Opportunity Information: Apply for PAR 23 091
The NIH grant opportunity "Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)" (PAR-23-091) is designed to push preclinical mental health research toward more informative, clinically relevant readouts of brain function. The central aim is to develop, optimize, and evaluate in vivo neurophysiological and behavioral measures in animal models that can act as practical screening assays during the early stages of therapeutic development. Instead of relying only on broad behavioral outcomes or indirect endpoints, the FOA emphasizes assays that capture "circuit engagement" and related neural processes that map onto mechanisms implicated in mental illnesses. In other words, the program is trying to improve how researchers determine whether a target or treatment candidate is actually affecting the brain systems that matter for psychiatric symptoms and dysfunction.
A key feature of the announcement is its focus on measures that can serve as surrogate markers for neural processes of clinical interest. The intent is that applicants build on existing knowledge from systems neuroscience and clinical neuroscience to create assays that are biologically grounded and interpretable in the context of human psychopathology. The work supported is expected to strengthen the therapeutic development pipeline by making animal data more predictive and mechanistically meaningful, particularly by showing how experimental interventions influence specific neurobiological mechanisms relevant to mental illnesses. These assays are framed as tools for early screening, meaning they are meant to help decide which targets and candidate treatments should move forward, based on evidence of relevant neural impact rather than only downstream behavioral change.
This opportunity uses the R01 grant mechanism and falls under the NIH health research activity category (CFDA 93.242). Clinical trials are not allowed, reinforcing that the supported projects should remain in the preclinical domain and focus on animal-based in vivo neurophysiology and behavior. The listed award ceiling is $250,000, and the original closing date provided is 2025-09-07. While the expected number of awards is not specified in the provided source data, the overall structure indicates a competitive, research-intensive program aimed at producing validated or well-characterized assay approaches that other therapeutic development efforts can use.
Eligibility is broad and includes many standard applicant types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; and public housing authorities/Indian housing authorities. It also includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses. The FOA explicitly highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations), signaling an interest in drawing from a wide range of scientific and institutional perspectives.
Overall, the opportunity is best understood as an NIH effort to improve the translational value of preclinical psychiatric research by funding the creation and refinement of animal-based, in vivo assays that measure whether treatments truly engage relevant neural circuits. The expectation is that funded projects will produce measures that can be used as robust screening tools in therapeutic development, bridging the gap between mechanistic neuroscience and practical decision-making about which interventions are most likely to have meaningful clinical relevance for mental illnesses.Apply for PAR 23 091
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 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): 93.242.
- This funding opportunity was created on 2023-01-06.
- Applicants must submit their applications by 2025-09-07. (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 $250,000.00 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 name and number of this NIH funding opportunity?
The opportunity is titled "Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)" and the FOA number is PAR-23-091.
What is the main goal of PAR-23-091?
The main goal is to push preclinical mental health research toward more informative and clinically relevant readouts of brain function by developing, optimizing, and evaluating in vivo neurophysiological and behavioral measures in animal models that can function as practical screening assays in early therapeutic development.
What kind of research is this FOA trying to encourage?
This FOA encourages research that creates assays designed to measure "circuit engagement" and related neural processes in vivo in animal models, with an emphasis on measures that map onto mechanisms implicated in mental illnesses and can inform early-stage go/no-go decisions for targets and treatment candidates.
What does "circuit engagement" mean in the context of this FOA?
Within the context provided, "circuit engagement" refers to evidence that a target or treatment candidate is affecting the specific brain systems and neural processes that are considered relevant to psychiatric symptoms and dysfunction, rather than relying only on broad behavioral outcomes or indirect endpoints.
How is this different from traditional preclinical behavioral screening?
Instead of focusing only on broad behavioral outcomes or indirect endpoints, this program emphasizes assays that capture neurobiological mechanisms and neural processes of clinical interest. The intent is to make preclinical findings more mechanistically interpretable and more predictive for therapeutic development decisions.
What types of measures does the FOA emphasize?
The FOA emphasizes in vivo neurophysiological and behavioral measures in animal models, particularly those that can act as surrogate markers for neural processes of clinical interest and that are grounded in knowledge from systems neuroscience and clinical neuroscience.
What are "surrogate markers" in this program?
In this program, surrogate markers are measures intended to stand in for neural processes of clinical interest. The FOA frames them as biologically grounded and interpretable readouts that can help determine whether an intervention impacts mechanisms relevant to mental illnesses.
