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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)

Title: Silvio O. Conte Centers for Interdisciplinary Research on Brain, Behavior, and Mental Health (P50)

Announcement Type
This FOA replaces PAR-02-121, PAR-04-004, and partially replaces PAR-02-123, previously released July 1, 2002; October 3, 2003; and July 1, 2002, respectively.

Program Announcement (PA) Number: PAR-07-430

Catalog of Federal Domestic Assistance Number(s)
93.853

Key Dates
Release Date: August 9, 2007
Letters of Intent Receipt Date: September 24, 2007
Application Receipt Date: October 24, 2007
Peer Review Date:  February/March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date:  October 25, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Institute of Mental Health (NIMH) invites applications for Conte Centers for Interdisciplinary Research in Brain, Behavior, and Mental Health (CCIRs). The purpose of these Centers is to support interdisciplinary teams of researchers engaging in integrative, novel, and creative experimental approaches to address high-risk, high-impact biological questions that will significantly advance the state of the science in understanding brain and behavior relevant to mental health. The Centers will support collaborative, interdisciplinary research conducted at multiple levels of analysis from genes to behavior in humans, animals, and model systems. Areas of interest include, but are not limited to, cellular, molecular, and genomic neuroscience, systems and cognitive neuroscience, basic behavioral science, and early phase drug discovery that includes model development directed towards preclinical testing and elucidation of drug mechanism of action. Proposed Centers should include studies conducted at multiple levels of analysis, and may be constructed around a single well defined hypothesis, around a series of related hypotheses, or with a central theme, and may include hypothesis testing and hypothesis generating projects as well as technology development. The CCIR program is intended to support research demonstrating an extraordinary level of synergy, integration, and potential for advancement of the state of the field. Support is provided both for individual research projects and for optional cores. Centers must be characterized by a strong interdisciplinary framework guiding highly integrated programs of cutting-edge research. Integration of projects and a demonstrated need for a Center mechanism in support of the proposed research are essential for successful applications.

Background

Tremendous strides have been made in recent years towards understanding both the microenvironment (genes, molecules, signaling pathways) and brain systems (cells, circuits, genetic and environmental factors) that control aspects of brain function and plasticity and how these processes may be disrupted in mental disorders. New opportunities for expanding this understanding are presented by whole genome association studies in clinical populations, elucidation of epigenetic mechanisms that modify the expression of genetic paths, imaging and molecular techniques that allow for assessment of multiple brain systems as mediators of integrated behaviors, and identification of novel molecules and pathways that regulate brain development or serve as possible targets for therapeutic discovery. Multi-channel and multi-modal studies of neural activity offer an unprecedented opportunity to understand the function of neural circuits. In addition, the application of exquisitely targeted molecular techniques has brought systems, cellular and molecular approaches to understanding brain function closer to one another than ever before, and our understanding of critical environmental, experiential, and physiological variables controlling behavioral processes is becoming increasingly refined. While exciting advances continue within specific disciplines, there is a growing need for scientific research that extends across traditional academic boundaries towards the goal of integrating findings and approaches to develop a systems level understanding of normal brain function and the processes that go awry in mental disorders. The CCIR 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, animals, and model systems. Examples of current scientific priorities and areas of emphasis can be found at http://www.nimh.nih.gov/dnbbs/dnbbs.cfm.

In addition to the Silvio O. Conte Centers for Interdisciplinary Research on Brain, Behavior, and Mental Health, NIMH has other center mechanisms with somewhat different programmatic goals.  The purposes of these other mechanisms, and links to the relevant announcements, are summarized below:

Scope of Research

Proposed Centers must be interdisciplinary with a minimum of three research projects that span two or more levels of analysis. The levels of analysis proposed must extend beyond the current state-of-the-art for multiple levels of analysis commonly conducted in the domain of science proposed. It is incumbent upon the applicant to explain how the proposed diversity of approaches is novel and how the diverse approaches will move the science forward in ways not possible before.

The proposed research projects must be closely integrated in their goals and objectives. Integration across projects of successful applications will be demonstrated not only by distinct approaches to a common scientific goal by individual projects but also by evidence of collaboration across projects and cores comprising the Center. In essence, the Center will provide a mechanism for expanding beyond the boundaries of the level of analyses of individual laboratories. Centers may include exploratory or high risk projects that may be less hypothesis driven but which add value to the Center and increase the potential for fundamentally important new discoveries towards understanding behavior and functional integration of brain action. Centers may also include cores to support the proposed objectives of the CCIR.

Centers may consist of projects and cores at a single institution or at multiple institutions. Collaborations between highly active laboratories using state-of-the-art methods are encouraged, even if this means that the investigators are geographically distributed. Plans for synergistic integration of projects and cores within a Center, whether at a single institution or geographically distributed, should be clearly stated.

Budget Limits

Total costs are limited to $1.9 million in any one year. This limit applies to new grants, their non-competing continuations, and any subsequent competitive renewals. The direct costs for the optional summer undergraduate research component may not exceed 5% of the total direct costs requested for a CCIR up to a maximum total cost for the optional summer undergraduate research component of $100,000. If this optional component is included in an application, the total cost limit will be $2 million in any one year

Competitive supplements will not be considered for CCIR grants. However, research supplements to promote diversity of the health-related research workforce (http://grants.nih.gov/grants/guide/pa-files/pa-05-015.html) are encouraged and, in appropriate situations, multiple diversity supplements will be considered.

It is anticipated that individual projects which are developed as outgrowths of a Center grant will seek independent funding through mechanisms such as the research program grant (R01) mechanism.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Special Requirements

Cores

Cores should support the proposed objectives of the CCIR and should support multiple projects as well as the overall goals of the Center. Cores may be proposed for administrative support, animal support, biostatistics and data management, imaging, chemistry, etc and should be well justified based on the needs of the Center’s research projects.

Annual Meetings and Administrative Site Visit

Center directors and key personnel should be prepared for annual visits to the NIH to discuss progress towards achieving the goals of the project as well as education, outreach, and diversity recruitment efforts. The Center will also receive periodic administrative site visits to evaluate progress on site. Costs for travel to these annual meetings and travel for off-site collaborators to attend the administrative site visits should be included in the budget.

Center Director: Qualifications and Effort

The Center director should have a demonstrated capability to organize, administer and direct the Center. This individual must demonstrate competence 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. The CCIR director must commit a minimum effort of 3 calendar months per year overall to the Center. 

Research Project Leaders: Qualifications and Effort

Leaders of component projects must demonstrate competence in the area of science proposed and have a productive record of bringing novel and significant projects to fruition as a principal investigator. Leaders of component projects must commit a minimum effort of 1.8 calendar months per year to the project. 

Core Leaders: Qualifications and Effort

Leaders of cores must demonstrate competence in the area of science proposed and have a record of interacting and working well with other investigators at their institution and elsewhere. Leaders of cores must commit a minimum effort of 0.6 calendar months per year to the core.

Scientific Advisory Board

The Center will be expected to have a Scientific Advisory Board, drawn from experts outside the Center project.  These advisors will be selected in consultation with NIMH staff and will meet annually to review and provide guidance on Center activities.  While a description of the Board's activities should be included in the application, potential members of the Board should not be contacted, named, or selected until an award has been made.  This stipulation will allow a wider pool of potential reviewers of the application.  Costs for activities of the Board should be included in the budget.

Center Website

Applicants should include a plan to construct a Center website for the dissemination of research data, software, and other resources of the Center to the research community and to the general public.

Data Sharing

Data collected by the Center are expected to become freely available to biomedical researchers and educators in the non-profit sector, such as institutions of higher education, research institutes, and government laboratories. Since the precise content of the data-sharing plan will vary depending on the data being collected and how the investigator is planning to share the data, a description should be provided of the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools will be provided, whether or not a data-sharing agreement will be required, and if so, a brief description of such an agreement (including criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing. Centers are particularly encouraged to use the Center website for Data Sharing. See: http://grants2.nih.gov/grants/policy/data_sharing

Software Sharing

Software developed by the Center is expected to be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of higher education, research institutes, and government laboratories.  The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages. The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center.  The application must include written statements from the officials of the applicant institutions responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application.  Typically the relevant responsible official will be in the applicant institution’s office of technology transfer or intellectual property, as opposed to an academic official such as a department head or dean. 

Sharing Model Organisms

Model organisms and related resources produced by the Center are expected to become freely available to biomedical researchers and educators in the non-profit sector, such as institutions of higher education, research institutes, and government laboratories. A description should be provided of how the novel strains will be made available to the scientific community and how technology transfer and intellectual property issues will be handled. See: http://grants.nih.gov/grants/policy/model_organism/

Previous CCNR and CDCNR applicants

Unfunded basic applications submitted in response to the PAR for Silvio O Conte Centers for Neuroscience Research (PAR-02-121), Silvio O. Conte Centers to Develop Collaborative Neuroscience Research (PAR-02-123), and Interdisciplinary Behavioral Science Centers for Mental Health (PAR-04-004) should be reconceptualized according to the new guidelines for CCIRs and be submitted as new applications responsive to the present announcement.

