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

Title: Centers Program for Research on HIV/AIDS and Mental Health (P30)

Announcement Type
This is a reissue of PAR 03-142, which was previously released June 20, 2003

Program Announcement (PA) Number: PAR-08-009

Catalog of Federal Domestic Assistance Number(s)
93.242

Key Dates
Release Date: October 17, 2007
Letters of Intent Receipt Date(s): December 7 annually
Application Receipt or Submission Dates(s): January 7 annually
Peer Review Date(s):  March annually
Council Review Date(s): May annually
Earliest Anticipated Start Date: July annually
Additional Information To Be Available Date (Url Activation Date):
Expiration Date:  January 8, 2010

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Purpose.  The Center for Mental Health Research on AIDS at the National Institute of Mental Health supports research Centers that provide Core support for multidisciplinary research programs focused on mental health and HIV/AIDS.  The purpose of this Centers Program is to improve and expand research by supporting infrastructure for administrative coordination; subject recruitment, tracking, and retention; quality control and assurance procedures; performing laboratory testing; performing statistical analyses; database management; sponsoring training and education; and scientific and organizational capacity, in order to provide leadership in the integration of multidisciplinary approaches to HIV/AIDS and mental health research, and to expand and develop information-sharing, expertise, technology, and technology transfer in the institutional and clinical communities.  The support of this infrastructure will serve to enhance and extend the effectiveness and public health impact of research related to mental health and HIV/AIDS.

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

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

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

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The Center for Mental Health Research on AIDS at the National Institute of Mental Health supports research Centers that provide Core support for multidisciplinary and high-priority research programs focused on mental health and HIV/AIDS.  The purpose of this Centers Program is to improve and expand research by supporting infrastructure for administrative coordination; subject recruitment, tracking, and retention; quality control and assurance procedures; performing laboratory testing; performing statistical analyses; database management; sponsoring training and education; and scientific and organizational capacity, in order to provide leadership in the integration of multidisciplinary approaches to HIV/AIDS and mental health research, and to expand and develop information-sharing, expertise, technology, and technology transfer in the institutional and clinical communities.  The support of this infrastructure will serve to enhance and extend the effectiveness and public health impact of research related to mental health and HIV/AIDS.

The NIMH seeks to foster a synergistic approach to conducting research on mental health issues related to HIV infection.  The goal of the NIMH AIDS Centers Program is to encourage the application of multiple scientific perspectives and approaches to stimulate inter-disciplinary collaboration and coordination.  NIMH AIDS Centers should stimulate translational AIDS research activities at institutions that receive significant AIDS funding.  NIMH AIDS Centers must have the potential to be broadly based investigative endeavors, encompassing or supporting research in a variety of areas including biological, biomedical, behavioral, neuroscience, prevention, clinical sciences, and services research.  However, each successful NIMH AIDS Center should also demonstrate excellence and leadership in thematic areas that capitalize on the experience and expertise of the Center investigators.  The Center can then serve as a catalyst to spearhead state-of-the-science activities related to this theme within the institution and surrounding communities.

Some important specific research objectives that can be fostered by NIMH AIDS Centers are: 1) identification of mutable behavioral risk factors that put individuals at risk for HIV infection, and development of cost-effective interventions to change those behaviors; 2) development of methods and strategies to aid HIV-infected individuals and their families in coping with HIV infection, preventing complications, and avoiding new sexually transmitted illnesses; 3) studying of the effects of HIV infection of the CNS; 4) identification of the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction; 5) development and testing of potential therapeutics to prevent or treat HIV/CNS disease; 6) studying the issues influencing adherence and non-adherence, and identification of methods to improve long-term adherence to drug therapy regimens, and behavioral modification to prevent the further spread of HIV; 7) development and testing of strategies to translate effective prevention interventions into real world settings both domestically and internationally; and 8) development of effective strategies to integrate behavioral science into biomedical approaches to HIV/AIDS disease management. The NIMH AIDS Centers will enable innovative, state-of-the-art research on HIV and mental health that could not or would not be conducted without the crucial support provided by them.  The overall integrative theme of an NIMH AIDS Center should be clearly described, and the need for support of the proposed Center Cores to facilitate the research projects should be justified.

NIMH AIDS Centers are expected to serve as local, regional, national and international research resources for established and promising investigators, and to provide opportunities for research training, career development, and mentoring, with an emphasis on fostering the career development of minority scientists to become successful and productive HIV/AIDS researchers.  NIMH AIDS Centers are encouraged to use a variety of strategies to achieve the research objectives of the award. Centers are encouraged to develop and expand collaborations with other research institutions; research networks funded by other NIH Institutes, Federal agencies or private organizations; international research programs; international and domestic community networks; and industry.

