Opportunity Information: Apply for RFA DA 22 009

The National Institutes of Health (NIH) funding opportunity titled "Organoid Modeling of Neural Stimulants and HIV Comorbidity of Human Brain (R01 - Clinical Trial Optional)" (Funding Opportunity Number RFA-DA-22-009) supports research aimed at understanding the biological mechanisms that drive HIV-associated neurological disorders (HAND). The central goal is to use modern human stem cell-based model systems, specifically induced microglia and cerebral organoids derived from human induced pluripotent stem cell (iPSC) lines, to investigate how HIV contributes to brain dysfunction and how that damage is altered or intensified when combined with exposure to neural stimulants.

A major emphasis of the announcement is comorbidity, meaning the combined impact of HIV infection and commonly used stimulants on the human brain. The FOA specifically calls out amphetamine, methamphetamine, cocaine, and nicotine as priority substances. Projects are expected to move beyond broad observations and instead probe disease and drug mechanisms at high resolution, including single-cell level analyses and investigations of neural circuit function. In practice, this points to studies that can dissect how individual brain cell types (including microglia, the brain’s resident immune cells) respond to HIV-related insults and stimulant exposure, and how those cellular changes translate into altered network activity in organoid-based circuits.

The mechanism of support is an R01 research project grant, and the opportunity is listed as "Clinical Trial Optional," indicating that proposed work does not need to include a clinical trial, though applicants should follow NIH definitions and rules if any human clinical intervention is proposed. The funding instrument is a grant, and the activity category is listed under education and health (CFDA 93.279). The opportunity was created on June 17, 2021, with an original closing date of November 17, 2021. The notice lists an award ceiling of $500,000, signaling the maximum annual or total cost level allowed under the FOA as posted (applicants typically confirm whether this ceiling refers to direct costs per year or another structure in the full FOA text and NIH policy references).

Eligibility is broad and includes many U.S.-based organizational types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; and public housing authorities/Indian housing authorities. It also includes nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses, along with additional categories described as "Others." The FOA explicitly encourages or recognizes participation from institutions serving specific communities and missions, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies.

International participation is allowed in specific ways. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are eligible to apply directly. In addition, foreign components (as defined in the NIH Grants Policy Statement) are permitted. At the same time, the FOA draws an important boundary: non-domestic components of U.S. organizations are not eligible to apply, meaning a U.S. institution generally cannot apply with a non-U.S. branch or component as the applicant organization under this FOA, even though foreign components and foreign applicants may be allowable under NIH rules as specified.

Overall, this opportunity is designed for teams combining neuroHIV expertise with stem cell biology and advanced neurotechnology. NIH is signaling strong interest in mechanistic, human-relevant model systems that can capture cell-type-specific and circuit-level effects of HIV in the brain, particularly in the real-world context where stimulant use is common and may worsen neurological outcomes.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Organoid Modeling of Neural Stimulants and HIV Comorbidity of Human Brain (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): 93.279.
  • This funding opportunity was created on 2021-06-17.
  • Applicants must submit their applications by 2021-11-17. (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 $500,000.00 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.
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Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this NIH opportunity?

The opportunity is titled "Organoid Modeling of Neural Stimulants and HIV Comorbidity of Human Brain (R01 - Clinical Trial Optional)" and the Funding Opportunity Number (FOA number) is RFA-DA-22-009.

What is the main purpose of this funding opportunity?

The purpose is to support research that clarifies the biological mechanisms driving HIV-associated neurological disorders (HAND), using modern human stem cell-based model systems to understand how HIV contributes to brain dysfunction and how that damage is altered or intensified by exposure to neural stimulants.

What does the FOA mean by focusing on "comorbidity"?

In this FOA, comorbidity refers to the combined impact of HIV and stimulant exposure on the human brain. The intent is to study how HIV-related brain injury may change or worsen when stimulant use is also present, rather than studying HIV or stimulants in isolation.

Which stimulants are specifically prioritized in this announcement?

The FOA calls out amphetamine, methamphetamine, cocaine, and nicotine as priority substances for stimulant-related comorbidity research.

What model systems are emphasized for studying neuroHIV mechanisms?

The FOA emphasizes human stem cell-based systems, specifically induced microglia and cerebral organoids derived from human induced pluripotent stem cell (iPSC) lines.

Why are microglia and cerebral organoids highlighted?

Microglia are the brain's resident immune cells and are central to neuroinflammatory and immune-related mechanisms that can contribute to brain dysfunction. Cerebral organoids offer a human-relevant, organoid-based environment where multiple brain cell types and aspects of network activity can be studied in a controlled system.

What kinds of scientific questions or approaches does NIH appear to want under this FOA?

NIH is signaling interest in mechanistic studies that go beyond broad observations. The FOA points to high-resolution work, including single-cell level analyses and investigations of neural circuit function, to link cell-type-specific responses to HIV-related insults and stimulant exposure with changes in network activity in organoid-based circuits.

Does an application need to include a clinical trial?

No. The opportunity is labeled "Clinical Trial Optional," meaning a clinical trial is not required. If any human clinical intervention is proposed, applicants are expected to follow NIH definitions and rules applicable to clinical trials.

What is the funding mechanism and support type?

The mechanism of support is an R01 research project grant. The funding instrument is a grant.

What is the activity category and CFDA listing provided?

The activity category is listed under education and health, with CFDA 93.279.

When was this opportunity created and what was the original closing date?

The opportunity was created on June 17, 2021, and the original closing date listed is November 17, 2021.

What is the award ceiling listed for this FOA?

The notice lists an award ceiling of $500,000, indicating the maximum annual or total cost level allowed under the FOA as posted. Applicants typically confirm whether the ceiling refers to direct costs per year or another budget structure by reviewing the full FOA text and relevant NIH policy references.

What types of U.S. organizations are eligible to apply?

Eligibility is broad and includes state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; and public housing authorities/Indian housing authorities. It also includes nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and additional categories described as "Others."

Are organizations with specific community-serving missions recognized or encouraged?

Yes. The FOA explicitly encourages or recognizes participation from institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also notes faith-based or community-based organizations and eligible federal agencies.

Can foreign (non-U.S.) organizations apply?

Yes. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are eligible to apply directly.

Are foreign components allowed within a project?

Yes. Foreign components (as defined in the NIH Grants Policy Statement) are permitted.

Is there any restriction related to non-U.S. components of U.S. organizations?

Yes. The FOA states that non-domestic components of U.S. organizations are not eligible to apply as the applicant organization under this FOA, even though foreign components and foreign applicants may be allowable under NIH rules as specified.

What overall research team capabilities does this FOA seem to be designed for?

The opportunity is designed for teams that can combine neuroHIV expertise with stem cell biology and advanced neurotechnology, especially approaches that can capture cell-type-specific and circuit-level effects of HIV in the brain and how those effects may be worsened by stimulant exposure.

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