Opportunity Information: Apply for RFA NS 19 025
The HEAL Initiative: Early Phase Pain Investigation Clinical Network (EPPIC-Net) - Specialized Clinical Centers funding opportunity (RFA-NS-19-025) is a National Institutes of Health (NIH) cooperative agreement (U24) designed to build out the Specialized Clinical Centers, also described as "hubs," that will anchor a national network focused on improving how new pain treatments are evaluated in humans. EPPIC-Net is positioned as a major component of the NIH Helping to End Addiction Long-term (HEAL) Initiative, with an emphasis on accelerating the development of effective, non-addictive pain therapeutics. The core idea is to stand up a ready-to-use, high-functioning clinical research infrastructure that can quickly move promising pain therapeutics into rigorous early-to-mid-stage human testing, while also generating better biological and clinical measurements that help explain why treatments work for some patients and not others.
Functionally, this opportunity is about creating a network that can do two things well and do them quickly: (1) run in-depth phenotyping and biomarker studies in people who have clearly defined pain conditions, and (2) design and execute high-quality Phase 2 clinical trials to evaluate novel pain therapeutics that may come from academic labs, industry partners, or other HEAL-related development pipelines. The emphasis on well-defined pain conditions and "high unmet therapeutic needs" signals that hubs are expected to focus on patient groups where current treatment options are limited, outcomes are poor, or mechanisms are not well understood. The goal is not just to test therapies, but to learn from patients in a structured way that improves trial design, target selection, and the ability to match therapies to the right pain subtypes.
EPPIC-Net is structured as a coordinated national system with three main components: one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and about 10 Specialized Clinical Centers (the hubs funded under this announcement). The CCC and DCC are competed under separate NIH announcements, while this specific FOA supports the hub sites that will recruit and enroll participants, carry out network studies, and serve as regional centers of excellence for particular pain conditions. In practice, a hub is expected to be a strong clinical research site, typically a regional medical center, with direct access to relevant patient populations and demonstrated expertise in characterizing the targeted pain condition(s). That expertise includes the clinical depth to define cohorts precisely and the operational capability to implement standardized assessments and biomarker collections across participants.
A defining feature of the hub model is that each hub is not a single isolated site. It is expected to provide scientific leadership and administrative oversight for a connected group of "spokes" (typically 2 to 10 satellite sites). This hub-and-spoke design is meant to expand recruitment capacity, improve geographic and demographic reach, and enable consistent execution of protocols across multiple care settings. The hub leads help ensure that spokes follow harmonized procedures, meet performance targets, and maintain research quality, while the network-wide coordinating centers align operations and data standards across all hubs nationally.
The funding instrument is a cooperative agreement, which usually means NIH program staff will have substantial involvement in the project beyond standard grant oversight. This aligns with the purpose of building a unified network that can rapidly stand up studies, adopt common data elements, and maintain consistent trial and biomarker methodologies across institutions. Although the network is intended to support Phase 2 clinical trials, the FOA title specifies "Clinical Trial Not Allowed," which generally indicates that the award itself is aimed at establishing and operating the infrastructure and readiness capabilities at hubs rather than having the hub award be the direct mechanism under which a clinical trial is formally conducted. The network may still conduct clinical trials through EPPIC-Net via other linked mechanisms and sources, including HEAL Partnership inputs or other NIH announcements, but this particular hub award is framed around supporting the specialized center role within the network.
Eligibility is broad and includes many organization types that can support clinical research infrastructure, such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and a range of government entities (state, county, city/township, special districts), as well as eligible Native American tribal governments and organizations and certain public housing authorities. This wide eligibility reflects the reality that clinical research capacity and specialized pain programs can live in many institutional settings, including academic medical centers, integrated health systems, and large regional hospitals with research arms.
Key administrative details include that the opportunity was issued by the U.S. Department of Health and Human Services, National Institutes of Health, with a creation date of December 10, 2018, and an original closing date of February 6, 2019. NIH anticipated making approximately 10 awards, consistent with the plan for roughly 10 hubs nationwide. The listing shows an award ceiling of $150,000, which should be interpreted in the context of the specific budget rules and project periods described in the full FOA, but it indicates a capped level at least for the amount represented in the summary data. The CFDA program numbers listed span multiple NIH institutes and programs, reinforcing that pain research and HEAL activities cut across several NIH components.
Overall, the opportunity is best understood as an effort to professionalize and scale early-phase pain research by funding specialized hub centers that can consistently identify the right patients, measure pain and related biology in a deeper and more standardized way, and plug efficiently into a national pipeline for Phase 2 testing of novel therapeutics. The hubs are the patient-facing engine of the network: they supply enrollment, clinical expertise, and local-to-regional site management through their spokes, while the coordinating centers provide centralized operational and data backbone support so that studies can be launched rapidly and interpreted reliably across the entire EPPIC-Net system.Apply for RFA NS 19 025
- 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 - Specialized Clinical Centers (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.
- 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.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 10 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).
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Frequently Asked Questions (FAQs)
What is the HEAL Initiative: EPPIC-Net Specialized Clinical Centers funding opportunity (RFA-NS-19-025)?
This opportunity is a National Institutes of Health (NIH) cooperative agreement (U24) intended to fund Specialized Clinical Centers, also called "hubs," for the HEAL Initiative's Early Phase Pain Investigation Clinical Network (EPPIC-Net). The purpose is to build a national, ready-to-use clinical research infrastructure that can accelerate early-to-mid-stage testing of promising non-addictive pain therapeutics in humans and improve the measurements used to understand pain and treatment response.
What is EPPIC-Net and how does it fit into the HEAL Initiative?
EPPIC-Net is positioned as a major component of the NIH Helping to End Addiction Long-term (HEAL) Initiative. It focuses on improving how new pain treatments are evaluated in people, with an emphasis on accelerating the development of effective, non-addictive pain therapeutics.
What is the main goal of funding Specialized Clinical Centers ("hubs")?
The goal is to establish strong, high-functioning hub sites that can quickly support network studies by recruiting and enrolling participants, implementing standardized clinical and biomarker assessments, and serving as regional centers of excellence for specific pain conditions. These hubs are meant to be the patient-facing engine of the national network.
What kinds of activities is the network designed to do quickly and well?
EPPIC-Net is designed to excel in two areas: (1) conducting in-depth phenotyping and biomarker studies in people with clearly defined pain conditions, and (2) designing and executing high-quality Phase 2 clinical trials to evaluate novel pain therapeutics, including those originating from academic labs, industry partners, or other HEAL-related pipelines.
What does it mean that hubs should focus on "well-defined pain conditions" and "high unmet therapeutic needs"?
It means hub sites are expected to concentrate on patient groups where current treatment options are limited, outcomes are poor, or pain mechanisms are not well understood. The intent is not only to test therapies, but also to learn from patients in a structured way that improves trial design, target selection, and the ability to match therapies to specific pain subtypes.
How is EPPIC-Net structured nationally?
EPPIC-Net is described as a coordinated national system with three main components: one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and about 10 Specialized Clinical Centers (the hubs funded under this announcement). The CCC and DCC are competed under separate NIH announcements.
What is the role of the Specialized Clinical Centers ("hubs") within EPPIC-Net?
The hubs are responsible for recruiting and enrolling participants, carrying out network studies, and serving as regional centers of excellence for particular pain conditions. Hubs are expected to have direct access to relevant patient populations and demonstrated expertise in characterizing the targeted pain condition(s), including the ability to define cohorts precisely and implement standardized assessments and biomarker collections.
What is the hub-and-spoke model described in this opportunity?
Each hub is expected to provide scientific leadership and administrative oversight for a connected group of "spokes," typically 2 to 10 satellite sites. This hub-and-spoke model is intended to expand recruitment capacity, improve geographic and demographic reach, and enable consistent protocol execution across multiple care settings.
What are "spokes" in the context of EPPIC-Net?
