It is critical that applicants follow the Research (R) 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

The NIMH Exploratory/Developmental Grant program supports exploratory and high-risk research projects that fall within the NIMH mission by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough or the development of novel techniques, agents, methods, measures, models, strategies, or to the generation of pilot or feasibility data. The preliminary work from these studies could lead to a major impact on biomedical, behavioral, or clinical mental health research, or on the delivery of mental health care. The evolution and vitality of the biomedical, behavioral, clinical and implementation sciences require a constant infusion of new ideas, techniques, and perspectives. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.

NIMH is interested in improving mental health for all individuals and groups, including women as well as men and underserved racial/ethnic populations, including American Indians/Alaska Natives, Asians, Pacific Islanders, immigrants and refugees, and sub-ethnic groups (e.g., Black Caribbean, Chinese, Haitian, Korean, Puerto Rican, South Asian, etc.). This will require better understanding of differences and disparities in risk and resilience factors for mental disorders, prognosis of mental disorders, responsiveness to treatments, and access to and continuity of high-quality care. It will also require enhanced understanding of the distinctive health characteristics and attributes of people who are socially disadvantaged and/or subject to discriminatory acts. Accordingly, research is needed to adequately address mental health needs by sex and gender and by race/ethnicity in genomics, translational, efficacy, effectiveness, and implementation research to detect and understand group differences.

This program is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new hypothesis or scientific area.

Areas of scientific emphasis for this FOA reflect areas of priority as detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities.

Specific research priorities are listed as follows.

Division of Neuroscience and Basic Behavioral Science (DNBBS): Supports research programs in basic neuroscience, genetics, resource and technology development, and drug discovery.

DNBBS high priority research areas include but are not limited to the following topics:

• Discover novel mechanisms of nervous system development (across genes, proteins, cells and circuitry) and signaling properties that underlie the emergence of cognition, emotion, and social behavior.
• Develop and use innovative strategies, including genome-wide and comparative approaches, to discover genes and gene regulatory mechanisms underlying brain function, cognition, emotion, and social behavior.
• Develop and apply innovative biological, biophysical or cell-based assays for interrogating novel biological targets or processes relevant to mental disorders.
• Discover cellular and molecular mechanisms whereby hormones and immune molecules modulate signaling in brain circuits relevant to emotion regulation, cognition, and social behavior.
• Identify novel therapeutic targets, ligands to modify targets, and neuroimaging tools to advance innovative treatment development for mental illnesses.
• Develop innovative preclinical assays and neurobiological measures of fundamental processes relevant to emotional and cognitive disorders.
• Develop new and use existing physiological and computational models to understand the biological functions of genes, gene products, cells, and brain circuits in health and atypical mental function.
• Develop and empirically evaluate computational and theoretical models that address plasticity of brain circuits during development impacting cognitive, affective, and social behaviors.
• Extend analyses of key determinants of cognitive, affective, and social processes across levels of analysis between genomic, molecular, cellular, circuits to behavior.
• Apply biologically-grounded theory- and data-driven computational models to understand the functions of genes, gene products, cells, and brain circuits in mental functions and complex behaviors.
• Identify, at a genome-wide level, genetic variants that increase risk for mental disorders and related traits in diverse populations from the US and around the world.
• Develop integrative and comparative approaches for understanding the biology of molecular and cellular networks implicated in mental disorders by genome-scale human genetics.
• Identify biological markers (e.g., genetic, proteomic, imaging) in experimental (model) systems and in humans that could be further validated as methods for diagnosing and/or detecting risk/vulnerability, onset, progress, and/or severity of mental disorders.

Division of Translational Research (DTR): Supports research that translates knowledge from basic science to discover the etiology, pathophysiology, and trajectory of mental disorders and develops effective interventions for children and adults.

DTR high priority research areas appropriate for the R21 mechanism include but are not limited to the following topics:

