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

Recent advances in human genetics are reshaping our understanding of the genetic architecture of mental disorders and their molecular pathophysiology. We now have a large number of significant replicable genetic signals associated with all major mental disorders including schizophrenia, bipolar disorder, and autism spectrum disorder. Many of the genetic signals contributing to disease risk are enriched in non-coding regulatory regions of the human genome. Additionally, psychiatric disorders, such as schizophrenia and autism spectrum disorder, are generally thought to result from dysfunction of neuronal circuitry involving multiple cortical and subcortical regions with disparate temporal, spatial, and cell-type specific etiologies. However, there is little or no data regarding network regulation of transcripts that span multiple developmental time periods, brain regions, and/or cell types in psychiatric disorders and associated dimensional and behavioral phenotypes. To gain insights into the molecular mechanisms underlying psychiatric disorders, it is critical to generate, integrate, and analyze data from multiple sets of comprehensive molecular profiles across brain areas and cell types in both diseased and healthy control brains. In addition, integrative multi-level analyses of multi-modal data that contains distinct biological information may facilitate the identification and prioritization of potential genetic targets and lead to drug discovery for these psychiatric disorders.

The PsychENCODE consortium (PEC), whose core projects resulted from the original Funding Opportunity Announcement (FOA), represents the largest integrative and collaborative effort in the field, with the common goal of mapping genomic regulatory elements on multiple molecular scales and developing molecular models of disease. Eventually, the PEC aims to generate spatio-temporal reference maps of functional genomic elements affecting human brain function and create a public resource of multidimensional genomic data. The PEC members are also collaborating with the Genotype-Tissue Expression project (GTEx), the Encyclopedia of DNA Elements (ENCODE), and other related consortia to enhance the power and impact of these analyses.

The PEC is making substantial headway and is actively sharing the resources that are being generated within the research community through the NIMH repository. However, progress in this area is only just beginning and much work is still needed to comprehensively characterize the functional diversity of genetic regulation in the brain at various genomic scales. Many regulatory elements are only functionally active in restricted cell contexts and/or specific developmental time periods, and only a small fraction of these cell types and periods (e.g. neurons, DLPFC, adult) are currently being studied. Through this FOA, the NIMH seeks to expand upon the ongoing efforts of the PEC to move towards a comprehensive functional characterization and deep molecular understanding of the brain. This goal will be achieved through new analyses and the production of new data on previously uncharacterized regions, cell types, and samples. A knowledge base of molecular information with spatial and temporal resolution across multiple domains is needed to elucidate the regulatory mechanisms and molecular networks that drive critical neurobiological processes involved in brain development and function, as well as dysfunction in psychiatric disorders.

This FOA will support research in the discovery and characterization of the full spectrum of non-coding functional genomic elements (e.g., enhancers, promoters, silencers, non-coding RNAs, chromatin interactions) across brain regions, cell types, and developmental time periods to elucidate their role(s) in the molecular pathophysiology of mental illness through genome-wide examination of various human cell and tissue sources (e.g., human brain). Applicants should propose projects that employ unbiased, cutting-edge, state-of-the-art, and high throughput genome-wide approaches, computational methods, and experimental assays using appropriate cells or tissues derived from patient populations to correlate findings with the development of mental illnesses and outcomes relevant to brain function. Another focus of this FOA is to support the identification of human-specific functional regulatory elements, preferably in different neural and glial cell types across brain regions in patient populations. Preference will be given to projects which are proposed by a highly interactive and synergistic team of investigators with complementary expertise. Successful applications will include expertise in genetics, neuro-developmental biology, psychiatry, high-throughput analyses, whole genome sequence analysis, computational bioinformatics, and/or other fields relevant to the FOA.

The scope of the projects proposed by applicants for this FOA should build upon the efforts currently supported by the PEC. For more details on the current PEC efforts, applicants should consult the PsychENCODE Knowledge Portal at psychencode.org. Applicants are strongly encouraged to include assessments of: 1) key developmental time periods, particularly the early post-natal and adolescent periods; 2) different neuronal and glial cell types/subtypes or cell lineages in brain regions implicated in molecular pathophysiology of psychiatric disorders where data is currently limited. Applicants are especially encouraged to propose assays that will explore classes of functional elements where information is currently scarce (e.g., chromatin conformation, transcription factor binding, single-cell analyses etc.) in order to gain a deeper understanding of the cell-type specific genetic regulatory architecture in human brain. Critically, the proposed research should be complementary to, and not duplicative of, the current efforts in PEC.

The specific areas of interest for this FOA include, but are not limited to:

• Generation and analysis of several types of genome-wide data (see list below) to develop high-resolution, comprehensive spatio-temporal maps of the functional regulatory elements in the human brain and understand how it contributes to development of mental disorders. Efforts should encompass samples spanning multiple developmental time periods or both disease and healthy postmortem samples. Efforts should focus on exploring cell type specific data across brain regions and/or developmental time periods where data is currently limited. Cell-type specific/single-cell methods are encouraged for data generation.

1) Different classes of non-coding RNAs (long non-coding RNAs, microRNAs, piwiRNAs, etc.) and RNA modifications

2) Range of functional DNA elements (e.g., promoters, enhancers, silencers, insulators, transcription factor binding sites, RNA binding protein sites, etc.) and DNA methylation

3) Long-range chromatin interactions, chromatin conformation, and chromatin states

4) Proteomic changes

5) Various genetic alterations (e.g., single nucleotide variants, copy number variants, structural variants, etc.) identified from high-depth, whole genome sequencing.

• Identification of transcriptomic, epigenomic, and proteomic signatures specific to disease states compared to healthy control brains, both within and across disorders.
• Cross-disorder analysis of human brain cell-type/region and age-specific functional regulatory elements that are differentially represented in diseased brains compared to healthy control brains to identify common and unique epigenomic and transcriptional regulatory mechanisms that are relevant to different neuropsychiatric disorders.
• Spatio-temporal analysis (i.e., across developmental time) of changes in RNA splicing, transcript and protein isoforms, allele-specific expression, chromatin conformation, quantitative trait loci (expression and/or epigenetic), etc. in the context of neuropsychiatric disorders.
• Cross-species comparison of functional elements using new or existing data from human and non-human primates. Comparisons to other species may be made using existing data with bioinformatics approaches.
• Cross-tissue (e.g., blood versus brain) comparison of the abundance and species of non-coding transcripts and functional elements from various brain regions to other tissues to identify tissue specificity and implications for research on mental disorders.
• Cross-cell type (e.g., different neuronal and glial cell types/subtypes and/or lineages in the human brain) comparisons of the abundance and species of non-coding transcripts and functional elements to better understand cell-type heterogeneity across various molecular scales, and its implications for the development of neuropsychiatric disorders. Single cell methods are encouraged.
• Functional annotation of putative causal variants and their contributions to disease states through aggregation, harmonization, and mining of newly generated multi-omic brain molecular data with additional genomic information available from the PEC and other large consortiums.
• Development of computational models to predict the relationships between genes and regulatory functional elements, the effects of genetic variants on the regulatory networks that these relationships describe, and/or the role of functional elements in spatio-temporal regulation of the genes/gene networks that drive critical neurobiological processes and neural circuits involved in the pathophysiology of psychiatric disorders.
• Application and/or development of novel analytical and computational methods to perform integrative analysis of multi-omic data generated within the PEC and across large scale genome wide efforts (primarily human data - see list of consortia examples below) in order to build predictive models of disease using systems biology approaches.
• Validation of predictive computational models and/or characterization of the functional role of prioritized candidate regulatory elements associated with disease risk through experimental approaches. This may include using biological outcomes from existing and/or new experimental data from in vitro (e.g., induced pluripotent stem cell or iPSC), in situ, or in vivo systems.

Applicants are expected to utilize unbiased state-of-the-art genomic approaches for data generation. Applicants are strongly encouraged to combine/integrate data generated by the PsychENCODE consortium, both newly generated and existing datasets, with data from GTEx , BRAIN cell census, and other consortia (e.g., Brainspan, CommonMind, ENCODE, Common Fund Epigenomics, Roadmap Epigenome Mapping Consortium [REMC], and the International Human Epigenome Consortia [IHEC], GENCODE, 1000 Genomes, Psychiatric Genomic Consortium, Autism Sequencing Consortium) to examine cellular and tissue heterogeneity in genetic regulation. Applicants should propose studies involving human cells/tissues, leveraging existing human brain collections that include the brains of patients with psychiatric disorders wherever possible, and studies should have a rationale for the selection of such cells/tissues, including the extent to which they can potentially elucidate the pathophysiology of mental disorders.

Applicants should develop milestones to ensure progress on the specific aims of the project. Milestones are goals that should include clear and objective criteria for success. Applicants are required to outline biannual milestones to provide clear indicators of a project s continued progress or developing difficulties.

Milestone descriptions may include, but are not limited to:

• tissue procurement and processing;
• single cell isolation;
• generation of multi-omic molecular datasets;
• timely sharing of datasets within the PEC and with the public;
• integration and analyses of multi-modal datasets for identification and comparisons of molecular signatures in diseased and healthy brains;
• performance of experimental functional characterization or computational model validation.

The milestones should be regarded as criteria for evaluating the progress and direction of the Research Project, and should not be just a restatement of the specific aims.

Projects awarded under this FOA and the companion FOA (PAR-17-257) will be governed by the PsychENCODE Consortium Executive Committee to facilitate and accelerate scientific progress through the coordination of research strategies, analytical methods, and data.

Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups accordingly. 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 in response to this FOA.

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

Email: [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 with the following modifications:

Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a 1/N indicator + Identical Title (e.g., 1/3 , where the 1/3 means this is site 1 of 3 sites in the set. The other sites will be labeled 2/3, etc.) Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.

Cover Letter Attachment: The Cover Letter is one pdf file only. The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., 1/3 ), and 3) the Applicant Institution. Each site should submit an identical listing.

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

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

Facilities and Other Resources:

Each application in a set of linked collaborative U01s must describe the facilities and resources available for that application. It is expected that this section of the application will be different in each of the linked applications. Applicants should especially focus on the unique resources at their institution and any sub-contracts which lend themselves to the completion of the project.

Other Attachments:

1. Project Management Plan

Linked applications must provide an identical Project Management Plan across sites, submitted as a single pdf attachment with the title "Project Management Plan."

Provide a plan detailing the measures that will be taken to ensure cross-disciplinary communication and integration across the team (i.e. the collaborating laboratories) and addressing the division of labor across the team. The Project Management Plan must provide a detailed description of how different elements of the project would operate in a synergistic and integrated manner, including a data coordination plan. The following guidelines and framework must be followed in developing this plan:

• Demonstrate how the proposed collaborative work will address questions that would be difficult to answer with data from a single site.
• Describe how scientific research procedures will be integrated across sites within a project, and cross-site comparability of training and procedures to assure reliability and quality control.
• Describe how data coordination will occur across linked applications, including standards and integration, and plans for ensuring comprehensive transparency of data reporting/sharing across sites as appropriate and consistent with achieving the goals of the program.
• Include plans for ensuring: replication, comprehensive transparency of data and rapid reporting/sharing of data to the PEC members, and rapid access to data and analytical resources by all the performance sites as appropriate.
• Include a plan for ensuring experimental rigor and control of bias (e.g., with sample size estimation, data handling), as appropriate across linked applications.
• Describe plans for maintenance of close collaboration and effective communication among members of the group through group meetings, including frequency and types of contact between participating researchers, and documenting and disseminating group meeting proceedings.
• Provide description of the leadership structure across linked applications, describing overall managerial and administrative responsibilities, specification of leadership roles, and responsibilities for specialized subparts of the research plan.
• Include a plan for publication and authorship rights across sites in linked applications and a process for arbitrating disagreements regarding publication and other issues.
• Include a plan for completion of the research project should a key member leave the group, including plans to replace the PD/PI if needed.

