HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed) | RFA NS 19 036

Opportunity Information: Apply for RFA NS 19 036

The HEAL Initiative: Early Phase Pain Investigation Clinical Network (EPPIC-Net) Specialized Clinical Centers opportunity (RFA-NS-19-036) is a National Institutes of Health (NIH) cooperative agreement (U24) aimed at building out the hub sites for a national clinical research network focused on accelerating the development of non-addictive pain therapeutics. This announcement is a reissue of an earlier solicitation to add an additional application receipt date, and it sits under the NIH Helping to End Addiction Long-term (HEAL) Initiative, which is a major federal effort to improve pain management and reduce reliance on opioids by speeding better treatment options into clinical testing.

EPPIC-Net is designed to function as a standing, ready-to-use infrastructure that can quickly launch rigorous early phase studies in clearly defined pain populations. The network emphasizes deep clinical characterization of participants (often described as intensive phenotyping) along with biomarker research, so that trials are not only testing whether a treatment works, but also learning which patient subgroups respond, how to measure meaningful biological or functional change, and how to improve trial design for future studies. A key emphasis is on pain conditions with high unmet need, meaning areas where current therapies are limited, ineffective, or carry unacceptable risks.

Structurally, EPPIC-Net is envisioned as a coordinated national system made up of three main components: a single Clinical Coordinating Center (CCC), a single Data Coordinating Center (DCC), and roughly 10 Specialized Clinical Centers, also called hubs. This specific funding opportunity is only for the hub sites. Separate NIH announcements solicit applications for the CCC (RFA-NS-18-036) and the DCC (RFA-NS-18-035), and the hubs are expected to work closely with those coordinating centers once awards are made. The cooperative agreement mechanism matters because it typically involves substantial NIH programmatic involvement during execution, with NIH working collaboratively with awardees on governance, prioritization, and operational decisions, rather than operating as a hands-off grant.

The Specialized Clinical Centers (hubs) are expected to be the primary patient-facing engines of the network. In practice, a hub is usually a regional medical center or comparable clinical research institution with the ability to recruit and enroll participants into EPPIC-Net studies and to deliver high-quality clinical research operations. Hubs are expected to have direct access to specific pain patient populations and demonstrated expertise in diagnosing, characterizing, and managing those pain conditions. Beyond running studies locally, each hub also provides leadership and oversight for a set of affiliated satellite sites known as spokes, generally ranging from 2 to 10 spokes per hub. This hub-and-spoke model is meant to broaden reach, speed enrollment, improve geographic and demographic diversity, and allow research to be conducted efficiently across multiple care settings while maintaining consistent standards.

From a research activity standpoint, EPPIC-Net is built to support rapid design and execution of high-quality Phase 2 clinical trials that evaluate promising novel pain therapeutics originating from academia or industry partners, as well as other sources. Trials and studies conducted through the network can also be tied to the broader HEAL Partnership ecosystem or initiated through other NIH funding pathways. Even though the description highlights Phase 2 trials and rapid testing, the specific FOA title includes "Clinical Trial Not Allowed," which generally signals that the hub award itself is intended to support infrastructure and readiness activities under this award mechanism, while any actual interventional clinical trials may be activated and funded through other linked processes or awards within the network governance. In other words, the hub funding establishes the capacity, staff, systems, and coordinated operations needed to run trials, while the individual trials may be authorized and supported through separate mechanisms.

Eligibility is broad and includes many types of U.S. public and private institutions and organizations, such as state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and tribal governments and tribal organizations. The opportunity also explicitly calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations, reflecting an intent to build a diverse, capable network with strong patient access and specialized expertise.

Key administrative details from the listing include: the agency is NIH; the funding instrument is a cooperative agreement (U24); the opportunity is categorized as discretionary; and it spans multiple CFDA program numbers (93.121, 93.213, 93.279, 93.361, 93.393, 93.846, 93.847, 93.853, 93.867), consistent with a multi-Institute NIH initiative like HEAL. The original closing date shown is June 3, 2019, and the listing includes an award ceiling of $150,000 (as displayed in the source data). Overall, the funding is geared toward standing up and operating specialized hub sites that can reliably recruit well-characterized pain cohorts, coordinate with spokes, and plug into a national infrastructure that can quickly move promising pain treatments into well-run early phase clinical evaluation.

• The 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 2019-04-18.
• Applicants must submit their applications by 2019-06-03. (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.
• 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.

Apply for RFA NS 19 036

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: