Circadian Patterns of Gene Expression Associated with Disease (R01 - Clinical Trial Optional) | RFA HL 20 016

Opportunity Information: Apply for RFA HL 20 016

The National Institutes of Health (NIH) funding opportunity titled "Circadian Patterns of Gene Expression Associated with Disease (R01 - Clinical Trial Optional)" (Funding Opportunity Number: RFA-HL-20-016) supports research aimed at figuring out how disruptions or abnormalities in circadian-ordered gene expression relate to human disease. The core idea is that many biological processes follow daily (roughly 24-hour) rhythms, and when those rhythms shift, weaken, or become misaligned, gene expression patterns can change in ways that may contribute to disease development, symptom severity, or treatment response. Through this FOA, NIH is seeking projects that can identify these abnormal circadian gene expression signatures and use them to deepen understanding of disease phenotypes, causes and mechanisms (etiology), risk stratification (who is more likely to develop disease or complications), resilience factors (why some people remain healthier despite risk), and therapeutic management (how timing or rhythm-informed approaches could improve care). The mechanism is an R01 research project grant, and clinical trials are optional, meaning applicants may propose either observational/measurement-focused human studies or interventional studies when appropriate, as long as they fit the scientific goals.

The scientific emphasis is on connecting time-of-day biology to gene expression changes that matter for disease. In practical terms, this can include studies that map gene expression across multiple time points to capture rhythmic patterns, compare healthy versus diseased rhythms, or evaluate how circadian misalignment (for example, due to shift work, sleep disruption, light exposure patterns, hospitalization routines, or disease-related physiological changes) alters gene expression programs. The FOA is geared toward generating insights that are clinically meaningful, such as identifying biomarkers that only appear (or are most detectable) at certain times, clarifying why symptoms fluctuate during the day, or improving how patients are categorized into risk groups based on circadian molecular profiles. It also points toward longer-term translational value, such as informing dosing schedules, optimizing timing of therapies, or tailoring behavioral interventions that restore or support normal rhythms.

Eligibility is broad and includes many common applicant types for NIH grants: 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; Native American tribal governments (federally recognized); public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with 501(c)(3) status; nonprofits without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly highlights additional eligible applicants 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and Indian/Native American tribal governments other than federally recognized ones. On the international side, non-U.S. entities (foreign institutions) are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means a U.S.-based applicant can include certain project elements conducted abroad when they are justified and compliant with NIH policy.

From an administrative perspective, the opportunity is categorized as discretionary funding and uses the grant funding instrument. The activity categories listed include education and health, and the CFDA numbers associated with the FOA are 93.233, 93.279, 93.837, 93.838, and 93.839. The source information lists an award ceiling of $400,000, indicating the maximum amount expected per award under the terms of this announcement. The FOA record shows a creation date of 2019-08-09 and an original closing date of 2019-11-07, which is the deadline that applied to that specific posting. The sponsoring agency is NIH, and the title and description emphasize that the central deliverable is improved understanding of disease through identification and characterization of circadian abnormalities in gene expression, with the downstream aim of enabling better prediction, stratification, and management of disease in real-world clinical contexts.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Circadian Patterns of Gene Expression Associated with Disease (R01 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.279, 93.837, 93.838, 93.839.
• This funding opportunity was created on 2019-08-09.
• Applicants must submit their applications by 2019-11-07. (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 $400,000.00 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 HL 20 016

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