Notice of Intent to Publish a Funding Opportunity Announcement for Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed)

Key Dates

None

National Institute of Allergy and Infectious Diseases (NIAID)

The National Institute of Allergy and Infectious Diseases intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications from single institutions or a consortium of institutions to participate in the Centers for Excellence in Translational Research (CETR) program. This cooperative agreement program will support multidisciplinary translational research Centers focused on generating, validating, and advancing medical countermeasures against bacteria and/or fungi that have known and emerging resistance to current therapies. Pathogens of interest for the NOFO will be a subset of the 2019 CDC Report on Antibiotic Resistance Threats in the US, https://www.cdc.gov/drugresistance/biggest-threats.html.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The NOFO is expected to be published in winter 2023 with an expected application due date in spring 2024.

This NOFO will utilize the U19 activity code. Details of the planned NOFO are provided below.

The goal of the Centers for Excellence in Translational Research (CETR) program is to advance medical countermeasure (MCM) development for antimicrobial resistant (AMR) bacteria and fungi. Proposed therapeutics, vaccines and diagnostics should target AMR bacteria at an advanced stage of preclinical development and/or AMR fungi at any stage from discovery through preclinical development. For applications developing AMR bacterial medical countermeasures and similarly advanced anti-fungal MCMs, a well-developed Product Development Strategy will be required, and industrial participation will be encouraged.

Each Center will be organized around a specific major objective, theme or program goal, that addresses development of MCMs for AMR bacteria and/or fungi (to be listed in the forthcoming NOFO).  NIAID anticipates considerable variety among Center themes and objectives, which can range, for example, from the development of countermeasures targeting a specific resistant pathogen or group of resistant pathogens, to the development of new technologies or platforms that target a wide array of pathogens. Because FDA authorization of MCMs identified through these programs should be a long-term goal, each Center should consider and address anticipated regulatory barriers for the targeted countermeasure or technology, particularly for new classes of MCMs for which there are no precedents for FDA approval. Broad spectrum MCMs though not required are encouraged.

Medical countermeasures supported by this NOFO include the following, or combinations of:

Therapeutics:

• For AMR bacteria, applications focusing on therapeutic projects in the lead optimization phase with existing lead candidates to support progression through pivotal nonclinical studies
• For fungal pathogens, efforts focusing on earlier lead discovery efforts in addition to more advanced preclinical development efforts

Vaccines:

• Development of vaccines and vaccine technologies against AMR bacteria and/or fungi.
• Identification and validation of antigen targets and immunogen design using systems vaccinology approaches and technologies.
• Vaccine development may include monovalent, multivalent, or broadly protective vaccines.
• Vaccine technologies may include enhancing immune response, adjuvants, increasing stability, cold-chain minimization, and/or simplified vaccine administration.

Diagnostics:

• Development of integrated, sensitive, culture-independent testing systems to identify AMR bacteria and/or fungi.
• Proposed technologies are expected to exceed performance specifications of currently available instruments/systems.

Further details will be included in the forthcoming NOFO.
 

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Candace Kerr, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6257
Email: candace.kerr@nih.gov