NIAID continues a program it established in 2014 with the funding opportunity announcement (FOA) for Centers of Excellence for Translational Research (CETR) (U19*, Clinical Trial Not Allowed).
Read on if you are interested in assembling and directing a CETR and furthering the program’s purpose: support multidisciplinary translational research centers focused on generating, validating, and advancing medical countermeasures to select NIAID Emerging Infectious Diseases/Pathogens.
*If you’re unfamiliar with the “U” in the U19 activity code, read our May 4, 2016 article “Just for ‘U’: A Closer Look at Cooperative Agreements.”
First, a Definition
Before proceeding, you should know what we mean by “translational research” as it pertains to this FOA. We define it as:
Research and developmental activities focused on transforming basic science outcomes (knowledge, technologies, infrastructure, etc.) into new and innovative approaches for prevention, diagnosis, and treatment of disease.
We encourage Centers focused on developing medical countermeasures that are effective against a variety of pathogens and toxins, technologies that can be widely applied to improve classes of products, and platforms that can reduce the time and cost of creating new products.
Each Center will be organized around a Center theme that must target select NIAID Emerging Infectious Diseases/Pathogens. For examples of potential Center themes and structure, see the FOA. Note that supported research and development activities must use either the virulent form of a human pathogen listed at NIAID Emerging Infectious Diseases/Pathogens under appropriate biosafety conditions or a CDC-approved excluded strain that is an attenuated form of the human pathogen.
To be responsive to this FOA, you must focus your application on translational activities towards developing one or more of the following specific countermeasures or technologies. For full details, refer to the FOA.
- Therapeutics—supports discovery and/or development of new or improved therapeutics (including immune-based and host-targeted forms) against antimicrobial-resistant bacteria/fungi or emerging viral pathogens.
- Vaccines—supports discovery and/or development of vaccines (including immunoprophylactics) focusing on multivalent/universal forms, vaccines targeting antimicrobial-resistant bacteria/fungi or select viral pathogens, or related vaccine technologies.
- Diagnostics—supports development of new and innovative integrated, rapid, easy-to-use, sensitive, culture-independent, sample-to-answer, diagnostic platforms and/or technologies that identify select antimicrobial-resistant bacterial pathogens and determine phenotypically their antimicrobial susceptibility and/or resistance.
Note: Though you may include clinical development strategies and/or clinical studies (e.g., sample collection, strain isolation) within an overall project, be aware that this FOA will not support clinical trials (CTs). Also, if you propose a mechanistic study, make sure it does not meet the broader definition of a CT. For more information, read our November 1, 2017 article “Determine Whether NIH Considers Your Mechanistic Study a Clinical Trial.”
Each Center will include the following components:
- Administrative Core, under the direction of the program director/principal investigator, will manage, coordinate, and supervise all Center activities. A Scientific Advisory Committee will be part of the Administrative Core and participate in developing and managing the CETR and its activities.
- Interdependent translational Research Projects focused on developing and advancing a new or improved medical countermeasure and/or associated platform/technology and targeting one or more select NIAID Emerging Infectious Diseases/Pathogens.
- Optional: One or more Scientific Core resources or facilities that are essential for the activities of two more research projects.
By the Numbers: Award Information
Here are some numbers you might want to keep in mind as you plan your application.
- $64 million: the amount NIAID intends to commit to this FOA in fiscal year (FY) 2019.
- 8 to 10: the number of awards NIAID intends to fund.
- $5 million: the application budget limit for FY 2019 direct costs. Note, however, that the amount you request must reflect the actual needs of your proposed project.
- 5: the maximum number of years allowed for the project period; however, the scope of your project should determine how many years you request.
Due Dates and Contact
A letter of intent is optional, but if you decide to send one, do so by February 28, 2018. Applications are due the following month on March 30.
Direct your questions to Dr. Michael Schaefer, the FOA’s scientific/research contact.