• Delineate specific neural circuits contributing to one or more major mental disorders or subtypes of mental disorders.
• Develop, test, and validate markers (e.g., genetic, proteomic, imaging, quantified behaviors measured with passive sensing devices, thought markers derived from natural language processing, subjective state markers derived from facial dynamics, etc.) for diagnosing or detecting risk/vulnerability, onset, progression, and/or severity of mental disorders to prevent disorders, serve as criteria to personalize treatment and evaluate treatment response in subsequent studies (note that clinical trials are not supported by this FOA).
• Identify mechanisms (e.g., biological, behavioral, environmental) that confer vulnerability to psychiatric illnesses.
• Discover novel targets for future therapeutic intervention by identifying causal relationships between neural circuits and symptom expression (note that clinical trials are not supported by this FOA).
• Develop, test, and validate methods to assess domains of psychopathology for use in future clinical trials in order to increase the efficiency of the mental illness treatment development critical path, emphasizing approaches based on partnerships with the FDA and industry.
• Delineate neurobehavioral mechanisms responsible for the development of psychopathology, including critical and sensitive periods in brain development and the effects of sex, behavior, and experience on the brain.
• Utilize behavioral phenotypes reflecting dimensional processes (e.g., attention, mood regulation) to maximize discovery of underlying neural systems and refine behavioral assessment tools so that they are comparable across age, species, and social experience (e.g., SES, culture)
• Develop novel computational approaches to reliably infer subjective state from naturalistic behaviors passively assessed and quantified outside of the laboratory.
• Test integrative models incorporating biological, behavioral, and experiential factors in the development of psychopathology, and utilize longitudinal research to track trajectories of risk and protection based on the combined and interactive influences among these factors.
• Based on expanded knowledge of neurobehavioral trajectories, identify early signs of risk that could represent targets for future studies that may employ preventive and treatment interventions.
• Assess the mechanisms of action of efficacious interventions in the brain in bench, pre-clinical context, or computational models (note that clinical trials are not supported by this FOA).

Division of AIDS Research (DAR): Supports research on behavioral strategies to stop the spread of HIV/AIDS, basic and clinical neuroscience of HIV infection, and the mental health effects of living with HIV/AIDS.

DAR high priority research areas include but are not limited to the following topics:

• Expand approaches to integrate behavioral science with effective biomedical strategies for HIV prevention.
• Advance developmental research to inform potential interventions delivered beyond the individual level, by incorporating appropriate context into intervention development.
• Increase intervention potency and long-term maintenance of effects, with an emphasis on targeting high-risk vulnerable populations.
• Develop strategies to increase HIV testing and improve linkage to care and timely treatment initiation.
• Develop and advance developmental research to inform potential interventions to improve HIV treatment outcomes through optimal treatment adherence and sustained engagement in care.
• Support implementation science and operations research to enhance dissemination strategies and public health impact of effective interventions.
• Examine evolving pathophysiologic mechanisms of HIV-induced CNS dysfunction in the setting of long-term antiretroviral therapy and viral suppression, and development of novel therapeutic approaches to mitigate CNS complications of HIV infection.
• Support the use of state-of-the-art (epi)genetic approaches to identify and validate viral and host genetic factors that influence the pathophysiology and manifestations of HIV-induced CNS dysfunction.
• Define and characterize HIV persistence in the CNS in the context of suppressive highly active antiretroviral therapy, and foster translational research to enable eradication of HIV from the brain.

Division of Services and Intervention Research (DSIR): Supports innovative research aimed at testing and optimizing the effectiveness of therapeutic and preventive interventions, improving delivery and quality of evidence-based services, and accelerating the dissemination, implementation, and continuous improvement of new practices in diverse settings.

DSIR encourages R21research consistent with Objectives 3 and 4 of the NIMH Strategic Research Priorities, including but not limited to the following:

• Secondary analysis to inform the refinement and optimization of therapeutic and preventive interventions (for more potent, efficient, and personalized interventions), including:
• Analyses of moderators and biomarkers of treatment response from large and/or combined existing clinical trials datasets;
• Computational approaches that utilize electronic health record data or data from existing clinical trials to identify and evaluate treatment matching strategies; and
• Computational approaches using existing data (EHR; trials) that enhance early treatment response prediction and/or rapidly identify patients who would benefit from augmented or alternative treatments.
• Innovative exploratory/developmental services research to improve delivery, quality, and reach of evidence-based services, including:
• Studies to identify mutable factors that may serve as targets for future services interventions aimed at improving access, continuity, equity, engagement, adoption, sustainment, scalability, utilization, quality, financing, and clinical outcomes;
• Studies to develop and test new research measures, methods, or novel analytic approaches (e.g., machine learning and big data analytics leveraging data from health care systems, decision analysis, predictive analytics), to enable early detection of mental disorders, to improve clinical and financial decision making within delivery systems (e.g., schools, workplace, primary and specialty care settings, criminal justice, virtual communities), etc.;
• Studies utilizing innovative technologies (e.g., mobile devices, health information systems, social networking platforms) to identify strategies for improving early detection of mental illnesses, for engaging and connecting service users to evidence-based care, and for increasing the reach, clinical impact, and scalability of services for un- and under-served populations; and
• Research on innovative service delivery models to identify approaches for improving coordination between inpatient, outpatient and pharmaceutical services, for continuous quality improvement strategies, and for de-implementing low value service and expanding the use of high value services.

