NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• 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

Other

• 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
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

Multiple PDs/PIs are required.

Due to the transdisciplinary nature of the projects and the focus on collaboration and expertise sharing, this FOA requires the applicants to comprise a diverse transdisciplinary team of investigators with expertise in the orthogonal fields of physical sciences including mathematics, physics and computational sciences, as well as neuroscience, neuropsychiatry, and other areas of the biological sciences. Successful MPI applications MUST have at least one PD/PI with formal training and expertise in the orthogonal fields of the physical sciences (e.g., data/computational science, physics, engineering, mathematics) and one PD/PI with synergistic expertise in neuroscience/neuropsychiatry.

Formal training and expertise can be established through undergraduate or graduate degrees or successful track record in that field that demonstrates impact on the field.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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. 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 NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Teams localized within close geographical proximity (intra-institutional or inter-institutional) are strongly preferred to allow for frequent in-person interaction. Applications with Key Personnel from distant locations will need to demonstrate that the integrated efforts can be successful without this co- localization

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources:

Applications must describe the facilities and resources available. Applicants should especially focus on the unique resources at their institution and any sub-contracts which lend themselves to the completion of a convergent project.

Other Attachments: The following items should be included as other attachments.

1. Project Management Plan

Applications must provide a Project Management Plan submitted as a single pdf attachment, with the title Project Management that includes the following information:

Provide a plan detailing the measures that will be taken to ensure cross-disciplinary communication and integration in the team (i.e. the collaborating laboratories) and addressing the division of labor in the team. The plan must provide a detailed description of how different elements of the project would operate in a synergistic and integrated manner. To be cross-disciplinary, projects proposed by the applicants should be a single integrated effort, incorporating methodologies and tools which span neuroscience/neuropsychiatry and the orthogonal fields of the physical sciences represented (i.e., combine physical/computational and biological knowledge and tools). Teams must carefully address how their individual laboratory's contributions converge on a project that spans the relevant disciplines.

Applications should describe the following:

• How procedures will be integrated across different laboratories and elements within a project. Plans should address reliability and quality control.
• How the overall managerial and administrative responsibilities will be divided in a team (i.e., which laboratory will coordinate various parts of the project and which will be responsible for overall coordination).
• What procedures will be used to assure sharing of resources across the laboratories in a team, as well as reliability and quality control of data and resources, as appropriate and consistent with achieving the goals of the program.
• How close collaboration, coordination, and effective communication will be maintained among laboratories in the team through regular meetings (in person/teleconference). This plan should include frequency and types of contact between participating researchers, and documenting and disseminating group meeting proceedings.
• The plans for project data coordination, including standards and integration, and plans for ensuring comprehensive transparency of data reporting/sharing across sites as appropriate and consistent with achieving the goals of the program.
• The plans for ensuring experimental rigor and control of bias (e.g., with sample size estimation, data handling), as appropriate.
• The plans for completion of the research project should a key member leave the Group, including plans to replace the PD/PI, if needed.

2. Data and Samples Plan

Applications must provide a Data and Samples Plan submitted as a single pdf attachment, with the title Data and Samples Plan that includes the following information:

Provide a detailed description of any available data and/or samples that will be leveraged for this project, including amounts, quality, type, location, procedure for acquiring, etc.

All instructions in the SF424 (R&R) Application Guide must be followed.

Key personnel, and collaborators should provide appropriate breadth and balance of physical sciences and neuroscience research expertise and complementary abilities organized around a scientific framework to address fundamental question(s) in neuropsychiatric research.

All instructions in the SF424 (R&R) Application Guide must be followed.

A minimum effort of 3 person months is required for each individual serving as PD/PI or multiple PD/PI(s).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

Provide plans that clearly describe which neuropsychiatric problem your team plans to investigate and how the proposed physical sciences perspective or approach could bring novel insight to neurobiology and neuropsychiatric disorders. Indicate how this project will advance the CN framework and utilize physical sciences, engineering, and/or other relevant knowledge in the most rigorous and reproducible manner possible to develop novel strategies for establishing causal linkage across levels of analysis. Specify how this project will innovatively address current scientific or technical barriers to causally linking levels of analysis.

