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-08-194

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-11-126

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242

FOA Purpose

The National Institute of Mental Health (NIMH) 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 provides the foundation for understanding mental disorders relevant to mental health; (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
Letter of Intent Due Date

May 23, 2011; April 25, 2012; April 25, 2013

Application Due Date(s)

June 21, 2011; May 25, 2012; May 25, 2013

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

October/November annually

Advisory Council Review

January annually

Earliest Start Date(s)

April annually

Expiration Date

May 26, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV of this FOA. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions in this FOA. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Research Objectives

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, NIMH invites applications for Conte Centers for Basic and/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 relevant to mental health 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. They 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, as well as proof-of-concept clinical trials and the translational integration of neuroscience and clinical research to identify the etiology, pathogenesis, developmental progression and 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 research on 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, as well as an opportunity to develop novel outreach/dissemination initiatives.

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 basic and/or translational scientific research that extends 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 recent National Advisory Mental Health Council (NAMHC) workgroups that further address recently 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:

Required 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 address three identified needs: 1) building a pipeline for individuals interested in a research career in a Conte Center research area; 2) encouraging the diversity of the workforce; and 3) facilitating 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 enhance the training in the neurobiology of mental disorders or in translational research offered at the participating institution(s), could contribute significantly to programmatic activities (e.g., retreat, symposium) organized by institutional training programs, and/or 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.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

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.

Optional Summer Research Experience and/or Outreach

Conte Center applicants may propose optional summer undergraduate research training and/or outreach programs beyond the required training and outreach activities described above. The total cost for establishing and/or maintaining the optional program(s) may be up to $150,000 total cost per year. Applications that include optional programs must establish novel programs, initiatives, and/or activities above and beyond standard training and outreach activities ongoing at the participating institution(s), and must be closely aligned with the research goals of the Conte Center.

Summer Research Experience

A Conte Center may develop and implement a summer research program for undergraduate students in Conte Center laboratories. Such a program would provide an opportunity for undergraduate students interested in interdisciplinary, mental health-related research to participate in a Conte Center research project during the summer months. Students may be affiliated with either the participating institution(s) or another academic institution. In addition to mentored research experiences in Conte Center laboratories, such a program would incorporate discussion of ethical issues in science, academic enhancement activities that would facilitate the transition to graduate school for the participants, mentoring, and any other programmatic activities that would enhance the participants experience and foster their interest in a research career in interdisciplinary, mental health-related research. It is expected that special attention will be given to the recruitment and retention of individuals from diverse groups (see below) to the summer program.

Novel Outreach and Dissemination Initiatives

In addition to the required outreach activities, Conte Centers may propose to develop and evaluate innovative model programs and materials for enhancing knowledge and understanding of the neuroscience and the biology underlying mental health disorders among K-12 students, the general public, health care practitioners, and/or educators. This optional outreach and dissemination initiative will provide support for the formation of partnerships between scientists and educators, media experts, community leaders, and/or other interested organizations for the development and evaluation of programs and materials that will enhance knowledge and understanding of the science underlying psychiatric disorders. The intended focus is on topics not well addressed in existing efforts by educational, community, or media activities. Programmatic activities must propose to increase science literacy and understanding among one or more of the groups listed above.

Special Areas of Interest for All Training Activities

For the required and optional research training, special attention should be given to the recruitment and retention of individuals from diverse backgrounds underrepresented in the biomedical, clinical, behavioral, and social sciences, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/nsf07308/content.cfm?pub_id=3633&id=3) The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Black or African American, Hispanic or Latino, American Indian, Alaska Native, Native Hawaiian, and other Pacific Islander. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received.

Award Budget

Total costs are limited to $2,000,000 in any one year. This limit applies to new grants, their non-competing continuations, and any subsequent competitive renewals. The optional summer research experience and novel outreach and dissemination program components together must not exceed $150,000 per year total costs. If one or more of these optional components are included in an application, the total cost limit will be $2,150,000 in any one year.

Before funding, the budgets will be scrutinized with care. Components or specific activities that are not as meritorious may be deleted, and a project may not be funded for the full number of years requested, if, for example, that duration of support is not deemed critical to achieving essential goals or if progress needs to be formally evaluated after fewer years.

Revisions (formerly competing supplements) will not be considered for Conte Center grants; however, administrative supplements to promote diversity of the research workforce (http://grants.nih.gov/grants/guide/pa-files/PA-08-190.html) are strongly encouraged, and in appropriate situations, multiple diversity supplements will be considered. See http://www.nimh.nih.gov/research-funding/training/diversity-and-reentry-research-supplements-for-nimh-grantees.shtml for NIMH- specific guidance about diversity supplements. Such diversity supplements may allow the Center to exceed the total cost limit.

Award Project Period

The total project period for applications submitted in response to this FOA 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

Center Director (Project Director/Prinicpal Investigator):

The Center Director (PD/PI) must meet the Center Director (PD/PI) credentials listed in Section V.1 Application Review Information. In addition, the Center Director must commit a minimum effort of 3 calendar months per year overall to the Center and be the 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). Only one individual may serve as the Conte Center Director. Multiple Center directors are not permitted.

Research Project Leaders:

Leaders of component research projects must meet the Research Project Leader credentials listed in Section V.1 Application Review Information. In addition, leaders of individual projects must commit a total minimum effort of 1.8 calendar months per year to each project. Multiple project leaders are allowed for individual research projects. If there are multiple project leaders on a project, the combined efforts of the identified project leaders must total 1.8 calendar months per year.

Core Leaders:

Leaders of cores must meet the Core Leader credentials listed in the review criteria section. In addition, leaders of cores must commit a minimum effort of 1 calendar month per year to the core. Multiple core leaders are allowed for cores. If there are multiple core leaders on a core, the efforts of the identified core leaders must total 1 calendar month per year.

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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

This FOA replaces PAR-08-194.

Previously unfunded applications received in response to PAR-08-194 may be resubmitted to this FOA once if they were submitted as new applications to the previous FOA..

Renewal applications from previously funded Conte Centers that were originally submitted in response to PAR-08-194 will be accepted.

Renewal applications from Centers funded in 2008 or earlier, in response to PAR-06-053, PAR-06-062, PAR-07-430, PAR-07-433, or PAR-07-434 or their predecessors, will not be accepted. Applicants seeking renewal of such Centers should reconceptualize their Centers and submit a new application in response to this FOA.

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

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

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:

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

The letter of intent should be sent electronically to:

Email: NIMHCONTE@mail.nih.gov

If it is not possible to send a letter of intent electronically, a hard copy may be sent to:

Chiiko Asanuma, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7183, MSC 9641
Bethesda, MD 20892-9641
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5288
FAX: (301) 451-5615

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Shuang-Bao Hu, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6156, MSC 9608
Bethesda, MD 20892-9608
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5160
FAX: (301) 443-4720
Email: shuangbaohu@mail.nih.gov

Page Limitations

Page limitations for the P50 are noted as follows:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Information for the Entire Center

Face Page

Information provided here should pertain to the entire Center.

Description, Performance Sites, and Key Personnel (Form Page 2)

Information provided here should pertain to the entire Center. Key Personnel should include the individual project leaders and core leaders. Others should be listed under Other Significant Contributors.

Table of Contents (Form Page 3)

Budget Information (Form Pages 4 and 5)

Categorical figures should be provided to reflect the budget of the overall Center. Since detailed budget justification will be provided separately for each project and core (as described below), only items for which justification is not provided elsewhere should be presented in narrative form here.

Biographical Sketch of the Center Director (not to exceed 4 pages)

A biographical sketch should be provided for the Center Director (use the PHS 398 Biographical Sketch form). The biographical sketch should include a personal statement describing why the scientific qualifications and leadership experience of the proposed Center Director makes him/her particularly well suited for leading the Center, a chronological list of previous positions, honors, and a list of 15 selected, peer-reviewed publications.

Resources

Resources described here should be restricted to those not described separately for the individual projects and cores (as described below).

Introduction to the Overall Center (for Resubmission Applications only should not exceed 1 page):

Applicants resubmitting their applications should summarize their responses to the issues and criticisms pertaining to the Overall Center raised in the previous Summary Statement in this section. Individual projects and cores should not include an Introduction section.

Specific Aims for the Overall center should not exceed 1 page

The Overall Center Plan (Research Strategy) should not exceed 12 pages total:

The Research Strategy should begin with anoverview of the center (recommended length is no more than 2 pages),, targeted to a broad audience, that includes:

1. An overview of the entire proposed Center and the scientific objectives to be achieved, 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 statement 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 fundamental mechanisms of brain development and function, gene regulation and function, behavior, 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, 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.

The Research Strategy should also include:

1. Preliminary Studies for New Applications or Progress Report for Renewal/Revision Applications: This section should include evidence for feasibility, 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. Evaluation Plan and Advisory Board: This section should describe an overall evaluation plan to assess progress toward the Center goals and objectives. The plan should describe how the evaluation will be conducted and identify explicit, quantitative milestones expected to be achieved by each project and core and by the Center as a whole both yearly and overall. The plan should also include a timeline and 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. Advisory board members should only be identified and convened after an application is funded.

The following items, which are not included in the 12-page limit, should be included after the Overall Center Research Strategy:

a. Literature cited

b. Letters of support

Information for Each Project

Cover Page (use continuation page, not PHS398 face page)

Please include Project Title and Number and the name of the Project Leader.

Description, Performance Sites, and Key Personnel (Form Page 2)

Information provided here should pertain specifically to the project. The list of key personnel should include individuals who, in addition to the project PI, contribute in a substantive, measurable way to the scientific development or execution of the project.

Budget Information (Form Pages 4 and 5)

Detailed budget information should be provided for each project or core, with a narrative justification given for all budget items.

Biographical Sketches of Key Personnel

Biographical sketches should be provided for key personnel of each project using the PHS 398 Biographical Sketch form (limit 4 pages). The biographical sketch should include a personal statement describing why the experience and qualifications of the proposed key personnel for each project make them particularly well suited for contributing to that project and to the Center, a chronological list of previous positions, honors, and 15 selected, peer-reviewed publications. PIs of each component project must commit a total of at least 1.8 calendar months to each Center project.

Resources

Resources should be described for each project.

Specific Aims for each Individual Project should not exceed 1 page

The Research Strategy for Individual Projects should not exceed 6 pages total per project.

The Research Strategy for Individual Projects that use clinical subjects should not exceed 12 pages total per project.

Each research strategy should begin with an Overview (recommended length is 1 page), targeted to a broad audience, that describes the overall goals and the impact of the science proposed in relation to the state-of-the-art of the field for a broad audience. The Overview must also explain the contribution of the project to the scientific objective of the overall Center, how the project will interact and benefit from other components of the Center and how the work is innovative. It is important to clarify the appropriateness of the center approach and environment in addition to detailing the research design. The Overview should be followed by the Research Strategy, Significance, Innovation, Approach, and Environment. The research strategy should also include preliminary data or a progress report.

The following items, which are not included in the Research Strategy page limit, should be included after the Research Strategy for each Individual Project:

a. Human Subjects

b. Vertebrate Animals

c. Literature cited

d. Letters of support

Information for Each Core

Cover Page (use continuation page, not PHS398 face page)

Please include a separate Title and Number and the name of the leader for each core.

Description, Performance Sites, and Key Personnel (Form Page 2)

This information needs to be supplied for each core. The list of key personnel should include individuals who, in addition to the core leader, contribute in a substantive, measurable way to the functions provided by the core.

Budget Information (Form Pages 4 and 5)

Detailed budget information should be provided for each core, with a narrative justification given for all budget items.

Each Center should have an administrative core that includes the budget for:

a. Data and resource sharing (personnel, materials, shipping costs)

b. Investigator and advisory board travel

c. Website

d. Required training and outreach

e. P&F program (if included in application)

f. Optional summer research program

g. Optional novel outreach and dissemination initiatives

Items a through e should be part of the standard budget (within the standard $2 million limit in total cost per year for Conte Centers).

The budget for data and resource sharing should include costs for activities such as the banking, analysis, and distribution of specimens to the research community, if applicable.

Investigator and advisory board travel should include standard travel expenses for Conte investigators for years 1, 2, 4, and 5. NIMH staff routinely conducts site visits of Conte Centers in the third year. A budget for assembling all investigators, graduate students, postdoctoral scholars, and the advisory board for a site visit should be built into the third year of the administrative core.

P&F programs may be proposed for up to 5% of the total cost of a Center (i.e., up to $100,000 per year for a Center with a proposed total cost of $2M) and included within the $2M total cost limit for Conte Centers. Each P&F award must be limited to 1 year in duration and $50,000 in total cost. The NIMH encourages cost-sharing of proposed P&F programs with applicant institutions.

The optional summer research experience and/or the novel outreach and dissemination program (items f & g) may propose a combined total of up to $150,000 in total cost above and beyond the standard $2 million limit in total cost for per year for Conte Centers. Allowable costs for the optional summer research experience and/or for novel outreach and dissemination program must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the particular initiatives proposed in the application. Specific anticipated expenditures for the optional summer research experience and/or novel outreach and dissemination program should be itemized on a separate set of budget pages.

Allowable expenses for the optional summer research experience could include compensation for a part-time program coordinator, compensation for the undergraduate participants, and justifiable expenses specifically related to the proposed academic enhancement and mentoring activities. Reimbursement for faculty mentoring is not an allowable expense if mentoring is a normal and usual faculty responsibility at the institution. Program-related expenses must be reasonable and clearly justified as specifically required by the proposed summer research experience and must not duplicate items generally available for educational programs at the applicant institution. Evidence of institutional commitment to the summer research experience component is strongly encouraged and should be detailed in this section.

Biographical Sketches of Key Personnel

Biographical sketches should be provided for key personnel of each core using the PHS 398 Biographical Sketch form (limit 4 pages). The biographical sketch should include a personal statement describing why the experience and qualifications of the proposed key personnel for each core make them particularly well suited for contributing to that core and to the Center, a chronological list of previous positions, honors, and 15 selected, peer-reviewed publications. PIs of each core must commit a total of at least 1.0 calendar month to each Center core.

Resources

Resources should be described for each core.

The Research Strategy for all the Cores combined should not exceed 12 pages.

Descriptions for each core should include a brief overview, describe the research strategy for each core, and indicate how the core will contribute to the overall goals of the Center as well as which projects will be supported by the core and the manner in which that support will be rendered by the core. The description of each core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed Center.

Special requirements for the Administrative Core Research Strategy:

a. Addressing Sharing of Resources (required): This should be included in the administrative core and should describe plans for the sharing of research data and research resources such as model organisms, software, antibodies, DNA constructs, etc., consistent with achieving the goals of the program.

b. Website (required): Plans for establishing and maintaining a Conte Center website targeted to a broad audience that describes the Conte Center and the implications of research supported by the Center for advancing our understanding of the biology of mental disorders should be described here. This website is intended to be distributed to a variety of educated audiences with broad backgrounds and interests, such as the NIMH Outreach Partners (see: http://www.nimh.nih.gov/outreach/partnership-program/index.shtml).

c. Standard Training and Public Outreach/Dissemination Plan (required): Referring to the training and public outreach goals outlined in Section 2.I.1, this section of the application will describe the training plan including the manner in which the proposed Conte Center relates to and will synergize with existing institutional training programs to strengthen overall training efforts at the participating institution(s), plans to build the pipeline of future investigators, plans to enhance the transition to research independence for trainees and scholars participating in Conte Center research as well as outreach and dissemination activities that will inform the public about Conte Center activities and enhance science literacy.

d. Diversity Recruitment Plan (required): A diversity recruitment plan for the training component(s) of the application should be included. It should describe the recruitment and retention efforts to diversify the biomedical, behavioral, clinical, and social sciences workforce through increased participation of talented individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from economically, socially, culturally, or educationally disadvantaged backgrounds.

e. Pilot and Feasibility (P&F) program (optional): P&F programs may be proposed for Conte Centers to provide opportunities for ESI-eligible new investigators to develop preliminary data that become the basis for an independent research application. Pilot projects must be within the scientific scope of the Conte Center project and leverage the resources associated with the Center. Applications for P&F programs should be included in the administrative core and should describe the internal procedures for application, review, evaluation of progress and IRB/IACUC compliance for these projects. All pilot projects must be within the scientific scope of the Conte Center. Copies of P&F applications that were successful, associated IACUC/IRB approvals, and any special provisions that are being made for these projects to move forward will need to be reported to the NIMH at the time the P&F award is made. Progress reports on funded P&F awards will be required each year. Budget for P&F programs must be included within the $2M total cost limit (see budget section above).

f. Optional Summer Research Experience (optional): If proposed, the summer undergraduate research program should be detailed with respect to: 1) the expected applicant pool (including members of groups underrepresented in the health-related research workforce); 2) how participants will be matched with appropriate laboratories; 2) planned mentoring, didactic, and programmatic activities; 3) expected qualifications of the program director, part-time program coordinator (if requested), and lab mentors; and 4) planned follow-up activities to enhance transition to the next career stage. Budget for the optional undergraduate research program should be included in the $150,000 available beyond the $2M total cost limit.

g. Novel outreach and dissemination programs (optional): For the optional outreach/dissemination initiative, novel science education programs/materials should be developed for one or more of the following groups: 1) students and teachers at the kindergarten through 12th grade level; 2) the general public; 3) health care practitioners; 4) members of the media; and 5) other groups that have a need to be scientifically literate. The description of the optional outreach/dissemination initiative must contain the following elements: (a) Specific goals to be achieved; (b) activities to be completed, with discussion of how these activities can accomplish the stated goals; (c) why this is a model program or innovative project; (d) a clear demonstration of an education and scientific partnership(s) with a description of the nature and extent of partnerships and collaborations to be developed and the roles of key participants in the planning and conduct of the project. Documentation of the interest and commitment of partnership members to the project must be provided; (e) The administrative plan to organize and manage the overall project and the timetable for the various tasks and activities for the entire project period requested; (f) how materials will be disseminated to a broad audience; (g) plans for continuation of the project after the grant period has ended; and (h) plans for assessments/evaluations for determining if the project is successful in achieving its objectives. Budget for the optional outreach/dissemination initiative should be included in the $150,000 available beyond the $2M total cost limit.

The following information should be provided for each core, consecutively, after the combined Research Strategy for the Cores:

a. Human Subjects

b. Vertebrate Animals

c. Literature cited

d. Letters of support

e. Letters documenting interest/commitment for collaborations

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 PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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-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.

For this particular announcement, please note the following: Conte Center applications will be reviewed on the basis of significance, investigators, innovation, approach, and environment.

Applications are anticipated in a variety of basic or translational scientific disciplines. Reviewers are, therefore, asked to evaluate each application in relation to the state-of-the-art within the scientific domains proposed. Thus, basic applications in scientific areas that are not ready for immediate translation, for example, will be evaluated as appropriate for the question/problem being addressed. They should not be penalized for a lack of immediate translational relevance.

Overall Impact

Reviewers will provide an overall impact/priority 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/PIs, 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 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?

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?

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

Evaluation Plan: Are the proposed milestones and timeline appropriate for each project and core, and for the Center as a whole? Are the proposed milestones measurable? Are there other intermediate and overall goals that should be monitored?

Review Criteria for Individual Projects

Reviewers will be asked to assess the scientific merit of individual projects on the basis of the criteria outlined below. Each category will be considered by the reviewers in evaluating the project, although a project does not need to be strong in all categories in order to be viewed as meritorious. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does the project make an important contribution to the Center as a whole? Does this project address an important research problem? How will it advance the scientific knowledge of the field? What will be the impact of these studies on the concepts, methods, tools, and/or technologies that drive this field?

Investigators: Is the Project Leader at the forefront of the area of science proposed? Does the Project Leader have a productive record of bringing novel and significant projects to fruition as an independent, R01 funded principal investigator?

Innovation: Is the project original and innovative? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?

Approach: Are the conceptual design, methods, and analyses adequately developed, well integrated, and well-reasoned? Is there sufficient evidence of feasibility? If the application involves risk, is the degree of risk counterbalanced by the benefits to be gained and the impact of the science in relation to the state-of-the-art of the field?

Environment: Is there evidence for tangible interactions between the project and other components of the Center? Is there a high degree of integration and interdependence between this project and other components? In what ways does the Center approach add to what can be done with this project through other modes of research support? What are the contributions made by this project to the overall goals of the Center? Is this project well integrated with the scientific objectives of the Center? Is there clear evidence of scientific interaction between this project and other components of the Center? Does the scientific environment in which the work will be done contribute to the probability of success, and does this project make effective use of the Center environment?

Review Criteria for Cores

Reviewers will be asked to evaluate and summarize the merit of the proposed cores using the criteria outlined below. Although all criteria will be considered by the reviewers in evaluating the cores, a core does not need to be strong in all categories in order to be viewed as meritorious.

Significance: Is the core appropriate and necessary for the proposed studies? Does the proposed plan for each core adequately indicate that it (will) effectively and efficiently support the research of the Conte Center in a manner that cannot be supported through other available (institutional or outside) resources? Does the proposed plan demonstrate that the activities of the core are essential to one or more Conte Center projects?

