Key Dates

Related Announcements

• November 29, 2023- Notice of Special Interest (NOSI): SBIR/STTR High-Priority Areas for Digital Mental Health Innovations. See Notice NOT-MH-24-120
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-23-231
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). See NOFO PA-23-233

Issued by

National Institute of Mental Health (NIMH)

Purpose

The National Institute of Mental Health (NIMH) is issuing this Notice of Special Interest (NOSI) to encourage Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications to support research and development of complex technologies that require funding levels and durations beyond those reflected in the standard SBIR/STTR guidelines. Note that diversity is encouraged, see Notice of NIH’s Interest in Diversity for more details.

Background

The overarching goal of the SBIR and STTR Programs at the NIMH is to support small businesses to develop technologies that can advance the mission of the Institute, including:

• basic neuroscience research relevant to mental disorders
• translational and clinical research of mental disorders
• clinical diagnosis or treatment of mental disorders
• dissemination of evidence-based mental health care

The NIMH Strategic Plan presents key scientific priorities across these domains and describes the need for tools to realize these priorities. Research priorities for the NIMH further include aspects of HIV/AIDS prevention, treatment, eradication of HIV/CNS reservoirs and care, in accordance with the Trans-NIH Plan for HIV-Related Research (https://www.oar.nih.gov/hiv-policy-and-research/strategic-plan). All topic areas of the NIMH’s mission are also of interest in the context of people living with HIV.

The SBIR & STTR programs are one source of support for the research and development of technologies that correspond to these identified research priorities. While some tools can be developed with budgets and project durations within the Congressional SBIR/STTR budget caps, others cannot.This NOSI encourages SBIR & STTR applications for support of research and development of particular types of technologies that require funding levels and durations beyond those reflected in these budget caps. See the SBA-Approved Waiver Topics for a complete list of NIMH technology areas that received a SBA budget waiver to expand budgets beyond the budget caps, when appropriately justified and needed:https://seed.nih.gov/sites/default/files/HHS_Topics_for_Budget_Waivers.pdf.

Technologies appropriate for this NOSI may request project durations of up to two years for Phase I and up to three years for Phase II. Generally, budgets of up to $450,000 total cost per year for Phase I awards, $750,000 total cost per year for Phase II awards, and $1,000,000 total cost per year for Phase IIB awards may be requested. Please reach out to program staff to discuss proposed budgets prior to submitting an application. All budget requests should be well justified.

Applications linked to this NOSI are expected to represent significant advances and innovation.

Specific Areas of Research Interest

Neurotechnology development to enhance research on brain structure and function

• Improved microscopy imaging: ability to enhance single cell resolution while maintaining spatial and depth resolution, in vivo and ex vivo, automation of processes.
• Improved measures of brain activity: multielectrode, range of depths, correlation with imaging/behavior, ability to streamline analysis, record for long periods of time, collect during social interactions, decrease size, improve signal/noise, reduce injury.
• Novel preclinical and clinical imaging technologies with the potential to enhance our understanding of complex circuit function or neuropathology, with a long-term goal to measure or predict mental health outcomes.
• Novel CNS activity/function measures for use in humans that are of high spatial/temporal resolution, high throughput, and/or non-invasive.
• Devices capable of closed loop stimulation-response feedback.
• Single cell technologies: next-generation approaches that can or have the potential to distinguish heterogeneous states of brain cells in mammalian and human brain samples
• Clinical Electrophysiology: dry electrodes, easy application, clinical grade processing/analysis pipelines, combination image-related technology products, determination of minimal electrode ability to reflect brain activity vs. multi-electrodes and sufficiency for clinical studies/trials.
• MRI (including fMRI): technical approaches to standardization, improved temporal/spatial resolution (including pediatric resolution), correlation with EEG/other activity measures.
• Software platforms to enable streamlined imaging and electrophysiology processing and analysis.

