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EXPIRED

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/NIH), (http://www.nimh.nih.gov)

Title: Interdisciplinary Developmental Science Centers for Mental Health (IDSC): Mature Centers (P50)

Announcement Type
New

Updates: The following updates relating to this announcement have been issued:

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-06-053

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: November 2, 2005
Letters of Intent Receipt Date(s): February 28, 2006, then February 14, 2007, and February 14, 2008
Application Receipt Dates(s): March 28, 2006, then March 14, 2007, and March 14, 2008
Peer Review Date(s): June-July
Council Review Date(s): September
Earliest Anticipated Start Date: September 30, 2006, 2007, 2008
Expiration Date: March 15, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

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

PURPOSE OF THIS ANNOUNCEMENT

The National Institute of Mental Health (NIMH) invites applications for Interdisciplinary Developmental Science Centers for Mental Health (IDSC): Mature Centers. The purpose of these Centers is to support integrative research environments conducting innovative cross-disciplinary investigations of neurobehavioral developmental mechanisms responsible for psychopathology in childhood and adolescence.

Mature Centers, supported through this announcement, utilize the P50 mechanism. Support is provided both for individual research projects and for core support that provides integration across center components. Mature Centers should be characterized by strong multidisciplinary frameworks guiding broadly integrative, well-developed programs of cutting-edge research.

A companion announcement, Interdisciplinary Developmental Science Centers for Mental Health (IDSC): Formative Centers (P20), may be found at (PAR-06-062). Relative to Mature Centers, Formative Centers are expected to be characterized by research approaches and interdisciplinary collaborations that are more exploratory and more modest in breadth and scale.

BACKGROUND

With increased sophistication in conceptual, methodological, and technological approaches, it has become possible to investigate the development of the brain in even very young children. Together with the large body of behavioral research on cognitive, emotional, and social development, it ultimately should be possible to track simultaneously--the development of brain structure and function, the development of psychological functions, and environmental exposures and experience, in order to specify their dynamic and reciprocal interrelationships. This integrated knowledge will be critical for the early identification, treatment and, ultimately, prevention of a range of mental disorders in childhood and adolescence. It is the challenge of an emerging science of neurobehavioral development to address these critical issues.

The report, America’s Children: Key National Indicators of Well-Being 2005 (http://childstats.gov/amchildren05/pdf/ac2005/ac_05.pdf), indicates that nearly 5 percent of children in the United States (an estimated 2.7 million children) experience definite or severe emotional or behavioral difficulties. Mental disorders affecting children and adolescents include Attention Deficit Hyperactivity Disorder (ADHD, ADD), Autism Spectrum Disorders, Eating Disorders, Mood Disorders (Depression, Bipolar Disorder), Personality Disorders, and Schizophrenia. Several recent NIMH reports ( Blueprint for Change: Research on Child and Adolescent Mental Health, 2001, http://www.nimh.nih.gov/publicat/nimhblueprint.pdf; Breaking Ground, Breaking Through: The Strategic Plan for Mood Disorders Research, 2004, http://www.nimh.nih.gov/strategic/mooddisorders.pdf; Setting Priorities for Basic Brain and Behavioral Science Research at NIMH, 2004, http://www.nimh.nih.gov/council/bbbsresearch.pdf) have called for innovative research approaches that will lead to discovering the causes of and best treatments for child and adolescent mental disorders. Stated priorities of these reports emphasized topics and approaches at the interface of disparate scientific disciplines, including brain-behavior relationships, expanded use of animal models, biobehavioral mechanisms responsible for sex differences, gene-environment interactions, and translational approaches (application of basic research findings or techniques to clinical topics or in clinical settings). Especially encouraged were developmental models to understand how interactions among genetic predispositions, brain maturation, and experiential influences (e.g., stress, trauma), unfold over time and account for vulnerability to, or resistance from, mental disorder.

Interdisciplinary Developmental Science Centers for Mental Health (IDSC) will support interactive collaborative research environments organized to address a cohesive, interrelated set of hypothesis-driven research questions. A hallmark of the IDSC program is innovation; successful centers will be those that demonstrate by their goals, collaborations, and research questions that they are bringing a fresh, multidisciplinary perspective to bear on the developmental science of mental disorders.. Centers must be defined by diversity in terms of populations of interest (e.g., human, non-human, clinical, normative), designs (e.g., laboratory experimental, longitudinal), level of analysis (e.g., biological, behavioral, social), techniques (e.g., genetic analysis, neuroimaging), and/or methods (e.g., animal models, human clinical assessment).. Translational approaches that include interrelated basic and applied research components are especially encouraged. Meaningful and committed interaction among different disciplines (e.g., developmental neuroscience, developmental psychobiology, developmental psychology, epidemiology, genetics, pediatrics, psychiatry) must be evident, and research components within a center (i.e., projects and cores) must be interrelated and interdependent. In addition, a critical aspect of the IDSC program is the provision of interdisciplinary and translational research experiences for students and junior faculty and the utilization of novel methods of bridging expertise boundaries.

