HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) | RFA NS 19 021

Opportunity Information: Apply for RFA NS 19 021

The funding opportunity titled "HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)" (Funding Opportunity Number RFA-NS-19-021) is a National Institutes of Health (NIH) cooperative agreement program under the U.S. Department of Health and Human Services. It sits within the NIH HEAL (Helping to End Addiction Long-term) Initiative and is focused on generating strong, practice-relevant evidence about what pain management strategies actually work in real clinical settings. The central emphasis is not on inventing brand-new treatments, but on rigorously testing the effectiveness of existing therapies and approaches for preventing pain and managing pain, including across the full spectrum from acute pain to chronic pain, and including pain that occurs alongside other diseases as well as pain that may be considered a condition in its own right.

The goal of the program is to support well-controlled clinical trials that can directly inform clinicians and health systems. NIH is looking for studies that measure outcomes that matter to patients and providers, especially improvements in function and reductions in pain. In other words, applicants are expected to show how their proposed trial will help the field move beyond uncertainty and toward clearer, evidence-based decisions about what interventions should be used, for whom, and under what circumstances. Because this is a cooperative agreement, NIH expects to have substantial scientific and programmatic involvement in the project, and the funded trials are expected to be conducted within the shared infrastructure of the HEAL Pain Management Effectiveness Research Network. That network-based structure is meant to improve coordination, harmonize trial practices, and make findings more comparable and usable across multiple studies.

The scope of interventions that can be studied is intentionally broad, as long as the trial fits within the mission and research interests of the participating NIH Institutes and Centers. Examples of eligible intervention types include medications and other pharmacologic strategies, biologics, clinical procedures, medical devices and assistive devices, health technologies, diagnostic testing strategies, behavioral change interventions, rehabilitation approaches, complementary therapies, integrated or multimodal care models, and delivery system strategies that change how pain care is organized and provided. The common thread is that the application must propose a controlled clinical trial designed to establish effectiveness, rather than a purely exploratory study, an observational project, or a basic science effort.

Mechanistically, the UG3/UH3 structure supports a phased approach: an initial planning and start-up phase (UG3) that is tied to specific milestones, followed by an implementation phase (UH3) for conducting the full clinical trial if the project successfully meets those milestones. This structure is designed to reduce the risk of launching large trials that are not operationally ready, and it encourages applicants to present clear, realistic plans for trial initiation, recruitment, and execution. The FOA explicitly requires a clinical trial, meaning the application should include the elements NIH expects for a trial-ready submission, such as well-defined intervention and comparator conditions, eligibility criteria, outcome measures, and a robust approach to trial conduct and oversight.

In terms of who can apply, eligibility is broad and includes many organization types that can credibly lead a clinical trial. Eligible applicants include state, county, and city or township 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; other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and additional entities as allowed in the FOA’s eligibility text. The program anticipates making about five awards. The listing shows an award ceiling of 0, which typically signals that a strict maximum was not specified in that particular data extract and that applicants should rely on the FOA text and NIH budget guidance for allowable costs and expectations.

Administratively, the opportunity was created on December 10, 2018, with an original closing date of February 1, 2019, and it is categorized as a discretionary cooperative agreement within a health-related funding activity area. Multiple CFDA numbers are associated with the program (including 93.121, 93.213, 93.242, 93.273, 93.307, 93.350, 93.361, 93.393, 93.846, 93.847, 93.853, 93.866, 93.867), reflecting participation by multiple NIH Institutes and Centers and the cross-cutting nature of pain research. Overall, the FOA is designed to produce high-quality, clinically actionable evidence on pain prevention and treatment strategies through coordinated trials run within the HEAL Pain Management Effectiveness Research Network, with the explicit intent of improving function, reducing pain, and strengthening decision-making in pain care.

• 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: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)" 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, 93.242, 93.273, 93.307, 93.350, 93.361, 93.393, 93.846, 93.847, 93.853, 93.866, 93.867.
• This funding opportunity was created on Dec 10, 2018.
• Applicants must submit their applications by Feb 01, 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 5 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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