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 Basic and Translational Mental Health Research (P50)

Announcement Type
Reissue.

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-194

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: July 3, 2008
Letters of Intent Receipt Date(s): August 25, 2008, August 25, 2009, August 25, 2010
Application Receipt Date(s): September 23, 2008, September 23, 2009, September 23, 2010
Peer Review Date(s): February 2009, February 2010, February 2011
Council Review Date(s): May 2009, May 2010, May 2010
Earliest Anticipated Start Date(s): July 2009, July 2010, July 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date:  September 24, 2010

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 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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 Basic and Translational Mental Health Research. 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 questions that will significantly advance the state of the science in brain and behavioral research relevant to mental health. Conte Centers comprise a collaborative, cutting-edge, interdisciplinary research program conducted at multiple levels of analysis spanning from genes to behavior to disease in humans, animals, and model systems, from infancy to adulthood as appropriate, based on a well-defined and unified scientific question (hypothesis) or problem. Areas of interest span the full range of basic neuroscience, basic behavioral science, genetics research, proof-of-concept clinical trials, as well as the translational integration of neuroscience and behavioral science with study of the etiology, pathogenesis, and/or the developmental progression of mental disorders across the lifespan. Proposed Centers should be directed towards a well-defined and unified scientific question or problem and in some instances may include discovery-based as well as technology development components. The Conte Centers program is intended to support research demonstrating an extraordinary level of synergy, integration, and potential for advancement of the state of the field, and is intended only for projects that could not be achieved by using other, more standard grant mechanisms. Support is provided both for individual research projects and for core support that is critical to the integration across Center components. Centers must be characterized by an interdisciplinary framework guiding highly integrated programs of cutting-edge research, with the aim of rapid, widespread sharing of the resulting data to accelerate research on mental health. A clear integration of projects and a strong vision of how the Center will advance the field beyond the goals of the individual projects are essential for successful applications.

The Conte Centers program also provides an opportunity to establish interdisciplinary and/or translational research experiences for individuals in pre- and postdoctoral training. NIMH expects that programs will recruit participants from diverse groups for these training opportunities.

Background

Mental disorders affect approximately 15 20 percent of the U.S. population annually. These disorders include schizophrenia, bipolar disorder, anxiety, depression, autism and other pervasive developmental disorders, obsessive compulsive disorder, post-traumatic stress disorder, and eating disorders - many of which begin very early in life. Tremendous strides have been made in recent years towards understanding the microenvironment (genes, molecules, signaling pathways) brain systems (cells, circuits, and networks) and additional factors (epigenetic and environmental factors) involved in higher cognitive processes as well as the underlying mechanisms that 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, and the recent explosion in technologies for the exquisite targeting of tools to monitor and manipulate discrete populations of neurons is revolutionizing the analysis of neural function at the molecular, cellular, and systems levels. While exciting advances continue within specific disciplines, there is a growing need for basic and translational scientific research that extends across traditional academic boundaries. The Conte Center 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/about/organization/dnbbs/index.shtml, http://www.nimh.nih.gov/about/organization/datr/index.shtml, http://www.nimh.nih.gov/about/organization/ddtr/index.shtml, and http://www.nimh.nih.gov/about/organization/dahbr/index.shtml.

Scope of Research

The primary purpose of each Conte Center is to support a multidisciplinary team of leading basic and clinical neuroscience researchers engaged in a highly integrated and focused program directed at a well-defined and unified scientific question (hypothesis) or problem. The following characteristics apply:

Budget Limits

Total costs are limited to $2 million in any one year. This limit applies to new grants, their non-competing continuations, and any subsequent competitive renewals. The optional summer undergraduate research program component must not exceed $150,000 per year total cost. If this optional component is included in an application, the total cost limit will be $2,150,000 in any one year.

Before funding, the budgets will be scrutinized with care and the award may not be made for the full amount that an applicant requested. Activities that are not as meritorious may be deleted, and a project may not be funded for the full five years that applicants are permitted to request, if, e.g. that duration of support is not deemed critical to achieving essential goals or if progress needs to be formally evaluated after fewer years.

