Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

This Funding Opportunity Announcement (FOA) encourages grant applications that incorporate a multi-dimensional perspective into studies of the neural mechanisms underlying emotional and/or social representations. The ability to integrate a broad array of emotional and social cues is impaired in many mental disorders, yet the neural mechanisms underlying these processes are not well understood. This FOA encourages investigators to take on the challenge of investigating how diverse multi-dimensional emotional and/or social cues are represented across integrated and temporally dynamic brain circuits. This FOA solicits applications that incorporate innovative approaches designed to move affective and social neuroscience beyond single region-based, modular, and/or static models of brain function and behavior.

Affective biases, deficiencies in interpreting social cues, and difficulties using emotional and social knowledge in context-appropriate ways are significant issues across many mental disorders. To understand the mechanisms contributing to perturbed emotional and/or social behaviors, we need a better understanding of the neural circuitry and neurodevelopmental processes underlying the perception, interpretation, and representation of emotional and/or social cues. This FOA solicits applications that incorporate a multi-dimensional approach to this challenge: the term 'multi-dimensional' is used to include consideration of multiple sensory modalities, the effects of complex contexts, and/or dynamic processes that unfold over a variety of time scales.

A large body of evidence using classical conditioning has implicated the amygdala in the recognition and memory of threatening emotional stimuli. However, fewer studies have assessed emotional behaviors within more complex and naturalistic settings or incorporated a broader range of multi-dimensional emotional, contextual, and social cues. More recent studies have shifted from a view that a single brain region is specialized for only one behavior, positing that an interactive network with distributed activity in space and time responds to diverse multimodal emotional stimuli. Although these studies show potential for advancing a multi-dimensional perspective of emotion processing and regulation, the nature of the dynamic neural interactions that govern the formation and development of coherent emotional percepts is largely unknown.

Similarly, studies of face perception have proposed one-to-one mapping between individual regions within occipito-temporal cortex and distinct aspects of facial cue processing. Multiple models propose that face perception occurs in a step-wise progression via parallel, regionally and functionally distinct neural pathways. Investigators have considered the possibility of extended, distributed, or cognitive stages of face processing, involving multiple, interacting brain networks and allowing for integration of complex features. However, very few studies have directly experimentally tested these multi-dimensional, dynamic, network-based theories.

Clearly, emotional and social experiences extend beyond threat and face processing, and activity within single brain regions is unlikely to account for the complexity of emotional and/or social behavior. This FOA solicits applications that incorporate innovative approaches designed to move the fields of affective and social neuroscience beyond single region-based, modular, and/or static models of brain function and behavior.

Objectives This FOA encourages research that will support Strategic Objectives 1 and 2 of the NIMH Strategic Plan for Research (http://www.nimh.nih.gov/about/strategic-planning-reports/nimh_strategicplanforresearch_508compliant_corrected_final_149979.pdf) by: 1) identifying neurobiological mechanisms and precise spatio-temporal interactions across brain networks that contribute to emotional and/or social behaviors, 2) determining the normative neurodevelopmental trajectories involved in processing multi-modal emotional and/or social cues, and 3) determining how disruptions in neurodevelopment or dysfunctions in neurobiological systems contribute to alterations in the emotional and/or social behaviors associated with mental illnesses.

This FOA seeks to stimulate novel research that incorporates behavioral paradigms capable of assessing the integration of multi-dimensional emotional or social information. For example, within and across species, emotional and social cues can occur in multiple modalities. Therefore, this FOA prioritizes experimental designs that include paradigms with more than one modality. Emotional and social experiences are not static: stimuli and contexts vary over time, and social interactions involve give and take between individuals. Therefore, this FOA seeks projects including continuous stimuli and analyses that account for temporal factors. Neurodevelopment and prior experience can affect the interpretation of emotional and social situations. Therefore, investigations of neurodevelopmental trajectories and the relationships between neurodevelopmental dysfunction and deficits in emotional and/or social processing are of particular interest.

To shed light on the neural circuits and systems involved in processing the complex emotional and/or social world, this FOA encourages investigators to extend beyond region-based, modular, static and/or purely sequential models of neurophysiological function. Investigators should consider including analyses that unveil how emotional and/or social representations arise from coordinated and dynamic patterns of neural activity across large scale neural networks. NIMH anticipates that this initiative will spur the use of state-of-the-art approaches to examine complex interactions across brain networks, and determine how precise spatiotemporal patterns of activity give rise to integrated, flexible emotional and/or social percepts, experiences, and actions.

