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 to Develop Collaborative Research in the Neuroscience of Mental Disorders (P20)

Announcement Type
This FOA replaces PAR-02-123, previously released July 1, 2002.

Program Announcement (PA) Number: PAR-07-434

Catalog of Federal Domestic Assistance Number(s)
93.853

Key Dates
Release Date:  August 17, 2007
Letter of Intent Receipt Date: September 24, 2007
Application Receipt Date: October 24, 2007
Peer Review Date(s):  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
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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 Silvio O. Conte Centers to Develop Collaborative Research in the Neuroscience of Mental Disorders (CCDCR): schizophrenia, mood disorders, and other severe mental illnesses.  The primary goal of this initiative is to support integration and translation of basic and clinical neuroscience research on severe mental illnesses.  Interdisciplinary, multidisciplinary, and integrative research is paramount to better understand the structure and function of the brain in health and mental illness.  Such cross-cutting research is often difficult to execute, as it commonly requires collaboration among scientists who work in different intellectual contexts, use different tools, and sometimes speak seemingly different languages.  Despite the importance of such collaborative efforts, support for teams of investigators—even established investigators—with little or no track record as a team, is difficult to obtain.  This initiative is intended to facilitate the development of collaborative research teams of established investigators by providing support for interactive research projects and cores to serve them.  Research supported by these centers should seek to clarify the neural substrates of mental disorders, including the etiology and pathogenesis of those disorders across the lifespan and the biological phenotypes associated with them.  Such knowledge will ultimately enhance capabilities to diagnose, monitor, treat, and prevent mental disorders.  This announcement represents a major NIMH commitment to these goals.

These Centers are intended to support collaborative, multi-disciplinary, hypothesis-driven research conducted at multiple levels of analysis with the primary goal being the bi-directional translation between basic/clinical neuroscience and clinical research.  Interdisciplinary teams of researchers engaging in integrative, novel, and creative experimental approaches are solicited to address high-risk, high-impact biological questions that will significantly advance the state of the science in service of elucidating the etiology, pathophysiology and pathogenesis of the major mental disorders.   Areas of interest include, but are not limited to, genetic and genomic analyses of mental disorders, proof of concept trials, identification of biomarkers, refinement of phenotypes and endophenotypes, and integration of the full range of neuroscience disciplines (cellular, developmental, genomic, molecular, systems and cognitive neuroscience) with mechanistic studies of a specific mental disorder.  The CCDCR program is intended to support research demonstrating an extraordinary level of synergy, integration, and potential for advancement of the state of the field.  Centers supported through this announcement utilize the P20 mechanism. Support is provided both for individual research projects and for core support that is critical to the integration across center components. Centers should be characterized by strong multidisciplinary frameworks guiding broadly integrated, programs of cutting-edge research. Integration of projects and demonstrated need for a Center mechanism in support of the proposed research is essential for successful applications.

BACKGROUND

The major mental disorders affect approximately 15-20 percent of the U.S. population annually.  These disorders include schizophrenia, mood disorders, anxiety disorders, sleep disorders, eating disorders, and dementias.  Many begin very early in life.  The staggering cost of treating these illnesses is surpassed only by the immeasurable cost in human suffering endured by these patients and their families through extended and recurring periods of illness and distress.

Extraordinary progress has been made in the past two decades in basic and clinical neuroscience and clinical research.  With the advent of revolutionary technologies including clinical genomics, neuroimaging, proteomics and molecular diagnostics, the field is poised to make fundamental advances in the detailed understanding of the etiology, pathogenesis and pathophysiology of the major mental disorders, from infancy through old age.  Such progress is the obvious precondition for the development of truly novel therapeutics and, ultimately, evidence-based preventive interventions.  Although exciting advances have been made and continue within specific disciplines, there is a growing need for scientific research that extends beyond traditional 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 CCDCR program provides a mechanism for establishing collaborative teams capable of pursuing research with the potential for scientific synthesis and discovery across levels of analyses from genes and molecular signaling through systems level integration, behavior, and disease in humans, animals, and model systems.  Examples of current scientific priorities and areas of emphasis can be found at http://www.nimh.nih.gov/datr/datr.cfm and http://www.nimh.nih.gov/dptr/dptr.cfm.

Scope of Research

The primary purpose of a CCDCR is to support early stage development of collaborative teams of high caliber investigators from diverse disciplines to study basic and/or clinical neuroscience issues related to the mission of the NIMH, and to position those teams to compete for support as a Silvio O. Conte Center for the Neuroscience of Mental Disorders (PAR-07-433). Therefore, those considering applying for CCDCR support are strongly urged to read the program announcements of the larger Translational Conte Center mechanism (see URL above) before preparing a CCDCR application.

A CCDCR is characterized as follows:

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 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 within and across projects and cores comprising the Center. In essence, the Center will provide a mechanism for expanding beyond the boundaries of level of analyses of individual laboratories. Centers may include exploratory or high risk components 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. Similarly, cores within Centers may include components for developing novel technologies that allow for better integration of findings across levels of study. 

Centers may consist of investigators 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 mitigating the effects of geographic separation should be clearly stated. 

Budget Limits

Total costs are limited to $1.0 million in any one year.  This limit applies to new grants, their non-competitive continuations and resubmission applications.  Competitive supplements will not be considered for these Center grants; diversity supplements are encouraged and in appropriate situations, multiple diversity supplements may be considered for an individual Center.  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 project grant (R01) mechanism. 

Special Requirements

Cores

Cores should support the proposed objectives of the CCDCR 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 and achievements toward the scientific 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 CCDCR director must commit a minimum effort of 2.4 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. 

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 conjunction 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 have 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 educational institutions, 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 (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave).  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 educational institutions, 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/

Outreach

Each application should describe plans for outreach activities that enhance general public awareness of the importance and implications of CCNMD 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, CCNMD-focused linkages with local science museums or related institutions, unique activities with the local school systems, CCNMD-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). 

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH exploratory center grant (P20) mechanism.  Applicants are solely responsible for planning, directing, and executing the proposed project.  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 P20 grants establishes the following limits to the requested budgets:  new or resubmission P20 applications may each request a maximum annual total cost of $1 million.  Applications may not exceed this cap in any one year.  A CCDCR application may be submitted for up to 4 years of funding.

Although the financial plans of the NIMH provides support for funding up to 2 CCDCRs 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:

Eligible institutions may include foreign components as research projects, cores, or as part of a research project or core, but foreign institutions and organizations are not eligible to submit CCDCR applications.  Consortia 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 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 P20 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) 435-0714, Email: GrantsInfo@nih.gov.

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.

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  
Letter of Intent Receipt Date:  September 24, 2007
Application Receipt Date:  October 24, 2007
Peer Review Date(s):  February/March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 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:

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 20892-9641
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-1692
FAX:  (301) 480-3514
Email:  szalcman@mail.nih.gov

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
Email:  jnoronha@mail.nih.gov

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. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an introduction addressing the previous critique.

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 (see also Section VI.3. Award Criteria).
 
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 P20 Center Grants

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.   This section might 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. 

Biographical Sketch of Center Director

A biographical sketch should be provided for the Center director (use the PHS 398 Biographical Sketch form – limit 3 pages). 

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

The general description should be no more than 7 pages, and 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 project 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 work proposed to further our understanding of the etiology, pathogenesis, and/or pathophysiology of a major mental disorder.

Feasibility and Preliminary Findings

This section should be no more than 5 pages and should include evidence for feasibility, preliminary findings, and progress report from the previous funding period, if appropriate.  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.   Citations of relevant publications by the applicants should be listed in this section and will not count towards the page limit. 

Resubmissions (formerly Amended Applications)

For resubmitted applications, a one-page introduction is allowed for each of the following components:  the overall Center; the Feasibility and Preliminary Findings; the Operational Plan for the Overall Center; each project; and each core, to describe changes from the previously submitted version. 

Operational Plan for the Overall Center

This section should not exceed 10 pages and 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 PI 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 CCDCR will require considerable scientific and managerial oversight by the Center PI. Therefore, the PI will be required to devote at least 2.4 calendar months 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 by the Center as a whole for each year.  The verbal description should be accompanied by a graphic representation (timeline).   This reasonableness of the proposed milestones and timeline will be evaluated during review and will be used in the future to assist the NIMH and their advisors 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.

Public Outreach Plan (not to exceed 2 pages)

Referring to the public outreach goals outlined in Section I.1, this section of the application will describe the plans for activities that will inform the public about CCNMD activities and enhance science literacy. 

6.A.2 Information for the Each Project or Core:

Cover Page

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

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 for each project or core using the PHS 398 Biographical Sketch form (limit 3 pages).  The Center Director must be able to commit at least 2.4 calendar months (overall effort) to the Center.  Leaders of component projects must commit at least 1.8 calendar months to the Center project. 

Resources

Resources should be described for each project or core.

Research Plan for Individual Projects or Cores

This section should not exceed 10 pages for an individual project and should not exceed 8 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.  (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:

Other:

Format of Appendix Materials

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

6.B  Plan for Sharing Research Data

It is the NIH policy that the research resources developed through this FOA become readily available to the research community for further research, development, and application, in the expectation that this will lead to knowledge of benefit to the public.

Applications are expected to include a plan to share data that may be gathered in the course of the project with the scientific community.  It is expected that the PD/PI’s data sharing plan will include a description 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 (e.g. under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave).

Reviewers will assess the adequacy of the proposed plan as detailed in the review criteria section.  The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. For more information on data sharing, see http://grants.nih.gov/grants/policy/data_sharing/

The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

6.C  Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Award Criteria.

Section V. Application Review Information


1.      Criteria

Only the review criteria described below will be considered in the review process.