Research Training and Outreach (required)

The scope and significance of research conducted in a CCIR and the underlying research infrastructure are likely to provide an outstanding opportunity for research training. A CCIR has two required and related research training objectives that are designed to maximize its impact. The first objective is research training in topics related to the theme and methodologies of the CCIR including synergistic efforts with existing training programs. The second objective is public outreach by CCIR participants and dissemination to the public of CCIR activities.

1. Research Training

It is expected that CCIR training activities will address three identified needs: 1) building the pipeline with individuals interested in a research career in a CCIR area; 2) increasing 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 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 CCIR 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 CCIR efforts should be synergistic and complementary to existing institutional training programs. For example, a CCIR could enhance the training in the neurobiology of mental disorders offered at the participating institution(s), could contribute to programmatic activities (e.g. retreat, symposium) organized by institutional training programs, and/or develop a new course offering at the institution(s). A CCIR is expected to provide unique opportunities for young investigators (PhD, MD, and MD/PhD) who have the potential for independent research careers to become skilled in the state-of-the-art experimental strategies, approaches, and techniques employed by CCIR projects and to facilitate their transition to research independence. Targeted professional development opportunities for graduate students and postdoctoral scientists supported on CCIR projects are strongly encouraged so that these individuals transition smoothly to the next career stage in a timely manner.

In all training activities, special attention should be given to the recruitment and retention of individuals from diverse groups including individuals from under-represented 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 (see http://grants.nih.gov/grants/guide/pa-files/pa-05-015.html for additional descriptive information on these groups) It may be appropriate for a CCIR to collaborate or build partnerships with scientists at institutions with a high percentage of, or a successful program for, individuals from diverse groups in order to enhance efforts to recruit individuals from diverse groups to a CCIR.

2. Public Outreach and Dissemination

Each application should describe plans for outreach activities that enhance general public awareness of the importance and implications of CCIR research for addressing fundamental scientific questions and their relationship to the mechanisms underlying mental disorders. Such efforts would also be expected to enhance science literacy. For example, such activities may include development of web-based resources for the public, CCIR-focused linkages with local science museums or related institutions, unique activities with the local school systems, CCIR-focused linkages with activities like Brain Awareness Week or National DNA Day, and/or cooperative activities with NIMH Outreach Partner Programs (http://www.nimh.nih.gov/outreach/partners/index.cfm).

Summer Undergraduate Research Program (optional)

A CCIR may also develop and implement a summer research program for undergraduate students in CCIR laboratories. Such a program would provide an opportunity for undergraduate students interested in interdisciplinary mental health-related research to participate in a CCIR 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 CCIR 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.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH specialized Center (P50) award mechanism. Applicants are solely responsible for planning, directing, and executing the proposed Center. The mechanism provides funding for a broad range of research and developmental activities in a wide range of disciplines that include functional genomics, basic neuroscience and basic behavioral science.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available  

NIMH policy for P50 grants establishes the following limits to the requested budgets: new P50 applications may each request a maximum annual total cost of $2 million if the optional summer undergraduate research program is included in the application or $1.9 million if it is not included. Applications may not exceed this cap in any one year. The direct costs for the optional summer undergraduate research program may not exceed 5% of the total direct costs requested for a CCIR. A CCIR application may be submitted for up to 5 years of funding.

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. Although the financial plans of the NIMH provides support for funding the equivalent of 2-3 new CCIRs each year, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1.    Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign institutions may participate as sites for research projects, cores, or as part of a research project or core, but foreign institutions and organizations are not eligible to submit CCIR applications.  Consortium agreements with foreign institutions must include provisions that ensure adequate representation of women, minorities, and children in all research components that involve clinical trials or any other type of human intervention and must be in compliance with NIH policies.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

2.    Cost Sharing or Matching

This program encourages, but does not require, cost sharing with academic institutions, research institutes, biotechnology, pharmaceutical, or disease foundations, as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Foreign institutions are not eligible for P50 grants.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms.   Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked. See #6 below for detailed application instructions.

3. Submission Dates and Times

Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates  
Letters of Intent Receipt Date: September 24, 2007
Application Receipt Date: October 24, 2007
Peer Review Date:  February/March2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent by the dates listed above that includes the following information:

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.