Projects responsive to this FOA must fall within one or more of the following broad areas:

• Examination of the neural circuit interactions required for processing multi-dimensional emotional and/or social cues;
• Measurement and modeling of the neurophysiological temporal dynamics associated with formation, storage, and manipulation of multi-dimensional emotional and/or social representations;
• Investigation of the developmental trajectories of emotional and/or social representations and associated brain networks across childhood and adolescence;
• Studies exploring how dysfunction in these circuits and systems relates to emotional and/or social dimensions of behavior in psychiatric populations (e.g., the Research Domain Criteria project).

Projects utilizing human and/or animal subjects are encouraged. As per NOT-OD-15-102, it is expected that all studies will include both males and females.

Rigor of Data: Translating discoveries into evidence-based treatments is predicated on the existence of strong, well powered, adequately controlled, and replicated data. In addition, the value of such research is greatly enhanced when detailed information is made available about study design, execution, analysis and interpretation. Examples of critical elements are detailed in NOT-OD-15-103.

This FOA uses the R21 grant mechanism while RFA-MH-17-300 uses the R01 mechanism. Exploratory and developmental research projects that lack preliminary data may be most appropriate for the R21 mechanism. These R21 projects may seek to test early-stage concepts, involve considerable risk, or propose development of novel methodologies that could have a major impact on our understanding of multi-dimensional emotional or social representations.

Examples of specific research areas of interest include, but are not limited to, the following:

• Experimental designs that consider two or more emotional and/or social modalities (e.g. visual (images and language), auditory (sounds, verbal content, verbal prosody), somatosensory, etc.).
• Experimental designs that incorporate both negatively and positively valenced stimuli.
• Integrated experiments using human and non-human animals to investigate the mechanisms of complex emotional and/or social behavior.
• Experimental designs that incorporate both perception and production of emotional and/or social signals.
• Neurobiological mechanisms involved in integrating ongoing states of brain activity and external stimuli into emotional and/or social percepts.
• Neural circuits that mediate context-dependent interpretations of external emotional and/or social cues.
• Neural circuits underlying supra-modal (modality-independent, abstract, amodal) emotional and/or social representations.
• Studies of how interconnected circuits act in a coordinated manner to support integration of higher-order cognitive, affective and/or social processes.
• Spatio-temporal neurodynamics involved in emotional and/or social processing. Examples include, but are not limited to: the timing of multi-modal events in ecological settings; feed-forward mechanisms and top-down interactions; sequential vs. parallel processing; effects of differential modalities and cross-modal prediction on coordinated oscillatory neurodynamics.
• Projects incorporating novel multivariate analyses with high dimensional data sets to identify relationships among neurobiological components which contribute to emotional and/or social behaviors.
• Projects incorporating novel technologies to investigate causal relations among neural circuits involved in complex emotional and/or social behavior.
• Studies employing neuromodulatory methods in combination with physiology readouts to establish causal relationships between specific neural mechanisms and emotional or social representations.
• Impact of experiences during developmental sensitive periods on the neural systems required for integration of multi-dimensional information into adaptive emotional and/or social percepts.
• Projects investigating how differential timing and rates of development across different brain circuits influence the development of complex emotional and/or social representations and inform optimal timing and targets of intervention.
• Studies exploring how dysfunction in these circuits and systems relates to emotional and/or social dimensions of behavior in psychiatric populations. Consistent with the Research Domain Criteria initiative, studies including clinical populations are encouraged to focus on narrow clinical problems and dimensional conceptualizations rather than heterogeneous categorical diagnoses (http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml).

Examples of studies that are not responsive to this FOA and will not be reviewed include:

• Studies focused on behavioral assessments of emotional and/or social processes without neurobiological measures.
• Studies investigating the involvement of single brain regions in emotional and/or social responses.
• Studies investigating the formation, representation, plasticity, or neurobiological mechanisms of primary sensory percepts.
• Studies investigating correlations between sensory modalities.
• Studies of neural mechanisms underlying classical conditioning.
• Studies utilizing candidate gene approaches to examine the correlation between genetic changes and emotional and/or social processing.
• Studies using invertebrates.
• Studies primarily focused on sexual behavior or homeostatic processes.
• Studies focused on prejudice, stereotyping, and in-group/out-group relationships.
• Clinical Trials. For investigators interested in developing clinical interventions, please see http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml.

Applicants are strongly encouraged to consult with Scientific/Research Contacts when developing plans for an application. Early contact will provide an opportunity to clarify NIMH priorities and guidelines as well as to discuss specific components of the application subject to peer review.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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.

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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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: [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.

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.

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: The Research Strategy should include the following information.

Significance

• Applications are expected to include multi-dimensional components (e.g. two or more emotional and/or social modalities; measures and analyses of neural interactions required for higher-order processing of emotional and/or social cues; measures and analyses of neurophysiological temporal dynamics; effects of experience or context; investigation of developmental trajectories) and should explicitly address how one or more of these components are incorporated.
• Approach
• Multi-dimensionality: Details should be provided regarding how experimental paradigms include more than one modality or consider the effects of context or experience.
• Species: The application should provide justification for the choice of species within the framework of emotional and social behavior/cognition and demonstrate that the emotional and/or social stimuli used are appropriate to the species studied.
• Behavioral paradigms and measures: A strong rationale should be provided for the selected behavioral measures. Appropriate controls should be included for non-selective behavioral effects. The application should articulate the degree to which behavioral tasks include robust and reproducible outcome measures that are associated with the neurobiological circuits implicated in emotional and/or social functions.
• Neurobiological approach and analyses: The application should articulate a sophisticated neurobiological approach that extends beyond region-based, modular, static and/or purely sequential models of neurophysiological function. When appropriate, details should be provided regarding experimental procedures testing how emotional and/or social stimuli engage distributed largescale neural networks and/or how emotional and social representations arise from coordinated and dynamic patterns of neural activity. If measures of neurophysiological spatio-temporal dynamics are included, analytical methods should be robust and sensitive, with sufficient temporal resolution and statistical power.
• Developmental trajectories: If considered, developmental time points should be well justified. Behavioral paradigms should be appropriate and validated for all included developmental time points. If a longitudinal design is proposed, statistical analyses should be appropriate for within-subject and/or repeated-measure designs.
• Clinical or at-risk populations: If included, demonstrate how the project utilizes dimensional conceptualizations to narrow clinical problems (as per RDoC) rather than including subjects identified by heterogeneous categorical diagnosis. Detail how the study takes into account RDoC or RDoC-like constructs when defining the subject eligibility (inclusion) and behavioral measures.

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:

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share human subjects data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIMH, and supported by other Institutes of NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation. Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. A resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions. 

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 Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

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

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.

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

NIH encourages 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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 experiments include multi-dimensional components, such as: two or more emotional and/or social modalities; measures and analyses of neural interactions required for higher-order processing of emotional and/or social cues; measures and analyses of neurophysiological temporal dynamics; effects of experience or context; investigation of developmental trajectories?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

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?

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?  Is the choice of species well-justified within the framework of emotional and social behavior/cognition? Are emotional and/or social stimuli appropriate to the species studied?

Does the experimental design include paradigms with more than one modality or consider the effects of context or experience? Is a strong rationale provided for the selected behavioral measures and are appropriate controls for non-selective behavioral effects considered? Do behavioral tasks include robust and reproducible outcome measures associated with the neurobiological circuits implicated in emotional and/or social functions?

Does the approach incorporate a sophisticated neurobiological approach that extends beyond region-based, modular, static and/or purely sequential models of neurophysiological function? Do investigators consider the ways in which emotional and/or social stimuli engage distributed largescale neural networks? Do the analyses consider how emotional and social representations arise from coordinated and dynamic patterns of neural activity? If measures of neurophysiological spatio-temporal dynamics are included, are the analytical methods robust and sensitive, with sufficient temporal resolution and statistical power?

If developmental trajectories are considered, are developmental time points well justified? Are behavioral paradigms appropriate and validated for all included developmental time points? If a longitudinal design is proposed, are statistical analyses appropriate for within-subject and/or repeated-measure designs?

If clinical or at-risk populations are included, does the project apply dimensional conceptualizations to narrow clinical problems (as per RDoC) rather than including subjects identified by heterogeneous categorical diagnosis?

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?

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.

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.

Not Applicable

Not Applicable

Not Applicable

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 NIMH, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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.

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 CenterTelephone: 800-518-4726 Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Janine M. Simmons, M.D., Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1576
Email: [email protected]

Aleksandra Vicentic, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1576
Email: [email protected]

David Armstrong
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
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.