Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH)
Funding Opportunity Title	Limited Competition: Genomic Risk and Resilience in 22q11 Deletion Syndrome: A Window into the Genetic Architecture of Mental Disorders (Collaborative R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-MH-13-120
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.242
Funding Opportunity Purpose	This limited competition Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), invites applications for collaborative R01 awards from the International Consortium for 22q Del Syndrome Research for the genomic analysis of existing samples from Consortium recruited research subjects. The goal of this FOA is to use 22q DS as a model to dissect the overall genetic architecture and to identify specific genomic risk and resilience factors of brain behavioral and neuropsychiatric phenotypes associated with the syndrome.

Posted Date	August 2, 2012
Open Date (Earliest Submission Date)	October 13, 2012
Letter of Intent Due Date	October 13, 2012
Application Due Date(s)	November 13, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February 2013
Advisory Council Review	May 2013
Earliest Start Date(s)	July 1, 2013
Expiration Date	November 14, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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 purpose of this limited competition Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH), is to provide support for collaborative R01 projects that expand the scope of the research of the International 22q11 Deletion Syndrome (22q11 DS) Research Consortium (the Consortium). The Consortium is a group of approximately 120 investigators from more than 20 countries on 3 continents that self-organized with the goal of combining efforts to further the study of 22q11DS and its associated phenotypes. Although 22q11DS is the most common genetic microdeletion syndrome, it only occurs in ~1:4,000 births and it is estimated that, worldwide, only 3,000-4,000 subjects with the syndrome are enrolled in medical genetic studies. Most of these studies are very small (20-100 individuals) and the advancement of the field necessitates the aggregation of all samples across research projects in a consortium that integrates clinical science with cutting edge genomics expertise.

22q11 DS (also known as DiGeorge Syndrome DGS MIM18840, or Velo-Cardio-Facial Syndrome VCFS MIM192430) is associated with diverse neuropsychiatric disorders. Children with 22q11DS have high prevalence of ADHD, anxiety, depression/dysthymia, autistic and psychotic features, and up to 30% of adolescents and adults develop schizophrenia or psychosis. Overall, the neurobehavioral profile of 22q11DS shows variable deficits in neurocognitive domains across all stages of development in a majority of subjects. Symptoms of mental illness often emerge during childhood and adolescence and undergo changes modulated by brain maturation and experience. 22q11 DS offers a unique window into studying the molecular architecture of these disorders and presents an opportunity to focus on the discovery of genomic risk and resilience factors. Already, converging findings on 22q11 DS phenotypes and genomics of mental illnesses suggest that detailed phenotypic and genomic dissections can elucidate pathophysiological pathways underlying brain and behavioral changes across major neuropsychiatric domains. However, small sample sizes, a lack of integration and standardization of phenotypic methods and a lack of application of cutting edge genomics technologies have hindered a systematic approach to the genetic study of 22q11 DS. Because the field of 22q11 DS research is fragmented, it is unlikely that any individual group would be able to gather sufficient samples to reach statistical power to make genetic conclusions about the etiology of the disorder. Thus, this initiative will support a joint project by the Consortium for 22q11 DS research with the goal of interrogating all existing samples to standardize existing phenotypic data along dimensional and clinical modalities and to identify genomic risk and resilience factors with a particular focus on the deletion region and its molecular interplay with other functional elements of the genome. The heterogeneity of neuropsychological and neuropsychiatric phenotypes associated with 22q11 DS provides a rich opportunity for dimensional exploration of genetic risk in the framework of the Research Domain Criteria Project (RDoC) (http://www.nimh.nih.gov/research-funding/rdoc/nimh-research-domain-criteria-rdoc.shtml). Investigators are encouraged to include research hypotheses on multiple functional domains (e.g., negative and positive valence, cognition, social processing, and arousal/regulation). The RDoC approach is particularly advantageous for international collaborative efforts because it alleviates concerns about inter-site variability in diagnostic criteria.

The goal of this FOA is to leverage existing cohorts and samples collected by members of the 22q11DS Consortium rather than to support new sample collection. However, recruitment and re-phenotyping are permitted for missing data or for the inclusion of first degree relatives if required to test specific hypotheses and through innovative and low cost approaches. Similarly, re-collection of samples is permitted in instances where previously collected DNA is of insufficient quality or quantity.

Competitive applications must explicitly demonstrate how the proposed collaborative work will address questions that would be difficult to answer with data from a single site or study. Feasibility of achieving the collaborative goals must be supported with sufficient information about sample size and demographics, including an inventory of existing genetic samples and phenotypic measures and justification for collection of new data.

This FOA encourages collaborative grant applications from the Consortium for research in a number of critical areas including, but not limited to:

• An intensive investigation of the 22q deletion interval and other genomic elements that play a role in the expression of the phenotypes associated with the syndrome using cutting edge genomic and bioinformatics approaches and platforms
• A systematic examination of neuropsychiatric and neurobehavioral phenotypes in 22q11 DS including assessing developmental trajectories of these phenotypes across studies represented in the Consortium
• Development of consensus phenotypic measures across studies with testing of common core measures for future longitudinal studies in 22q11 DS.
• Development of a resource for the Consortium and the scientific community including common databases encompassing the range of measures across all domains and all participating sites.

Applications must address the leadership structure across linked applications and how data coordination will be handled. Essential elements include frequency and type of contact between participating researchers and specification of leadership roles and whether or not particular individuals or sites will coordinate specialized subcomponents of the research plan (e.g., genetic processing and analysis, development of neuorocognitive indices). The data coordination plan should also include information about processes for joint decision-making regarding research activities and publication, as well as procedures for resolving disagreements and grievance.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIMH intends to commit approximately $3,000,000 in FY 2013 to fund up to 6 awards.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	The total project period for applications submitted in response to this FOA may not exceed 4 years.

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.

Only the institutions/organizations that comprise the International 22q11 Deletion Syndrome Research Consortium are eligible to apply.

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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)) are 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

This FOA requires the use of the linked NIH Collaborative Research Project Grant (R01) award mechanism and there has been some confusion with regard to the applicability to the NIH multiple PD(s)/PI(s) policy. Multiple PD(s)/PI(s) are allowed on any single application and the policy for doing so is included in this FOA. Because the collaborative R01 mechanism already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PD(s)/PI(s) on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should NOT be designated as multiple PDs/PIs on each application of a collaborative set.

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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 research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Thomas Lehner Ph.D., M.P.H.
Office of Genomics Research Coordination
National Institute of Mental Health
6001 Executive Boulevard, Room 7189, MSC 9643
Bethesda, MD 20892-9643
Rockville, MD 20852 (for courier/express mail service)
Telephone: (301) 443-9869
FAX: (301) 402-4740
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

To allow NIH to identify a group of applications as a related set of collaborative R01s, the titles for each R01 in the set must have the following format: a 1/N indicator + Identical title (e.g., 1/6-Multisite Comparison of Drug A vs. Drug B for Treatment of Disorder X , where the 1/6 means this is site 1 of 6 sites in the set. The other sites will be labeled 2/6, 3/6, etc.) Titles may not exceed 80 characters in length, including the tag, e.g., 1/6, at the beginning of the title.

The PHS398 Cover Letter is one pdf file only. Therefore, it must include the information requested below on the collaborative sites. 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 R01s being submitted, including for each: 1) the PD(s)/PI(s) name(s), 2) the Title (including the tag, e.g., 1/6 ), and 3) the Applicant Institution. Each site should submit an identical listing.

A list of the collaborative applications as described in the Cover Letter must also be included in Item 11. Other Attachments. The information provided in this attachment MUST include a listing of all the applications that are a part of the set of collaborative R01s being submitted, including for each: 1) the PD(s)/PI(s) name(s), 2) the Title (including the tag, e.g., 1/6 ), and 3) the Applicant Institution. Each site should submit an identical listing. This file should begin with a heading called Collaborative Applications . When saving the file, please name the file Collaborative_Applications as well, to ensure this section of the application is bookmarked appropriately.

Applicants are advised that the Resources section, which should address not only physical resources, but also the intellectual and collaborative resources for executing the project [see Section 4.4, Item 10. Facilities & Other Resources of the SF424 (R&R)] can be utilized to address relevant Resource-related collaborative issues. Instructions for this section include the following language:

• Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment of subject populations or will employ useful collaborative arrangements.

If there are multiple performance sites within a single application, describe the resources available at each site.

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

• Applications must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross-site comparability of training to assure reliability and quality control.
• The collaborative mechanisms currently require an OVERVIEW section that is part of the one-page specific aims attachment to the SF424 application form. This OVERVIEW section should be identical for all applications that are linked together for the collaborative R01. The requirements of the OVERVIEW are as follows:

The overview should provide an overall rationale for applying as a collaborative study; the role of each site; the approach to project management; and elements unique to any of the sites.

This information is required in order to address the coordination of the collaborative effort explicit in collaborative R01s. Collaboration is an additional criterion for review listed under "Additional Review Criteria". This criterion is not scored separately but is incorporated within the Overall Impact (see Section V. Application Review Information).

The application from each site must contain an identical RESEARCH PLAN - Section 2, Items 2-5. The Research Strategy, Section 2, Item 3, must include a description of those aspects of the project that are common to all sites of the collaboration. Investigators should use this section to describe the research procedures or protocol, the study population from which samples are drawn, data analyses, and any other characteristics that support each site’s importance to the overall project. All variations in the research plan between sites, no matter how minor, should be highlighted in a subsection with the heading "ELEMENTS UNIQUE TO THIS SITE." 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.

The PD(s)/PI(s) may or may not wish to designate a Steering Committee or other decision making body, or identify one individual as the lead coordinator for the group of linked applications as a whole, for purposes of NIMH correspondence. Plans for ensuring: access to data by all sites; analytic resources; publication and authorship rights; rapid availability for public use of research materials and other means of distributing research materials to the wider scientific community; and a process for arbitrating disagreements on publication and other issues, should be included in the application.

Any site that contracts out some portions of this work should list this fact under "ELEMENTS UNIQUE TO EACH SITE," and provide a full description of the nature, purpose and oversight of this contractual arrangement.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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

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

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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.

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 SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete and/or nonresponsive 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.

Applications must be submitted as a linked group or set of R01s, usually one R01 per participating PD(s)/PI(s). For each set of linked collaborative R01 applications, it is expected that each application will be coordinated and interlocked with the others as each application will contribute an essential component to the overall study. In the case of multi-site clinical trials, it is anticipated that the same protocol will be submitted by each site. However, there are likely to be elements unique to some sites (e.g., data coordination, fidelity assessment, statistical analyses), and for intervention trials with large numbers of sites, a separate, independent coordinating and data management center may be warranted. Based on the particular science proposed and the determined need for substantial involvement by NIMH staff, NIMH may convert a linked set of collaborative R01s into cooperative agreement U01s or U10s, following peer review.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority 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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

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

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the approach take advantage of the unique features of the data sets and subject populations available from each contributing site? Do the applications incorporate precise phenotypic measures including RDOC domains?

Environment

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/priority score, but will not give separate scores for these items.

Collaboration

Does the research plan justify the need for a collaborative multi-site project using this FOA? Are sufficient and feasible mechanisms in place to ensure collaboration across sites to achieve scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis and reporting of results? Are there adequate plans for shared decision making among PDs/PIs with regard to personnel, clinical decisions, changes in study protocol, and authorship?

Leadership Structure and Data Coordination

Does the application provide a full description of the leadership structure across the linked applications as well as a data coordination plan? Does the description address frequency and type of contact between participating researchers; specification of leadership roles across linked applications; and a description of whether particular individuals or sites will coordinate specialized subcomponents of the research plan (e.g., genetic processing and analysis, development of neurocognitive indices)? Does the data coordination plan include information about processes for joint decision-making regarding research activities and publication, as well as procedures for resolving disagreements and grievance?

Feasibility

Is sufficient information provided about sample size and demographics, including an inventory of existing genetic samples and phenotypic measures? If new data collection is proposed, is the justification appropriate and compelling?

Scientific Synergies

Does the application explicitly demonstrate how the proposed collaborative work will address questions that would be difficult to answer with data from a single site or study?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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 NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Thomas Lehner Ph.D., M.P.H.
National Institute of Mental Health
Telephone: (301) 443-9869
Email: [email protected]

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

Victoria Carper
National Institute of Mental Health
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 Parts 74 and 92.