Drug Discovery/Development

• Novel CNS drug targets and novel compounds for treating psychiatric disorders.
• Unbiased compound screening assays: in vitro/in vivo, to assess CNS effects.
• Technologies and approaches to enable researchers to better understand and manipulate the dynamic structure and/or function of brain localized GPCRs and/or potentially identify novel selective and specific agonists, antagonists, or allosteric modulators for these receptor subtypes, with a focus on mental health function or dysfunction.
• Early-stage clinical trials to test novel pharmacologic agents using pharmacokinetic/pharmacodynamic designs to optimize dosing for future efficacy trials.

Novel Brain Modulation Methods/Devices as Potential Therapeutics

• Dose dependent, targeted CNS stimulation
• Assessing space, time, context
• Treatment of psychiatric disorders, symptoms, clinical deficits.

Biological Markers for CNS Dysregulation/Function and Mental Illness

• Objective, measurable biological indicators of physiological or disease processes.
• Including constellations of biomarkers used in concert that address the complex nature of mental illness
• Context of uses such as objective assessment of compound efficacy in drug trials, diagnosis of mental disorders, pharmacodynamics, assessment of the susceptibility to a particular disorder, or patient monitoring.
• Empirical evidence is expected for the biomarker selected as well as its association with the CNS; exploratory studies would be inappropriate for the SBIR/STTR program.
• Biomarker development and validation studies proposed in SBIR/STTR applications are expected to include:
  • subject level data
  • analytical validation (accurately and reliably measure the analyte of interest in the laboratory),
  • understanding sources of technical and biological variability in the biomarker measures, including:
    • test-retest reliability
    • task-specific brain activation (signal strength)
    • longitudinal evaluation of measurement properties
    • data quality
    • data analyses
    • clinical validation (detection or prediction of an associated disorder/domain of function in measurements from targeted patient groups),
    • multi-site testing to inform reproducibility and create standardization of protocols for the biomarker and its intended use.

Digital Health Technologies

Technologies are needed to augment clinical care, and to enhance clinical research and clinical trial design/implementation at the subject/patient level in the areas of:

• Monitoring mental health risk factors, symptoms
• Diagnosis/assessments
• Treatment decision aides
• Treatments and ongoing care
• Tools for training clinical staff or for fidelity monitoring
• Service delivery tools

For more information on NIMH priorities in digital health technologies, please see the companion NOSI NOT-MH-24-120.

Technologies Addressing Basic, Behavioral and Implementation Science related to people living with HIV

• Novel diagnostic approaches and therapeutic strategies to assess and treat HIV associated CNS complications in ART suppressed individuals.
• Molecular neuroimaging approaches to identify viral reservoirs in the CNS and tools to eradicate persistent viral reservoirs from the CNS.
• Development of novel in-vitro and in-vivo models to support neuroHIV research and advance understanding of HIV immune-CNS interactions.
• Novel tools and approaches to identify populations most vulnerable to HIV.
• Tools to facilitate dissemination and implementation of evidence-based HIV/AIDS behavioral risk reduction and adherence interventions.
• Novel tools to rapidly link individuals diagnosed with HIV to care, improve adherence and sustain patient retention.
• Development of point of care tests for viral load, CD4 measurement and ART drug adherence.

Applicants are encouraged to discuss proposed research with the scientific/research contact listed below prior to application submission to ensure it fits NIMH priorities and to help identify the most appropriate grant mechanism to use.

Application and Submission Information

This notice applies to due dates on or after Janaury 5, 2024 and subsequent receipt dates through Janaury 6, 2027.

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcement through the expiration date of this notice.

• PA-23-230 PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-23-231 PHS 2023-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PA-23-232 PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-23-233 PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-MH-24-110 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Research/Scientific/Research Contact(s)

Paige Anderson, M.S.
National Institute of Mental Health (NIMH)
Telephone: 301-827-6550
Email: paige.anderson@nih.gov

Financial/Grants Management Contact(s)

Jane Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
Email: linja@mail.nih.gov