Is the focus basic neuroscience, therapeutic development, or both?
Based on the description provided, the focus sits at the intersection of mechanistic neuroscience and therapeutic development. The goal is to build assay tools that strengthen the therapeutic development pipeline by making animal data more predictive and mechanistically meaningful.
What stage of the therapeutic pipeline is this FOA meant to support?
It is aimed at the early stages of therapeutic development. The assays are framed as early screening tools to help decide which targets and candidate treatments should move forward based on evidence of relevant neural impact.
What is the NIH activity code and mechanism for this opportunity?
This opportunity uses the NIH R01 grant mechanism.
Are clinical trials allowed under PAR-23-091?
No. The FOA is explicitly labeled "Clinical Trial Not Allowed," which reinforces that supported projects should remain in the preclinical domain.
What kinds of models are expected for the proposed work?
The description emphasizes animal-based in vivo neurophysiology and behavior, indicating that the assays should be developed and evaluated in animal models with in vivo readouts.
Does the FOA require the assays to be clinically interpretable?
The FOA intent is that applicants build on systems neuroscience and clinical neuroscience so the resulting assays are biologically grounded and interpretable in the context of human psychopathology.
What outcomes are expected from funded projects?
Funded projects are expected to produce validated or well-characterized assay approaches that can be used as robust screening tools in therapeutic development and help bridge the gap between mechanistic neuroscience and practical decision-making about interventions for mental illnesses.
What is the funding ceiling listed for this opportunity?
The listed award ceiling is $250,000.
When is the closing date for this opportunity?
The original closing date provided is 2025-09-07.
What is the CFDA (assistance listing) number or category mentioned?
The opportunity is listed under CFDA 93.242 (NIH health research activity category as provided).
How many awards will NIH make under this FOA?
The expected number of awards is not specified in the information provided.
Who is 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; public housing authorities/Indian housing authorities; Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
Are institutions focused on serving specific communities explicitly encouraged or listed as eligible?
Yes. The FOA explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, and Tribally Controlled Colleges and Universities, among others.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly included among eligible applicants.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are listed as eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among eligible applicants.
Are regional organizations eligible?
Yes. Regional organizations are listed as eligible applicants.
Can non-U.S. (foreign) organizations apply?
Yes. The FOA indicates that non-U.S. entities (foreign organizations) are eligible.
Is this opportunity mainly about improving translation from animal models to human mental health?
Yes. The opportunity is described as an NIH effort to improve the translational value of preclinical psychiatric research by funding animal-based in vivo assays that better indicate whether treatments engage relevant neural circuits tied to mental illnesses.
Why does the FOA prioritize mechanistic readouts over broad behavioral outcomes?
The stated rationale is to strengthen the therapeutic development pipeline by generating animal data that are more predictive and mechanistically meaningful, particularly by showing how interventions influence specific neurobiological mechanisms relevant to mental illnesses rather than only downstream behavior.
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| Programs for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) (R25 Clinical Trial Not Allowed) Apply for RFA HL 24 004 Funding Number: RFA HL 24 004 Agency: National Institutes of Health Category: Health Funding Amount: $317,000 |
| Programs for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) Coordination Center (U24 Clinical Trial Not Allowed) Apply for RFA HL 24 003 Funding Number: RFA HL 24 003 Agency: National Institutes of Health Category: Health Funding Amount: $350,000 |
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| Planning for the TMD Collaborative for IMproving PAtient-Centered Translational Research (TMD IMPACT) (R34 Clinical Trial Not Allowed) Apply for RFA DE 23 014 Funding Number: RFA DE 23 014 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
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| Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional) Apply for PAR 23 061 Funding Number: PAR 23 061 Agency: National Institutes of Health Category: Health Funding Amount: $275,000 |
| Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes (R34 Clinical Trial Optional) Apply for PAR 23 060 Funding Number: PAR 23 060 Agency: National Institutes of Health Category: Health Funding Amount: $450,000 |
| Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional) Apply for PAR 23 062 Funding Number: PAR 23 062 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Alzheimer's Disease Research Centers (P30 Clinical Trial Not Allowed) Apply for RFA AG 24 001 Funding Number: RFA AG 24 001 Agency: National Institutes of Health Category: Health Funding Amount: $2,925,000 |
| Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) Apply for PAR 23 084 Funding Number: PAR 23 084 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional) Apply for PAR 23 101 Funding Number: PAR 23 101 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional) Apply for PAR 23 087 Funding Number: PAR 23 087 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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