HEAL Initiative: Biofabricated 3D Tissue Models of Nociception, Opioid Use Disorder and Overdose for Drug Screening (UH2/UH3 Clinical Trial Not Allowed) | RFA TR 19 005

Opportunity Information: Apply for RFA TR 19 005

This NIH HEAL Initiative funding opportunity (RFA-TR-19-005) supports cooperative agreement projects that bring together NIH intramural scientists and extramural research teams to create and use advanced 3D biofabricated human tissue models as drug screening platforms focused on nociception (pain signaling), opioid use disorder (OUD), and opioid overdose. The central idea is to improve preclinical testing by moving beyond traditional 2D cell cultures and some animal models, and instead building more physiologically relevant, multicellular human tissue constructs that can better predict how candidate therapeutics will work. By strengthening the tools used early in the pipeline, the program aims to accelerate discovery and development of safer, non-addictive treatments for pain as well as better interventions for addiction and overdose. The FOA sits within the broader NIH Helping to End Addiction Long-term (HEAL) Initiative, which coordinates NIH-wide efforts to improve treatment for opioid misuse and addiction while also advancing effective pain management options.

The mechanism is a two-phase UH2/UH3 structure. The UH2 phase is essentially the development and validation stage: teams are expected to apply 3D biofabrication technologies to engineer novel multicellular tissue constructs suitable for drug screening. These constructs should be built using human induced pluripotent stem cell (iPSC)-derived cell types that represent key components of the pain and addiction biology, such as sensory/pain neurons and relevant brain-region cell types, along with other tissues implicated in nociception, addiction pathways, and overdose physiology. A notable emphasis is placed on incorporating models of the blood-brain barrier (BBB), reflecting the importance of drug penetration, CNS exposure, and neurovascular interactions in both analgesic development and addiction/overdose research. The goal in UH2 is to produce robust, reproducible 3D tissue models that can serve as credible screening platforms.

The UH3 phase is the implementation stage, where the expectation shifts from building models to using them. Projects transition into conducting drug screens with the 3D tissue models established during UH2, applying the platform to evaluate candidate compounds or interventions relevant to pain, OUD, and/or overdose. In other words, UH3 is where the platform is put to work to generate actionable screening data that can inform preclinical decision-making. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning the supported work is preclinical and platform-focused rather than involving prospective studies in human participants.

Eligibility is broad across U.S.-based organizations and includes state, county, city, and special district governments; public and private institutions of higher education; independent school districts; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights inclusion of a range of mission-driven and capacity-building institution types such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities, along with faith-based or community-based organizations and eligible federal agencies. At the same time, it clearly restricts foreign involvement: non-U.S. entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

Administratively, the opportunity is issued by the National Institutes of Health as a discretionary funding program using a cooperative agreement model, which typically indicates substantial NIH programmatic involvement during the project. It falls under health-related activity categories and is associated with CFDA numbers 93.350 and 93.853. The original closing date listed for this specific announcement was February 28, 2019, and it was created on December 10, 2018.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "HEAL Initiative: Biofabricated 3D Tissue Models of Nociception, Opioid Use Disorder and Overdose for Drug Screening (UH2/UH3 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): 93.350, 93.853.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-02-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 TR 19 005

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