Describe how the project will link contiguous levels of analysis and provide sufficient scientific justification for the chosen approach (i.e., which levels they are connecting and why they are causally contiguous) in the context of one or more phenotypes or traits related to neuropsychiatric disorders which the project intends to investigate. Describe how the project will connect of at least three contiguous levels of analysis. If planning to connect only two levels, provide strong justification that the proposed connection is of particular scientific value and of such depth as to make the addition of a third level unrealistic for the time period of the award (e.g., multiscale models of genetic risk connected to complex circuit-level activity).

If examining the genetic level, indicate plans to employ genomic findings in psychiatry based on large-scale unbiased genome-wide assessments. If a candidate gene approach is indicated, document the unbiased studies which provided the basis for this approach and present plans to provide a broad functional context for the proposed candidate(s). When considering the circuit-level of analysis, describe the extent to which the circuits that will be examined have been characterized in terms of our understanding of the behaviors that they sub-serve, taking into account the underlying anatomy and structural and functional connectivity. Describe any plans to take into account dynamic interactions between the nervous system and external (e.g., environmental) and internal (e.g., other organ systems including immune system) factors in the production of human behavioral dysfunction in their computational models. In particular, describe any plans to address how similar genetic insults can result in disparate phenotypes.

Detail how the project will be cohesive and integrated across all elements to combine computational methods and experimental approaches and how the project will demonstrably engage and incorporate scientists from the transdisciplinary team in meaningful ways.

Computational Model Development

Applicants should:

• Describe how they will build and/or develop their causal and/or probabilistic frameworks/theories/models to link contiguous levels of analysis (e.g., linking new or existing theoretical, statistical or computational models; using unbiased data-driven approaches, machine learning, artificial intelligence, etc.). Describe how the proposed frameworks/theories/modeling will integrate multiple pieces of information at each of the levels. Describe plans for data analysis and quality control. Clearly define the purpose and role in the explanatory process for the computational frameworks/theories/models across the chosen levels of analysis. Specify the degree to which the computational framework/theory/model will be biologically realistic, an explicit explanation of how mental (behavioral-level) or neurobiological (systems-level) processes will be mapped to their corresponding mathematical concepts, if applicable, and any limitations inherent in the frameworks/theories/model. If necessary to fully describe different chosen traits or functions, describe plans for the development of multiple causal and/or probabilistic frameworks/theories/models
• Describe the choice of data types at each level (genomics [genome, transcriptome, epigenome, proteome, etc.], molecular [pathways, cascades, ion-flux, etc.], biophysical [tensile strength, etc.], physiological, electrophysiological [EEG, ECOG], imaging, stable recording of neuronal spikes, population-level neuronal activity and synaptic activity across spatiotemporal scales, different imaging modalities, etc.) as it relates to generating or validating the proposed model. Describe what novel strategies will be used to integrate and analyze multi-dimensional datasets. Describe how approaches will be developed to work with or reduce the dimensionality of these datasets. Describe how datasets will be integrated in a manner that permits hypothesis testing across various levels of complexity.
• If addressing genetic/genomic level of analysis, describe how the role of known genetic risk factors for neuropsychiatric disorders (e.g., large-scale genome-wide association studies, rare de novo mutations and structural variations, and tissue-specific or cell-type specific transcriptional and epigenetic profiles) will be addressed in generating dysfunction at other levels of analysis. Describe how genomic data and findings from large-scale genomic studies and initiatives, including the BRAIN Cell Census, Allen Brain Atlas, CommonMind, GENCODE, Roadmap Epigenomics Mapping Consortium, International Human Epigenome Consortium, Psychiatric Genomic Consortium, GTEx, ENCODE, PsychENCODE Consortium, Autism Sequencing Consortium, Bipolar Sequencing Consortium, etc., will be leveraged for this purpose.

Experimental Validation

Applicants Should:

Describe how the computational framework/theory/model will be refined and validated through experimental data. Explicitly detail the follow-up strategies that will be used to test and confirm the findings from the proposed computational frameworks/theories/models and indicate how novel strategies will be deployed for iteratively improved model building with a particular focus on causality. Indicate the strategies the will be utilized for iterative refinements of computational frameworks/theories/models. Describe any plans for use of in silico experiments and/or new or existing data from biological experiments, that utilize in vitro, in situ or in vivo systems for these refinements. If utilizing in vitro systems, describe how they are well-suited to model or recapitulate complex cellular heterogeneity and interactions in the human brain (e.g., cell-based platforms, such as 3D brain organoids derived from induced pluripotent stem cells).