Applicants pursuing pilot services research studies that do not involve development and testing of services interventions, such as (1) studies to identify mutable factors that impact access, utilization, quality, financing, outcomes including disparities in outcomes, or scalability of mental health services, which may serve as targets in future intervention development; 2) development and testing of new research tools, measures, or methods; or 3) testing the feasibility of integrating existing data sets to understand factors affecting access, quality or outcomes of care are also encouraged to consider PAR-15-323 (Pilot Services Research Grants Not Involving Interventions (R34)). PD(s)/PI(s)s interesting in submitting clinical trials applications focused on the development and testing of therapeutic-, preventive- and services- interventions should see the NIMH Clinical Trials Funding Opportunity Announcements web page for a list of clinical trials FOAs and consult with Scientific/Research Staff regarding FOAs that are appropriately matched to the study scope and stage of intervention development and testing.

Office for Research on Disparities and Global Mental Health (ORDGMH): Supports research on global mental health, health disparities, and women's mental health with a focus on prevention, treatment, and implementation research in low- and middle-income countries. See research areas described under DSIR, above.

Office of Genomics Research Coordination (OGRC): Supports research to elucidate genomic risk factors that underlie mental disorders.

OGRC high priority areas include, but are not limited to, projects that will enhance the value of the resources being generated by NIMH such as:

• Computational methods development for analysis of large scale genomic or multi-scale molecular data.
• Innovative methods development for genomics, proteomic, etc. exploration of post-mortem human samples, especially single cell analysis.
• Projects making innovative use of genomics resources (e.g., NIMH Repository and Genomics Resource; SYNAPSE).

Office of Technology Development and Coordination (OTDC): Supports basic and applied research related to the development of scientific tools, technologies, and approaches related to brain and behavioral research.

OTDC high priority research areas include but are not limited to the following topics:

• New instruments related to understanding the brain such as brain imaging devices or microscopes.
• The development of new technologies using existing instruments that will aid in our understanding of the brain such as cell labelling technologies.
• Development of novel molecular and genetic tools to dissect brain circuitry.
• Development of cell type-specific molecular sensors and additional tools and approaches to address circuit-specific manipulation and monitoring.
• The development or enhancement of relevant software tools.
• The secondary analysis of data in existing publicly available data archives.
• Development of novel statistical and analytic approaches for handling large datasets.
• Software tools for enhancing and scaling automated image processing, connectivity analysis, and data interpretation, including algorithms, information extraction routines, and user interfaces.
• Novel approaches to increase availability and utility of public resources such as atlases and databases.

Examples of the types of projects supported by NIMH through the R21 program include: pilot or feasibility studies; development of research methodology; high risk studies; development of new research technology; small-scale, self-contained projects; and analysis of existing data sets. This FOA will not support clinical trials.

Updated priorities for NIMH research are detailed on NIMH research priorities website. Applicants are encouraged to contact Scientific/Research contacts prior to developing an application.

Applications for Exploratory/Developmental Research Grant awards should include projects distinct from those supported through the traditional R01 activity code. For example, long-term projects, or projects designed to increase knowledge in a well-established area, are not appropriate for this FOA. Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the NIH Small Research Grant Program.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application's Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

See Section VIII. Other Information for award authorities and regulations.

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

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, 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.

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:

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.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 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 with the following additional instructions:

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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

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 emphasize 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?

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?

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?

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.

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 the 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 NIMH program priorities.
• Relevance of the proposed project to the scientific mission and research priorities of NIMH.

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 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 RPPR, 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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Division of AIDS Research

Pim Brouwers, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3863
Email: ebrouwer@mail.nih.gov

Division of Neuroscience and Basic Behavioral Science

Susan Koester, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: koesters@mail.nih.gov

Division of Services and Intervention Research

Matt Rudorfer, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1111
Email: mrudorfe@mail.nih.gov

Division of Translational Research

Mi Hillefors, MD, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-2738
Email: hillefom@mail.nih.gov
Office of Technology Development and Coordination

Ruben P. Alvarez, Ed.D.
National Institute of Mental Health ( NIMH )
Telephone: 301-443-4058
Email: ruben.alvarez@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

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.