Spokes are satellite sites affiliated with a hub. They help increase participant recruitment and broaden reach. The hub leads are expected to ensure spokes follow harmonized procedures, meet performance targets, and maintain research quality.
What is a cooperative agreement (U24), and why does it matter here?
This opportunity uses a cooperative agreement (U24), which typically indicates substantial involvement by NIH program staff beyond standard grant oversight. That approach aligns with building a unified national network that can rapidly stand up studies, adopt common data elements, and maintain consistent trial and biomarker methodologies across institutions.
Does this funding opportunity allow clinical trials?
The FOA title specifies "Clinical Trial Not Allowed." Based on the description provided, this indicates the award is aimed at establishing and operating hub infrastructure and readiness capabilities rather than serving as the direct mechanism under which a clinical trial is formally conducted.
If "Clinical Trial Not Allowed," how does EPPIC-Net support Phase 2 trials?
EPPIC-Net is intended to support Phase 2 clinical trials as part of the broader network. The provided description indicates that trials may still be conducted through EPPIC-Net via other linked mechanisms and sources (including HEAL Partnership inputs or other NIH announcements), even if this specific hub award is framed around the specialized center role and infrastructure.
Who is the funding agency for this opportunity?
The opportunity was issued by the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH).
When was this opportunity created and when did it close?
The creation date listed is December 10, 2018, and the original closing date listed is February 6, 2019.
How many awards were anticipated?
NIH anticipated making approximately 10 awards, consistent with the plan for roughly 10 hubs nationwide.
What is the award ceiling mentioned in the summary?
The listing shows an award ceiling of $150,000. The description notes this should be interpreted in the context of the full FOA's specific budget rules and project periods, but it indicates a capped level at least for the amount represented in the summary data.
What types of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and a range of government entities (state, county, city/township, special districts). Eligibility also includes eligible Native American tribal governments and organizations and certain public housing authorities.
Why is eligibility so broad for this program?
The description suggests broad eligibility reflects that clinical research capacity and specialized pain programs can exist in many institutional settings, including academic medical centers, integrated health systems, and large regional hospitals with research arms.
What kind of institution typically serves as a hub?
A hub is expected to be a strong clinical research site, typically a regional medical center, with direct access to relevant patient populations and demonstrated expertise in the targeted pain condition(s), along with operational capability to implement standardized assessments and biomarker collections.
What makes these hubs different from independent research sites?
Hubs are designed to operate as part of a coordinated national system and are expected to oversee multiple spoke sites. They also work within network-wide coordination for operations and data standards through the CCC and DCC, enabling rapid study launch and consistent interpretation across the network.
What does "phenotyping" mean in this program's context?
In this context, phenotyping refers to in-depth characterization of people with clearly defined pain conditions using standardized clinical assessments and related measures, often paired with biomarker work, to better understand pain subtypes and differences in treatment response.
What are biomarkers used for in EPPIC-Net?
Biomarker studies are emphasized as a way to generate better biological and clinical measurements that help explain why treatments work for some patients and not others, supporting improved trial design and the potential to match therapies to the right pain subtypes.
Where do the pain therapeutics tested by the network come from?
The network is intended to evaluate novel pain therapeutics that may come from academic laboratories, industry partners, or other HEAL-related development pipelines.
What are the CCC and DCC, and are they funded under this opportunity?
The Clinical Coordinating Center (CCC) and the Data Coordinating Center (DCC) are central network components. They are competed under separate NIH announcements, while this specific opportunity supports the Specialized Clinical Centers (hubs).
What is the relationship between hubs and the coordinating centers?
Hubs conduct participant-facing activities such as enrollment and study execution (including managing spoke sites), while the coordinating centers provide centralized operational support and a data backbone. Together, this structure is meant to allow studies to be launched rapidly and interpreted reliably across the national network.
What do the CFDA program numbers indicate for this opportunity?
The CFDA program numbers listed span multiple NIH institutes and programs, which reinforces that pain research and HEAL-related activities involve multiple components across NIH.
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