• For any proposed biological experiments: Describe how existing tools and measures, such as those from the BRAIN and RDoC initiatives, will be adapted for use in the project. Describe the development of any new tools or measures and document the need for their development to carry out the aims of the project. Describe how cutting edge technologies (e.g., DREADS, optogenetics, advanced microscopy, emerging technologies with spatial and temporal resolution [ECOG array], closed-loop brain stimulation, imaging, etc.) will be used to identify cells/cell populations, structures, and/or processes/functions involved in disease pathogenesis is also encouraged where possible. If prospective phenotypic measurements in humans are described, indicate to what extent detailed, standardized, and validated measurements were used (e.g., PhenX Toolkit, NIH Toolbox, RDoC) where available and appropriate.
• If prospective phenotypic measurements in humans (e.g., PhenX Toolkit, NIH Toolbox, RDoC) is especially encouraged where available and appropriate.
• Describe how available data will be leveraged and/or new data generated to develop, refine, and validate your framework/theory/model. Indicate the extent to which data from human populations (e.g., clinical phenotypes, genotypes, imaging, electrophysiology, etc.), will be utilized. Describe any use of animal data and detail how the use of this data is appropriate in the context of the human trait or function under investigation (i.e. how these data are able to represent or inform our understanding of the human trait or function in question). If using animal models, indicate whether the models are etiologically relevant, with the same genetic modification as human patients for construct validity. If directly addressing behavior, indicate the extent to which non-human primate and human data will be incorporated. Provide justification any new data collection that will be done as part of the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Plans should include sharing clinical and genotypic data with the NIMH Repository and Genomics Resource (NRGR), genotype-phenotype data with the database of Genotypes and Phenotypes (dbGaP), and/or clinical and associated genotype and phenotype data to the NIMH Data Archives (NDA), as appropriate.
• The NIH Genomic Data Sharing Policy will apply to any large scale human or non-human genomic data generated under this project, as well as the use of these data for subsequent research (https://gds.nih.gov/03policy2.html).
• Applicants should refer to the NIMH guide notice NOT-MH-15-012; NOT-MH-14-015; NOT-MH-09-005 for NIMH specific data and biospecimen sharing expectations.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. 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

Part I. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Participation of NIH Intramural Scientists:

An NIH intramural scientist may serve as a co-investigator, collaborator, or consultant. However, an Intramural scientist may not receive salary, equipment, supplies, or other remuneration from awards resulting from this FOA. The Intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research. The participation of an intramural scientist is independent of, and unrelated to, the role of the NIMH Project Scientist. The involvement of Intramural scientists needs to be consistent with NIH Policy and all applicable federal laws and regulations: https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-conduct_research.pdf

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

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Do the PD(s)/PI(s) clearly describe which neuropsychiatric problem they plan to investigate and how the proposed physical sciences perspective or approach could bring novel insight to neurobiology and neuropsychiatric disorders? How well does the project address connecting contiguous levels of analysis in the context of a neuropsychiatric disorder? How well do the aims test and advance the convergent neuroscience-based approaches of the project? If the aims of the application are achieved, how will scientific knowledge in neuropsychiatric research be advanced? Does the proposed work have a strong likelihood of revealing causal linkages across contiguous levels of analysis in the context of brain function and dysfunction related to psychiatric disorders? If the project includes a genetic level of analysis, does it signify an important advancement in explaining genetic causality across levels?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

To what extent does the project utilize the combined physical/computational/mathematical sciences, neuropsychiatric, and neuroscience research expertise to address linking contiguous levels of analysis? How will the project benefit from the unique scientific expertise represented by the PD/PI (and/or key personnel)? To what extent is there complementary and synergistic expertise? To what extent is the project management plan appropriate to optimize the management of a multidisciplinary project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

How novel is the project's application of multidisciplinary-based approaches and perspectives (neurobiological, physical, mathematical, computational sciences, engineering, etc.) to linking contiguous levels of analysis? To what extent does the application propose novel strategies for establishing causal linkages across contiguous levels of analysis? Does the application represent an innovative solution which overcomes current scientific or technical barriers? To what extent does the application propose novel strategies for integrating and analyzing multi-dimensional datasets, to reduce their dimensionality, and facilitate hypothesis testing across various levels of complexity? Will cutting-edge technologies be used where available?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

How well does the project integrate approaches from the orthogonal fields (i.e. physical/computational/mathematical sciences and neuropsychiatric research) to address linking contiguous levels of analysis? Does the project propose to understand causality in the context of a specific human trait or function? To what extent was sufficient and appropriate justification provided for the choice of the contiguous levels of analysis proposed to be linked? Were at least three contiguous levels of analysis proposed? If not, was the choice of two levels appropriately and adequately justified? To what extent are the multidisciplinary approaches, including the computational and biological aspects of the proposed project, appropriately integrated? To what extent are the described choices of data type, data set, and computational framework/theory/model, etc. appropriate for connecting the chosen levels of analysis in the context of the neuropsychiatric phenotype under investigation? If the genomic level was included in the proposed project: was adequate reference made to findings from unbiased genome-wide studies and was the use of this information appropriate for connecting the chosen levels of analysis in the context of the neuropsychiatric phenotype under investigation? If a candidate approach was proposed: was this approach adequately justified using findings from unbiased genome-wide studies and to what extent was a broad context proposed for the candidate? To what extent are the methods and approaches proposed appropriate for establishing causal linkages across contiguous levels of analysis? Are key technical barriers and dependencies identified? Are existing data leveraged when possible? If new data collection is proposed, is the justification appropriate and compelling? If use of animal data or model organisms is proposed: is it appropriate in the context of the human trait or function under investigation? To what extent are the experimental approaches or biological data chosen to test and validate the computational model adequate and appropriate? To what extent are the proposed methodologies for developing the computational frameworks/theories/models appropriate? To what extent are the methodologies for integrating multi-dimensional datasets to reduce their dimensionality and facilitate hypothesis testing across various levels of complexity appropriate? Are existing tools and measures utilized and leveraged appropriately? If new tool development is proposed, is it appropriately justified?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

How well does the project environment promote collaborations and transdisciplinary research? To what extent does the environment facilitate the operation of a single cohesive project which integrates the physical sciences with neuroscience/neuropsychiatry?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Project Management Plan

Is the Project Management Plan adequate and appropriate to ensure coordination of the different elements of the project? To what extent would this plan ensure that all elements would operate in a synergistic and integrated manner within and across sites? To what extent does the plan include adequate procedures to assure reliability and quality control, comprehensive transparency of data reporting, and sharing of resources? To what extent does the application include adequate plans for maintenance of close collaboration and effective communication among members within and across application sites? To what extent are the plans for data standards and data integration adequate to the need of the project? To what extent are adequate plans presented for the completion of the project following the loss of a key member of the group?

Data and Samples Plan

Are all proposed uses of existing data and samples adequately described?

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Adequacy of plans to integrate expertise from fields outside of neuroscience.
• Adequacy of focus on a human trait or function relevant to psychopathology
• Adequacy of plans to validate the conceptual frameworks, theoretical approaches and computational explanatory models developed through explicit follow-up strategies and experimental approaches.
• Use of the MPI mechanism for at least one of the linked applications to include at least one PD/PI with expertise in orthogonal fields of the physical sciences (e.g., data/computational science, physics, engineering, mathematics) and one PD/PI with synergistic expertise in neuroscience/neuropsychiatry.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

Projects awarded under this FOA and the companion FOAs will actively participate in the Convergent Neuroscience Network for Psychiatry (CNN-Psych) to facilitate coordination of the new projects with the ongoing efforts within the Network and accelerate scientific progress through the coordination of research strategies, analytical methods and data with other research groups within the Network to address the aforementioned research objectives of the FOA.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Geetha Senthil, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-402-0754
Email: [email protected]

Kathy Anderson, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-5944
Email: [email protected]

Susan Koester, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: [email protected]

Elizabeth Powell, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0786
Email: [email protected]

Nick Gaiano, Ph.D.
Center for Scientific Review
Telephone: 301-435-1033
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.