CCRP Initiative: Chemical Threat Agent Exposure Resource and Coordination Core (ExRC) (U2C Clinical Trial Not Allowed) | RFA ES 23 009

Frequently Asked Questions (FAQs) - RFA-ES-23-009 (NIH Cooperative Agreement)

What is RFA-ES-23-009 funding?

RFA-ES-23-009 is a National Institutes of Health (NIH) cooperative agreement to create and operate a Chemical Threat Agent Exposure Resource and Coordination Core (ExRC). The intent is to build a shared, service-oriented core that supports the Chemical Countermeasures Research Program (CCRP) by providing infrastructure, coordination, and technical support for studies involving specific Chemicals of Concern (CoC).

Is this opportunity meant to fund a single research project?

No. The central goal is not to support one standalone research project. The award is designed to establish an enabling hub (the ExRC) that provides exposure-related capabilities and coordination services that multiple CCRP-funded investigators can use.

What is the ExRC (Chemical Threat Agent Exposure Resource and Coordination Core)?

The ExRC is a shared resource core intended to help CCRP investigators generate consistent, high-quality exposure data and conduct early-stage work related to chemical threat agent exposures. It is described as an infrastructure and service platform rather than an individual research effort.

What is the main purpose of the ExRC?

The ExRC is meant to function as an enabling hub for CCRP research by providing practical exposure capabilities, standardized protocols for selected toxicants, and coordination/technical support so investigators can use comparable methods and measurements across studies.

What kinds of activities is the ExRC expected to support?

Based on the description, the ExRC is expected to support activities such as building and providing practical exposure capabilities, developing and harmonizing standardized exposure protocols for selected Chemicals of Concern, coordinating service requests and scheduling, supporting quality control to improve consistency of exposure data, and enabling controlled exposure studies that help characterize disease processes and injury mechanisms.

What are "Chemicals of Concern" (CoC) in this context?

"Chemicals of Concern" refers to specific toxicants or chemical threat agents prioritized within CCRP research efforts. The ExRC is intended to support studies involving these selected chemicals by helping create standardized exposure approaches and comparable measurements.

Does the FOA allow clinical trials?

No. Clinical trials are explicitly not allowed under this U2C mechanism, which reinforces that the focus is on preclinical and translational groundwork rather than human testing.

What stage of research is this FOA focused on?

The emphasis is on preclinical and translational groundwork, including generating consistent exposure data, characterizing pathophysiological mechanisms, and supporting early-stage countermeasure development in controlled exposure settings.

How does the ExRC help with understanding health effects from chemical threat agents?

The ExRC is expected to provide access to facilities and resources that allow investigators to use diverse experimental models to characterize how chemical threat agents drive disease processes and injury mechanisms (pathophysiological mechanisms). Standardized exposure protocols and comparable measurements are central to this goal.

How does the ExRC relate to chemical countermeasure development?

The core is intended to help accelerate early-stage countermeasure development by supporting studies that can screen, refine, or evaluate candidate interventions in controlled exposure settings. The work is described as early-stage support rather than clinical testing.

Why is this a cooperative agreement, and what does that mean for awardees?

This opportunity uses a cooperative agreement funding instrument, and NIH anticipates substantial programmatic involvement. In practice, that means the awardee is likely to coordinate closely with NIH/CCRP staff and align the ExRC priorities, services, and workflows with CCRP program needs.

Is NIH expected to be involved in how the ExRC operates?

Yes. Because it is a cooperative agreement, NIH expects substantial programmatic involvement, suggesting ongoing coordination with NIH/CCRP staff regarding priorities, services, and workflows.

Is the ExRC intended to serve multiple CCRP investigators?

Yes. The ExRC is described as a shared, service-oriented core that CCRP-funded investigators can rely on for exposure-related infrastructure, coordination, and technical support rather than each lab creating its own specialized setup.

What kinds of coordination services are implied for the ExRC?

The description suggests the core may coordinate scheduling, service requests, protocol harmonization, and quality control. It also notes the potential for training or consultation to help CCRP researchers conduct exposure-related studies reliably.

Is geographic accessibility important for this core?

Yes. The FOA signals that the ExRC should be established across diverse geographic regions, indicating an emphasis on broad accessibility and the ability to serve investigators in different locations.

Who is eligible to apply?

Eligibility is broad and includes domestic organizations such as state, county, and local governments; 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 (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in the nonprofit categories as specified); for-profit organizations other than small businesses; and small businesses.

Are specific institution types called out as eligible?

Yes. The announcement highlights additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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.

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

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicants.

Can a U.S. applicant include foreign components or activities?

Yes, foreign components are allowed as defined in the NIH Grants Policy Statement. This generally means a domestic applicant may include certain foreign collaborations or activities if justified and permitted under NIH policy.

What is the funding instrument for this opportunity?

This is a discretionary funding opportunity using the cooperative agreement funding instrument.

What is the program area or category of this opportunity?

The opportunity is categorized under environment and health activities.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.113, 93.853, 93.855, and 93.867.

What is the award ceiling?

The stated award ceiling is $750,000.

How many awards will NIH make?

The number of expected awards is not specified in the provided information.

When was this opportunity created and when did it close?

The opportunity was created on June 21, 2023, with an original closing date of September 28, 2023.

What is the biggest takeaway for applicants considering this FOA?

The key point is that NIH is looking for an organization to build and operate a shared exposure resource and coordination core that serves CCRP-funded investigators, emphasizing standardized exposure capabilities and comparable data generation for Chemicals of Concern, with substantial NIH program involvement and no clinical trials allowed.