Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). This funding opportunity encourages applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders.

It focuses on the development or significant enhancement of novel tools (hardware and/or software) for brain stimulation in humans. Applications should be engineering/pre-clinical based and focus on hardware and software development and validation.

PAR-25-286: Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed) R21 Exploratory/Developmental Research Grant Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders.

Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared.

Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device.

Although the application should focus on the engineering development and bench top testing of the tool, animals and limited, non-clinical trial human testing necessary to demonstrate initial proof of concept is allowable. This NOFO uses the R21 grant mechanism, encouraging shorter, higher-risk applications, whereas its companion funding opportunity PAR-25-287 seeks R01 grant applications.

Funding Opportunity Goal(s) The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The use of brain stimulation devices provides a unique opportunity to develop novel treatments for mental health disorders.

Brain stimulation devices provide both the most efficacious (electroconvulsive therapy, ECT) and one of the most recently-cleared (transcranial magnetic stimulation, TMS) treatments for depression.

However, while these successes demonstrate the potential to improve clinical care, limitations of the few existing U.S. Food and Drug Administration (FDA) approved/cleared devices (e.g., cognitive side effects of ECT, variability in response to TMS) hamper widespread clinical use.

In order to develop efficacious treatments that will be widely utilized across a variety of disorders, the development of innovative brain stimulation devices and novel approaches with existing devices is urgently needed. New devices, developed with a focus on aspects unique to mental health indications, are needed to fully explore the potential of brain stimulation treatments.

The majority of clinical studies using brain stimulation therapies for mental health disorders utilize existing devices developed for other neurological conditions. Deep brain stimulation (DBS) and vagal nerve stimulation (VNS) electrodes were developed for the treatment of Parkinson’s Disease and epilepsy. They have subsequently been studied, with minimal to no modification, for use in mental health disorders with mixed results.

New devices, whose development is informed by basic and clinical science findings in mental health research, may provide improved treatments for patients. For example, while current DBS electrodes are limited to one or two stimulation sites, neuroimaging studies have demonstrated the distributed, network-based nature of mental health disorders.

Therefore, distributed, multi-focal electrode arrays may be necessary to modulate networks back into a desired state. New forms of energy (e.g., ultrasound) also have the potential to be incorporated into the next generation of brain stimulation devices. In addition to the development of new devices, significantly enhancing the capabilities of existing devices presents an opportunity to improve clinical care.

While drug treatments become static (in terms of chemical composition) once developed, brain stimulation devices are amenable to hardware/software changes that can readily translate to improved patient care. Examples of these approaches include development of real time electric field (e-field) modeling software and augmented reality delivery systems to enable practitioners to interactively target regions of interest with TMS.

The ability to close the loop with a brain stimulation device and neuroimaging/recordings could also result in improved clinical outcomes. Improved devices that focus on developing novel approaches to delivery of previously demonstrated effective treatments are also of interest.

Although ECT provides the best remission rates for depression, the widespread generalized seizure induced by the device produces cognitive side effects that limit its use. The development of novel devices that deliver more focused stimulation resulting in a smaller, controllable seizure, may produce high levels of response while minimizing side effects.

Additionally, approaches that improve the focality, depth, or closed-loop delivery of TMS could improve response rates. This notice of funding opportunity (NOFO) encourages the development of novel brain stimulation devices and accompanying hardware/software additions that enable improved delivery of brain stimulation treatments for mental health indications.

Applications submitted in response to this NOFO should promote the development or significant enhancement of novel tools (hardware/software) for brain stimulation in humans. Incremental changes to existing devices (e.g., software updates) are not within the scope of this announcement.

Applications are not expected to be hypothesis-driven, but should propose design-directed, developmental, or discovery-driven technology research using integrative approaches.

Applications must be 1) submitted by multi-disciplinary teams with expertise in fields such as such as engineering, device development, physical, mathematical, computational sciences, as well as neuroscience, neuropsychiatry, other areas of the biological sciences, and clinical and regulatory science/affairs and 2) promote either the development of novel tools (hardware and/or software) or significant enhancement of existing tools (hardware and/or software).

Applications should be engineering/pre-clinical based and focus on hardware and software development and validation. Although the application should focus on the engineering development of the tool, animal and limited, non-clinical trial, human testing to demonstrate initial proof of concept is allowable.

Applications that seek to study specific scientific or clinical hypotheses that simply utilize devices are outside the scope of this NOFO. The R21 grant mechanism of this NOFO is to encourage high risk, proof of concept, applications that may lack preliminary data, or smaller projects that are closer to final form and do not require longer time for development and innovation.

Applications may propose to develop novel invasive or non-invasive brain stimulation devices. New devices should be designed to significantly advance the field and go beyond current stimulation and low-channel count recording/stimulating capabilities. Existing magnetic and electrical stimulation methods have limited spatial and temporal precision.

To overcome these obstacles and move beyond incremental advances, collaborations between physicists, engineers, neuroscientists, and clinicians are encouraged. The perspective and expertise of such integrative teams could enable the development and testing of novel approaches that leverage other types of energy or stimulation methods in a way that can lead to novel tools for scientific discovery and for therapeutic brain stimulation.

Applications that propose to improve spatiotemporal precision, stimulate at depth, enable multi-focal recording/stimulation, and utilize novel stimulation paradigms are encouraged. Appropriate modeling and/or preliminary data (if available) should be presented to demonstrate the feasibility of the stated approach.

While the application may be in the initial stages of device development and may therefore still be in the animal testing phase, the proposed tools and methods must be designed for use in humans. Animal testing should focus on questions of safety and/or focus on preclinical studies to validate or refine the device. Industry partnership is encouraged.

Applications may also propose to develop additional capabilities for existing FDA-approved or cleared brain stimulation devices and related technologies. However, proposed improvements to existing devices and related technology should be significant and innovative, rather than incremental.

Appropriate improvements may include, for example: 1) incorporating advanced approaches to stimulation delivery, such as real-time realistic head/electric field modeling that incorporates patient-specific tractography or cellular-level resolution; 2) synchronizing behavioral recordings with brain recordings in novel ways; or 3) developing novel delivery methods, such as augmented and virtual-reality approaches.

For existing devices, approaches that seek to improve the focality and depth of stimulation, controllability of the delivered dose, sham control delivery, or recording capabilities are encouraged. Software approaches that seek to develop novel approaches (e.g., machine learning) to biomarker-driven targeted delivery of stimulation are also encouraged.

Topics of interest for this NOFO include, but are not limited to: Multi-focal electrode interfaces. These devices should demonstrate the capability to record and stimulate distributed brain regions implicated in mental health disorders. Devices capable of both recording and stimulating neural activity, with the ability for closed-loop control.

These devices should be able to demonstrate clear capability to record oscillations of interest to mental health applications. Validation of novel approaches, such as transcranial ultrasound for neuromodulation to stimulate the brain focally. Integrative technologies that could advance multimodal or combination approaches.

Dense behavioral phenotyping is now possible, both in the lab and in naturalistic environments. The ability to temporally synchronize large behavioral data sets with large neural data sets is of high priority. Devices that enable targeted stimulation via optogenetic (or other circuit therapeutic) techniques in humans.

Next-generation ECT devices that more focally deliver energy for controllable seizure generation. A wireless, miniaturized, portable, and closed-loop EEG-stimulation system. Ideally, this should be of a size to be easily worn (i.e., fits comfortably inside a baseball cap).

Improved portability of brain stimulation devices, without reduction in targeting capabilities. Pre-clinical studies necessary to obtain regulatory approval for human testing. Development of higher spatial resolution realistic head modeling approaches that improve the delivery of FDA-cleared treatments, such as TMS.

Development and/or validation of high-precision, navigation, and imaging systems to improve localization of transcranial focused ultrasound (such as MR-acoustic radiation force imaging) and/or to improve modeling of potential thermal or mechanical bioeffects. Improved focality and depth of stimulation, along with controllability for FDA-approved or cleared devices for a particular indication.

Development of closed-loop recording and stimulating for non-invasive devices, such that imaging/recording informs active stimulation. Software approaches, such as machine learning, that incorporate patient-specific biomarkers into brain stimulation treatment algorithms. New approaches to sham conditions that enable more reliable controlled trials.

Applications Not Responsive to this NOFO Studies that are not responsive to this NOFO and will not be reviewed include the following: Devices with low spatial resolution. Models that focus on standard brains and are not specific to individual patient anatomy. Incremental improvements to existing devices, such as operating software system updates.

Devices with no clear potential for human application. Studies of scientific or clinical hypotheses that simply utilize current brain stimulation devices. Innovation in this biomedical engineering NOFO has a broad definition that includes development of new methods, ideas, or tools, integration of existing components into new combinations that deliver greater capabilities, new efficiencies, and/or greater effects.

Applications to this NOFO are not expected to be hypothesis-driven, but should propose design-directed, developmental, or discovery-driven technology research using integrative approaches.

Overall impact of these advances may include reducing disparities in care, promoting wellness and independent living, increasing access to and utility of technologies to improve quality of life, reducing cost and complexity of procedures, and increasing throughput, sensitivity, and specificity of diagnostic tests.

To fully evaluate the study's scientific validity and the safety implications for participants, studies involving human participation must include information on any planned or reasonably anticipated co-enrollment for participants in this study, including any studies participants are actively participating in at enrollment or any reasonably anticipated co-enrollment in additional studies during participation in the present study.

Applications seeking to explore scientific questions (in humans or animals) in areas outside of the scope of this NOFO should apply to the NIH Parent R01 ( PA-20-185) , and NIH Parent Clinical Trial Required R21 ( PA-20-194).

Those seeking to assess devices as treatments in a clinical population should refer to the NIMH Policy for Submission of Applications Containing Clinical Trials NOT-MH-14-007 and NIMH Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 and R21 Announcements. See NOT-MH-19-006 for information on NIMH requirements.

All applicants are strongly encouraged to contact the designated Scientific/Research Contacts at NIMH prior to submission. Applicants who seek to develop and validate next-generation tools, methods, and analytic approaches to precisely quantify behaviors and combine them with simultaneous recordings of brain activity in humans should apply to the Brain Initiative R61/R33 NOFO RFA-MH-26-100 .

Applicants seeking to pursue translational activities and clinical studies to advance the development of therapeutic, and diagnostic devices for use in the treatment of psychiatric disorders, or in targeting specific domains of clinical functioning across psychiatric disorders should respond to UG3/UH3 NOFO, PAR-21-315 .

Applicants who seek to propose a larger project should respond to the companion R01 NOFO, PAR-25-287 Small businesses should consider applying to the SBIR/STTR programs to support the technology development. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Resubmission of PAR-22-038 and this NOFO Revision of PAR-22-038 and this NOFO The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

The total project period may not exceed 2 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

Due to the multi-disciplinary nature of the projects and the focus on collaboration and expertise sharing, this NOFO requires the applicants to comprise a multi-disciplinary team of investigators with expertise from fields such as engineering, device development, regulatory, physical, mathematical, computational sciences, as well as neuroscience, neuropsychiatry, and other areas of the biological sciences.

Applicants are expected to include a transdisciplinary team of investigators with expertise from fields such as engineering, device development, regulatory, physical, mathematical, computational sciences, as well as neuroscience, neuropsychiatry, and other areas of the biological sciences. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

Intellectual Property (IP) Strategy: Applications must include an IP strategy. Applications that do not include the attachment will not be reviewed. This attachment should be entitled "IP Strategy.

pdf". Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials, if applicable.

Describe the IP landscape for your therapeutic device including any known constraints that could impede the development of their therapeutic device or diagnostic (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar technologies that are under patent and/or on the market, etc.) and how they will be addressed to achieve the goals of the program.

Describe potential issues addressed regarding the IP landscape for the device being developed, and the means for addressing any IP hurdles/barriers. If the device or technology whose IP is not owned by the applicant's institution, discuss any questions that may constrain or impede the ability to operate and move the technology forward consistent with achieving the goals of the program.

If patents pertinent to the therapeutic device being developed under this application have been filed, indicate the details of filing dates, what types of patents are filed, application status, and associated United States Patent Office (USPTO) links.

Describe future IP filing plans for the technology or device, including how multiple-PD/PI and/or multiple-institution applications will share or otherwise manage IP and for coordinate these efforts (e.g., licensing, managing IP) among the institutions. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: Applicants must include the following: Describe how the proposed approach will use the concepts from engineering, physical science, computational or other multidisciplinary methods to address the biomedical problem identified in the application.

If the proposed next generation brain stimulation device is an integration of existing intervention elements into a new combination, describe how the new device will lead to new capabilities to treat mental illness.

Describe how the investigative team demonstrates sufficient depth and breadth of the multiple disciplines necessary to complete the project Describe how the investigative team's experience and range of engineering and technical skills provides the expertise necessary to 1) complete the proposed work and 2) develop and validate quantitative tools and technologies with respect to next generation brain stimulation devices using bioengineering approaches.

If industry collaborators are identified, describe how they will contribute substantive device and/or hardware expertise and time commitment to advance the project, and how the collaborative arrangements will promote a multidisciplinary approach to brain stimulation device development. Anticipated risks and limitations. Describe any planned or reasonably anticipated co-enrollment for participants in this study, if applicable.

Information may include but is not limited to: Assessment and justification for permitting or excluding co-enrollment. Ethical implications and the risks, burdens, and benefits of co-enrollment to the participants and the scientific validity of the study. Confirmation that anticipated co-enrollment is included in the protocol provided to the IRB, FDA (if applicable), and the DSMB (if applicable).

Actions taken to ensure participants are fully informed about the risks, burdens, and benefits that may result from co-enrollment in the studies. Actions taken to reduce potential confusion about the differentiation between clinical care and research or individual research studies (for example, consider who conducts the informed consent).

Mitigating actions taken to address concerns or risks that may arise from co-enrollment (e.g., adjustments to exclusion criteria). Any animal or non-clinical trial human testing should be justified in the context of necessity for device development. Any proposed work in animals must include a description of how the methods would be scaled up for use in humans.

In recognition of the fact that these methods might be in early stages of development, work with human volunteers can, but does not need to, be included. Applications are expected to also include the following sections in the Research Strategy : Current State-of-the-Art: Define the current state of related brain stimulation technology as a benchmark against which the proposed new technology or improvements will be measured.

Given that projects are likely to be early-stage and high-risk in nature, this should include the specific proof-of-concept test(s) that will indicate whether/how a proposed tool actually "works", along with alternative strategies should that effort fail to perform as expected.

Tests should include a comparison against existing benchmark technologies; if a tool is truly first-in-class, comparisons may be done against a nearest neighbor technology. Briefly note how results will be used to inform future phases of tool development, such as testing in other model systems or in human brain. Describe any relationship with industry/commercial partners (if applicable).

This should include details on what, if any material, substantive device and/or hardware expertise and time commitment partners will contribute to advance the project. The regulatory process for the new technology should be described in the application, when applicable.

If a memorandum of understanding (MOU), confidential disclosure agreement (CDA), or collaborative research agreement (CRA) has been signed by both parties, this should be described by the applicant. Describe the potential translational pathway for their devices. This should include a description of the regulatory and reimbursement pathway for their device or specific type of technology.

Future commercialization, implementation, and dissemination plans should be discussed. Include timeline and milestone plans that propose indicators of progress at critical junctures. These should be tailored to the unique scope of each project and written concretely enough to evaluate what exactly will have been achieved (e.g., crucial steps in tool making) during the course of the project.

Quantitative metrics for evaluating device development should be included. A letter of support from any industry partners (if applicable) must be included. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100 ).

Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate