Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Dimensional Approaches to Research Classification in Psychiatric Disorders (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-MH-12-100

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-MH-13-080

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 Funding Opportunity Announcement (FOA) seeks research grant applications designed to develop innovative ways of understanding mental disorders through classifying patients in clinical studies on the basis of experimental research criteria rather than traditional diagnostic categories. This FOA stems from the NIMH Research Domain Criteria (RDoC) project that is intended to further a long-range goal of contributing to diagnostic systems as informed by research on genetics, neuroscience, and behavior.  The purpose of this FOA is to encourage applications to study mechanisms that may cut across multiple traditional diagnostic categories. Applications submitted in response to this FOA should be based upon RDoC criteria (see http://www.nimh.nih.gov/research-funding/rdoc.shtml for the RDoC criteria developed to date).  Five organizing domains have been identified in the draft specification.  These include Negative Valence Systems (i.e., aversive motivational dimensions), Positive Valence Systems, Cognitive Systems, Social Process Systems, and Arousal/Regulatory Systems. Consensus workshops and guidance documents on Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Working Memory (subsidiary of Cognitive Systems), and Social Processes, are to have been completed by the time applications in response to this FOA are due, and applications must focus on at least one of the constructs that have been defined in these RDoC workshops, as indicated in the workshop proceedings.  Interested applicants are encouraged to consult the NIMH RDoC web site (http://www.nimh.nih.gov/research-funding/rdoc.shtml) for current information regarding these constructs.   

Key Dates
Posted Date

June 29, 2012

Open Date (Earliest Submission Date)

September 22, 2012

Letter of Intent Due Date

September 22, 2012

Application Due Date(s)

October 22, 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 2013

Expiration Date

October 23, 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose and Objectives

The NIMH Strategic Plan calls for the clarification of the underlying causes of mental disorders across the life span, with efforts towards integrating genetic, neurobiological, imaging, behavioral, and clinical data.  This FOA addresses Strategy 1.4 of the NIMH Strategic Plan: Develop, for research purposes, new ways of classifying mental disorders based on dimensions of observable behavior and neurobiological measures. NIMH has begun the implementation of Strategy 1.4 via the Research Domain Criteria (RDoC) project.  This project, developed by an internal NIMH working group in conjunction with a small group of external consultants, has created a framework and process with which to implement the research classification system called for by Strategy 1.4. The essence of the project is to identify organizing dimensions that cut across multiple disorders as traditionally defined, and to promote research according to these dimensions rather than traditional diagnostic categories. Applications that focus primarily on validating a DSM diagnostic category will NOT be considered responsive to this funding opportunity. Rather, this FOA encourages projects that are consistent with the organizing dimensions identified by the RDoC project.  The RDoC project aims to support the development of an integrative scientific literature that can inform future diagnostic systems which will be based on genetics, neuroscience, and psychology.  Five organizing domains have been identified in the draft specification.  These include Negative Valence Systems (i.e., aversive motivational dimensions), Positive Valence Systems, Cognitive Systems, Social Process Systems, and Arousal/Regulatory Systems. Consensus workshops on Negative Valence Systems (i.e., aversive motivational dimensions), Positive Valence Systems, Cognitive Systems, and Social Process Systems are to have been completed before applications in response to this FOA are due, and applications must focus on at least one of the constructs that have been identified in the completed RDoC workshops, as indicated in the workshop proceedings.  Interested applicants are encouraged to consult the NIMH RDoC web site (http://www.nimh.nih.gov/research-funding/rdoc.shtml) for current information regarding these domains.

This FOA invites submission of research project grant applications that focus on explicating and validating the domains and their subsidiary constructs that have resulted from RDoC consensus workshops.  Priority will be given to applications that evaluate relevant constructs via convergent measurement across multiple units of analysis, and applications that would elaborate aspects of the constructs that are underdeveloped. See the Specific Areas of Research Interest section, below, for illustrations.

Background and Rationale

Currently, the diagnosis of mental disorders is based on clinical observations and reports by patients, caregivers, parents, and teachers. This approach, formalized in the Diagnostic and Statistical Manual-III (DSM-III) in 1980 and refined in subsequent DSM versions, has served to improve diagnostic reliability in clinical practice and research. The diagnostic categories represented in the DSM-IV and the International Classification of Diseases-10 (ICD-10), containing virtually identical disorder codes, remain the consensus standard for diagnosis of mental disorders, and are employed for insurance billing, U.S Food and Drug Administration requirements, and other institutional uses. By default, DSM diagnoses have also become standard for characterizing research participants in grant applications and publications.

Its dominance notwithstanding, the DSM diagnostic scheme has not assimilated recent breakthroughs in genetics and neuroscience. Most genetic and neural circuit anomalies appear to link either with multiple DSM diagnostic categories or with narrow subgroups within diagnoses.  A questionable assumption that the clusters of self-reported symptoms codified in the DSM define unique and homogeneous disorders could be constraining advances in the biology of mental illness.  Consequently inadequate understanding of pathophysiology would in turn hamper the development of better treatments.  Notwithstanding these difficulties, there is general consensus at this time that the biology of mental illness is insufficiently developed to support a classification scheme based on the integration of genetics, neuroscience, and psychopathology.  The purpose of the RDoC project is to promote such integrative science so that advances in genomics, pathophysiology, and psychology can substantially inform diagnosis.

The purpose of the initial phase of the RDoC project is to promote research employing clinical subjects from multiple diagnostic groups appropriate to the research question, in order to establish construct validity for some proposed organizing dimensions of psychopathology. This is to be done through research on brain-behavior relationships that integrates findings from multiple scientific disciplines.  It is hoped that in later stages of development, measures of the integrated constructs can be developed for practical clinical use.

Specific Areas of Research Interest

Potential applicants should read the material at the RDoC website (http://www.nimh.nih.gov/research-funding/rdoc.shtml). This site contains a detailed description of the background, rationale, draft matrix of domains and units of analysis, examples of potential research applications, and results of workshops convened to generate consensus specifications. In accord with the focus on integrative science, each RDoC construct will map onto seven units of analysis:  behavior, cells, circuits, genes, molecules, physiology, and self-reports. Note that independent variables may be selected from any of the units of analysis and would typically include subjects from multiple diagnostic groups. Research plans should incorporate dependent variables from at least two units of analysis to converge upon the construct to be studied. 

The RDoC project involves a series of consensus workshops, one for each of the organizing domains listed above. The purpose of each workshop is to identify promising constructs within the domain, define each construct (and its overlaps and differences from other constructs), and specify elements at each of the units of analysis that converge on the construct. The draft matrix entries represent elements (genes, molecules, circuit measures, behavioral tasks, questionnaires, etc.) that have been vetted by the workshop process and appear especially promising for inclusion in research plans.  Applicants may opt for other relevant measures where a strong justification can be made.

This FOA invites applications to study constructs only that have been addressed by RDoC workshops, and thereby have a definition and list of pertinent elements at each unit of analysis. The FOA also invites evaluation of the continuity of adult RDoC constructs in child and adolescent populations, and the adaptation or development of relevant measures for children. To date, workshops have been completed for Negative Valence Systems, Working Memory, Positive Valence systems, Cognitive Systems, and Social Processes.  The relevant materials can be found at the RDoC website under the bullet “RDoC Workshop Proceedings,” no later than July 3, 2012.  Applications may study constructs that are essentially related to the constructs and circuits delineated in the RDoC matrix.  For example, emotion regulation is a construct that refers to dynamic regulation of threat-related amygdala activity by the ventromedial prefrontal cortex, and so could be reasonably related to the RDoC threat construct. 

Examples of research projects that might be submitted under this FOA include, but are not limited to:

Priority will be given to applications that have a well-justified plan to include patients from multiple diagnostic groups (including Not Otherwise Specified and forme fruste diagnoses) as appropriate for explicating the dimensions and constructs of interest in the study design. Studies that include patients from a single diagnostic group may also be considered if there is a particularly strong justification for examining constructs of interest within one diagnostic category.  A defensible approach might be to study all patients presenting themselves at a specialty clinic, e.g., mood disorders clinic, anxiety clinic, or psychotic disorders clinic, regardless of whether they meet criteria for a particular DSM diagnosis. 

The intent of this FOA is to stimulate human-only work that is appropriate to the RDoC domains and to constructs that have been identified to date through the RDoC workshop process.  An application concerning a dimensional construct that has NOT been defined in one of the RDOC workshops would NOT be considered responsive to this FOA, but may be submitted independently as a standard investigator-initiated application.  Similarly, applications that propose both animal and human studies relevant to RDoC dimensions would NOT be considered responsive to this FOA but may be submitted independently as standard investigator-initiated applications.  Although it would be permissible to include multiple RDoC constructs in one research plan, constructs that are the focus of study for this FOA must have been identified by the RDoC workshops completed to date. Applications that propose to study a mix of RDoC-vetted constructs and others that have not been articulated in an RDoC workshop (even if the non-vetted constructs are listed in the draft RDoC matrix but have not yet been addressed by a workshop) will NOT be considered responsive to this FOA, but may be submitted independently as standard investigator-initiated applications.  Investigators should refer to the proceedings of the completed RDoC workshops, as posted on the NIMH website, to ascertain what RDoC constructs have been defined in each workshop.

Section II. Award Information
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 five to six grants in response to this FOA.  The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $400,000 annual direct costs, including consortia and consortia F&A.  

Award Project Period

Scope of the proposed project should determine the project period. The maximum project period is 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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.

Required Registrations

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.

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.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 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.

Collaborative R01 applications will not be accepted in response to this FOA.  When multiple institutions are involved, one institution must be designated as the prime institution and funding for the others must be requested via a subcontract administered by the prime institution. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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:

The letter of intent should be sent to:

Michael Kozak, Ph. D.
Division of Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7127, MSC 9625
Bethesda, MD 20892-9625
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-6471
Email: kozakm@mail.nih.gov

Required and Optional Components

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.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies(GWAS)) as provided in the SF424 (R&R) Application Guide. .

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 Institutions

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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 {IC} Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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? Does the project investigate organizing dimensions of psychopathology that cut across multiple disorders as traditionally defined?  Does the project have potential to inform future diagnostic systems based on genetics, neuroscience, and psychology? Does the project have potential to explicate or validate one or more of the domains or their subsidiary constructs that have been addressed to date by RDoC consensus workshops, i.e., Negative Valence Systems, Positive Valence Systems, Cognitive Systems,  Working Memory (subsidiary of Cognitive Systems) , and Social Processes? 

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?   

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 project pursue construct evaluation via convergent measurement across at least two units of analysis?  Does the application have a well-justified plan to include patients from multiple diagnostic groups as appropriate for explicating the dimensions and constructs of interest in the study design?  If the study includes patients from a single diagnostic group is there a particularly strong justification for examining constructs of interest within one diagnostic category? 

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? 

Additional Review Criteria

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.

Conformity to RDoC Concepts

The committee will consider whether the proposed work involves evaluation of RDoC constructs across at least two levels of analysis, and via dimensional, rather than categorical, assessment methods.

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.

Additional Review Considerations

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.

2. Review and Selection Process

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:

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:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

3. Reporting

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Michael Kozak, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-6471
Email:  kozakm@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-3534
Email:  armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone:  (301) 443-2805
Email:  siscor@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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