better diagnostics can improve antibiotic selection, support infection control, and reduce unnecessary broad-spectrum antibiotic use by clarifying what organism (and potentially what resistance profile) is present much earlier than culture-based workflows.
A defining feature of this announcement is its emphasis on partnerships and translational readiness. Applications are required to include a Product Development Strategy, signaling that NIH wanted applicants to present more than a conceptual plan or early-stage proof of principle. A credible Product Development Strategy generally implies a structured path toward a usable diagnostic product, including milestones, performance targets, validation plans, workflow considerations, and steps toward manufacturability or scale-up where relevant. In the same spirit, the FOA requires substantive participation by at least one industrial participant. This requirement reflects a preference for teams that can realistically navigate the engineering, manufacturing, quality systems, regulatory planning, and commercialization-related challenges that often prevent promising diagnostic concepts from reaching clinical practice.
The mechanism is an R01 research project grant, and the opportunity was categorized as discretionary funding using the grant funding instrument, aligned with NIH program areas under CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The estimated total funding level listed for the FOA was $12,000,000, with no cost sharing or matching requirement. The posting and timing details indicate this was a time-limited solicitation: posted March 11, 2014, with an original and current closing date of June 19, 2014, and an archive date of July 20, 2014.
Eligibility was broad, reflecting NIH’s intent to attract a mix of academic, clinical, governmental, nonprofit, and commercial expertise suitable for diagnostics development. Eligible applicants included public and private institutions of higher education, small businesses, for-profit organizations (including those other than small businesses), nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), and a wide range of government entities (city/township, county, state, special district, and others). The FOA also explicitly included organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, and faith-based or community-based organizations, among others. Notably, non-U.S. entities were eligible to apply, foreign institutions were eligible, and foreign components as defined under NIH policy were allowed, indicating the program’s openness to global expertise and collaboration in addressing antimicrobial resistance.
From an applicant’s perspective, the opportunity can be understood as NIH seeking development-focused diagnostic R01 projects that combine strong scientific and technical innovation with an explicit plan to produce something that could be adopted in healthcare settings. The presence of an industry partner is not a minor formality here; it is intended to strengthen the likelihood that a diagnostic concept can be engineered into a robust product and advanced toward real clinical impact. For applicants, the key themes to align with would have been: rapid and culture-independent detection, high analytical performance (sensitivity and specificity), clinical relevance to high-priority resistant Gram-negative pathogens, and a development plan grounded in product realities rather than purely academic experimentation.
The sponsoring agency was the National Institutes of Health. The FOA’s full announcement was hosted on the NIH grants site, and the provided contact path for technical access issues was through the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), indicating the administrative support channel for applicants who had trouble accessing or linking to the full solicitation text.
FAQs: Partnerships for Diagnostics to Address Antimicrobial Resistance of Select Bacterial Pathogens (R01) - RFA-AI-14-019
What is the main purpose of this NIH funding opportunity?
The opportunity was designed to support R01 research projects that move beyond basic discovery and into practical diagnostic development for urgent clinical needs in antimicrobial resistance. The focus is on developing and/or producing diagnostic tools that can detect high-priority antimicrobial-resistant Gram-negative bacteria quickly and accurately.
What kind of diagnostics is NIH looking for under this FOA?
Diagnostics that are rapid, sensitive, and specific, and that can detect targeted antimicrobial-resistant Gram-negative bacteria without relying on traditional culture methods. The intent is to identify resistant pathogens directly from patient samples or other relevant clinical materials to shorten the time to actionable results.
Does the FOA emphasize culture-independent testing?
Yes. A central goal is to enable rapid and accurate detection without relying on traditional culture-based workflows, supporting faster clinical decision-making.
Which bacterial pathogens are specifically highlighted?
The FOA explicitly highlights the following healthcare-associated bacterial threats: Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species, and extraintestinal pathogenic Escherichia coli.
Why are these pathogens a priority in this announcement?
They are common causes of serious hospital and healthcare-associated infections and are known for acquiring and spreading resistance mechanisms that can undermine empiric therapy and available treatment options.
What clinical problem is this FOA trying to solve?
It aims to reduce the delay between suspicion of infection and actionable diagnostic results. Faster identification can improve antibiotic selection, support infection control, and reduce unnecessary broad-spectrum antibiotic use by clarifying the organism (and potentially its resistance profile) earlier than culture-based workflows.
Is this opportunity focused on basic research or translational development?
It is explicitly development-focused. It supports projects that go beyond early discovery toward practical diagnostic development aimed at real clinical needs and adoption in healthcare settings.
What funding mechanism is used for this program?
The mechanism is an NIH R01 research project grant.
Is this considered discretionary funding and what is the funding instrument?
Yes. The opportunity was categorized as discretionary funding using the grant funding instrument.
What NIH/CFDA program areas are associated with this FOA?
The FOA is aligned with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
What was the estimated total funding level for this solicitation?
The estimated total funding level listed was $12,000,000.
Is cost sharing or matching required?
No. The FOA states there was no cost sharing or matching requirement.
What is a defining feature of this FOA compared with a typical academic R01?
A defining feature is its emphasis on partnerships and translational readiness. Applications were required to include a Product Development Strategy and to include substantive participation by at least one industrial participant.
Is an industry partner required?
Yes. The FOA requires substantive participation by at least one industrial participant, reflecting a preference for teams positioned to handle product engineering, manufacturing, quality systems, regulatory planning, and commercialization-related challenges.
What is meant by “substantive participation†by an industrial participant?
The FOA indicates this is not intended as a minor formality. The intent is that an industry participant meaningfully strengthens the project’s ability to develop a robust diagnostic product and advance it toward clinical impact.
What is the required Product Development Strategy?
Applications were required to include a Product Development Strategy that goes beyond a conceptual plan or proof of principle. The FOA frames this as a structured path toward a usable diagnostic product.
What kinds of elements would a credible Product Development Strategy typically address (as implied by the FOA)?
As described, it generally implies milestones, performance targets, validation plans, workflow considerations, and steps toward manufacturability or scale-up where relevant.
What performance characteristics are emphasized for the diagnostics?
The FOA emphasizes diagnostics that are rapid, sensitive, and specific, and that can deliver clinically useful results sooner than traditional culture-based approaches.
What types of samples are the diagnostics expected to work with?
The FOA indicates diagnostics should identify resistant pathogens directly from patient samples or relevant clinical materials.
Who was eligible to apply?
Eligibility was broad and included public and private institutions of higher education, small businesses, for-profit organizations (including those other than small businesses), nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), and a wide range of government entities (city/township, county, state, special district, and others).
Are minority-serving and community-based institutions included in eligibility?
Yes. The FOA explicitly included organizations such as HBCUs, Hispanic-Serving Institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, and faith-based or community-based organizations, among others.
Are non-U.S. organizations eligible?
Yes. The FOA states that non-U.S. entities were eligible to apply, foreign institutions were eligible, and foreign components (as defined under NIH policy) were allowed.
What does allowing foreign components imply about the program’s approach?
It indicates openness to global expertise and collaboration in addressing antimicrobial resistance, consistent with the international nature of the AMR challenge.
When was the FOA posted and what were the key dates?
The FOA was posted March 11, 2014. The original and current closing date was June 19, 2014. The archive date was July 20, 2014.
Is this a current funding opportunity?
Based on the dates provided, it was a time-limited solicitation that has been archived (archive date July 20, 2014).
Who was the sponsoring agency?
The sponsoring agency was the National Institutes of Health (NIH).
Where was the full announcement hosted?
The FOA’s full announcement was hosted on the NIH grants site.
Who should be contacted for technical access issues to the solicitation text?
The provided contact path for technical access issues was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
What core themes should an application align with (based on the FOA description)?
The key themes described are rapid and culture-independent detection, high analytical performance (sensitivity and specificity), clinical relevance to high-priority resistant Gram-negative pathogens, and a development plan grounded in product realities, strengthened by an industry partnership.
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