Opportunity Information: Apply for PAR 18 657
The National Institutes of Health (NIH) funding opportunity PAR-18-657 supports the creation or continuation of Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence using the U54 cooperative agreement mechanism, with clinical trials allowed but not required (clinical trial optional). The overall purpose of the CounterACT program is to accelerate research and development of medical countermeasures, specifically therapeutics that could treat or mitigate harm from dangerous chemical exposures. The program is framed around real-world chemical threats that may arise from deliberate attacks (for example, terrorism) or from accidental releases tied to industrial manufacturing, storage, or transportation.
The FOA defines chemical threats broadly, covering classic chemical warfare agents as well as toxic industrial chemicals, pharmaceutical-based agents, and pesticides. Funded work is meant to push promising ideas along a translational pipeline, starting with identifying and characterizing biological targets and candidate therapeutics, then optimizing those candidates, and ultimately demonstrating in vivo efficacy in a way that matches the product's intended use in humans. For renewal applications in particular, the NIH signals an expectation that the research will mature to the point of producing an optimized lead compound that is ready for advanced development, meaning the center should be positioned to hand off a refined candidate for later-stage preclinical development and eventual regulatory-facing steps.
Structurally, each Center of Excellence is required to be more than a single-project award. The center must include at least three distinct research projects, all coordinated through an administrative core. In addition, applicants may propose up to three optional scientific cores that provide shared capabilities (such as specialized assays, animal models, chemistry support, or other centralized resources) to improve efficiency and consistency across projects. A research education core is also required, reflecting a program goal of developing talent, expertise, and a sustained workforce able to conduct countermeasure research over time.
A key feature of the FOA is its emphasis on milestone-driven translational planning. Each research project must include clear, discrete milestones that function as go/no-go decision points. In practice, this means the proposed work should be organized so that progress can be objectively evaluated at critical stages (for example, demonstrating target engagement, meeting potency or selectivity thresholds, confirming pharmacokinetic properties, or achieving predefined efficacy endpoints in relevant in vivo models). This milestone structure is intended to keep projects focused on outcomes that meaningfully reduce development risk, and to ensure that resources are concentrated on candidates that continue to meet performance criteria as the work advances.
From an administrative perspective, the award is a cooperative agreement, which typically indicates substantial NIH program involvement compared with a standard research project grant. The activity category spans education, environment, health, and related human services domains, and the listing includes multiple CFDA numbers: 93.113, 93.279, 93.846, 93.853, 93.865, and 93.867. The opportunity was created on February 13, 2018, and the original closing date listed is October 8, 2020. The award ceiling shown is $2,000,000, and the agency is NIH.
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized. Academic eligibility includes public and state-controlled institutions of higher education and private institutions of higher education. Organizational eligibility extends to nonprofits with and without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses. The FOA also explicitly mentions additional categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
At the same time, the FOA draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign collaborations or subcomponents if they meet NIH policy requirements and are justified within the scientific plan.
Overall, the opportunity is designed for teams capable of running a coordinated, multi-project center that can move potential therapies from early discovery through optimization and proof-of-concept in vivo testing, using rigorous milestones to guide continuation decisions. The program focus is not simply on basic science about toxic chemicals, but on producing tangible therapeutic candidates and development-ready outcomes that improve national readiness for chemical emergencies.Apply for PAR 18 657
- The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.279, 93.846, 93.853, 93.865, 93.867.
- This funding opportunity was created on 2018-02-13.
- Applicants must submit their applications by 2020-10-08. (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 $2,000,000.00 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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FAQs: NIH PAR-18-657 CounterACT Research Centers of Excellence (U54)
What is PAR-18-657?
PAR-18-657 is an NIH funding opportunity announcement that supports the creation or continuation of Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence using the U54 cooperative agreement mechanism.
What is the main purpose of this funding opportunity?
The purpose is to accelerate research and development of medical countermeasures, specifically therapeutics intended to treat or mitigate harm caused by dangerous chemical exposures. The program is oriented toward real-world threats, including deliberate chemical attacks (such as terrorism) and accidental chemical releases related to industrial manufacturing, storage, or transportation.
What kinds of chemical threats are in scope?
