Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed) | RFA AI 23 065

Frequently Asked Questions (FAQs)

What is the CETR (Centers of Excellence for Translational Research) funding opportunity?

The Centers of Excellence for Translational Research (CETR) opportunity (RFA-AI-23-065) is an NIH cooperative agreement that supports multidisciplinary translational research centers focused on advancing anti-infective medical countermeasures toward real-world medical use. The program is designed to help move promising ideas through rigorous preclinical and translational steps that often slow or block progress, especially for antimicrobial-resistant threats.

What is the main goal of this program?

The overall aim is to accelerate the generation, validation, and advancement of medical countermeasures targeting specific high-priority bacterial or fungal pathogens identified in the NOFO, particularly organisms with known and emerging resistance to existing therapies. The emphasis is on producing strong validation datasets, demonstrating feasibility, and addressing key development questions needed to improve translational readiness.

What kinds of pathogens does CETR focus on?

The program targets bacterial or fungal pathogens that are explicitly specified in the solicitation (NOFO). These organisms must be relevant to antimicrobial resistance challenges, including known and emerging resistance to current therapies.

Does this NOFO support clinical trials?

No. This opportunity uses the U19 activity code and is labeled "Clinical Trial Not Allowed." Supported work is intended to remain on the translational research side and does not fund human subject clinical trial activities under this mechanism.

What does "U19 Clinical Trial Not Allowed" mean in practical terms?

It means applicants should propose coordinated translational research activities (such as preclinical development and validation) rather than clinical trial work involving human participants. The center is expected to generate translational outputs that move candidates closer to later-stage testing, but without conducting clinical trials as part of this award.

What type of NIH award mechanism is this?

This funding opportunity is a cooperative agreement (U19). A cooperative agreement typically involves substantial programmatic involvement from NIH staff compared with a standard research grant.

How is a cooperative agreement different from a standard research grant?

In a cooperative agreement, NIH generally takes an active partnership role. Based on the description provided, this can include involvement in milestone setting, progress review, coordination across funded centers, expectations for data/resource sharing, and alignment with broader program goals.

What kind of program structure is NIH looking for?

NIH is looking for a true center-style program with coordinated projects and shared resources that function as a cohesive translational research center, rather than a set of loosely connected studies. The expectation is an integrated approach that combines multiple capabilities needed to advance countermeasures.

What disciplines or expertise are relevant for a CETR center?

The opportunity emphasizes multidisciplinary teams and gives examples of relevant expertise areas, including microbiology, immunology, medicinal chemistry, pharmacology, diagnostics development, bioinformatics, and translational/clinical laboratory science.

What types of activities and outputs are emphasized?

The emphasis is on translational readiness and de-risking medical countermeasure development. This includes producing validation datasets, demonstrating feasibility, and resolving key development questions that commonly stall progress against antimicrobial-resistant bacterial or fungal threats.

Is the focus limited to a single project, or can applicants propose multiple components?

The program is described as center-scale and expects coordinated projects plus shared resources. This suggests applicants may propose multiple integrated components (such as projects and cores) that operate together as one cohesive center.

What is the maximum award amount (award ceiling)?

The listed award ceiling is $5,000,000. This level of funding indicates NIH anticipates relatively large, center-scale budgets capable of supporting multiple integrated activities and shared platforms.

What kinds of shared resources might be supported under a center-scale budget?

Based on the description, center budgets may support integrated components such as project cores, shared platforms, specialized assays, translational services, and coordinated management needed to operate as a cohesive translational center.

What is the CFDA number and what does it indicate?

The associated CFDA number is 93.855. This places the opportunity within NIH infectious disease and related biomedical research funding streams.

What is the activity category for this opportunity?

The activity category listed is Health.

Who is eligible to apply?

The NOFO allows applications from a broad range of organization types, including government entities, institutions of higher education, nonprofits, for-profits, small businesses, tribal governments and organizations, public housing/Indian housing authorities, and other entities.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education. The NOFO also explicitly includes categories such as HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.

Are nonprofit organizations eligible?

Yes. The eligibility list includes nonprofits with or without 501(c)(3) status (with the specific exclusion noted in the provided text regarding institutions of higher education in those nonprofit categories as listed).

Are for-profit organizations and small businesses eligible?

Yes. Eligible applicants include for-profit organizations (other than small businesses) and small businesses.

Are government entities eligible?

Yes. Eligible applicants include state, county, city/township, and special district governments, as well as independent school districts and eligible federal government agencies.

Are tribal organizations eligible?

Yes. The eligibility list includes federally recognized Native American tribal governments and other tribal organizations, as well as Tribally Controlled Colleges and Universities (TCCUs).

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly listed as eligible applicants.

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

Yes. The NOFO explicitly includes non-U.S. entities (foreign organizations) among eligible applicant categories, indicating international participation may be allowed when scientifically justified.

Does NIH expect a single institution or can a consortium apply?

The breadth of eligible organization types and the center-based nature of the program suggest NIH is open to single institutions or consortia that can assemble the required mix of capabilities to run a cohesive translational center.

When was this opportunity posted?

The posting (creation) date provided is December 13, 2023.

What is the original application closing date?

The original application closing date provided is April 29, 2024.

How many awards does NIH expect to make?

The "Expected Awards" field is not populated in the provided information. The high award ceiling and cooperative agreement structure suggest a competitive, selective program, but the exact number of awards is not stated here.

What does NIH mean by "medical countermeasures" in this context?

In this context, medical countermeasures are anti-infective approaches intended to address high-priority bacterial or fungal threats, especially those with antimicrobial resistance. The program focuses on advancing candidate countermeasures through preclinical and translational development steps to move them closer to practical medical use.

What is the central theme applicants should demonstrate in their proposal?

Applicants are expected to demonstrate a clear, coordinated plan to push candidate countermeasures through rigorous preclinical and translational development steps, supported by multidisciplinary expertise and shared resources, while staying within the "Clinical Trial Not Allowed" scope.