Applicants are strongly encouraged to consult with NIMH program staff with regard to questions concerning program-specific requirements and research areas that are of highest priority.

Although the specific structure and organization of individual NIMH AIDS Centers will vary, the following characteristics must be included in each application.  Applicants should carefully review these characteristics because they are important factors in the evaluation and scoring of the application by peer reviewers.

NIMH AIDS Center applications must describe in detail the essential function of each Core of the Center, how each Core will contribute to the overall theme and organization of the Center, and how each Core will be used by the participating research projects.  NIMH AIDS Center Cores should provide resources to its institution's AIDS research efforts through support of activities that cannot effectively be provided by standard research grants.  An example of such support is promoting translational research activities, i.e., studies bringing findings from the laboratory to the clinic, and vice versa.  Specific aims of the proposed components of each of the Center Cores should be defined, and a time line for addressing each of those aims should be presented.  A process for evaluating the progress of each Core should be developed, with identification of outcome measurements clearly defined.  Accountability and progress measures for each Core can include process indicators (e.g., specific services and technologies offered and utilized); workload indicators (e.g., numbers of faculty users, specific research projects or grants supported, and numbers and types of conferences, symposia, and workshops); and success indicators (e.g., patents awarded, number and quality of publications and grants supported by the Center, especially those concerning interdisciplinary and translational research).

Research Environment

Each NIMH AIDS Center must provide an environment that promotes the conduct of the highest quality, state-of-the-science research, exhibiting leadership and innovation in its particular area(s) of investigation.  Through its activities, the Center must demonstrate that it is a significant scientific research resource that will demonstratably enhance the capability of the research environment in which it is proposed.  Measures of evaluation that validate this enhanced capability should also be described.  Applicants should be very specific in illustrating the advantages of the overall Center structure, how the Center will be beneficial, and how the Center will contribute to advancing the field.  The application of multiple scientific perspectives and a synergistic approach as well as thematic integration should be defining features of the Center. 

For competing continuations, applicants should identify original approved specific aims and clearly describe the progress made on each specific aim, provide evidence of relevant publications produced in the previous funding period, and articulate how this progress has enhanced the research capability at the Institution.  Competing continuation Centers should also include a description of how the presence of the Center has improved the conduct of research in the thematic area of expertise, as evidenced by broad dissemination of research products, citations by other published materials, or other indicators of scientific advancement. Specific examples of broad achievements should be detailed, with attention to achievements that could not have been accomplished without the presence of the Center. Collaborations with community-based organizations (CBOs) should also be included in descriptions of the research environment.

Center Director

The NIMH AIDS Center Director must be scientifically and administratively qualified to manage the complexity of the research objectives of the Center and outline a plan to successfully meet those objectives. A critical requirement is that the Center Director must be able to demonstrate leadership with regard to the scientific program and the team of individuals involved in that program. The Center Director should develop a reasonable set of short term goals for the Center, and articulate a long term vision for the Center's function, with a well-developed plan for how the Center will identify and respond to new and changing priorities and emerging initiatives. The director will have final responsibility for the scientific, administrative, and operational aspects of the Center.  The Center Director is responsible for overall coordination of the Center and for the development of the Center as a significant local, regional, national, and international resource.  Because the role of the Center Director is crucial to the success of the Center, an individual should not serve as Director of more than one NIH Center grant.  In addition, it is expected that the Center Director will make a significant and sustained justifiable commitment of time and effort to the Center, based on the breadth and complexity of the Center program and the effort needed to administer it, and foster the development of senior staff to ensure the Center is positioned to maintain its commitment to advancing HIV research well into the future.

Training

As a leader in its particular thematic areas of investigation, the NIMH AIDS Center should attract new investigators and provide for mentoring and career development.  An important component of the Center and its research efforts is the training, career development and mentoring of new investigators who show potential for significant contributions and independent research careers.  The applicant institution must therefore demonstrate that it has the capacity to participate in training predoctoral and postdoctoral students for careers in HIV/mental health research, and the capacity to provide career development and mentoring opportunities for potential researchers.  Center grant funds may not be used to pay stipends or other trainee costs; however, the Center staff are encouraged to participate in the development of training programs, and Center resources may be made available for trainee use.  In addition, as the Centers are considered to be local, regional, national, and international resources, Center applicants should also describe plans for facilitating the sharing of data with the scientific community, the mechanisms to be used for data-sharing, and the procedures for training staff in using those mechanisms. Evidence that training goals for new investigators have been met should be included in recompeting applications, and may include such indicators as recruitment and retention, scientific contributions (e.g., first authored publications), and small grant awards.

Travel

Travel expenses for the Center Director to attend one Center Director's meeting in the Washington DC area should be included. Limited support is available to cover travel of the Center Director and other investigators to scientific meetings that are justified as essential to the conduct of research supported by the Center. Travel of technical staff for training that is justified as essential to enhancing the quality of the research projects is also allowed.

Organization

NIMH AIDS Center applications are expected to be multi-disciplinary in scope, applying multiple scientific perspectives and approaches to foster inter -disciplinary collaboration and coordination, and are expected to include a depth of expertise and experience not ordinarily present in an individual research project application. The mechanisms that will foster interactions and collaborations among Center investigators should be described in detail in a well- organized plan that explains how these interactions and collaborations will result in enhanced quality, productivity and overall progress in research in the Center.  An effective Center provides an environment that encourages cross-fertilization of ideas, provides an interactive research environment, and encourages creativity and innovation.  The applicant should describe clearly how interactions and collaborations of participating investigators will enhance and expand the development and productivity of their research efforts, and how participating investigators will benefit from shared resources, formal and informal planning activities, and developmental or pilot support provided through the NIMH AIDS Center grant.

NIMH AIDS Center must be organized to include the Cores listed below:

Administrative Core

The Center must have an appropriate and adequate administrative structure with an internal organization capable of planning, conducting, and evaluating Center activities. A strategic plan must be outlined which identifies the immediate and long-term goals of the Center.  A process for implementing the activities to achieve the goals set by the Center should be clearly defined.  For new Center applications, the highest priority goals should be identified with a detailed plan outlining the activities proposed to meet those goals for each year of the grant.  Goals for each successive year should build on those identified for the first year of funding.  Competing continuation Centers must provide information on how the Center has achieved the goals of the previous funding period and how the goals of the future years build on the past successes. Of particular importance for competitive renewals is to describe the successful activities that have been accomplished that could not have been realized without the Center support.

A structure must be provided that has clear lines of authority to promote planning and evaluation activities as well as collaborations and interactions within, among and between programmatic elements of the Center in an efficient and cost-effective manner.  A mechanism for internal review, decision-making, and priority-setting processes appropriate to conduct the activities of the Center must be defined.  Appropriate criteria and review processes must be established and described to sustain investigator participation in the Center based on productivity, research direction, and overall contribution.  The administrative structure must include a standing outside advisory committee charged with providing appropriate and objective advice and evaluation as needed to the Center Director.  The plan for meeting with the outside advisory committee should be outlined, and a process for responding to recommendations of the committee(s) should be delineated. Information from this Center Advisory Committee meeting should become part of the annual progress report, including the date/s of the meeting, a written report from the Advisory committee, and the Center Director’s written responses to the advisory committee report.

The Administrative Core may include a limited number of administrative and clerical personnel, with a detailed description of their responsibilities for the Center and strong justification for the level of support requested.  However, salary and support for central administrative personnel usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel, are not allowable.  Administrative support services, including supplies, duplicating equipment, telephones, or maintenance contracts for equipment are allowed when not covered by institutional overhead charges.  Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowed.  Rent may be allowed only in unusual and exceptional circumstances whereby the applicant institution has excellent researchers and potential for mental health-related HIV/AIDS research, but has documented insufficient on-site space.

Research Cores

The structure of the NIMH AIDS Center will include the establishment of at least two Research Cores to support shared resources that are not easily funded through standard research funding mechanisms.  The number and goals of the Research Cores should be reflective of the overall level of funding requested for the Center.  Research Cores can be developed around any research activity that can provide resources to basic and clinical investigators.  The Research Cores are expected to be used as shared resources and services and are intended to provide access to knowledge and technology that enhances the research productivity of the Center, scientific interaction within the Center and consultation being provided by the Center.  These Research Cores also provide access to services that facilitate the research and strengthen the administrative and organizational cohesion of the Center.  Research proposed to be conducted within the Research Core structure is allowed when directed toward improving and expanding the resource.  Each Research Core should clearly describe a plan for identifying new or expanded services that it provides.  In addition, each Research Core should clearly describe a plan for identifying potential users of the shared resources, and for providing the resources to investigators who may request them.  The potential benefits of these resources and a mechanism to evaluate these benefits must be detailed in the description of the Research Core.

The Research Core Director must be scientifically qualified to handle the nature and complexity of the research objectives of the Research Core.  Each Core Director must be experienced in the scientific area in which the Core functions, and have demonstrated the ability to assume responsibility for and manage the scientific, administrative, and operational aspects of the Research Core.  The time commitment of the Core Director should be based on the breadth and complexity of the Core and the effort needed to administer it.

Developmental Core

The NIMH AIDS Center structure must include a Developmental Core.  Funds allocated to this Core are to provide start-up funds for new, innovative pilot projects by independent investigators.  The intent of this Core is to support scientific studies for short periods of time to develop preliminary data for peer-reviewed research applications.  Funds from this Core can be used to support pilot projects, feasibility studies, new or emerging research opportunities, and AIDS research activities of newly recruited faculty; restricted to these uses only.

Generally, the total amount of money allocated to pilot projects should not exceed 10% of the Center grant's total annual direct costs (exceptions should be strongly justified).  These projects should have the potential for developing into larger projects that could compete for funds on their own.  The support of pilot projects or feasibility studies should be of relatively short duration (e.g., 1-2 years), depending upon the nature of the research.  A process by which high-quality, innovative pilot proposals are identified by or solicited from investigators must be developed and clearly described.  The mechanism for reviewing potential projects, making funding decisions and awards, and monitoring projects to ensure effective use of pilot project funds must be clearly described.  As with all research to be conducted under the Center's auspices, pilot projects must comply with applicable NIH policies, and the necessary human subject and animal welfare assurances must be submitted.

The Director of the Developmental Core must be scientifically qualified to direct the activities of the Core.  This Core Director must be experienced in the scientific areas in which the core proposes to develop pilot projects and must have an understanding of the scientific process of developing ideas into applications.  This Director should also demonstrate the ability to assume responsibility for the scientific, administrative, and operational aspects of the Developmental Core.

Competing continuation Center applications should supply information about the progress, accomplishments and relevant publications of all projects supported by the Developmental Core of the previous funding period of the Center.  This information should also include current funding status of completed pilot projects, whether data generated from pilot projects provided a basis for projects with independent funding, and whether investigators funded through this mechanism, particularly junior investigators, were successful at competing for independent funding.

Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the NIH Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated on the Notice of Grant Award.  Under these rules, the Center Director has flexibility to meet unexpected Center requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the Center (as shown on the Notice of Grant Award).  The Center is intended to provide reasonable costs for any or all of those activities noted below which are clearly related to the specialized research needs of the Center and allowed by NIH policy.

Section II. Award Information

1. Mechanism(s) of Support

This FOA will use the NIH Core Center Grant (P30) award mechanism.  As an applicant you will be solely responsible for planning, directing, and executing the proposed project.

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

2. Funds Available

NIMH will provide up to a maximum of $2,250,000 total costs per year for an AIDS Center grant. This cap is fixed and will not allow escalations for personnel salaries.  The maximum total costs may be exceeded for competing supplements for discreet opportunities, but not for resubmissions of unfunded cores or large multi-year supplements: any additional deviation from the maximum requires prior approval from the NIMH.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2.  Cost Sharing or Matching

This program encourages, but does not require, cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

In order to be eligible for an NIMH AIDS Center grant, applicants must demonstrate a minimum funded research base of four NIMH-funded research grants, and at least two more peer-reviewed AIDS and AIDS-related research awards at the time that the Center is funded and throughout the award period.  The additional grants may be from other NIH Institutes or from peer-reviewed funding from alternate sources.  This research base must demonstrate synergy and collaboration for AIDS-related behavior research or research investigating the neurological and neurobehavioral complications of HIV infection.  The research base includes grants and contracts utilizing the following mechanisms:  P01, R01, R03, R21, R35, R37, U01, U10, U19, and K series awards.

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 301-451-0088.

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Foreign institutions are not eligible to apply.

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): December 7 annually
Application Receipt or Submission Dates(s): January 7 annually
Peer Review Date(s):  March annually
Council Review Date(s): May annually
Earliest Anticipated Start Date: July annually

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 NIMH 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.

The letter of intent should be sent to:

Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6218
Bethesda, MD  20892-9619
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  dr89b@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above.  Submit a signed original of the application, including the Checklist, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive Room 1040 MSC-7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

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

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9529
Rockville, MD 20852 (for express/courier service)

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

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

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 application must include an Introduction addressing the previous critique.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

SUPPLEMENTAL INSTRUCTIONS

Applicants must ensure that their applications are responsive to the research goals of NIMH and to the essential organizational and administrative characteristics of a NIMH Center as described below.

To facilitate the review process, the application should be organized according to  the outline described here.

Overview (not to exceed 10 pages; an additional 3-page Introduction is allowed for resubmission applications to address the prior summary statement)

An overview should include:  an overall description of the proposed Center, including objectives and integrating theme; justification of Center goals and proposed organization; evidence of the cohesiveness of the proposed Center; a brief description of background and responsibilities of the Center Director, key personnel, and participating investigators; and a diagram illustrating the organization and function of the programmatic and advisory structure of the Center.  The overview should describe how the Center functions will develop and expand collaborations, bringing the thematic expertise to the local, regional, national and international scientific community.  New Center applications should describe plans to develop these broad collaborations, delineating a process for evaluating progress.  Renewal Center applications must describe past successes and new goals as well as provide convincing justification that continued support under this mechanism will continue to be highly productive.  Changes in structure or focus that have taken place over the previous funding period that have been done to strengthen or broaden the efforts of the Center should be clearly described.  Both new and renewal Center applications should describe the institutional commitment to the Center.  A strong commitment of the parent institution can be demonstrated by providing sufficient resources and space to ensure organizational stability and fulfillment of Center objectives.  The organizational status of the Center within the institution should be comparable to that of other similar organizational units within the institution.  The parent institution should also provide assurance of its commitment to continuing support of the Center in the event of a change in Center directorship and have in place a well-defined plan for this situation.

Research Plan (not to exceed 25 pages; an additional 3-page Introduction is allowed for resubmission applications to address the prior summary statement)

The research plan must include: a detailed description of the goals of the Center and how leadership and expertise will be provided as a resource for the scientific personnel and projects that form the Center; an action plan to achieve those goals, and a short- and long-term timeline for achieving those goals; the strengths of and opportunities provided by the proposed Center; strengths of the methods to be used; information about resources and facilities available to augment the Center's capabilities; policies and procedures for strategic planning, monitoring, and evaluating the Center activities; an overview of the core structure, including a justification for specific cores and a plan for how the cores will interact with and support the programmatic elements of the Center; and a description of how the Center will facilitate the existing science at the Institution. 

Renewal Centers (formerly “competing continuations”) should include an historical perspective describing the major successes of the previous funding periods and how continued funding will build on those successes.  Changes in structure or focus that have taken place over the previous funding period that have been done to strengthen or broaden the efforts of the Center should be clearly described.  Evidence for future Center success should be clearly stated.Renewal Centers also must provide evidence of leadership and expertise appropriate for the thematic areas of the Center, as well as strong justification of the need to continue the activities of the Center.

Cores (not to exceed 10 pages for each core; an additional 2-page introduction is allowed for each core in resubmission applications, to address the prior summary statement )

A detailed description of each individual Core must include the aims and activities of the Core and a description of how the aims will be met; a justification and description of the personnel within each Core; the proposed users of the Center resources and the percent of time that they expect to use those resources; a plan for outreach to other potential users; a description of the core's resources and environment; and a plan for evaluating the activities of the Core.

Supplementary Instructions ONLY for Revision Applications (formerly Competing Supplements) for Cores (not to exceed 15 pages for each core)

For a revision (formerly, a competing supplement application), in which a single research core is proposed for support, as either a new core or as a resubmission (revised core), an Overview and a Research Plan of the Core should be described. This section may devote up to 3 of the 15 pages to respond to the prior critiques (if a resubmission is proposed). Conversely, if the applicant is submitting a new core or a core that is very different from one proposed in a previous application, up to 1 of the 15 pages should be devoted to describing how the Core was determined to be submitted.  If there was a previous review, this 1 page should describe why the core/project is “new” and not a “resubmission”.

Plan for Sharing Research Data

All applicants are expected to include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared. The reasonableness of the data sharing plan or data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

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

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. 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 FOA will be evaluated for scientific and technical merit by an appropriate review group convened by NIMH in accordance with review criteria stated below.

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

The following will be considered in making funding decisions:

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health.  In the written comments reviewers will be asked to discuss the following aspects of the application 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, weighting them as appropriate for each application.  The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high 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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Specific Review Criteria for this FOA:

Review Criteria for Overall Center

Significance:

Approach:

Innovation:

Investigator:

Environment:

REVIEW CRITERIA FOR CORES

Administrative Core

Research Cores

Developmental Core

2.A.  Additional Review Criteria:

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

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

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

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

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

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

2.B. Additional Review Considerations

Budget: Reviewers will be asked to evaluate 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, but the reviewers will be asked to comment on the relation of the size of the overall budget to the significance and impact of the proposed research after the scoring. 

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

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

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award 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 Notice of  Award 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 encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6212, MSC 9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  dr89b@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:

Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Email: rc253d@nih.gov

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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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 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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NIH Funding Opportunities and Notices

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