Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional)

Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional) is sponsored by NIH NIMH. This opportunity supports mission-aligned projects and measurable outcomes.

PAR-25-291: Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional) 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 Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional) 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 to pursue invasive neural recording studies focused on mental health-relevant questions.

Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate, via the same electrodes, allows for direct causal tests by modulating network dynamics.

This NOFO aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential.

Intervention-development clinical trials of therapeutic devices are outside the scope of this NOFO, though development of novel tools/methods to enable relevant mental health studies is encouraged. This NOFO uses the R21 grant mechanism, encouraging shorter, higher-risk applications, whereas its companion funding opportunity, PAR-25-290 , 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 purpose of this notice of funding opportunity (NOFO) is to encourage researchers to utilize invasive neural recording opportunities in humans to study the underlying neural circuity of mental health disorders.

Invasive neural recordings in humans provide an unparalleled window into the human brain to explore the neural circuitry underlying complex moods, emotions, cognition, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate those circuits, via the same electrodes, allows for direct causal tests by modulating network dynamics.

Understanding what circuits are involved in complex behaviors in humans, how the circuits evolve over time and in response to modulation and how to manipulate relevant circuits into preferred states, will inform brain stimulation therapies of the future. Applications submitted to this NOFO should focus on mental health questions of high translational potential, though need not lead to immediate therapies.

This NOFO encourages applications that incorporate teams with varied scientific backgrounds. Teams may include members from the fields of neurosurgery, electrophysiology, neuroscience, engineering, psychiatry, biostatistics, ethics, and psychology with the expertise necessary to conduct rigorous human-based research.

Teams will define what brain recording opportunity will be used and why their behavioral assay has mental health relevance. Although small sample sizes are to be expected, researchers are highly encouraged to collaborate to increase patient recruitment. Deep brain stimulation (DBS) has the potential to treat the most treatment-refractory patients.

However, previous large clinical trials failed to demonstrate positive effects of DBS over sham stimulation. Deeper understanding of the circuitry underlying mental health disorders is necessary to advance both invasive and non-invasive approaches to treating mental health disorders.

Invasive neural recordings provide an excellent opportunity to explore the circuitry underlying complex human behavior and to translate lessons from animal research. These opportunities arise during the normal treatment course of a variety of clinical conditions. Invasive recordings in humans have advanced our understanding of language, sensorimotor control, and memory.

Similar methods to those used to advance these areas of human neuroscience could be utilized to explore mental health-relevant questions.

Invasive recording opportunities can include intra-operative micro-electrode or strip recordings during DBS surgery, acute epilepsy monitoring electrocorticography (ECoG) or depth electrode recordings, or chronic deep brain stimulation/responsive neural stimulation (DBS/RNS) devices capable of recording and stimulating.

In many cases, the underlying condition necessitating implantation will not be related to a mental health clinical indication. However, many relevant patient populations (e.g., epilepsy and Parkinson’s patients) represent an enriched sample of mental health comorbidities.

Careful measurement of fluctuating mood, cognitive, and behavioral patterns of both patients with and without mental health disorders can provide unique insights into behavioral network dynamics, as demonstrated by early research in this field. Direct neural stimulation will complement invasive recordings by enabling researchers to test mechanistic hypotheses and explore therapeutic options.

Network activity correlated with mood/cognitive/behavioral changes (using dense behavioral assessments) can be modulated to assess behavioral improvements. Similar approaches could directly test circuit-based hypotheses and inform stimulation parameters to be utilized in DBS therapies.

Likewise, a map of neural networks elucidated by electrophysiological methods could inform device development by demonstrating the mental health-specific anatomical requirements necessary for future brain stimulation therapies. While current DBS and non-invasive brain stimulation therapies target localized areas, this research may demonstrate the distributed networks involved in disorders, and therefore inform the design of new devices.

Specific Areas of Interest Research related to this initiative may include, but is not limited to, studies of: Acute intra-operative recordings from single-unit or strip electrodes. Mood evaluations or mental health-relevant cognitive/behavioral tasks that can be completed in the operating room are encouraged.

Quantification of behaviors (e.g., facial expression, vocal expression) that may be associated with internal subjective states (e.g., mood, thoughts/impulses, perceptions) may be explored to tag simultaneously acquired neurophysiological signals to elucidate circuits related to subjective states relevant for psychiatric disorders. Sub-acute recordings from the epilepsy monitoring unit or related situations.

Patients with ECoG or stereo-electroencephalography (sEEG) electrodes could participate in a variety of tasks, depending on the placement of electrodes (e.g., amygdala, orbitofrontal cortex, or anterior cingulate cortex). Mood variations could be assessed using ecological momentary assessment (EMA) and other digital health tools to correlate mood fluctuations with neural circuitry changes.

Researchers could stimulate portions of the network to assess the effect on network dynamics and behavior. Chronic recordings from recording/stimulating DBS systems. Patients implanted for a clinical indication, either for a mental health disorder or not, can participate in research aimed at exploring relevant networks (though treatment development should not be the focus of the proposed research).

Assessments of network stability and responses to perturbations, along with their relationship to long-term/dense behavioral measures and digital phenotyping. Research Domain Criteria ( RDoC )-based circuit assessments.

Researchers could use RDoC-inspired paradigms in the above clinical scenarios to assess the relevant neural circuits of cognitive, affective, and social domains at a higher spatial and temporal precision than possible with non-invasive measures. Novel technological approaches. Novel methods of neural or behavioral recording and stimulation are encouraged.

This could include novel Artifical Intelligence/Machine Learning (AI/ML) approaches, novel electrodes, recording devices, virtual or augmented reality interfaces, or digital phenotyping/dense behavioral trackers. Prospective or retrospective data. Both prospective or retrospective data can be utilized for this funding opportunity.

The R21 grant mechanism of this funding opportunity encourages shorter, higher-risk applications with less (or no) preliminary data while the R01 encourages longer projects with preliminary data (see PAR-25-290 .

Applications Not Responsive to the NOFO Applications proposing the following will be considered non-responsive and will not be reviewed: Stand-alone development of novel technology that are not incorporated into an underlying scientific question. Applications that do not include information on neuroethical considerations. Imaging approaches not coupled with intra-cranial recording or stimulating.

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.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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 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. Optional: Accepting applications that either propose or do not propose clinical trial(s).

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 maximum project period is 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. 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.

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: Describe how the proposed project will advance understanding of neural circuits relevant to mental health disorders.

Describe how the proposed research has high translational potential for mental health disorders, in the near or long term. Describe how the proposed approach incorporates the use of current state-of-the-art tools available. Describe how the proposed research team includes a team of clinical neuroscience researchers with varied scientific backgrounds capable of conducting invasive human studies.

Teams may include members from the fields of neurosurgery, electrophysiology, neuroscience, engineering, psychiatry, biostatistics, ethics and psychology with the expertise necessary to conduct rigorous human-based research. Describe how the research environment is suited to invasive studies.

Describe how new approaches will improve the field's ability to conduct mental health-relevant research for research involving novel technological approaches (such as Artificial Intelligence/Machine Learning (AI/ML) approaches, novel electrodes, recording devices, virtual or augmented reality interfaces, or digital phenotyping/dense behavioral trackers).

Describe how ethical and practical considerations are included in the study design for issues specific to invasive human neuroscience research (e.g., informed consent, undue influence, dual roles of clinician and investigator, etc).

Describe how novel approaches of combining invasive recording, stimulating, and behavioral measures relevant to mental health conditions are included, how the approach for collecting neural recordings is feasible, and how neural and behavioral measures will be synchronized. Describe any planned or reasonably anticipated co-enrollment for participants in this study, if appliable.

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). 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.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. To progress the goal of advancing research through widespread data sharing among researchers, investigators funded under this NOFO are expected to share those data via the National 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 web site provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page .

Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission.

Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied.

Details on preparing a Data Management and Sharing Plan (DMS Plan) is available for review on Writing a Data Management & Sharing Plan . NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary . Appendix: Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the How to Apply- Application Guide. No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. Use of Common Data Elements in NIH-funded Research Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.

CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.

NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" ( http://cde. nih.

gov/ ) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.

Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research.

Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator ( https://nda.

nih. gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs. xlsx ) is available to facilitate the calculation of these costs.

NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Management and Sharing for Applicants and Awardees. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9. 1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide . Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide . See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Recipients