Opportunity Information: Apply for RFA NS 19 023

The HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (CCC) funding opportunity (RFA-NS-19-023) is a National Institutes of Health (NIH) cooperative agreement (U24) intended to stand up and run the central coordinating “engine” for a national pain research network called EPPIC-Net. EPPIC-Net is positioned as a key piece of the NIH Helping to End Addiction Long-term (HEAL) Partnership, with the broader goal of accelerating the development of safer, more effective treatments for pain and reducing reliance on opioids. The focus of the network is early phase, patient-centered pain research that can move efficiently from identifying the right patient subgroups and biological signals to testing promising treatments in well-executed Phase 2 studies.

At the heart of this program is the idea that pain is not a single condition, and that progress depends on studying carefully defined pain populations with significant unmet medical need. EPPIC-Net is designed to provide a ready-to-use national infrastructure that supports deep clinical phenotyping (detailed characterization of patients, symptoms, function, comorbidities, and other clinically meaningful features) and biomarker work (measures that may help identify mechanisms of pain, classify patients into more precise subgroups, or predict treatment response). With that foundation, the network is also meant to rapidly design and implement high-quality Phase 2 clinical studies to evaluate novel therapeutics, including candidates coming from academic investigators, industry partners, the HEAL Partnership itself, or other NIH initiatives.

Structurally, EPPIC-Net is made up of three major components: a single Clinical Coordinating Center (the subject of this FOA), a single Data Coordinating Center (DCC, solicited under a separate FOA), and roughly 10 specialized clinical centers referred to as Hubs (also solicited under a separate FOA). The CCC is intended to function as the operational and scientific coordination hub for the network’s clinical activities. In practical terms, the CCC is expected to help shape study concepts into workable protocols, coordinate across multiple clinical sites, and facilitate smooth study execution so that trials and related studies can be launched quickly and conducted consistently across the network. While the DCC is responsible for the core data management and related analytics infrastructure, and the Hubs provide the patient access and disease-area expertise, the CCC is the place where the moving parts come together on the clinical operations side so that studies run on time, on budget, and to high quality standards.

The award mechanism is a cooperative agreement, which generally means NIH is expected to have substantial programmatic involvement rather than acting only as a passive funder. That fits the network model described here: NIH is building a coordinated national platform that can run multiple studies over time, not just funding a single stand-alone project. The FOA indicates that the CCC will “help design and facilitate the implementation” of clinical trials and studies, reflecting a hands-on role in organizing and enabling network research rather than simply conducting independent research in isolation.

Although the title includes “Clinical Trial Not Allowed” for the U24 application itself, the purpose of the network explicitly includes supporting and conducting Phase 2 clinical trials through EPPIC-Net once the infrastructure is in place. In other words, the CCC award is for creating and operating the coordinating infrastructure and functions; the actual interventional trials are expected to be run through the network structure and may be supported through HEAL or other NIH pathways, consistent with how large NIH clinical research networks are typically organized.

Eligibility is broad and includes many common applicant types that can credibly operate a national coordinating center. Eligible applicants listed 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; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other entities as described in NIH’s additional eligibility information. The sponsoring agency is the Department of Health and Human Services (HHS), National Institutes of Health. The opportunity was created on December 10, 2018, with an original closing date of February 6, 2019. The posting indicates an expected number of awards of one, consistent with the plan to fund a single CCC for the entire network, and lists an award ceiling of 0, which typically signals that a fixed maximum was not specified in that field rather than implying no funding.

In short, this FOA funds the centralized Clinical Coordinating Center that makes EPPIC-Net workable as a national platform. The CCC is expected to enable efficient multi-site early phase pain research by coordinating protocol development and study implementation across specialized clinical hubs, in close alignment with NIH’s HEAL priorities. The end goal is a faster, more reliable path from understanding pain subtypes and biomarkers to running rigorous Phase 2 tests of promising non-addictive pain therapeutics in the patient populations that most need better options.

  • The Department of Health and Human Services, National Institutes of Health in the education, food and nutrition, health sector is offering a public funding opportunity titled "HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trial Not Allowed" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.279, 93.361, 93.393, 93.846, 93.847, 93.853, 93.867, 93.879.
  • This funding opportunity was created on Dec 10, 2018.
  • Applicants must submit their applications by Feb 06, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The number of recipients for this funding is limited to 1 candidate(s).
  • 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 (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA NS 19 023

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Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the HEAL Initiative: Early Phase Pain Investigation Clinical Network (EPPIC-Net) - Clinical Coordinating Center (CCC) funding opportunity, RFA-NS-19-023. It is an NIH cooperative agreement using the U24 activity code.

Which federal agency is offering this award?

The sponsoring agency is the Department of Health and Human Services (HHS), National Institutes of Health (NIH).

What is EPPIC-Net?

EPPIC-Net is a national pain research network designed to support early phase, patient-centered pain research. It is positioned as a key component of the NIH Helping to End Addiction Long-term (HEAL) Partnership, with an emphasis on accelerating safer, more effective pain treatments and reducing reliance on opioids.

What is the overall purpose of EPPIC-Net?

The network is intended to move efficiently from identifying the right pain patient subgroups and biological signals (including biomarkers) to testing promising treatments in well-executed Phase 2 clinical studies.

Why does the program emphasize patient subgroups and pain phenotyping?

The program is built around the idea that pain is not a single condition. Progress depends on studying carefully defined pain populations with significant unmet medical need. The network supports deep clinical phenotyping to characterize patients in clinically meaningful ways (such as symptoms, function, and comorbidities).

What kinds of research capabilities is EPPIC-Net designed to provide?

EPPIC-Net is designed to provide a ready-to-use national infrastructure that supports deep clinical phenotyping and biomarker work, and then uses that foundation to rapidly design and implement high-quality Phase 2 clinical studies of novel therapeutics.

What are "biomarkers" in the context of this opportunity?

In this program, biomarkers are measures that may help identify mechanisms of pain, classify patients into more precise subgroups, or predict treatment response.

What is the Clinical Coordinating Center (CCC)?

The CCC is the central coordinating "engine" for EPPIC-Net's clinical activities. It is intended to function as the operational and scientific coordination hub that helps make multi-site clinical studies run efficiently and consistently across the network.

What does the CCC do in practical terms?

Based on the description provided, the CCC is expected to help shape study concepts into workable protocols, coordinate across multiple clinical sites, and facilitate smooth study execution so that studies can be launched quickly and conducted consistently across the network.

How is EPPIC-Net structured?

EPPIC-Net is described as having three major components: a single Clinical Coordinating Center (CCC), a single Data Coordinating Center (DCC, under a separate FOA), and roughly 10 specialized clinical centers referred to as Hubs (also under a separate FOA).

Is this award funding the Data Coordinating Center (DCC) or the clinical Hubs?

No. This specific opportunity is for the single Clinical Coordinating Center (CCC). The DCC and the Hubs are solicited under separate funding opportunities.

How does the CCC differ from the Data Coordinating Center (DCC)?

As described, the DCC is responsible for core data management and related analytics infrastructure. The CCC is where the clinical operations "moving parts" come together to coordinate protocol development and clinical study implementation across multiple sites.

How does the CCC relate to the clinical Hubs?

The Hubs are described as specialized clinical centers that provide patient access and disease-area expertise. The CCC coordinates across these sites to support consistent, efficient execution of studies across the network.

What stage of clinical research is emphasized by EPPIC-Net?

The network focus is early phase, patient-centered pain research, with a specific emphasis on designing and implementing rigorous Phase 2 clinical studies to evaluate novel therapeutics.

What types of therapeutics might be evaluated through the network?

The network is meant to evaluate novel therapeutics, including candidates coming from academic investigators, industry partners, the HEAL Partnership itself, or other NIH initiatives.

What is the relationship between this program and opioid reduction goals?

The network is positioned within the HEAL Partnership, with the broader goal of accelerating safer and more effective treatments for pain and reducing reliance on opioids.

What funding mechanism is used for the CCC?

The CCC award mechanism is a cooperative agreement (U24).

What does it mean that this is a cooperative agreement?

A cooperative agreement generally indicates that NIH is expected to have substantial programmatic involvement. This fits the network model described, where NIH is building a coordinated national platform intended to run multiple studies over time.

The opportunity says "Clinical Trial Not Allowed." Does that mean no trials will happen?

The "Clinical Trial Not Allowed" label applies to the U24 application itself, which is for creating and operating the coordinating infrastructure and functions. The network's purpose explicitly includes supporting and conducting Phase 2 clinical trials through EPPIC-Net once the infrastructure is in place.

So what is actually being funded under this CCC award?

This award funds the centralized coordinating infrastructure and operational functions needed to make EPPIC-Net work as a national platform, including clinical coordination activities such as protocol development support and multi-site implementation coordination.

How many CCC awards does NIH expect to make?

The posting indicates an expected number of awards of one, consistent with the plan to fund a single CCC for the entire network.

Who is eligible to apply?

Eligibility is described as broad. Eligible applicants listed 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; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other entities as described in NIH's additional eligibility information.

Is industry eligible to apply?

Yes. The eligibility list includes for-profit organizations (other than small businesses) and small businesses.

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

Yes. The eligibility list includes nonprofit organizations with or without 501(c)(3) status.

Are tribal governments and tribal organizations eligible?

Yes. Tribal governments and tribal organizations are explicitly listed among eligible applicants.

What are the key dates mentioned for this opportunity?

The opportunity was created on December 10, 2018, with an original closing date of February 6, 2019.

What is the award ceiling?

The posting lists an award ceiling of 0. As described in the opportunity summary provided, this typically signals that a fixed maximum was not specified in that field rather than implying no funding.

What is the main goal of funding a single national CCC?

The goal is to enable efficient, high-quality multi-site early phase pain research by coordinating protocol development and study implementation across specialized clinical hubs, aligned with NIH HEAL priorities.

What is the intended long-term outcome of EPPIC-Net?

The end goal described is a faster, more reliable path from understanding pain subtypes and biomarkers to running rigorous Phase 2 tests of promising non-addictive pain therapeutics in patient populations that most need better options.

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