Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

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

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of PAR-08-009

Related Notices

  • May 20, 2013 - See Notice NOT-MH-13-016. Notice of Change in Application Types Allowed.

Funding Opportunity Announcement (FOA) Number

PAR-11-019

Companion FOA
  
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)

93.242  

FOA Purpose

The National Institute of Mental Health’s (NIMH) Division of AIDS (DAR) encourages applications for Center Core grants (P30) to support either HIV/AIDS Research Centers (ARC) or Developmental ARCs (D-ARC). The ARC/D-ARC Program is intended to provide infrastructural support that facilitates the development of high impact science in HIV/AIDS and mental health that is relevant to the NIMH mission. It intends to support innovative, interdisciplinary research in several areas, including basic, applied, clinical, translational, and implementation science. The ARC/D-ARC program gives priority to institutions that receive significant levels of funding from NIMH and other NIH Institutes or Centers.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

December 7, 2010

Letter of Intent Due Date

December 7, 2010

August 7 annually, thereafter

Application Due Date(s)

January 7, 2011; September 7, 2011; September 7, 2012,;September 7, 2013

AIDS Application Due Date(s)

January 7, 2011 (for renewals and resubmissions only)

September 7 annually, thereafter.

Scientific Merit Review

March 2011 (for renewals and resubmissions)

October each year thereafter

Advisory Council Review

May 2011 (for renewals and resubmissions)

January each year thereafter

Earliest Start Date(s)

July 2011 (for renewals and resubmissions)

April each year thereafter

Expiration Date

September 8, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV of this FOA. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions in the FOA. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The National Institute of Mental Health’s (NIMH) Division of AIDS (DAR) encourages applications for Center Core grants (P30) to support either HIV/AIDS Research Centers (ARC) or Developmental ARCs (D-ARC). These Research Centers and Developmental Centers are referred to collectively as the ARC program, which is intended to provide infrastructural support that facilitates the development of high impact science in HIV/AIDS and mental health relevant to the NIMH mission. The ARC program supports innovative, interdisciplinary research in several areas, including basic, applied, clinical, translational, and implementation science. The ARC program gives priority to institutions that receive significant levels of funding for HIV/AIDS research from NIMH and other NIH Institutes or Centers.

The mission of the ARC program is to support cross-cutting, interdisciplinary research at the intersection of mental health and HIV/AIDS, particularly science that advances the understanding, prevention, and treatment of HIV-associated morbidity. ARC program awards permit the centralized coordination of affiliated research activities, foster the development of scientific innovations and new collaborations, encourage interdisciplinary research, and facilitate the dissemination of public health advances to implementing agencies, academia, affected communities, and policymakers. These Centers must have the potential to support studies in a variety of areas including biological, biomedical, behavioral, neuroscience, prevention, clinical sciences, and services research. 

Potential research areas that may serve as organizing themes or key areas of interest for the ARC program include but are not limited to: 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 to cope with HIV infection, preventing complications, and avoiding new sexually transmitted illnesses; 3) identification of the effects of HIV infection of the central nervous system (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) examination of 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 ARC program is expected to make several other important contributions. First, its Centers should demonstrate excellence and leadership in thematic areas that capitalize on the expertise of affiliated investigators. In this way, ARC program affiliated scientists serve as thought leaders who can guide the field in new directions in mental health and HIV/AIDS research based on the accumulating evidence. Second, given infrastructural support, ARC/D-ARCs are expected to compete successfully for funding from NIH and other sources and, in doing so, address key scientific questions relevant to their thematic areas of interest. Third, the ARC program is intended to build capacity by attracting new or established investigators to HIV/AIDS research and to provide opportunities for research training, career development, and academic mentoring, particularly for those committed to studying HIV/AIDS prevention in most at-risk communities in the U.S. and developing countries.

Applicants to the ARC program are strongly encouraged to develop and maintain collaborations with industry, government, community, implementing agencies, and other scientific networks and institutions in order to optimize the impact of Center-supported scientific advances and activities. In a related vein, ARC/D-ARCs have the potential to assemble the evidence base critical to health policy decision-making pertaining to resource allocation, strategic priorities, and best practices. Those ARC/D-ARCs with an intervention science emphasis are also expected to advance the science of dissemination and implementation of evidence-based interventions that have the potential to lower HIV incidence and prevalence and improve health outcomes when delivered as part of full-scale programs. In these ways, ARC/D-ARCs are expected to serve as local, regional, national, and global resources for rigorous mental health and HIV/AIDS prevention science.

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

Research Environment

ARC program applicants are expected to be based in environments that provide sufficient institutional support and resources to ensure their success. Funded Centers must, in turn, create an environment that promotes the conduct of rigorous, hypothesis-driven, scientific research relevant to its key thematic areas. Evaluation plans that measure progress toward strengthening the research capacity of the home institution are strongly recommended, particularly for competing continuation applications. Evidence of such impacts may include broad dissemination of research products, citations by other published materials, or other indicators of scientific advancement. Achievements that would not have occurred without the Center support should be highlighted. Collaborations with community-based organizations (CBOs) should be included in descriptions of the research environment.

Center Director

The Center Director must be an internationally recognized scientist and an accomplished administrator capable of leading a complex, interdisciplinary organization to achieve its key aims and objectives. He or she must develop short- and long-term strategic objectives and offer detailed plans for how the Center will identify and respond to emerging priorities and initiatives. Directors have final responsibility for the scientific, administrative, and operational aspects of their Centers. 

It is expected that Center Directors will make a significant and sustained commitment of time and effort to the Center, based on the breadth and complexity of the Center's scientific program and the effort needed to administer it, and foster the development of senior staff to ensure that the Center is equipped to advance HIV research well into the future. Center and Core Directors are expected to devote a minimum of 30% and 20% effort to their roles, respectively.  Center Directors may be the PI for only one NIH Center grant.

Training

The ARC program offers a unique opportunity to advance the training, career development, and mentoring of new investigators with the potential to make key scientific contributions and to embark on independent research careers. The applicant institution must therefore demonstrate that it has the capacity to participate in training pre-doctoral and postdoctoral students for careers in HIV/AIDS and mental health research, and the capacity to provide career development and mentoring support to trainees.

Funds from the ARC program may not be used to pay stipends or other trainee costs; however, affiliated scientists are encouraged to participate in the development of training programs and Center resources may be made available for trainee use. 

Travel

Travel expenses for key personnel to attend annual NIMH AIDS Research Center Directors meetings in Washington DC should be budgeted. 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 an allowable expense.

Organization

Funded Centers are expected to be interdisciplinary, collaborative, and well-coordinated. Each Center will be comprised of Administrative and Developmental Cores, and at least one Research Core for D-ARCs and at least three Research Cores for ARCs.

D-ARCs are intended to facilitate the establishment of new Centers that will be competitive for ARC status as soon as possible. For cost containment purposes, D-ARC funding is for up to four years and is capped at $750,000 total cost per year. Together, key personnel for D-ARC applications must have a minimum of 3 active NIMH research project awards (R-series) and 1 additional NIH award at the time of application and over the project period of the award. Centers unable to maintain the minimum required number of awards may be phased out. D-ARC organizational structure must include one Administrative Core, one Developmental Core, and at least one Research Core. Renewal applications for D-ARCs are not permitted.

ARCs provide infrastructural support for world class HIV/AIDS and mental health research. For cost containment purposes, ARC funding is for five years and is capped at $1,750,000 total cost per year. Together, key personnel for ARC applications must have a minimum of 4 active NIMH research project awards (R-series) and 2 additional NIH awards at the time of application and over the project period of the award. Centers unable to maintain the minimum required number of awards may be phased out. ARC organizational structure must include one Administrative and one Developmental Core, and at least three Research Cores. Renewal applications for ARCs are permitted.

ARC applications must describe in detail each Core’s essential function and aims, relevance to the Center’s thematic areas, and added-value of research projects and other grants that would not have been awarded without Center support. Applications should include an evaluation plan for demonstrating progress toward stated aims using metrics such as number of awards and areas of expertise of affiliated faculty, number and impact of Center-supported publications, etc.

Applicants should describe clearly how interactions and collaborations of key personnel will enhance and expand the development and productivity of Center research efforts, and how other investigators will benefit from shared resources, formal and informal planning activities, and developmental or pilot support provided by the Center award.

Administrative Core

All Centers must have an Administrative Core that provides scientific direction and administrative leadership, performs key decision-making functions, develops and implements strategic plans, monitors and evaluates progress toward Center goals and objectives, and ensures efficient fiscal operations.

A strategic plan must be outlined that 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. All Center applications should identify the highest priority goals with a detailed plan of activities to meet those goals for each year of the award. 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 renewals is a description of successful achievements that would not have been realized without the Center award.

Mechanisms for internal review, decision-making, and priority-setting processes appropriate to planned activities must be defined. Appropriate criteria and review processes for evaluating affiliated investigators' ongoing participation in the Center should be established and include such factors as productivity, research direction, and overall contribution. The administrative structure must include an external advisory committee charged with providing objective advice and evaluation of Centers' strategic directions, research programs, community engagement, capacity building, and other key activities. A plan for meeting with the advisory committee should be outlined and a process for responding to its recommendations should be delineated. Information from this advisory committee meeting should become part of the annual progress report, including the date/s of the meeting; a brief, written report from the advisory committee; and the Center Director’s written responses to the advisory committee's recommendations, if any. Advisory Committee members should not be named in the application.

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, but only when clearly justified and allocable to this specific grant. 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 a documented shortage of space on campus.

Developmental Core

All Centers must include a Developmental Core that serves a range of Center functions, such as capacity building, providing internal peer review and support services, funding pilot or preliminary research, facilitating science generation, training in grant and manuscript writing, organizing seminars and conferences, and establishing new interdisciplinary collaborations that address emerging scientific priorities.

Developmental cores may use up to 10% of the annual P30 award to offer short-term funding support for preliminary studies that will inform the development of larger, peer-reviewed research applications that can compete successfully for NIH or other funding. These funds can only be used to support 1 – 2 year, formative or feasibility studies proposed by new or established investigators, including the research activities of newly recruited faculty.

A systematic approach for soliciting, reviewing, and selecting rigorous pilot studies should be described. All pilot projects must comply with applicable NIH policies and the evidence that proposed plans for protection of human subjects; inclusion of women, minorities, and children; and assurance of animal welfare must be submitted to the NIMH Program Official prior to study initiation.

Developmental Core Directors must also inform the NIH program official of all pending awards involving foreign sites and ensure that the necessary State Department Clearances are obtained prior to study initiation. Applicants should provide status updates for previously supported preliminary studies and report the percentage of studies that subsequently obtain support from the NIH or other funders.

Developmental Core Directors must have the appropriate scientific training, mentoring experience, organizational skills, and administrative qualifications appropriate to the position. The Developmental Core Director assumes responsibility for the scientific, administrative, and operational aspects of the Core.

Research Cores

D-ARCs must establish at least one Research Core and ARCs must establish at least three Research Cores that help to define the key thematic areas of scientific interest in HIV/AIDS and mental health. 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 should be 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.   

Research Core Directors must be recognized scientists and skilled administrators who are well qualified to lead the Core to achieve its goals and objectives. Each Core Director must be experienced in the relevant scientific area and assume responsibility for the scientific, administrative, and operational aspects of the 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 but should not fall below 20%.

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 in the Notice of Grant Award. Under these rules, the Center Director has flexibility to meet unexpected Center needs 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.

Evaluation Plan: 

Applicants must describe an overall evaluation plan to assess progress toward the Center goals and objectives. The plan should describe how the evaluation will be conducted and identify the principal measures, potential data sources, and timeline. The measures included should assess the administrative and scientific accomplishments, both yearly and overall, of the Center. Evaluation results should be included in each annual progress report and as part of the final report for the grant.

This section should be included within the 12-page limit of the Center Research Strategy. Applications submitted without an evaluation plan may be delayed in the review process or not reviewed.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal (ARCs may submit a renewal application. Renewals are not permitted for D-ARCs).
Resubmission

Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants may request up to $750,000 total costs, per year for a Developmental AIDS Research Center (D-ARC) or $1,750,000 total costs per year for an AIDS Research Centers (ARC). This budget cap can be exceeded only under special opportunities for supplements.  For further details, consult with the Scientific Contact under Section VII below.

Award Project Period

The total project period for a D-ARC may not exceed four years. An ARC may request a project period of up to five years.

The D-ARC is not renewable.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Any NIMH applicant with at least four active NIH grants and/or contracts who intends to seek a fifth award should contact NIMH staff for guidance, prior to applying (see http://www.nimh.nih.gov/research-funding/grants/nimh-policy-on-multiple-awards.shtml).

Institutions eligible under this FOA should have both ongoing funded research activity and a demonstrated need for support to take full advantage of their research potential. The existence of research activity is evidenced by the presence of ongoing HIV/AIDS and mental health research funded under PHS grants or equivalent sources of peer-reviewed support, and recent record of peer-reviewed scientific publications.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Christopher Gordon, Ph.D.
Division of AIDS Research
National Institute on Mental Health (NIMH)
6001 Executive Boulevard, Room 6106, MSC 9619
Bethesda, MD 20892-9619
Rockville, MD 20851 (for express/courier service)
Telephone: 301-443-6100
Email: cgordon1@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the appendix files 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
Rockville, MD 20852 (for express/courier service)

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

 The application should include the following components in the following order:

The following guidance should be followed in constructing the main Sections of the Research Plan:

Center Overview (not to exceed 12 pages combined with the Center Research Strategy; an additional 1-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.

Applicants must ensure that their applications are appropriate for  the research goals of NIMH and to the essential organizational and administrative characteristics of a NIMH Center.

Applicants must describe an overall evaluation plan to assess progress toward the Center goals and objectives. The plan should describe how the evaluation will be conducted and identify the principal measures, potential data sources, and timeline. The measures included should assess the administrative and scientific accomplishments, both yearly and overall, of the Center. Evaluation results should be included in each annual progress report and as part of the final report for the grant.

Center Research Strategy (not to exceed 12 pages combined with the Overview; an additional 1-page Introduction is allowed for resubmission applications to address the prior summary statement)

The overall research strategy 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 applications (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 applications 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.

As stated previously, an evaluation plan should be included within the 12-page limit of the Research Strategy. Applications submitted without an evaluation plan may be delayed in the review process or not reviewed.

Core Description and Plans (not to exceed 6 pages for each Core; an additional 1-page introduction is allowed for each Core in revision 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 for Revision Applications (formerly Competing Supplements) for Cores ONLY (not to exceed 6 pages for each Core)

Revision applications may include a 1-page introduction to respond to prior critiques. A research plan should be included for applications proposing new or amended research Cores, and a rationale provided if Cores are substantially different from those proposed previously. Introductions for revision applications should justify any changes in Cores' structures or foci. The Research Strategy section may not exceed 6 pages.

Publications:

Other:

Format of Appendix Materials:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review , NIH. Applications that are incomplete will not be reviewed.

Human Subjects Protections

Written NIMH prior approval must be obtained before the start of any subproject or pilot project (either new or with delayed onset) involving human subjects or vertebrate animals. The purpose of this policy is to ensure that there is no change in scope or aims or deviation from the award terms and conditions, and that applicable requirements have been met. All subprojects and pilot projects must have first undergone an internal institutional scientific review that should include an evaluation of human subjects protections, and should have been approved for submission to NIMH. Human subject’s information should be provided in the Center application in accordance with the Research Plan, Section E on Human Subjects in the PHS Form 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html). Vertebrate animal information should be provided in accordance with the five items described under Section F of the PHS Form 398.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the center director and other senior investigators at the forefront of their respective fields? Have they devoted sufficient time to the center research and to mentoring activities, particularly for underserved ethnic or racial minority investigators? Do they have the experience and authority necessary to organize, administer and direct the center? If a partnership with community organizations is proposed, have the applicants developed a plan that will draw community stakeholders to work with them in this center and promote their sustained involvement?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Do the aims of the center grow from the current state of science and from a clear and convincing theoretical or conceptual model? Do the projects challenge existing paradigms; address innovative hypotheses or critical barriers to progress in the field?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is there adequate rationale to support the importance of a center, as opposed to other mechanisms (e.g., individual R01 applications)? Does a conceptual and theoretical framework focused on a significant public-health topic inform the center organization and research focus? If a narrow center focus is chosen, is it adequately justified based on the state of science and are the outcomes sufficiently broad to make significant advances in science? Is the concept of a center articulated, including: (1) an integrated theme bringing together a multidisciplinary team of investigators in a common mission, (2) development of a pooled, Core database that can yield results beyond that accomplished with individual projects alone, (3) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise, (4) a research mentorship component for new investigators through research training and career development mechanisms, and (5) a process for stimulation and evaluation of new pilot study proposals? Is the approach for the center adequately developed, well integrated, and appropriate to the general aims of the center? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are collaborations across sites well justified and reasonable to carry out the research activities? Is the evaluation plan well-defined, including (1) specific and feasible measures of progress, (2) adequate and available data sources, and (3) a timeline with major milestones in the evaluation? Is the evaluation plan adequate for assessing the effectiveness of the Center in achieving its goals and objectives, both yearly and overall?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Does the center draw on the strengths of the institution? Are convincing letters of support and collaboration included? Is there evidence of institutional support? Are the collaborating sites chosen for the center the appropriate ones to address the research questions proposed?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

 Core-Specific Review Criteria

In addition to the general criteria described above, there are specific review questions to be addressed within the Approach of each individual Core:

Administrative Core
Developmental Core
Research Cores

Is the time commitment of the Core Director adequate based on the breadth and complexity of the Core and the effort needed to administer it?

Coordination and Cohesiveness

For the center as a whole, is the coordination among the operations and research Cores adequately explained? Is the usefulness of the research Cores and pilot studies magnified by their inclusion in a center? Is there synergistic potential among Centers research components? Is there justification for each research Core and pilot/developmental studies in terms of the central theme and the overall research goals of the center? Does the center have the potential to achieve a whole greater than the sum of its parts? Are the plans for interactions with participating institutions and organizations adequately explained? Are the management plans and arrangements feasible? Are the plans and mechanisms to evaluate the centers progress explained?

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIMH (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Councill. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.     

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Dianne Rausch, PhD
Acting Director, Division of AIDS Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6218, MSC 9616
Rockville, MD 20852-9616
Telephone:  (301) 443-7281
FAX:  (301)443-9719
Email:  drausch@mail.nih.gov

Peer Review Contact(s)

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: armstrd@mail.nih.gov.

Financial/Grants Management Contact(s)

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

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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