Tropical Medicine Research Centers (U01 Clinical Trial Not Allowed) | RFA AI 21 004

Frequently Asked Questions (FAQs): Tropical Medicine Research Centers (TMRCs) - RFA-AI-21-004

What is the Tropical Medicine Research Centers (TMRCs) funding opportunity?

The TMRCs funding opportunity (RFA-AI-21-004) is a National Institutes of Health (NIH) initiative administered through the National Institute of Allergy and Infectious Diseases (NIAID). It supports research centers focused on select Neglected Tropical Diseases (NTDs) in locations where these diseases are endemic.

Which NIH Institute runs this program?

The program is run through NIAID (the National Institute of Allergy and Infectious Diseases), which is part of NIH.

What type of award mechanism is used?

The award mechanism is a U01 cooperative agreement.

What does a U01 cooperative agreement mean for applicants?

A U01 cooperative agreement indicates a partnership model where NIH/NIAID is expected to have substantial scientific involvement compared with a typical grant. In practice, the center’s work is supported through collaboration with NIH/NIAID rather than being entirely investigator-directed without NIH scientific involvement.

Are clinical trials allowed under this funding opportunity?

No. Clinical trials are not allowed under this FOA. Proposed work must be structured as non-trial clinical research and/or preclinical, field, laboratory, implementation-supportive, or translational activities that do not meet the definition of a clinical trial.

If clinical trials are not allowed, what kinds of research are appropriate?

The FOA supports research that can include non-trial clinical research as well as preclinical, field-based, laboratory, implementation-supportive, or translational work, as long as it does not meet the definition of a clinical trial.

What is the scientific focus of the TMRC program?

The program is designed to fund research that builds a deeper and more actionable understanding of NTDs and helps translate that knowledge into better tools and strategies for real-world use in endemic settings.

What parts of the disease spectrum can TMRC research cover?

The FOA highlights research across the full disease spectrum, including etiology (causes and drivers of infection and disease), epidemiology (who is affected, where, when, and why), pathogenesis (biological mechanisms of disease), clinical manifestations (how illness presents and progresses), and improved approaches for diagnosis, prevention, treatment, and control.

What are examples of project topics that fit the FOA’s scope?

Examples mentioned or implied by the FOA’s scope include studies clarifying transmission dynamics and risk factors; work to identify and validate biomarkers or diagnostics; research to inform prevention and control strategies; and studies that support vector control approaches.

Is the program focused on translating research into practical use?

Yes. A central theme is generating knowledge and results that can be translated into better tools and strategies for real-world use, particularly in endemic environments.

Does the FOA emphasize work that is feasible in low- and middle-income countries (LMICs)?

Yes. The FOA emphasizes results that can be adapted to the operational realities of low- and middle-income countries (LMICs), as defined by World Bank classifications, where infrastructure, cost, supply chain constraints, and workforce capacity can determine whether an approach can be implemented effectively.

Is capacity building in endemic countries part of the TMRC model?

Yes. A central purpose of the TMRC model is capacity building and durable collaboration in endemic countries, not just funding stand-alone research.

What does capacity building and collaboration look like in this FOA?

The FOA stresses creating and sustaining in-country research capacity, stimulating scientific collaboration and global partnerships, and working closely with in-country scientists to develop training activities.

Does the FOA encourage involvement of junior or early-stage investigators?

Yes. The FOA explicitly aims to create opportunities for junior and early-stage investigators to conduct NTD research, signaling that mentorship, career development pathways, and meaningful roles for newer investigators are valued components of a strong center application.

Does the FOA mention sample or specimen sharing?

Yes. The FOA highlights enabling sample sharing to accelerate translational research.

What kinds of sample-sharing plans are implied by the FOA?

Applicants should anticipate plans and infrastructure for responsible specimen collection, storage, governance, and access. The intent is to support downstream translational work to develop or evaluate new drugs, diagnostics, vaccines, therapeutics, or vector control strategies, while still staying within the non-clinical-trial limitation.

Who is eligible to apply?

Eligibility is broad and includes U.S. and non-U.S. organizations. The FOA lists eligible applicants such as state, county, city/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 and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities.

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

Yes. Non-domestic (non-U.S.) entities/foreign organizations are explicitly included among eligible applicants.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) and small businesses are listed as eligible applicants.

Are nonprofits eligible even if they do not have 501(c)(3) status?

Yes. Nonprofits with and without 501(c)(3) status are included in the eligibility list.

Are U.S. colleges and universities eligible?

Yes. Public and state-controlled institutions of higher education as well as private institutions of higher education are listed as eligible applicants.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA calls out Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs) among eligible categories.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are included in the additional eligible categories.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among eligible categories.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are included in the eligibility list.

Does the FOA expect multi-institutional or network-style centers?

Yes. The breadth of eligible organizations is consistent with an expectation that successful TMRCs will often be multi-institutional networks combining strong scientific capabilities with on-the-ground partnerships, training capacity, and sustained engagement in endemic settings.

What is the funding activity category for this opportunity?

The opportunity falls under the Health funding activity category.

What CFDA number is associated with this opportunity?

The FOA references CFDA number 93.855.

What was the original posting creation date?

The creation date listed in the provided information is 2021-03-05.

What was the original closing date?

The original closing date listed in the provided information is 2021-06-18.

Is the award ceiling provided in the information here?

No. The award ceiling is not specified in the provided source data.

Is the expected number of awards provided in the information here?

No. The expected number of awards is not specified in the provided source data.

What is the overall intent of the TMRC FOA in plain terms?

Overall, the TMRC FOA supports center-like, collaborative research programs that produce practical, LMIC-ready advances against NTDs while strengthening local research ecosystems, training pipelines, and translational platforms in endemic countries, within a cooperative agreement framework and without conducting clinical trials.