The FOA defines chemical threats broadly. It includes classic chemical warfare agents as well as toxic industrial chemicals, pharmaceutical-based agents, and pesticides.
Is the program focused on basic research or translational product development?
The emphasis is translational. Funded work is intended to move promising ideas along a pipeline: identifying and characterizing biological targets and candidate therapeutics, optimizing those candidates, and demonstrating in vivo efficacy aligned with the candidate's intended use in humans.
Are clinical trials required?
No. Clinical trials are allowed but not required. The FOA is described as "clinical trial optional."
What is the expected endpoint or deliverable for funded Centers?
The FOA emphasizes producing tangible therapeutic candidates and development-ready outcomes. For renewal applications in particular, NIH signals an expectation that research matures to an optimized lead compound that is ready for advanced development and positioned for handoff into later-stage preclinical development and eventual regulatory-facing steps.
What does it mean that this is a U54 cooperative agreement?
A U54 is a cooperative agreement mechanism. The FOA notes that this typically indicates substantial NIH program involvement compared with a standard research project grant.
How must a CounterACT Research Center of Excellence be structured?
Each Center must be more than a single-project award. It is required to include at least three distinct research projects that are coordinated through an administrative core.
Is an administrative core required?
Yes. The Center's projects must be coordinated through an administrative core, making it a required component of the overall structure.
Are scientific cores allowed or required?
Applicants may propose up to three optional scientific cores. These shared cores can provide centralized capabilities (for example, specialized assays, animal models, chemistry support, or other shared resources) to improve efficiency and consistency across projects.
Is there an education or training component required?
Yes. A research education core is required. This reflects the program goal of developing talent and sustaining a workforce with expertise in medical countermeasure research over time.
What does "milestone-driven translational planning" mean in this FOA?
Each research project must include clear, discrete milestones that function as go/no-go decision points. The proposed work should be organized so progress can be evaluated objectively at critical stages.
What are examples of milestones or go/no-go criteria mentioned?
The FOA describes milestones such as demonstrating target engagement, meeting potency or selectivity thresholds, confirming pharmacokinetic properties, or achieving predefined efficacy endpoints in relevant in vivo models.
Why does the FOA emphasize milestones?
The milestone structure is intended to keep projects focused on outcomes that reduce development risk and to ensure resources are concentrated on candidates that continue to meet performance criteria as the work advances.
Does the FOA require in vivo efficacy testing?
The FOA indicates that funded work should ultimately demonstrate in vivo efficacy in a way that matches the product's intended use in humans as part of the translational pipeline.
Who is the funding agency for this opportunity?
The agency is the National Institutes of Health (NIH).
What is the award ceiling listed for this opportunity?
The award ceiling shown is $2,000,000.
When was this opportunity created and what is the closing date shown?
The opportunity was created on February 13, 2018. The original closing date listed is October 8, 2020.
Which CFDA numbers are associated with this opportunity?
The listing includes multiple CFDA numbers: 93.113, 93.279, 93.846, 93.853, 93.865, and 93.867.
What activity categories are associated with the opportunity?
The activity category spans education, environment, health, and related human services domains.
What types of U.S. government entities are eligible to apply?
Eligibility includes state governments, county governments, city or township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education as well as private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Eligibility includes nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.
Are minority-serving institutions and other special categories included in eligibility?
Yes. The FOA explicitly mentions Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly mentioned among eligible categories.
Are federal agencies, regional organizations, and U.S. territories eligible?
Yes. The FOA mentions eligible federal agencies, regional organizations, and U.S. territories or possessions.
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.
Can a U.S. organization apply if it has a non-domestic component?
Non-domestic components of U.S. organizations are not eligible to apply. However, the FOA states that foreign components are allowed as defined in the NIH Grants Policy Statement, meaning certain foreign collaborations or subcomponents may be included if consistent with NIH policy and justified in the scientific plan.
What is the overall program goal beyond individual projects?
The FOA is designed for coordinated teams capable of running a multi-project center that moves potential therapies from early discovery through optimization and proof-of-concept in vivo testing. The broader goal is national readiness for chemical emergencies by advancing practical therapeutic countermeasures.
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