2. Milestones and Timeline Plan

Linked applications must provide an identical Milestones and Timeline Plan across sites, submitted as a single pdf attachment with the title Milestones and Timeline, that includes the following information:

Describe a timeline (Gantt chart) for completion of project aims, including unambiguous, quantifiable, and scientifically justified biannual milestones to provide clear indicators of a project’s continued progress or developing difficulties. Milestone descriptions may include, but are not limited to:

• tissue procurement and processing;
• single cell isolation;
• generation of multi-omic molecular datasets;
• sharing of datasets with the PEC and the public;
• integration and analyses of multi-modal datasets for identification, and comparisons of molecular signatures in diseased and healthy brains;
• performance of experimental functional characterization or computational model validation.

The milestones should be regarded as criteria for evaluating the progress and direction of the Research Project, and should not just be a restatement of the specific aims.

3. Data and Samples Plan

Linked applications must provide an identical Data and Samples Plan across sites, submitted as a single pdf attachment with the title Data and Samples Plan, that includes the following information:

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

All instructions in the SF424 (R&R) Application Guide must be followed. It is expected that the projects will include synergistic research teams comprised of outstanding scientists from diverse scientific disciplines with expertise in neurodevelopment, genetics, psychiatry, computational bioinformatics, analysis of genome-wide data, high-throughput technologies, and/or other fields relevant to the FOA, as well as expertise in understanding the complexities of psychiatric genomics. As appropriate, Senior/Key Personnel should demonstrate their experience and expertise in these areas

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:

Specific Aims:

The collaborative mechanism requires an Overview section as part of the specific aims attachment. This attachment must provide: 1) an overall rationale for applying as a collaborative study; 2) outline the role of each site and how they will contribute to achieve the FOA objectives; 3) Specific Aims of the collaborative project. This Specific Aims attachment must be identical in each of the applications that are linked together in a collaborative U01 set.

Research Strategy

Applications from each site must contain a Research Strategy that clearly describes those aspects of the project that are common to all sites of the linked applications.

The Research Strategy must be identical across linked collaborative U01 applications, with the exception of the section under the header "Elements Unique to This Site." All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site" (estimated to be no more than 1 page of the Research Strategy Section). In this subsection, PDs/PIs should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, etc. Any site that contracts out some portions of this work should list this fact under "Elements Unique to This Site," and provide a full description of the nature, purpose, and oversight of this contractual arrangement.

Applications must conform with current guidelines, taking care to address important elements related to Significance, Approach, and Innovation.

Applicants are requested to clearly address the following aspects:

• Describe the status of current research efforts, and/or how the research proposed addresses the objectives of the FOA to build upon existing efforts of the PsychENCODE Consortium and Common Mind Consortium.
• Propose the use of samples from various brain regions, cell types, and cell-subtypes collected across key developmental time points relevant to psychiatric disorders where data is currently limited (e.g., brain regions such as nucleus accumbens, caudate-putamen, striatum, hippocampus, amygdala, thalamus, neuromodulatory regions, cerebellum, subgenual cingulate cortex, etc.; time periods such as early post-natal development, etc.).
• Provide a rationale and justification for the choice of data types, cell-types, brain regions, developmental time periods, number of samples, technologies, data collection, and validation strategies. Include the extent to which these choices can potentially elucidate the pathophysiology of mental disorders.
• Propose use of unbiased molecular approaches and state-of-the-art technologies, using appropriate cells or tissues derived from healthy and diseased brains to correlate findings with the pathophysiology of psychiatric disorders. Such technologies and methods should be scalable, robust, well-validated, cost effective, and high-throughput.
• Propose generation of comprehensive, high-resolution, multi-omic molecular datasets (e.g., genomic, transcriptomic, epigenomic, proteomic, epitranscriptomic, chromatin architecture, etc.)
• Include utilization of a sufficient number of patient-derived samples to achieve appropriate statistical power.
• Describe plans for adopting and following, whenever possible, standards and protocols established by ENCODE, REMC, and IHEC. Standard ontologies should be used for experimental metadata and other data whenever possible (see http://www.bioontology.org).
• Provide justification for proposed DNA/RNA sequencing read length and read depth, and dynamic range for protein expression to detect and catalogue a full spectrum of genomic, transcriptomic, epigenomic, and proteomic variations in healthy and diseased brains.
• Include cutting-edge computational and bioinformatics approaches for data processing, quality control, data integration, data harmonization, and multi-level analyses of diverse data types to build comprehensive molecular models of psychiatric phenotypes.
• Propose robust plans for accurate annotation of DNA/RNA sequence to distinguish between sequencing errors and real polymorphisms plans to minimize false positives.
• Describe the capabilities for data production and storage.
• Describe plans for state-of-the-art computational analyses of multi-omic data that will be utilized, adapted, or developed.
• Provide evidence of feasibility of the proposed studies, based on preliminary data, as well as qualifications and track record of the key personnel for performing critical aspects of the research study (e.g., computational methods, functional analysis).
• Provide appropriate and sufficient details commensurate with the relative emphasis of computational versus experimental/functional approaches.

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.
• All applicants should provide a comprehensive plan for the rapid and timely release of all raw and processed data (e.g., molecular and phenotypic data) and accompanying metadata, biomaterials, and tools to the wider scientific community through public data repositories, in accordance with NIH and NIMH data and resource sharing policies and guidelines.
• The NIH Genomic Data Sharing Policy will apply to any large scale human or non-human genomic data generated under this project, as well as the use of these data for subsequent research https://gds.nih.gov/03policy2.html ).
• Plans should include sharing clinical and genotypic data with the NIMH Repository and Genomics Resource (NRGR), genotype-phenotype data with the database of Genotypes and Phenotypes (dbGaP), and/or clinical and associated genotype and phenotype data to the NIMH Data Archives (NDA), as appropriate.
• Applicants should refer to the NIMH guide notice NOT-MH-15-012; NOT-MH-14-015; NOT-MH-09-005 for NIMH-specific data and biospecimen sharing expectations.
• Per NIMH policy (NOT-MH-13-002), awardees who generate or use human subject-derived reprogrammed cells are expected to submit relevant source cells (e.g., fibroblasts, olfactory epithelial cells, blood) and reprogrammed derivatives (e.g., induced pluripotent stem cells/iPSCs or other renewable cell lines) to the NIMH Genetics Resource and Repository.

Appendix:

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

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

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

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

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

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

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

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

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

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

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Participation of NIH Intramural Scientists:

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

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

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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

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

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

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How effectively will the project use comprehensive genome-wide approaches to expand our knowledge of the potential role of non-coding elements in the development of serious mental illnesses? To what extent does the application address exploring and establishing a comprehensive landscape of multi-modal molecular alterations across brain regions of patients with psychiatric disorders, and developing molecular models of those disorders? To what extent are the plans sufficiently bold to constitute a substantial advancement in the ability to generate, integrate, and analyze multi-modal molecular datasets (e.g., genomic, transcriptomic, epigenomic, proteomic, epitranscriptomic, chromatin architecture, etc.) to build comprehensive molecular models that will provide transformative insights into the molecular networks and complex pathways that confer susceptibility to psychiatric illnesses?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? To what extent do the PD(s)/PI(s) and other key personnel have adequate expertise in genetics, neurodevelopment, neurobiology, psychiatry, computational and bioinformatics methodologies, analysis of genome-wide data, protein biochemistry, and/or other fields relevant to the project, as well as expertise and understanding of the complexities of psychiatric genomics? To what extent are the track records of the PD(s)/PI(s) and other key personnel in the production and analysis of high-throughput multi-omic data adequate to conduct the proposed research successfully?

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? To what extent does the project propose to include tissues, regions, cell types/subtypes, and key developmental time points under-represented in current studies and databases? Does the project adequately address issues of statistical power? Does the project include cutting-edge, unbiased genomic and computational approaches for data processing, quality control, integration, and multi-level analyses of diverse data types to build comprehensive molecular models of psychiatric phenotypes? Does the application propose adequate and robust plans for accurate annotation of DNA/RNA sequence to minimize false positives? Does the application utilize robust, well-validated, cost effective, scalable, and high-throughput techniques and methods? Does the proposed project address DNA/RNA sequencing read length and depth, and dynamic range for protein expression to detect and catalogue the full spectrum of genomic, transcriptomic, epigenomic and proteomic variations in healthy and diseased brains? Does the application describe plans for adopting and following the standards and protocols established by ENCODE, REMC, and the International Human Epigenome Consortium whenever possible? Are key technical barriers and dependencies identified?

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.

Project Management Plan

Does the research plan justify the need for a collaborative multi-site project using this FOA? Is the Project Management Plan adequate and appropriate to ensure coordination of the different elements of the project? To what extent would this plan ensure that all elements would operate in a synergistic and integrated manner within and across sites? To what extent does the plan include adequate procedures to assure reliability and quality control, comprehensive transparency of data reporting, and sharing of resources? To what extent does the application include adequate plans for maintenance of close collaboration and effective communication among members within and across application sites? To what extent are the plans for data standards and data integration adequate to the need of the project? To what extent are adequate plans presented for the completion of the project following the loss of a key member of the group? Does the application describe processes for joint decision-making regarding research activities and publication, as well as procedures for resolving disagreements and grievance?

Milestones and Timelines Plan

Does the project propose realistic timelines and milestones? To what extent do the milestones adequately encompass all critical aspects of the project?

Data and Samples Plan

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

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

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

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

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

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

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

For Renewals, the committee will consider the progress made in the last funding period.

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 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.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Adequacy of the data sharing plan as appropriate and consistent with achieving the goals of the program.
• The adequacy of the proposed team of investigators in terms of their complementary expertise in genetics, neurodevelopmental biology, psychiatry, high-throughput single-cell analysis, whole genome sequence analysis, computational bioinformatics, and/or other fields relevant to the FOA, as well as the fit of the team of investigators.
• Adequacy of focus on time periods, cell types/subtypes, brain regions, and functional elements where data is currently limited.
• Complementarity to current PEC efforts.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

All awardees under this FOA and the companion FOA (PAR-17-257) will be governed by the PsychENCODE Consortium (PEC) Executive Committee composed of the PDs/PIs of each project within the network, NIMH Project Scientist(s), and the NIMH Program Officer to assist in monitoring and developing scientific content and direction of the program.

The PD(s)/PI(s) will have the primary responsibility to:

• Define objectives and approaches, as well as plan and conduct the proposed research, and assume responsibility and accountability to both the applicant organization and to the NIMH for performance and proper conduct of all research supported in this initiative, in accordance with the Terms and Conditions of Award.
• Coordinate and attend PEC Executive Committee meetings at least monthly. The PD/PIs will be responsible for preparing concise proceedings or minutes (two or three pages), which will be distributed to the members of the PEC within one week of the meeting.
• Provide leadership in thought, ideas, and actions; working with the organization, structure, and advisors of the network.
• Accept close interaction with, and participation of, NIH staff in aspects of management of the network; cooperating and assisting with implementing the recommendations of the Executive Committee to facilitate coordination among all U01 grantees under this FOA and its companion PAR-17-257.
• Communicate and publish major findings by the PEC members in a timely manner. Publication or oral presentation of work done under this agreement will be accompanied by appropriate acknowledgment of NIMH support, including the assigned cooperative agreement award number.

Ownership of all analytic tools, protocols, and assays developed during the course of the research rests with the respective PI(s) who generated them.

The Awardee Institution, and/or Research Project Leader's Institution, will retain primary custody of, and have primary rights to, data as specified under the NIMH approved data and research resource sharing plans (described above). The Government, via the NIMH Project Scientist(s), will have access to data generated under this cooperative agreement and may periodically review the data consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIMH Project Scientist (or designated alternate in the event that the Project Scientist is not available) will have substantial programmatic/scientific involvement to:

• Coordinate and facilitate the interactions among the research teams supported under this FOA and companion FOA PAR-17-257.
• Serve as a resource with respect to other ongoing NIH activities that may be relevant to this effort, and providing expert advice to the awardees on specific scientific and/or analytic issues.
• Assist in the design, development, and coordination of the different stages of the study within their role as a participant on the PEC Executive Committee.
• Review analysis plans to ensure that they are within the scope of this effort, and consistent with the results of peer review.
• Recommend additional research endeavors or update the timeline and milestones of the project as necessary, within the constraints of the approved research and negotiated budget. To help carry out these duties, the Project Scientist may consult with non-NIH experts in the field.
• Coordinate and review the timeline for processing procedures, data submission and integration, and distribution to approved investigators with the assistance of the PD(s)/PI(s).
• Serve as a voting member(s) of the PEC Executive Committee.
• Participate in PEC Executive Committee meetings and conference calls.

In addition, a NIMH Program Officer has the usual stewardship responsibility for monitoring the conduct and progress of the project to ensure milestones are accomplished in accordance with the timeline. The Program Officer carries primary responsibility for periodic review and approval of the study protocol in relation to stated recommendations regarding continuance of the project, receives all required reports, determines that satisfactory progress is being made, and attends the PEC Executive Committee meetings as a non-voting participant. The Program Officer negotiates throughput, quality control, validation, and cost goals with the awardees as necessary, and suggests reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not being met, and may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures.

Areas of Joint Responsibility include:

All awardees under this FOA will be governed by the PEC Executive Committee composed of the PDs/PIs of each grant, NIMH Project Scientist(s), and the NIMH Program Officer to assist in monitoring and developing scientific content and direction of the program. The PEC Executive Committee will select, by majority vote, a Chair from among the PD/PIs for a two-year term.

The PEC Executive Committee will:

• Ensure synergistic functioning and coordination across grants supported under this FOA and companion FOA PAR-17-257.
• Assist in monitoring and developing scientific content and direction of the PEC.
• Identify synergies across projects.
• Coordinate data standardization and validation across projects.
• Share data and resources among the PEC members and with the broader scientific community in a timely manner, as per the data sharing plan and the PEC Executive Committee recommendations.
• Set research priorities and milestones for the overall PEC.
• Guide and evaluate the progress and direction of the research conducted by the awardees.
• Establish a timeline of the expected progression of the research activities.
• Form appropriate subgroups to develop uniform procedures and practices, such as for data quality measures and assessment, nomenclature and annotation conventions for data depositions, and so forth.
• Form appropriate subgroups to closely collaborate on the selection and generation of appropriate cell/tissue specimens. In such cases, for example, common policies, uniform practices (as needed), and data exchange will be adopted by the PEC awardees to enable harmonization and eliminate duplication/overlap.
• Coordinate and attend monthly meetings of the PEC Executive Committee to review progress, identify emerging opportunities for strategic partnerships, and decide optimal research approaches and protocol designs as warranted.

It is expected that decisions made, or actions taken, by the PEC Executive Committee will be by consensus, or majority vote when needed; each project (project being either a single U01 supported under PAR-17-257 or a collaborative U01 set supported under this FOA) will have one vote in PEC Executive Committee decisions, with the NIMH Project Scientist (or alternate) having one vote. The NIMH Program Officer will not have a vote. All PEC Executive Committee members will attend at least one annual meeting in person to discuss progress and share research findings. Outside consultants/experts may be asked to participate in PEC Executive Committee meetings and discussions, but will not have a vote on committee decisions. Membership on the PEC Executive Committee becomes effective upon issuance of the Notice of Grant Award. The PD/PIs agree to accept the close coordination, cooperation, and participation of a NIMH Project Scientist and the Executive Committee to facilitate coordination of all U01 awards under this initiative.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Executive Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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

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

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

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

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

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

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

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

Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
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.