RESEARCH APPROACHES

A core feature of the IDSC program is a developmental approach to the understanding of the biological, behavioral, and experiential processes that go awry in psychopathology. Features of a developmental approach include the grounding of mental disorders in their fundamental developmental behavioral and neurobiological components, elucidating the development of the nervous system, identifying critical causal sequences, determining the boundaries of plasticity (e.g., the timing of experiential influences in relation to neurobiological development), identifying early precursors and risk/protective processes, and anchoring new preventive and treatment interventions in this comprehensive knowledge base.

As noted above, an IDSC must be characterized by diversity across its component research approaches, unified by a common theme. Following are illustrations of the range of research approaches that might be included within IDSCs:

In keeping with NIH priorities related to Health Disparities, the broadest possible representation of subjects (e.g., in terms of ethnicity, race, sex) is strongly encouraged. Where possible, power should be sufficient for testing differences within and among groups that are likely to yield information of ultimate public health importance.

NIMH has a number of centers programs, each with its own goals. It is important to select the most appropriate program in order to maximize the responsiveness of an application. Therefore, potential applicants are encouraged to examine the announcements for these additional programs and to seek guidance from the designated Institute staff regarding selection of the most appropriate program (for inquiries about the IDSC program, see Agency Contacts, below):

Advanced Centers for Interventions and Services Research:
http://grants.nih.gov/grants/guide/pa-files/PAR-05-161.html

Developing Centers for Interventions and Services Research:
http://grants.nih.gov/grants/guide/pa-files/par-05-144.html

Centers Program for Research on HIV/AIDS and Mental Health:
http://grants1.nih.gov/grants/guide/pa-files/par-03-142.html

Translational Research Centers in Behavioral Science:
http://grants.nih.gov/grants/guide/pa-files/par-04-151.html

Interdisciplinary Behavioral Science Centers for Mental Health:
http://grants.nih.gov/grants/guide/pa-files/par-04-004.html

Silvio O. Conte Centers to Develop Collaborative Neuroscience Research:
http://grants.nih.gov/grants/guide/pa-files/par-02-123.html (or reissuance)

Silvio O. Conte Centers for Neuroscience Research:
http://grants.nih.gov/grants/guide/pa-files/par-02-121.html (or reissuance)

Silvio O. Conte Centers for the Neuroscience of Mental Disorders:
http://grants.nih.gov/grants/guide/pa-files/par-02-122.html (or reissuance)

CENTER CHARACTERISTICS

ACTIVITIES SUPPORTED

To provide a suitable structure for achieving the objectives of this program, IDSCs may request funds for the following:

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH P50 (Specialized Center) award mechanism.

The applicant is solely responsible for planning, directing, and executing the proposed project. A grant supporting an IDSC is not transferable to another institution.

Mature Centers (P50) are limited to $1.5 million direct costs in any one year. Support is provided for three or more individual research projects as well as for well-justified core support. Support may be requested for a project period of up to five years. Should there be future opportunities to apply for renewal, each Mature Center will be limited to a maximum of ten years of support in total.

Competitive supplements will not be considered for these Center grants. It is anticipated that individual projects that are outgrowths of Center activity will seek independent funding through mechanisms such as research project grants (e.g., R01s).

Since IDSCs are defined by their multidisciplinary, integrative nature and not by departmental or geographic boundaries, projects constituting a given Center may be based at a variety of institutions, supported through consortium arrangements.

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" for the entire Center and for each project and core must be provided in the application.

2. Funds Available

The direct cost limit for Mature (P50) Centers is $1.5 million per year. The earliest possible start date is September 30, 2006. Depending on availability of funds and the size and quality of individual applications, NIMH may support up to 1-2 new Mature Centers per year under this announcement.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Applications may be submitted by organizations with any of the following characteristics:

Foreign institutions are not eligible for an IDSC award, although foreign components are possible, e.g., via consortium arrangements.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research (see criteria in CENTER CHARACTERISTICS above) is invited to work with his/her 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 programs.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the NIH Grants Policy Statement. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
Not applicable

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 (revised 9/2004). For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms (revised 9/2004). 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.

SUPPLEMENTARY INSTRUCTIONS

An application for an IDSC must describe the overall goals of the Center, the hypotheses to be tested, and the methods to be used. The application must clearly articulate the reasons a Center approach is needed for the proposed activities, as well as the unique benefits that will accrue from a Center.

Utilizing the PHS Form 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html), the application should include the following components in the designated order:

Information for the entire Center:

Information for each Project or Core:

Additional information for the entire Center:

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 28, 2006, then February 14, 2007, and February 14,2008
Application Receipt Date(s): March 28, 2006, then March 14, 2007, and March 14, 2008
Peer Review Date: June-July, 2006, 2007, 2008
Council Review Date: September 2006, 2007, 2008
Earliest Anticipated Start Date: September 2006, 2007, 2008

Interested parties are strongly encouraged to contact Dr. Mary Ellen Oliveri, by email at [email protected], as early as possible in the conceptualization and planning of a possible IDSC application in order to assess the responsiveness of the proposed center to the mission of NIMH and to the goals of this PA. Applications judged not to be responsive may be returned to the applicant without review.

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 above and at the beginning of this document.

The letter of intent should be sent to:

Mary Ellen Oliveri, Ph.D.
Division of Pediatric Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
[Non-USPS express or courier service: Rockville, MD 20852]
Telephone: (301) 443-5944
Email: [email protected]

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 same time, two additional copies of the application must be sent to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (express/courier service; non-USPS service)

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 and for responsiveness to this PA by NIMH. Incomplete or unresponsive applications will be returned without review.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit 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 an application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at 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 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

Plan for Sharing Research Data

IDSC applications must include a plan for sharing research data with the scientific community. Describe the expected timeline for sharing the anonymized raw data, format, other documentation, any analytic tools to be provided, any conditions on the use of data, and the mode of data sharing (e.g., under the applicant’s own auspices versus through a data archive).

The reasonableness of the data sharing plan 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 adequacy of the plan will be considered by NIMH staff in determining whether a grant will be awarded, and the approved plan will be a condition of the award.

Sharing Research Resources

NIH policy requires 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.

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. Reporting.

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 PA 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:

Although primary assessments of scientific merit will be based on the Center as a whole, one or more individual projects or cores could receive lower priority in some instances, possibly resulting in the funding of a Center smaller than proposed. As noted above, if fewer than three of the Center’s individual projects are judged to be meritorious, this may preclude funding of the entire Center.

The following will be considered in making funding decisions:

CRITERIA FOR REVIEW OF THE CENTER AS A WHOLE:

Innovation and Intrinsic Merit: The overall quality, scientific merit, substantive relevance to the goals of this PA, and innovation of the Center research; the likelihood that the Center will lead to fundamental advances, to new discoveries, and/or to technological improvements.

Appropriateness of the Center Approach: The need for and suitability of a multidisciplinary Center approach; whether a Center approach will add significantly to what could be accomplished through other modes of research support; demonstration of synergy in the Center’s conceptualization and approach. The integration and interdependence of component projects and cores is of utmost significance and should be described explicitly.

Research Competence: The qualifications and scientific credentials of the Center Director, the constituent project directors, and other investigators; these individuals should be regarded by their peers as leaders in, and at the forefront of, their respective fields.

Center Director Credentials: Demonstrated ability of the Center Director to organize, direct, and administer the Center and, in addition, be the Principal Investigator on at least one of the individual projects. It is expected that this individual will devote a minimum of 30 percent to a Mature Center grant. The Director must be the scientific leader of the Center.

Institutional Commitment: The nature and level of resource commitments and resources available from the home institution and from other participating institutions, and plans for interactions among the participating institutions.

Appropriateness of Management Plans and Arrangements: The feasibility and adequacy of the organizational and administrative plans; the appropriateness of the budget; and the mechanisms to evaluate the Center’s progress.

Quality of Plans for Research Apprenticeships: The effectiveness of approaches used to attract and involve junior investigators and students who show potential for significant contributions and independent research careers.

Quality of Linkages between the proposed Center and ongoing training programs in the institutional environment.

Outreach: Quality of approaches used to disseminate information regarding the Center’s activities as they relate to public understanding of science and mental health and illness.

CRITERIA FOR REVIEW OF INDIVIDUAL COMPONENTS (PROJECTS AND CORES) WITHIN THE CENTER:

Significance: Does this component address an important problem? How will it help advance scientific knowledge related to child and adolescent mental disorders? What is this component’s integrative contribution to the center as a whole?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate? Are potential problem areas acknowledged and alternative approaches considered?

Innovation: Does this component develop or employ novel concepts, approaches, methodologies, tools, or technologies?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the PI of the Project or Core an established scientist in the appropriate field?

Environment: Does this component benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

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.B. 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.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan 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.D. Sharing Research Resources

Resource Sharing Plan: The adequacy of the resource sharing plan will be assessed by the reviewers. It also will be considered by NIMH staff when making recommendations about funding applications. The resource sharing plan will be part of the terms and conditions of the award. The effectiveness of the resource sharing plan will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. 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 14 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 Notice of Award. 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.

Section VII. Agency Contacts

We strongly encourage your inquiries concerning this funding opportunity as early as possible in the application planning process. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Mary Ellen Oliveri, Ph.D.
Division of Pediatric Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
[Non-USPS express or courier service: Rockville, MD 20852]
Telephone: (301) 443-5944
Email: [email protected]

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Room 6138, MSC 9609
Bethesda, MD 20892
Telephone: (301) 443-3534
Email: [email protected]

3. Financial or Grants Management Contacts:

Joy Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
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 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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/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 PA 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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