Revisions (formerly competing supplements) will not be considered for Conte Center grants. However, administrative supplements to promote diversity of the research workforce (http://grants.nih.gov/grants/guide/pa-files/pa-05-015.html) are strongly encouraged and, in appropriate situations, multiple diversity supplements will be considered (see http://www.nimh.nih.gov/research-funding/training/diversity-and-reentry-research-supplements-for-nimh-grantees.shtml for NIMH-specific guidance about diversity supplements). Such diversity supplements may allow the Center to exceed the total cost limit.

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.

Special Requirements

Cores

Cores should support the proposed objectives of the Conte Center and should support multiple projects as well as the overall goals of the Center. An administrative Core is required. Additional Cores may be proposed for animal support, biostatistics and data management, imaging, chemistry, etc and should be well justified based on the needs of the Centers research projects.

Renewals (Competing Continuations)

Renewal applications from previously funded Conte Centers will not be accepted in response to this new FOA. Previously funded Conte Center awardees who would have submitted a renewal should re-conceptualize their projects according to the new guidelines for Conte Centers, and submit their application as new applications to this announcement.

The total length of support for any Center is limited to a maximum of 10 years.

Resubmissions (Previously called Revisions)

This FOA replaces PAR-06-053, PAR-06-062, PAR-07-430, PAR-07-433, and PAR-07-434.

Previously unfunded applications submitted in response to PAR-06-053, PAR-06-062, PAR-07-430, PAR-07-433, or PAR-07-434 should be re-conceptualized according to the new guidelines for Conte Centers and be submitted as new applications for this announcement.

Starting in September of 2009, unfunded applications that were submitted in response to this announcement may be resubmitted..

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 leadership in the area of science proposed, have a strong record of high impact scientific achievements, and must head at least one of the research projects. The Conte Center 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 be at the forefront in the area of science proposed and have a successful record of bringing novel and significant projects to fruition as the 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 1 calendar month 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.

Research Training and Outreach (required)

The scope and significance of research conducted in a CONTE CENTER and the underlying research infrastructure are likely to provide an outstanding opportunity for research training. A CONTE CENTER 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 CONTE CENTER including synergistic efforts with existing training programs. The second objective is public outreach by CONTE CENTER participants and dissemination to the public of CONTE CENTER activities.

1. Research Training

It is expected that CONTE CENTER training activities will address three identified needs: 1) building a pipeline for individuals interested in a research career in a CONTE CENTER 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 CONTE CENTER and relevant predoctoral and/or postdoctoral institutional research training programs at the participating institution(s) is expected to enhance the research workforce trained in innovative, interdisciplinary approaches and state-of-the-art methods. Such CONTE CENTER efforts should be synergistic and complementary to existing institutional training programs. For example, a CONTE CENTER could enhance the training in the neurobiology of mental disorders or in translational research offered at the participating institution(s), could contribute to programmatic activities (e.g., retreat, symposium) organized by institutional training programs, and/or develop a new course offering at the institution(s). A CONTE CENTER 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 CONTE CENTER projects and to facilitate their transition to research independence. Targeted professional development opportunities for graduate students and postdoctoral scientists supported on CONTE CENTER projects are strongly encouraged so that these individuals transition smoothly to the next career stage in a timely manner.

In all training-related 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. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

The NIH is particularly interested in encouraging the recruitment and retention of the following groups of individuals:

A.      Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included.

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

C.     Individuals from disadvantaged backgrounds who are defined as:

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

2.      Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

It may be appropriate for a CONTE CENTER 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 CONTE CENTER. Conte Center investigators may also wish to consider developing synergies with NIMH Career Opportunities in Research (NIMH COR) Honors Undergraduate Research Training Grant (T34) programs which support pre-baccalaureate research training for individuals from diverse backgrounds, e.g., by serving as sites for summer research experiences for COR trainees.

