The Rat Opioid Genome Project: Clinical Trials not Allowed (U01- Clinical Trial Not Allowed) | RFA DA 20 010

Opportunity Information: Apply for RFA DA 20 010

The Rat Opioid Genome Project: Clinical Trials not Allowed is a National Institutes of Health (NIH) funding opportunity (RFA-DA-20-010) that supports research aimed at clarifying how genetic, genomic, and molecular epigenetic variation contributes to opioid use disorder (OUD) risk and progression, using rat-based approaches. The opportunity uses a U01 cooperative agreement mechanism, which typically means awardees should expect substantial scientific or programmatic involvement from NIH staff compared to a standard research grant. As the title indicates, proposing clinical trials is not permitted under this announcement; the work is meant to be preclinical and mechanistic rather than human interventional testing.

The project has two central scientific goals, both focused on mapping biological drivers to meaningful OUD-related outcomes. First, it seeks to identify genetic, genomic, and molecular (including epigenetic) variants that influence phenotypes tied to different stages along the OUD trajectory. In practical terms, this means studying measurable traits and behaviors that correspond to early and intermediate steps in addiction development, with the intention of pinpointing biological targets that could eventually support prevention or early-stage intervention strategies. Second, it aims to uncover variants that underlie comorbid conditions and related phenotypes that appear alongside OUD or contribute to severe, late-stage outcomes. This part of the program is framed around enabling the development of therapeutics that could reduce mortality and improve outcomes for people at the most dangerous end of the OUD spectrum, such as those at high risk of overdose or with serious co-occurring conditions.

From an applicant standpoint, the eligibility pool is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city/township, and special district governments; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations (other than small businesses); small businesses; and other organizations as allowed by NIH policy. The announcement explicitly calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

Foreign participation is explicitly restricted. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. In addition, foreign components, as defined in the NIH Grants Policy Statement, are not allowed. In effect, the work must be conducted entirely within allowable U.S.-based organizational structures without foreign components.

Administratively, the opportunity is categorized as discretionary funding and falls under the education and health activity category, with CFDA number 93.279. The original closing date listed is November 19, 2019, and the opportunity record was created on September 12, 2019. While the notice includes fields like award ceiling and expected awards, those specific values are not provided in the source text you shared. Overall, the program is best understood as an NIH-led, collaborative research effort to build a stronger biological foundation for understanding OUD across its course, using rat genomics and epigenomics to identify actionable targets that could later inform prevention strategies and life-saving treatments, without moving into clinical trial territory under this specific announcement.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Rat Opioid Genome Project: Clinical Trials not Allowed (U01- 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): 93.279.
• This funding opportunity was created on 2019-09-12.
• Applicants must submit their applications by 2019-11-19. (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.

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