2.       Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate review group convened by NIMH in accordance with the review criteria stated below.

As part of this initial merit review, all applications will:

The following will be considered in making funding decisions:

2.A.1. Review Criteria for Overall Center

The primary criterion for success of the Center application will be the overall scientific merit of the Center and the integration of the individual components.  This integration will be viewed as the strongest argument that the research proposed cannot be completed through individual R01s or other individual research grant mechanisms.

Significance and Innovation:

Innovation and Intrinsic Merit:  Does this proposal address an important scientific problem?  If the aims of the application are achieved, how will scientific knowledge be advanced?  What will be the effect of these studies on the concepts, methods, and technologies that drive this field?  How big an impact will the proposed Center have on the state of the art of the field?

Integration of and Translation Across Basic Science and Clinical Research Components:  Does the proposed Center adequately bridge basic and clinical science approaches so that activities in each component inform and advance the others?

Approach:

Appropriateness of the Center Approach:  Is an interdisciplinary Center approach necessary and suitable for the proposed work?  Will a Center approach add significantly to what could be accomplished through other modes of research support?  Is there synergy in the Center’s conceptualization and approach? 

Investigators:

Research Competence:  Are the qualifications of the Center director and project leaders appropriate for undertaking a large, potentially high risk Center project?  Is the work proposed appropriate to the experience level of the Center director and the project leaders?  Do the key personnel bring complementary and integrated expertise to the overall Center?

Center Director Credentials:  Does the Center director have a demonstrated ability to organize, direct, and administer the Center and, in addition, be the Principal Investigator on at least one of the individual projects. Does this individual have demonstrated competence in the area of science proposed and a strong record of high impact scientific achievements?   

Special Criteria:

Appropriateness of Management Plans and Arrangements:  Are the organizational and administrative plans feasible and adequate?  Is the budget appropriate? Are the mechanisms to evaluate the Center’s progress appropriate? 

Milestones and Timeline:  Are the proposed milestones and timeline appropriate for each project and for the Center as a whole?  Are the proposed milestones measurable?  Are there other intermediate goals that should be monitored?

Public Outreach:  Is the public outreach and dissemination plan of high quality and likely to increase science literacy?  Is this plan likely to enhance understanding of the fundamental research conducted in the CCNMD and its relationship to the mechanisms underlying mental disorders?

2.A.2.  Review Criteria for Individual Projects

Reviewers will be asked to assess the merit of individual projects on the basis of the criteria outlined below.   Each criterion will be considered by the reviewers in evaluating the project, although a project does not need to be strong in all criteria 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. 

Appropriateness of the Center MechanismIs 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?

Significance:  Does this component 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?  What is this component’s integrative contribution to the Center as a whole?  

Approach:  Is the conceptual design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Is there sufficient evidence for feasibility?  Are potential problem areas identified and alternative tactics proposed?  Is there clear evidence of scientific interaction between the Center as a whole and the project?  If the project is ongoing and has changed research direction, is there appropriate rationale for the new approach? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

InnovationIs the project original and innovative? For example: does the project challenge existing paradigms; address an innovative hypothesis, gap area, or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?   

Investigators: Has the project leader demonstrated competence in the area of science proposed?  Does the project leader have a productive record of bringing novel and significant projects to fruition as a principal investigator

EnvironmentDoes the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit form unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? If applicable, is there evidence of effective use of the proposed cores?  

2.A.3. Review Criteria for Cores

Reviewers will be asked to assess the merit of the proposed cores on the basis of the criteria outlined below. Each criterion will be considered by the reviewers in evaluating the cores, although a core does not need to be strong in all criteria in order to be viewed as meritorious. 

Appropriateness and Necessity:  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 CCDCR in a manner that can not 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 CCDCR projects?

Integration with Center Projects:  Does the proposed plan demonstrate that the activities of the core are well integrated with those of the projects and 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?

Investigators:  Does the proposed plan address the qualifications, past performance (if applicable), and time commitments of the Core Director(s)?  Is there evidence that appropriate expertise will be available to carry out the functions proposed for the core?

2.B. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.C. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.D. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.E. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
 
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

4. Evaluation

In carrying out its stewardship of its funding programs, the NIH is likely to request information essential to an assessment of the effectiveness of this mechanism.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for period updates on various measures of scientific outcomes and trainee success resulting from this program, such as employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. 

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Steven J. Zalcman, M.D.
Division of Adult Translational Research and Treatment Development
Neuroscience Center, Room 7121, MSC 9639
6001 Executive Boulevard
Rockville, MD 20852 (courier)
Bethesda, MD 20892-9641
Phone: 301-443-1692   FAX: 301-480-3514
Email: szalcman@mail.nih.gov

Mary Ellen Oliveri, Ph.D.
Division of Pediatric Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Blvd, Room 6189, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD, 20852 (for express/courier service)
Telephone:  (301) 443-5944
FAX:  (301) 480-4415
Email:  moliveri@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

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

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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