2. Public Outreach and Dissemination

Each application should describe plans for outreach activities that enhance general public awareness of the importance and implications of CONTE CENTER research for addressing fundamental and translational scientific questions relevant to mental disorders. Such efforts would also be expected to enhance science literacy. Such activities are expected to include development of web-based resources for the public. In addition, such activities may also include CONTE CENTER-focused linkages with local science museums or related institutions, unique activities with the local school systems, CONTE CENTER-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 CONTE CENTER may also develop and implement a summer research program for undergraduate students in CONTE CENTER laboratories. Such a program would provide an opportunity for undergraduate students interested in interdisciplinary mental health-related research to participate in a CONTE CENTER research project during the summer months. Students may be affiliated with either the participating institution(s) or another academic institution. In addition to mentored research experiences in CONTE CENTER laboratories, such a program would incorporate discussion of ethical issues in science, academic enhancement activities that would facilitate the transition to graduate school for the participants, mentoring, and any other programmatic activities that would enhance the participants experience and foster their interest in a research career in interdisciplinary mental health-related research. It is expected that special attention will be given to the recruitment and retention of individuals from diverse groups (see above) to the summer program.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the Specialized Center (P50) award mechanism. The applicant will be 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 FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

NIMH policy for P50 grants establishes the following limits to the requested budgets: new or competing renewals of P50 applications may each request a maximum annual total cost of $2,150,000 if the optional training program is included in the application or $2 million if it is not included. The facilities and administrative (F&A) costs related to subcontracts to other institutions or organizations are included in the total cost cap of $2,150,000 million. Applications may not exceed this cap in any one year. The total costs for the optional summer undergraduate research program may not exceed $150,000. A Conte Center 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

This FOA replaces PAR-06-053, PAR-06-062, PAR-07-430, PAR-07-433, and PAR-07-434.

Previously unfunded applications should be reconceptualized and submitted as new. Starting in September 2009, applicants to this FOA may submit a resubmission application, but such an application must include an Introduction addressing the previous peer review critique (Summary Statement

Renewal applications from previously funded Conte Centers will not be accepted. Applicants seeking renewal of such Centers should reconceptualize their current Centers and submit a new application in response to this FOA. For Centers funded out of this FOA, future renewal applications may be submitted. A total of 10 years of support may be awarded under this new program

Applicants may submit more than one application, provided that each application is scientifically distinct.

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): August 25, 2008, August 25, 2009, August 25, 2010
Application Receipt Date(s): September 23, 2008, September 23, 2009, September 23, 2010
Peer Review Date(s): February 2009, February 2010, February 2011
Council Review Date(s): May 2009, May 2010, May 2010
Earliest Anticipated Start Date(s): July 2009, July 2010, July 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent 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 is to be sent by the date listed in Section IV.3.A.

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

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all CDs of the appendix materials must 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 received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be 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.

Pre-award costs are allowable. A grantee may, at its 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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Guidance for Applicants for P50 Conte Centers

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. Key Personnel should include the individual project leaders and core leaders. Others should be listed under Other Significant Contributors.

Table of Contents (Form Page 3)

Budget Information (Form Pages 4 and 5)

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

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

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

Resources

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

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

Starting in September of 2009, applicants resubmitting their applications should summarize their responses to the issues and criticisms pertaining to the Overall Center raised in the previous Summary Statement in this section. Individual projects and cores should not include an Introduction section. 

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

The research strategy section should begin with a 2-page Overview directed to a broad audience that includes:

1.      An overview of the entire proposed Center and the scientific objective to be achieved, the specific aims, relevant background and significance and a description of the impact of the science proposed in relation to the state-of-the-art of the field. This statement should also include an explanation of how the work proposed is innovative.

2.      Value added by an interdisciplinary Centers approach. This should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Centers 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.

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

The research strategy section should also include:

1. Background and significance (if this was not already covered in the overview section)

2.       Preliminary Studies: 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.

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

4.      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.

