Opportunity Information: Apply for RFA AI 18 046
The Vaccine and Treatment Evaluation Units (VTEUs) (UM1 Clinical Trial Required) funding opportunity (RFA-AI-18-046) is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) cooperative agreement designed to support a network of clinical research sites that can carry out NIAID-led infectious disease clinical research and clinical trials. The core idea is to fund capable, trial-ready units that can implement clinical site protocols and generate high-quality evidence on how well new and existing medical products work in people, with strong emphasis on operational readiness, regulatory compliance, and the ability to enroll and follow participants under rigorous clinical trial standards.
Under this announcement, VTEUs are expected to conduct clinical research and clinical trials evaluating a broad range of countermeasures for infectious diseases. That includes vaccines and other preventive biologics, therapeutics, diagnostics, and associated biomarkers such as prognostic and predictive markers, as well as devices relevant to prevention or treatment. The VTEUs function as the on-the-ground clinical infrastructure for the NIAID Infectious Diseases Clinical Research Consortium (IDCRC), meaning they are the sites where protocols are executed, participants are recruited and managed, study products are administered when applicable, and clinical data and specimens are collected according to protocol and Good Clinical Practice expectations.
A key feature of this program is that it is part of a consortium structure with shared leadership and coordinated scientific direction. A companion funding opportunity supports a separate Leadership Group (LG), which provides the overall administrative and scientific leadership for the consortium. In practice, that means VTEU awardees are not operating as isolated grantees; they are integrated into a coordinated network where studies are planned, prioritized, and overseen collaboratively with NIAID and the LG. Because the mechanism is a cooperative agreement (UM1), NIAID is expected to have substantial involvement in the conduct of the funded activities, including coordination, oversight, and consortium-level decision-making typical of large, multi-site clinical trial networks.
Scientifically, the VTEUs are oriented toward evaluating products in NIAID priority infectious disease areas. The announcement highlights malaria and neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases as primary focus areas. At the same time, the network is explicitly expected to maintain surge capacity for emerging infectious diseases. That surge expectation is important: it signals that beyond steady-state research priorities, these sites should be able to pivot quickly when a new threat arises, ramp up enrollment and trial operations, and support rapid evaluation of relevant vaccines, therapeutics, or diagnostics during outbreaks or public health emergencies.
The opportunity falls under the Health funding activity category and is tied to CFDA number 93.855. The listed award ceiling is $400,000, and the original closing date was February 15, 2019, with a creation date of October 1, 2018. Even without additional details in the excerpt about project period length or exact budget structure, the inclusion of a ceiling communicates that applicants were expected to propose a feasible, well-justified clinical trial support operation within defined cost constraints, consistent with a site-based clinical research unit role within a larger consortium.
Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized) and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments that are not federally recognized, and U.S. territories or possessions.
Foreign eligibility is specifically limited. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement. In practical terms, that usually means a U.S. applicant can include certain foreign activities or collaborations as components of the project when justified and compliant with NIH policy, but the primary awardee organization must be domestic and the core administrative structure cannot be a foreign institution or a foreign branch of a U.S. institution.
Overall, this FOA is about maintaining a standing, highly capable clinical trial site network that can reliably execute NIAID/IDCRC protocols across multiple infectious disease areas, produce credible clinical evidence on vaccines and treatments and related tools, and rapidly scale or redirect effort when emerging infectious disease threats demand urgent clinical evaluation.Apply for RFA AI 18 046
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Vaccine and Treatment Evaluation Units (VTEUs) (UM1 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2018-10-01.
- Applicants must submit their applications by 2019-02-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs): Vaccine and Treatment Evaluation Units (VTEUs) (UM1 Clinical Trial Required) - RFA-AI-18-046
What is this funding opportunity?
This opportunity is the Vaccine and Treatment Evaluation Units (VTEUs) (UM1 Clinical Trial Required) funding opportunity (RFA-AI-18-046). It is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) cooperative agreement intended to support a network of clinical research sites that can carry out NIAID-led infectious disease clinical research and clinical trials.
What is the main goal of the VTEU program?
The main goal is to fund trial-ready clinical research units that can implement clinical site protocols and generate high-quality evidence on how well new and existing medical products work in people. The program emphasizes operational readiness, regulatory compliance, and the ability to enroll and follow participants under rigorous clinical trial standards.
What does VTEU stand for?
VTEU stands for Vaccine and Treatment Evaluation Unit.
What does "UM1 Clinical Trial Required" mean in this context?
The mechanism is a UM1 cooperative agreement where clinical trials are required as part of the funded activities. The award supports clinical site capabilities and performance of infectious disease clinical research and clinical trials as directed through the consortium structure and NIAID involvement described in the announcement.
Is this a grant or a cooperative agreement?
It is a cooperative agreement (UM1). This means NIAID is expected to have substantial involvement in the conduct of the funded activities, including coordination, oversight, and consortium-level decision-making typical of large multi-site clinical trial networks.
How are VTEU awardees expected to work with NIAID?
VTEU awardees are expected to work in a coordinated network with NIAID having substantial involvement, including oversight, coordination, and participation in consortium-level decision-making. The VTEUs are not described as operating independently; they are integrated into a broader consortium structure.
What consortium are the VTEUs part of?
The VTEUs function as the on-the-ground clinical infrastructure for the NIAID Infectious Diseases Clinical Research Consortium (IDCRC). They are the clinical sites where protocols are executed and participants are recruited and managed.
What is the role of the Leadership Group (LG) mentioned in the opportunity?
A companion funding opportunity supports a separate Leadership Group (LG) that provides overall administrative and scientific leadership for the consortium. In practice, this means studies are planned, prioritized, and overseen collaboratively with NIAID and the LG, and VTEUs operate as part of this coordinated structure.
What types of research and trials are VTEUs expected to conduct?
VTEUs are expected to conduct clinical research and clinical trials evaluating a broad range of countermeasures for infectious diseases. This includes vaccines and other preventive biologics, therapeutics, diagnostics, associated biomarkers (such as prognostic and predictive markers), and devices relevant to prevention or treatment.
What are examples of "countermeasures" covered by this program?
Countermeasures described in the announcement include vaccines, other preventive biologics, therapeutics, diagnostics, biomarkers (including prognostic and predictive markers), and devices relevant to infectious disease prevention or treatment.
What clinical site activities are VTEUs expected to perform?
VTEUs are described as the sites where protocols are executed, participants are recruited and managed, study products are administered when applicable, and clinical data and specimens are collected according to protocol and Good Clinical Practice expectations.
What infectious disease areas are highlighted as priorities?
The announcement highlights malaria and neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases as primary focus areas.
Does the program address emerging infectious diseases?
Yes. The network is explicitly expected to maintain surge capacity for emerging infectious diseases, meaning sites should be able to pivot quickly in response to new threats and support rapid evaluation of relevant vaccines, therapeutics, or diagnostics during outbreaks or public health emergencies.
What does "surge capacity" mean for a VTEU?
Based on the description, surge capacity means the ability to rapidly scale or redirect clinical trial operations when an emerging infectious disease threat arises, including ramping up enrollment and trial activities to support urgent evaluation during outbreaks or public health emergencies.
What is the funding activity category for this opportunity?
The opportunity falls under the Health funding activity category.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.855.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $400,000.
What do the posted dates indicate (creation date and closing date)?
The creation date is October 1, 2018, and the original closing date was February 15, 2019.
Who is eligible to apply?
Eligibility is broad for U.S.-based organizations and government entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized) and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Are minority-serving institutions and similar organizations included in eligibility?
Yes. The opportunity explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based, community-based, regional, and federal entities eligible?
Yes. The announcement explicitly includes faith-based or community-based organizations, regional organizations, and eligible federal agencies among eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly listed among eligible applicant categories.
Can foreign (non-U.S.) organizations apply directly?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed in any form?
Yes. Foreign components are allowed as defined by the NIH Grants Policy Statement. This generally means a U.S. applicant may include certain foreign activities or collaborations as components of the project when justified and compliant with NIH policy, but the primary awardee must be domestic.
Is this opportunity intended for standalone projects or networked work?
It is intended for networked work. VTEUs are integrated into a coordinated consortium with shared leadership and coordinated scientific direction, collaborating with NIAID and the Leadership Group (LG).
What is meant by "trial-ready" in the opportunity description?
"Trial-ready" refers to being capable of implementing clinical site protocols and operating under rigorous clinical trial standards, including strong operational readiness, regulatory compliance, and the ability to enroll and follow participants while producing high-quality clinical evidence.
What quality or compliance standards are emphasized?
The announcement emphasizes regulatory compliance and indicates that clinical data and specimens are collected according to protocol and Good Clinical Practice expectations.
What is the overall purpose of funding VTEUs through this FOA?
The overall purpose is to maintain a standing, highly capable clinical trial site network that can reliably execute NIAID/IDCRC protocols across multiple infectious disease areas, produce credible clinical evidence on vaccines, treatments, and related tools, and rapidly scale or redirect effort when emerging infectious disease threats require urgent clinical evaluation.
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