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

Silvio O. Conte Centers for Basic or Translational Mental Health Research (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of PAR-11-126

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • March 14, 2014 - See Notice NOT-OD-14-070. Adjustments to May 25-28, 2014 Grant Application Due Dates.

Funding Opportunity Announcement (FOA) Number

PAR -14-120

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 Funding Opportunity Announcement (FOA) invites applications for Silvio O. Conte Centers for Basic or Translational Mental Health Research. The institute seeks teams of researchers working at different levels of analysis and employing integrative, novel, and creative experimental approaches to address high-risk, high-impact questions with the primary objective of: (a) advancing the state of the science in brain and behavior research that will ultimately provide the foundation for understanding mental disorders; (b) supporting the integration and translation of basic and clinical neuroscience research on severe mental illnesses; and/or (c) advancing our understanding of the neurobehavioral developmental mechanisms and trajectories of psychopathology that begin in childhood and adolescence. The Conte Centers program is intended to support interdisciplinary basic and/or translational research demonstrating an extraordinary level of synergy, integration, and potential for advancing the state of the field. This program is intended only for projects that could not be achieved using other, more standard grant mechanisms. The Conte Centers program also provides an opportunity to establish interdisciplinary basic and/or translational research experiences for individuals in training.  

Key Dates
Posted Date

February 26, 2014

Open Date (Earliest Submission Date)

April 25, 2014

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

(Extended to May 29, 2014 per NOT-OD-14-070), Originally May 25, 2014; May 25, 2015; May 25, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2014; October/November 2015; October/November 2016

Advisory Council Review

January 2015; January 2016; January 2017

Earliest Start Date

April 2015; April 2016; April 2017

Expiration Date

March 26, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
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

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.  To advance this mission, this Funding Opportunity Announcement (FOA) invites applications for Conte Centers for Basic or Translational Mental Health Research. The purpose of these Centers is to support interdisciplinary teams of researchers engaged in integrative, novel, and creative experimental approaches to address high-risk, high-impact scientific questions that will significantly advance the state of the science in brain and behavioral research that will ultimately provide the foundation for understanding mental disorders and/or transform the understanding and treatment of mental illnesses, as well as developing data and other research resources that are available to the scientific community to further advance research in this field. Conte Centers exemplify a collaborative, cutting-edge, interdisciplinary research program conducted at multiple levels of analysis spanning genes to circuits to behavior to disease in model systems and humans, from the prenatal period through adulthood.  Successful centers address a well-defined and unified scientific question (hypothesis) or problem. Areas of interest span the full range of basic neuroscience, basic behavioral science and genetics, and the translational integration of neuroscience.  They also include testing in humans to identify the etiology, pathogenesis, developmental progression, potential biomarkers and/or the mechanistic substrates of potential interventions with a view towards the eventual prevention or cure of mental disorders across the lifespan. Proposed Centers should be directed towards a well-defined and unified scientific question or problem and, in some instances, may include discovery-based as well as technology development components in support of the primary scientific question. The Conte Centers program is intended to support research that demonstrates an extraordinary level of synergy, integration, and potential impact on our understanding of basic brain mechanisms and/or the pathophysiology, progression, and treatment of mental disorders.  The program is intended only for projects that could not be achieved using other, more standard grant mechanisms. Support is provided both for individual research projects and for cores that are critical for the integration across Center components. Centers must be characterized by an interdisciplinary framework guiding highly integrated programs of cutting-edge research, and provide plans for rapid, widespread sharing of the resulting data, methods, and resources to accelerate basic or translational research relevant to mental disorders. A strong vision of how the Center will advance the field beyond the goals of the individual projects is essential for successful applications.

The Conte Centers program also provides an opportunity to establish interdisciplinary and/or translational research experiences for individuals at multiple levels of training.

Background

Mental disorders affect approximately 15-20 percent of the U.S. population annually. These disorders include schizophrenia, bipolar disorder, anxiety, depression, autism spectrum disorders, obsessive compulsive disorder, post-traumatic stress disorder, attention deficit disorder, and eating disorders - many of which begin early in life. Tremendous strides have been made in recent years towards understanding the microenvironment (genes, molecules, and signaling pathways), brain systems (cells, circuits, and networks) and epigenetic and environmental factors involved in cognitive and affective processes as well as the underlying mechanisms that may be disrupted in mental disorders. New opportunities for expanding this understanding are presented by advances in genetic/genomic technologies, elucidation of epigenetic mechanisms that modify gene expression, imaging and molecular techniques that allow for assessment of multiple brain systems as mediators of integrated behaviors in individuals of all ages, and identification of novel molecules and pathways that regulate brain development/function or serve as possible targets for therapeutic discovery. Multi-channel and multi-modal recording and imaging techniques offer new opportunities to understand the function of neural circuits and networks as well as the ability to monitor and manipulate discrete populations of neurons relevant for understanding the systems disrupted in mental disorders. While exciting advances continue within specific disciplines, there is a growing need for collaborative research programs at the basic level and/or at translational levels that extend across traditional disciplinary boundaries.

Scope of Research

The primary purpose of each Conte Center is to support a multidisciplinary team of leading basic and/or clinical neuroscience researchers engaged in a highly integrated and focused program directed at a well-defined and unified scientific question (hypothesis) or problem.  The Conte Center program continues to seek highly meritorious applications across the full spectrum of basic research and/or translational research supported by the NIMH (the breadth of research supported by NIMH can be found at http://www.nimh.nih.gov/about/organization/dnbbs/index.shtml, http://www.nimh.nih.gov/about/organization/datr/index.shtml, and http://www.nimh.nih.gov/about/organization/ddtr/index.shtml).  Conte Centers should comprise a collaborative, cutting-edge, multidisciplinary research program conducted at multiple levels of analysis. 

The NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) was developed to inspire and support research that takes advantage of recent technological advances and opportunities, and to bring into sharper focus questions and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders.  Specific research opportunities identified recently in relation to the plan’s four strategic objectives can be found on http://www.nimh.nih.gov/research-funding/research-priorities/index.shtml

Potential applicants are also encouraged to consult the reports of two National Advisory Mental Health Council (NAMHC) workgroups that further address identified areas of need and opportunity relevant to research on mental disorders.  The NAMHC report, Transformative Neurodevelopmental Research in Mental Illness (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/neurodevelopment_workgroup_report.pdf), provides recommendations for advancing research on the neurodevelopmental origins of mental disorders with the goal of speeding the translation of basic neurodevelopmental findings into clinical research.  The NAMHC report, From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illness (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/directors-message.shtml), provides guidance on promising research investments to be made with the goal of harnessing new therapeutic opportunities for the development of preemptive and personalized interventions. 

The Conte Centers program provides a mechanism for maximizing the potential for scientific synthesis and discovery across levels of analyses from genes and molecular signaling through systems level integration and behavior in humans and model systems across the lifespan.  Thus, the Conte Centers program provides a unique opportunity to address one or more of the strategies and priorities outlined in the NIMH Strategic Plan and the related NAMHC reports. 

Some general characteristics of Conte Centers are listed below: 

Applicants are strongly encouraged to consult appropriate NIMH staff, starting with the conceptualization process, to ascertain a good alignment of their planned Center goals with program priorities. 

Website, Training and Outreach

A website, research training coordination, and participation in public outreach activities are required for each Conte Center.  

Website

Conte Centers are required to develop and maintain a website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center towards advancing our understanding of the biology of mental disorders. 

Research Training

Conte Center training activities are expected to build a pipeline for individuals interested in a research career in a Conte Center research area and facilitate the transition of individuals to research independence. This required training component is expected to take advantage of unique aspects of the Conte Center research program, the combination of participating investigators’ talents, and other unique institutional resources to offer innovative, substantive training opportunities for predoctoral and postdoctoral trainees, at a minimum.

Close coordination between the Conte Center and relevant predoctoral and/or postdoctoral institutional research training programs at the participating institution(s) is expected to enhance the research workforce trained in innovative, interdisciplinary approaches and state-of-the-art methods. Such Conte Center efforts should be synergistic and complementary to existing institutional training programs. For example, a Conte Center could: 1) enhance the training in the neurobiology of mental disorders or in translational research offered at the participating institution(s); 2) contribute significantly to programmatic activities (e.g., retreat, symposium) organized by institutional training programs; and/or 3) develop a new course offering at the institution(s).  Targeted professional development opportunities for graduate students and postdoctoral scientists supported on Conte Center projects are strongly encouraged so that these individuals transition smoothly to the next career stage in a timely manner.

Public Outreach and Dissemination

Required outreach activities may include Conte Center-focused partnerships with local school systems, science museums or related institutions.  These activities may involve participation of Conte Center investigators in special lectures or laboratory demonstrations as part of ongoing outreach programs, such as Brain Awareness Week, National DNA Day, and the NIMH Outreach Partner Program (http://www.nimh.nih.gov/outreach/partners/index.cfm).  Visits from classroom groups would also be appropriate to include as a required outreach activity.    

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity..

Application Types Allowed

New
Renewals from PAR-08-194 and  PAR-11-124
Resubmissions from PAR-08-194 and PAR-11-124

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount awarded and the number of awards are contingent upon NIH appropriations and will depend upon the numbers, quality, duration, and costs of meritorious applications received.

Award Budget

Total costs are limited to $2,000,000 in any one year.  

Award Project Period

The total project period may not exceed 5 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

Center Directors (PD/PIs) must have a demonstrated capability to organize, administer, and direct the Center.  They must also demonstrate leadership in the area of science proposed and have a strong record of high impact scientific achievements.   

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Conte Centers can be renewed once for a maximum duration of support of 10 years.  

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 electronically to:

Email: NIMHCONTE@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Project

6

Res Support Core

6 (3 pages recommended)


Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

It is expected that a Center Director (PD/PI) will have a demonstrated capability to organize, administer, and direct the Center.  A Center Director must demonstrate leadership in the area of science proposed, have a strong record of high impact scientific achievements, and must head at least one of the research projects and the administrative core. 

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: An Introduction to Application is required for Resubmissions.  Applicants should summarize all responses to the issues and criticisms raised in the previous Summary Statement.

Specific Aims:  Provide a concise description of the overall Center aims.  Outline how the projects and Core(s) will contribute to attaining the Center objectives.

Research Strategy:  

The Research Strategy should begin with an overview of the center describing the scientific problems being addressed, the integration of the Center components, and why these components are essential for accomplishing the goals of the overall Center.  The overview should be targeted to a broad audience and be concise (recommended length is no more than 2 pages).  The overview should include:

1.  Goals, relevant background and significance and a description of the impact of the science proposed in relation to the state-of-the-art of the field. This section should also include an explanation of how the work proposed is innovative.

2.  Value added by an interdisciplinary Centers approach. This section should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Center’s major objectives, a description of how the Center as a whole will benefit from interdisciplinary interactions, an explanation of why this work cannot be accomplished by a cluster of R01s, and why the whole is significantly better than the sum of its parts.

3.  An explanation of the potential importance and relevance of the proposed research to further our understanding of the basic mechanisms of brain development and function, gene regulation and function, behavior, as well as disease etiology and/or treatment of mental health disorders. Disorders of interest to NIMH include depression, bipolar disorder, post-traumatic stress disorder, anxiety, schizophrenia, obsessive compulsive disorder, autism spectrum disorders, and other developmental disorders.  NIMH is particularly interested in understanding brain changes that occur during sensitive periods of brain development and periods of increased vulnerability to psychopathology. 

4.  If a scientific project or core involves risk, applicants should explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field. 

5.  The NIMH is committed to rigor in experimental design and reporting (NOT-MH-14-004). Applicants are reminded to address study design elements that are critical for ensuring data reliability throughout Conte Center applications (see: http://www.nimh.nih.gov/research-priorities/policies/enhancing-the-reliability-of-nimh-supported-research-through-rigorous-study-design-and-reporting.shtml) for examples of critical elements for a well-designed study 

The Research Strategy should also include:

1.  Preliminary Data: This section should include evidence for feasibility and preliminary findings and/or progress made during the previous funding period. This section should also present very clear evidence that the research team has been/will be able to work together effectively to accomplish the research proposed in the projects.

2.  Center Approach: This section should describe the working scientific and logistical design, as well as the resource support necessary to implement the research. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. (Documentation of these arrangements should be included in the Letters of Support section.)  Cost sharing or institutional support, if any, should be described in this section.

3.  Timeline, Milestones, Evaluation Plan and Advisory Board:  A graphic Timeline and a descriptive Milestones section must be included in the Research Strategy section for the Overall Center.  Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress.  This section should also include specific proof-of-concept test(s) along with any alternative strategies should any component efforts fail to perform as expected.  The timeline should include the establishment of a to-be-named advisory board to be convened annually to assess progress and accomplishments, and to advise the Center.  It is very important that potential advisory board members not be identified in the application in order to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration by NIMH review staff for the peer review panel that evaluates Conte Center applications.  For new Conte Center applications, advisory board members should only be identified and convened after an application is funded.  For renewal applications, the names of individuals who served as advisory board members during the previous 5 years should be listed.  During the project period, the Center Director will be expected to refer to these milestones in annual progress reports.  

Letters of Support:  Include letters of support relevant to the overall center here.  Letters detailing contributions to individual components are to be placed in their respective individual Project and Core components.  

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.  All information on the sharing of resources should be included in the Administrative Core. 

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.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:   Do not complete. 

Project /Performance Site Location(s) (Administrative Core)

Indicate the performance site that applies to the Administrative Core.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Each proposed Center Director must commit a minimum effort of 3 calendar months per year overall to the Center and be a leader of one of the projects and of the administrative core.  The 3 calendar months should be a total of the Center Director's efforts on his/her project(s) and core(s).  The 3 calendar month requirement also applies to any individual listed as a PD/PI in a multiple PD/PI Center. 

Leaders of cores, including the administrative core, must commit a minimum effort of 1 calendar month per year to the core.  If there are multiple leaders for the Administrative Core, the combined efforts of the identified Administrative Core Leaders must total 1 calendar month. 

The Administrative Core budget should include costs for:

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction is allowed for each component.

Specific Aims:   Provide a concise description of the goals of the Administrative Core.

Research Strategy:  

The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary systems biology research, training and outreach, to foster synergy, and to support planning and evaluation activities.  

Highlight features of the Administrative Core that will enhance the collaborative effort, including optimizing communication, decision-making and sharing between the Project and/or Scientific Core teams.

Describe how each Project or Scientific Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Project or Research Support Core needs.  The description of the Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide.  Moreover, information must be provided about how the collective operation of the Core will be effected in a coherent manner. 

Additional information required in the Administrative Core Research Strategy:

Letters of Support:  Include letters of support relevant to the administrative core. 

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.

Information on the sharing of all resources generated by Center activities should be consolidated and detailed in this section, and include the following elements: 

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.   

Planned Enrollment Report  (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

Project

When preparing your application in ASSIST, use Component Type ‘Project’ for all projects.

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

SF424 (R&R) Cover (Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Other Attachments:  Each project involving patients may append a 6-page PDF attachment to describe recruitment and/or experimental details pertaining to the patient populations to be studied.  Patient information for each project involving patients should be loaded as a separate PDF attachment, titled "Patient_Information_Project XX", where XX represents the number of the corresponding project. 

Project Narrative:   Do not complete. 

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

Budget (Project)

Budget forms appropriate for the specific component must be included in the application package.  

Leaders of each Project must commit a total minimum effort of 1.8 calendar months per year to each project.  Multiple project leaders are allowed for Projects.  If there are multiple leaders on a Project, the combined efforts of the identified project leaders must total 1.8 calendar months per year per Project. 

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Project)

Introduction to Application: An Introduction to Application is allowed for Resubmissions.

Specific Aims: This section should provide a concise description of the aims for the individual project. 

Research Strategy:  Significance:  Describe overall goals and the impact of the science proposed in the project in relation to the state-of-the-art of the field.  This section should also explain the contribution of the project to the overall goals of the Center, how the project will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment. 

Innovation:  Describe the unique and innovative contributions that will be made by this project.  Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project. 

Approach:  Describe the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls, and alternative approaches for the project and how these might impact on progress in the overall Center.  

Environment:  Describe the scientific environment in the context of anticipated interactions between this project and other components of the Center and anticipated progress in the overall Center.  This section should also explain how available resources will contribute to the success of the project in the context of the overall goals of the Center. 

Note:  If the project involves patients, additional information pertaining to the patient populations may be provided in the optional "Patient Information" section.

Letters of Support:   Include letters of support relevant to the project.

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.  All information on the sharing of resources should be consolidated in the Administrative Core.   

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.   

Planned Enrollment Report  (Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Project)

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

Research Support Core

When preparing your application in ASSIST, use Component Type ‘Res Support Core.’

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

SF424 (R&R) Cover (Research Support Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Support Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Support Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Research Support Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Support Core)

Budget (Research Support Core)

Budget forms appropriate for the specific component will be included in the application package.

Leaders of Research Support Cores must commit a minimum effort of 1 calendar month per year to the Research Support Core.  Multiple leaders are allowed for Research Support Cores.  If there are multiple leaders, the efforts of the identified leaders must total 1 calendar month per year per core.    

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Research Support Core)

Introduction to Application: An Introduction to Application is allowed for Resubmissions.

Specific Aims: Provide a concise description of the goals of the Research Support Core.  Explain how the Research Support Core will contribute individual Projects and to attaining the Center objectives.   

Research Strategy:  A Research Support Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities.  Descriptions for each core should include a brief overview and a description of the services and resources to be provided to other Center components.  This section should address how the core will contribute to the overall goals of the Center as well as which projects will be supported by the Research Support Core and the manner in which that support will be rendered by the core.  The description of each Research Support Core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed center.   Issues to be addressed include: quality control, procedures for selecting projects that use the Research Support Core, cost effectiveness, and increased efficiency. While scientific activities per se are not an essential part of a Research Support Core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Letters of Support:  Include letters of support relevant to the Research Support Core. 

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.  All information about Resource Sharing Plans should be consolidated in the Administrative Core section of the application. 

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.

Planned Enrollment Report  (Research Support Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Support Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 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.

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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

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 - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Scored Review Criteria - Overall

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?  If the application involves risk, is the degree of risk counterbalanced by the benefits to be gained and the powerful influence of the science in relation to the state-of-the-art of the field?

Investigator(s)

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

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 Center? 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 Center 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?   

Is an interdisciplinary Center approach necessary and suitable for the proposed work?  Will an integrated Center approach add significantly to what could be accomplished through other modes of research support?  Is there synergy in the relation of the projects to the overall Center objective?  Are the management plans appropriate? 

Have the applicants addressed appropriate considerations in their research designs to maximize the reliability and replicability of their findings? 

Is there a clear, detailed plan for managing the Center's research and administration, fostering synergy, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources, that conveys a high likelihood of effective, productive management of the Center as a whole?  Is there an organizational structure that will facilitate coordination and integration of Center activities and progress?

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 - Overall

As applicable for the Center 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.

Evaluation Plan:  Are the proposed milestones and timeline described in sufficient detail?  Are the proposed milestones feasible, well developed, and quantifiable with regard to the specific aims for each project and core, and for the goals of the Center as a whole? Are there other intermediate and overall goals that should be monitored?

Center Components:  Individual Center Components (Administrative Core, Research Support Cores, Projects and Projects Involving Patients) will be assessed for relevant strengths and weaknesses in the context of the Overall Center but will not be scored.  

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed Center 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.

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

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.

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

As applicable for the Center 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.

Applications from Foreign Organizations

Not Applicable

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).

Is the information provided for the following points sufficient and are the plans appropriate?

Plan for post award disposition of resources. 

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 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:

Applications will be assigned 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:

3. Anticipated Announcement and Award Dates

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

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, SAM 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 or 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Basic Neuroscience Applications:

Chiiko Asanuma, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health (NIMH)
Telephone: 301-443-5288
Email: casanuma@mail.nih.gov

Translational Applications (Adult):

Steven J. Zalcman, M.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health (NIMH)
Telephone: 301-443-1692
Email: szalcman@mail.nih.gov

Translational Applications (Developmental):

Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health (NIMH)
Telephone: 301-443-5944
Email: kanders1@mail.nih.gov

Training:

Nancy L. Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health (NIMH)
Telephone: 301-443-3107
Email: ndesmond@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)

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