6.A.2 Information for Each Project

Face Page (use continuation page NOT PHS398 face page)

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

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

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

Budget Information (Form Pages 4 and 5)

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

Biographical Sketches of Key Personnel

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

Resources

Resources should be described for each project.

The Research Strategies for Individual Projects should not exceed (6 pages total per project):

 Each research strategy should begin with a one-page Overview that includes the specific aims and describes the impact of the science proposed in relation to the state-of-the-art of the field for a broad audience. The Overview must also explain the contribution of the project to the scientific objective of the overall Center and how the project will interact and benefit from other components of the Center and how the work is innovative.   It is important to clarify the appropriateness of the center approach and environment in addition to detailing the research design.  The Research Strategy should also include Background and Significance, Preliminary Studies, and a description of the scientific Approach..

Each Research Plan should also include the following that are not part of the Research Strategy:

a.      Human Subjects

b.      Vertebrate Animals

c.      Other information

d.      Literature cited

e.      Letters of support

* Individual Projects that involve clinical subjects may provide up to 4 pages of additional information pertaining to their clinical research. The additional information should be included with the appendix materials (see below).

6.A.2 Information for Each Core.

Face Page (use continuation page NOT PHS398 face page)

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

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

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

Budget Information (Form Pages 4 and 5)

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

Each Center should have an administrative core that includes the budget for data and resource sharing (personnel, materials, shipping costs), PI travel, advisory board, website, the required training and outreach component, and 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 and should be detailed in this section. The budget for data and resource sharing should include costs for activities such as the banking, analysis, and distribution of specimens to the research community, if applicable.

Biographical Sketches of Key Personnel

Biographical sketches should be provided for key personnel of each core using the PHS 398 Biographical Sketch form (limit 4 pages). The biosketch should include a personal statement describing why the experience and qualifications of the proposed key personnel for each core make them particularly well suited for contributing to that core and to the Center, a chronological list of previous positions, honors, and approximately 15 selected peer reviewed publications. Core Leaders must commit at least 1 calendar month to each core.

Resources

Resources should be described for each core.

The Research Strategy for all the Cores combined should not exceed 12 pages.  Descriptions for each core should 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. (See below about special requirements for the Administrative Core.)

  1.  Human Subjects
  2. Vertebrate Animals
  3.  Other information
  4.  Literature cited
  5.  Letters of support
*An Administrative Core is required for each center and must include the following:
  1.  Sharing Plans, Advisory Board, & Website: This should be included in the administrative core and should describe plans for the sharing of research data and research resources such as model organisms and software, convening the advisory board (potential members of the advisory board should not be named), and plans for the establishment of the Center website.
  2. Required Training and Public Outreach/Dissemination Plan: 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 Conte Center relates to and will synergize with existing institutional training programs to strengthen overall training efforts at the participating institution(s), plans to build the pipeline of future investigators, plans to enhance the transition to research independence for young investigators as well as outreach and dissemination activities that will inform the public about Conte Center activities and enhance science literacy.
  3.  Optional Summer Undergraduate Research Program: 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.

Formatting Instructions for Cores: The Core section should begin with the face page through resources for each core, followed by the combined research strategy for all the cores combined, followed by the Human Subjects through Letters of Support for each Core.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.  (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Materials Allowed in the Appendix:

Applicants may submit up to 3 of the following types of publications for each project only (not for cores).

Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents may be submitted in the Appendix as necessary.

Paper PHS398 applications must include on the Appendix CD, full-sized glossy photographs of material such as electron micrographs or gels; however, an image of each (may be reduced in size but readily legible) must also be included within the page limitations.

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

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by the NIMH in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious impact/priority score. 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.

Review Criteria for Overall Center

The Center applications will be reviewed on the basis of significance,investigators, innovation, approach, and environment. In addition, the Center application will be assessed on overall scientific merit, the degree of synergy in the integration of the individual components within the Center, and the integration of the Center to achieve the stated objectives. Further overall criteria include:

Overall Impact: The overall impact section and score will reflect the reviewers? assessments of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, and will reflect the overall significance and the importance of a highly integrated Center mechanism to achieve the stated objectives, as well as the individual review criteria for the center, individual projects, and cores, as detailed below.   

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the proposal involves risk, is the degree of risk counterbalanced by the benefits to be gained and the impact of science in relation to the state-of-the-art of the field?

Investigator(s):

Center Director Credentials: Does the Center director have the demonstrated ability to organize, direct, and administer the Center and, in addition, be the Principal Investigator on at least one of the individual projects? Has this individual demonstrated competence in the area of science proposed and a strong record of high impact scientific achievements? Does the Center director commit a minimum effort of 3 months per year to the Center and head at least one of the projects?

Center Investigator(s): Are the Center investigators 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 individual project and core leaders? Do the key personnel bring proven track records of complementary and integrated expertise to the overall Center?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?


If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Appropriateness of the Center Approach and Management Plans: 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 relation of the projects to the overall Center objective? Are the management plans appropriate?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Review Criteria for Individual Projects

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

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

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

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

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

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

Review Criteria for Cores

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

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

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

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

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

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

Special Review Criteria for the Administrative Core:

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?

Research Training and Public Outreach/Dissemination: Is the research training plan of high quality and is it likely to be effective? Are adequate plans presented to develop new research training opportunities and to integrate them with and enhance ongoing training at the participating institution(s)? Are adequate plans presented to achieve effective training of individuals from diverse groups? Is the public outreach and dissemination plan of high quality, likely to reach a broad and diverse audience, and likely to increase science literacy? Is this plan likely to enhance understanding of the fundamental research conducted in the CONTE CENTER and its relationship to the mechanisms underlying mental disorders? If applicable, is the summer undergraduate research program of high quality and likely to encourage the participants to pursue a research career in the mental health arena?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.


Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

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.

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.

In consideration of stated aim of this FOA that is, the rapid widespread sharing of the resulting data to accelerate research on mental health approved resource sharing plans will be stipulated in the Notice of Grant Award as a term and condition of award.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should include a section on the training and public outreach components of the Center including a description of how the Center is addressing the identified training needs described in Section I.1 and of the Centers public outreach and dissemination efforts. If the optional summer undergraduate research program is part of the awarded Center, the Progress Report should also describe the development and implementation of this program, modifications to the originally proposed program (if applicable), details about the applicant pool and the participants, as well as information about subsequent research activities of the participants including matriculation to graduate/medical school. Use the Trainee Diversity Report Form Page from the PHS 2590 (http://grants.nih.gov/grants/funding/2590/traineediversity.pdf) to report on the diversity of the participants supported by the summer undergraduate research program during the reporting period. In Part A of the report, indicate for all participants the numbers that all into each ethnic and racial category. The number of multi-racial participants will be entered into the row more than one race. Normally, the unknown or not-reported categories will not be needed. In Part B of the report, indicate for Hispanic or Latino participants the numbers that fall into each racial category. In Part C of the report, indicate the number of participants with Disabilities or who are from Disadvantaged Backgrounds.

Reporting Requirements for Participants in the Summer Undergraduate Research Program (if applicable):  The institution must submit a completed Statement of Appointment form (PHS Form 2271, Rev. 11/07) for each participant appointed or reappointed to the summer program. This form must be completed at the beginning of the initial appointment and annually thereafter for reappointments.  Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH. 

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 periodic 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 necessary for 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:

Applicants are encouraged to discuss their ideas with the appropriate NIMH contacts early in the process and should check the NIMH Conte Center FAQs for additional information pertinent to their applications.

1. Scientific/Research Contacts:

Basic Applications:

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

Translational Applications (Adult):

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

Translational Applications (Developmental):

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

Training Contact:

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

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

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

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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 impact/priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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/archive/archive/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.

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.

Inclusion of Women, Minorities, and Children:
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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigators NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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/.


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