Investigators: Does the proposed plan address the qualifications, past performance (if applicable), and time commitments of the Core Leader(s)? Is there evidence that appropriate expertise will be available to carry out the functions proposed for the core? Does the Core Leader demonstrate competence in the area of science proposed? Does he/she have a record of interacting and working well with other investigators at their institution and any collaborating institutions?

Innovation: Does the core develop or employ novel concepts, approaches, methodologies, tools, or technologies?

Approach: Are the conceptual design, methods, and analyses adequately developed, well integrated, and well-reasoned? Is there sufficient evidence of feasibility? Are potential problem areas identified and alternative tactics proposed?

Environment: Does the proposed plan demonstrate that the activities of the core are well integrated with those of the projects and that the investigators within the projects are working closely with those of the core to meet project objectives? If applicable, does the proposed plan demonstrate the activities of the core related to the performance of specialized analyses or development of technologies or methodologies that enhance and benefit the projects?

Special Review Criteria for the Administrative Core:

Pilot and Feasibility Program: Are the internal application and review procedures appropriate for ensuring the selection of meritorious applications? Are sufficient animal/human subject oversight procedures described? Are appropriate measures in place for monitoring progress on the P&F projects?

Research Training: Are the required and/or the optional research training plan(s) of high quality and likely to be effective? Are adequate plans presented to develop new research training opportunities and to integrate them with and enhance ongoing training at the participating institution(s)? Are adequate plans presented to achieve effective training of individuals from diverse groups? If applicable, is the optional summer undergraduate research program of high quality and likely to encourage the participants to pursue a research career in the mental health arena?

Public Outreach/Dissemination: Are the required and/or the novel public outreach and dissemination plan of high quality, likely to reach a broad and diverse audience, and likely to increase science literacy? Is this plan likely to enhance understanding of the fundamental research conducted in the Conte Center and its relationship to the mechanisms underlying mental disorders?

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

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 - Overall

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.

Recruitment and Retention Plan to Enhance Diversity: Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.

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).

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 (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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/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 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

In addition to the standard information required in PHS 2590, the NIMH requires Conte Centers to report on the following:

AVAILABILITY OF DATA

It is expected that biological resources including genetically modified mice generated under this award will be made available to the broad scientific community in a timely fashion through appropriate, publicly accessible databases and through NIH-supported repositories. Materials should be shared no later than immediately following publication unless otherwise noted and approved by NIMH staff. Materials to be shared include, but are not limited to: shRNAs, plasmids, viruses, optogenetic tools, and genetically modified mice. The grantee is expected to provide information on progress made with grantee’s accepted sharing plans as well as a list of new requests received and samples provided in their annual progress reports. Broad compliance with NIH policies is a condition for the continued funding of Conte Centers.

EVALUATION PLAN and ADVISORY BOARD MEETINGS

Evaluation results, including a summary of milestones reached as well as the advisory board discussion and recommendations, should be included in each annual progress report and as part of the final report for the grant.

PILOT AND FEASIBILITY (P&F) PROGRAM (if relevant)

Copies of P&F applications that were successful (selected for funding), associated IACUC/IRB approvals, and any special provisions that are being made for these projects to move forward will need to be reported to the NIMH at the time the P&F award is made. Progress reports on funded P&F awards should be included in the annual progress reports.

OPTIONAL SUMMER RESEARCH PROGRAM: Annual progress reports should provide information on recruitment efforts, characteristics of the undergraduate participants, the program, and any changes proposed to enhance future years programs.

OPTIONAL OUTREACH/DISSEMINATION INITIATIVE: Progress on the development/evaluation of novel programs and materials for science education should be included in the annual progress reports.

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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)

Basic Neuroscience Applications:

Chiiko Asanuma, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7183, MSC 9641
Bethesda, MD 20892-9641
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5288
FAX: (301) 451-5615
Email: cs2j@nih.gov

Translational Applications (Adult):

Steven J. Zalcman, M.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7121, MSC 9639
Bethesda, MD 20892-9639
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1692
FAX: (301) 480-3514
Email: szalcman@mail.nih.gov

Translational Applications (Developmental):

Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5944
FAX: (301) 480-4415
Email: kanders1@mail.nih.gov

Training Contact:

Nancy L. Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645
Telephone: (301) 443-3107
FAX: (301)443-1731
Email: ndesmond@nih.gov

Outreach Contact:

James D. Churchill, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6198, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3621
FAX: (301) 480-4415
Email: churchillj@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX: (301)443-4720
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Victoria Carper, MPA
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: carpervictoria@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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