The letter of intent should 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
Rockville, MD 20852 (courier)
Bethesda, MD 20892-9641
Phone: 301-443-5288 FAX: 301-451-5615
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above.  Submit a signed 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 (For express/courier use Bethesda, MD  20817)

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

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone:  (301) 496-9609
Fax: (301) 443-4720
E-mail:  [email protected]

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at their own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee s ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
 
6. Other Submission Requirements

Guidance for Applicants for P50 CCIRs

6.A.1 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.

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.

Include here the budget and justification for the required training and outreach component and, if applicable, for the optional summer undergraduate research program. Allowable costs for the optional summer undergraduate component must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the particular summer program proposed in the application. Allowable expenses for the optional undergraduate summer research program 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 program and must not duplicate items generally available for educational programs at the applicant institution. Evidence of institutional commitment to the summer undergraduate component is strongly encouraged.

This section might also include information on the appropriateness of the budget with regard to the conduct of activities related to the banking, analysis, and distribution of specimens to the research community, if applicable.

Biographical Sketch of the Center Director (not to exceed 3 pages)

A biographical sketch should be provided for the Center director (use the PHS 398 Biographical Sketch form).

Resources

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

General Description of the Overall Center (not to exceed 2 pages)

The general description should include the following information:

1.       An overview of the entire proposed Center and the goals to be achieved, that includes a vision statement, describing the impact of the science proposed in relation to the state-of-the-art of the field in a broad context. This statement should include an explanation of how the work proposed is innovative .

2.       Value added by an interdisciplinary Centers approach. This 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 its major objectives, a description of how the Center as a whole will benefit from the 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 work 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, etc. NIMH is particularly interested in understanding brain changes that occur during development and during important developmental transitions, such as adolescence.

Feasibility and Preliminary Findings (not to exceed 3 pages)

This section should include evidence for feasibility, and preliminary findings. 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.

Operational Plan for the Overall Center (not to exceed 3 pages)

This section should describe the working administrative and logistical arrangements, 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.

The Center Director is responsible for ensuring that scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated (and reallocated, as necessary) to meet those goals. It is anticipated that the success of a CCIR will require considerable scientific and managerial oversight by the Center Director. Therefore, the Center Director will be required to devote at least 3 calendar months overall to the Center.

Milestones and Timeline: The operational plan must include a section listing expected milestones as well as a timeline. This section should detail specific milestones expected to be achieved by each project and core and by the Center as a whole for each year. The description should be accompanied by a graphic representation (timeline). The reasonableness of the proposed milestones and timeline will be evaluated during review and will be used in the future to assist the NIMH in evaluating progress toward the project's goals. Applicants should present explicit, quantitative milestones.

Cost sharing or institutional support, if any, should be described in this section.

Required Training and Public Outreach/Dissemination Plan (not to exceed 2 pages)

Referring to the training and public outreach goals outlined in Section I.1, this section of the application will describe the training plan including the manner in which the proposed CCIR 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 young investigators as well as outreach and dissemination activities that will inform the public about CCIR activities and enhance science literacy.

Optional Summer Undergraduate Research Program (not to exceed 1 page)

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 part-time program coordinator and lab mentors; and 4) planned follow-up activities to enhance transition to the next career stage.

6.A.2 Information for Each Project or Core

Cover Page

Please include Project or Core Title and Number and Project or Core Leader

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

Information provided here should pertain specifically to the project or core.

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 or core using the PHS 398 Biographical Sketch form (limit 3 pages). The Center Director must be able to commit at least 3.0 calendar months to the overall Center. PIs of component projects must commit at least 1.8 calendar months to the Center project. Core Leaders must commit at least 0.6 calendar months to the Center core.

Resources

Resources should be described for each project or core.

Research Plan for Individual Projects or Cores

This section should not exceed 7 pages for an individual project and should not exceed 3 pages for an individual core, and should include the following (items # 5 # 9 do not count towards the page limits):

1.       Each individual project must include a half-page overview that includes (this overview is not required for the cores):

2.       The specific aims.

3.       Background and significance (for individual project components only)

4.       Description of the research design and methods, including preliminary data and progress report, for a competing continuation application. (For the cores, the description should 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. )

5.       Human Subjects

6.       Vertebrate Animals

7.       Other information

8.       Literature cited

9.       Letters of support

6.A.3 Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Materials Allowed in the Appendix:

Publications: