NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the 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

Purpose

The National Institute of Mental Health invites applications to address implementation questions facing World Bank designated low- and middle-income countries (LMICs) in their efforts to scale up sustainable, evidence-based mental health interventions and thereby eliminate the mental health treatment gap for children, women, and men. The mental health treatment gap refers to the proportion of persons who need, but do not receive, care. In this funding opportunity announcement (FOA), the terms "scale up" and "going to scale" refer to intentional efforts to maximize the positive impact of mental health interventions successfully tested in experimental studies in order to benefit mental health care at the national level or at a regional level within a country, and to foster evidence-based mental health policy and program development on a lasting basis. Each awarded project is to integrate implementation research on scaling up sustainable, evidence-based mental health interventions (e.g., psychotherapeutic interventions, psychotropic medications, prevention, treatment, rehabilitation) with research capacity-building activities within LMICs in any one of the following geographical regions: East Asia and the Pacific; Europe and Central Asia; Latin America and the Caribbean; Middle East and North Africa; South Asia; Sub-Saharan Africa. As a group, awardees of this FOA and RFA-MH-16-350 will constitute a global network for mental health implementation research in LMICs. The network will have capabilities for answering research questions about going to scale with mental health interventions, sustaining high-quality mental health care in resource-limited settings, and fostering evidence-based mental health policy and program development.

Sustainable scale up of evidence-based mental health interventions requires implementation research to gauge readiness, identify effective training models, monitor implementation and quality of mental health interventions over time, assess outcomes and costs, and refine the scale-up process, to name a few of the many important scale-up issues. Therefore, one goal of this FOA is to align proposed implementation research with LMICs' existing or imminent scale-up efforts, which are to have demonstrable public and/or private support. To ensure that the proposed research responds to local needs, interests, and capacities, it is to be designed, planned, and conducted in collaboration with LMIC government agencies, nongovernmental organizations, and health care institutions. The products of the proposed research are expected to provide LMICs with the knowledge, tools, and strategies needed to maximize the positive impact of mental health interventions at a national or regional level, to sustain delivery of evidence-based mental health care, and to foster evidence-based mental health policy and program development.

Scale-up efforts to make evidence-based mental health care equitably available at a national or regional level also require infrastructure and partnerships, especially collaborations among researchers, mental health service users, mental health service providers, and government agencies that will implement and sustain services. Therefore, a second goal of this FOA is to support research partnerships and activities in LMICs that will build and sustain capacity to (a) conduct implementation research, and (b) use science-based methods and information to develop mental health policies and programs, and thereby increase the evidence base for scaling up and sustaining the delivery of evidence-based mental health interventions in resource-limited settings. In order to respond to local needs, interests, and capacities, research capacity-building activities should be designed, planned, and conducted in collaboration with LMIC government agencies, non-governmental organizations, and health care institutions.

Background

The Grand Challenges in Global Mental Health initiative identified expanding access to effective mental health care as a major challenge worldwide. The World Health Organization's comprehensive Mental Health Action Plan 2013-2020 has set a goal for increasing service coverage for severe mental illnesses 20% by the year 2020. The mental health treatment gap (i.e., the proportion of persons who need, but do not receive, care) exists globally, and collateral issues in low-resource settings make closing the treatment gap especially challenging. More than 80% of the world's population lives in LMICs, and the burden of disease associated with mental illnesses in these countries is rising. Moreover, the gap between treatment need and the allocation of human, scientific, and fiscal resources for mental health care in LMICs is great. The median number of psychiatrists per 100,000 people is 0.05 in LMICs, compared to 8.6 in high-income countries. The need for rigorous mental health research is immense, and research activity in this area is disproportionately lower than for other areas of health. At the same time, financing for mental health is insufficient: on average, there is a 200-fold difference between investments in low-income and high-income countries. These situational factors require innovative solutions for scaling up evidence-based mental health care in LMICs.

Recent policy shifts and growing evidence of the efficacy, cost-effectiveness, and successful delivery of a range of treatments for mental illnesses in LMICs have set the stage for larger scale efforts to reduce the mental health treatment gap in these countries. Multiple randomized clinical trials involving multiple LMICs have demonstrated the effectiveness of various mental health interventions, including cognitive-behavioral, interpersonal, and cognitive processing therapies. The delivery of mental health services via task sharing (i.e., delivery of mental health services by providers with more abbreviated training under the supervision of specialists) has been shown to be acceptable, feasible, and effective in LMICs in Africa, Asia, and Latin America, where specialty mental health care is vastly under-resourced. Moreover, the use of lay health workers to provide mental health care to individuals with common mental illnesses appears to be both cost-effective and cost-saving. However, few of these innovations have been scaled up to benefit large populations or large geographic areas in LMICs. In attempting to remedy this, the WHO and, increasingly, LMICs themselves, are promoting policies to expand mental health care. Countries in Asia, Africa, and Latin America have responded to the WHO's challenge to expand mental health service coverage by developing or revising their mental health policies; others are following suit. Taken together, these evidence-based interventions, increasing awareness of need, and mounting political resolve have created fruitful contexts in which to ask and answer critical questions about how to scale up and sustain high-quality mental health interventions and how to foster and sustain evidence-based mental health policy and program development in low-resource settings around the globe.

The objective of this FOA is to stimulate and support research partnerships that will (a) conduct implementation research aligned with LMIC efforts to scale up sustainable, evidence-based mental health interventions and thereby close the mental health treatment gap, and (b) build and sustain capacity in LMICs to conduct implementation research and use science-based methods and information to develop mental health policies and programs.

To meet the research goal of supporting scale up of evidence-based mental health interventions, each application must address a locally-relevant aspect of scaling up at a national or regional level within a designated LMIC. Relevant research questions include, but are not limited to, the following:

• What data systems are most effective for monitoring the reach, accessibility, quality, costs, and effectiveness of mental health services in a given health system? How can implementation of these systems enable data-driven decision-making for optimal mental health service delivery?
• How can competency-based training, certification, and/or compensation be used to improve the quality of mental health services across a health system?
• What models of implementation and measures of quality and outcomes produce the best results for:
• System-wide scale up of training and supervision for mental health service providers (including non-specialist lay health workers)?
• Integration of screening for mental illnesses and core packages of care for mental illnesses into existing delivery platforms (e.g., primary health care, schools, HIV service delivery systems, etc.)?
• Delivery of transdiagnostic interventions for mental illnesses in health sector and non-health sector settings?
• What financing and implementation models are most effective for scaling up integrated care to treat comorbid mental illnesses and other chronic medical illnesses?
• How do local and national policies /guidelines designed to achieve equitable mental health care access, quality, and outcomes across population subgroups (e.g., women, poor, rural, racial/ethnic minorities) affect the scale up and outcomes of mental health services?
• How do costs and effectiveness of mental health service delivery in primary care settings differ with the deployment of mid-level specialists (e.g. psychiatric clinical officer) versus community health workers supported by non-specialist primary care providers (nurses or generic clinical officers)?

NIMH encourages scale-up and research activities that build on the demonstrated successes of other service delivery systems/platforms in LMICs (e.g., HIV care and treatment, maternal and child health care, education) and use these platforms for scaling up mental health services. Note, however, that research on the scale up of mental health services exclusively for HIV+ populations is discouraged. NIMH also encourages the use and enhancement of existing, sustainable data bases, where possible, in answering study questions.

To meet the goal of building and sustaining capacity to conduct implementation research and using science-based methods and information to develop mental health policies and programs, each application must involve two or more LMICs in capacity-building endeavors - to include the lead LMIC (where the implementation research is to be carried out) and one or more additional countries in the region. NIMH encourages the use of existing LMIC systems, platforms, or data bases, where possible, for building LMIC capacity to conduct implementation research and to foster evidence-based mental health policy and program development.

Regions: Research and research capacity building must be conducted in World Bank or World Health Organization designated LMICs in one of the following geographic regions:

• East Asia and the Pacific
• Europe and Central Asia
• Latin America and the Caribbean
• Middle East and North Africa
• South Asia
• Sub-Saharan Africa

Applications should include all of the five elements below:

• Propose a research partnership to conduct research and capacity-building activities that includes representatives from one or more academic institutions, government agencies, and non-governmental agencies.
• Propose implementation research on scaling up sustainable, evidence-based mental health interventions (e.g., psychotherapeutic interventions, psychotropic medications, prevention, treatment, rehabilitation) within one or more LMICs.
• Provide evidence that (a) the proposed implementation research is aligned with the designated LMIC's scale-up efforts, and (b) there is adequate funding and other material public and/or private support to ensure that the designated LMIC's scale-up efforts will proceed or continue to proceed as planned.
• Propose a plan for building capacity in two or more LMICs, including the lead LMIC in which the implementation research is to take place, and one or more additional countries in order to (a) conduct implementation research and (b) use science-based methods and information to develop mental health policies and programs.
• Provide evidence that the proposed research and capacity-building activities are responsive to local needs, interests, and capacities.

Applications should not:

• Propose research to be conducted primarily in and/or by United States or other high income country institutions.
• Propose research on the scale up of mental health services exclusively for HIV+ populations.

NIMH will hold two pre-application teleconferences to which all prospective applicants are invited. The first teleconference will be held on May 17, 2016 from 9:00 a.m.-11:00 a.m. (ET) for investigators who are interested in information about the topics of interest or programmatic requirements of the FOA. The second teleconference will be held on May 24, 2016 from 9:00 a.m.-11:00 a.m. (EST) for investigators interested in a technical overview of using ASSIST (Application Submission System & Interface for Submission Tracking) for the preparation and submission of their application. Participating in the teleconferences is neither required nor necessary for a successful application. The teleconferences are intended to be an opportunity to clarify questions that prospective applicants may have about the FOA objectives (first teleconference) and the technicalities of submitting an application online using ASSIST (second teleconference). Potential applicants are encouraged to submit their questions or comments to ORDGMH@mail.nih.gov in advance of both calls. Applicants interested in participating in the technical assistance calls should email ORDGMH@mail.nih.gov to obtain a dial-in number. A set of questions and answers related to this FOA will be posted after the pre-application teleconferences.

See Section VIII. Other Information for award authorities and regulations.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

nimhreferral@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core (use for Administrative Core)	6
Scale Up Component (use for Scale Up Study Component)	12
Capacity Building	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; maximum of 1
• Scale Up Study Component: required; maximum of 1
• Capacity-building Component: required; maximum of 1

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Provide a concise description of the overall project aims, including the research partnership that will (a) conduct implementation research on scaling up evidence-based mental health interventions in order to help close the mental health treatment gap in a designated LMIC, and (b) build and sustain local/regional capacity in two or more designated LMICs (including the lead LMIC where the research is to take place) to conduct implementation research and to use science-based methods and information to develop mental health policies and programs.

Research Strategy: This section summarizes the overall multi-component application. The multi-component application should be viewed as a confederation of interrelated components, each capable of standing on its own merit, but complementary to one another. This is an important section for describing the conceptual wholeness of the overall project by giving a statement of the general problem area and by laying out a broad strategy for addressing the problem. As the strategy develops, each component (i.e., Administrative Core, Scale-Up Study, and Capacity Building) should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique. Include a synopsis of plans to establish or enhance and maintain a research partnership designed to (a) conduct a study that aligns with the designated LMIC's scale-up efforts at the national or regional level, and (b) build and sustain capacity to conduct implementation research and use science-based methods and information to develop mental health policies and programs.

At a minimum, the partnership must include all three of the following types of organizations:

• One or more research institutions, defined as:
• For-profit or non-profit organization
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State and local governments
• Eligible agencies of the Federal government
• Domestic or foreign institutions/organizations
• Faith-based or Community-based organizations
• One or more individuals of the lead LMIC's Ministry of Health (or other government agency with a substantial health-related function, e.g., Ministry of Social Welfare; Department of Health; Ministry of Health and Family Welfare; Ministry of Health, Labor, and Welfare; Ministry of Public Health, Secretariat of Health; Ministry of Social Affairs, Public Health, and the Environment). The government representative(s) must have a policymaking, evaluation, or research role within the agency.
• One or more LMIC non-governmental organizations that provide access to service user and service provider viewpoints.

Discuss how the project governance structure and processes will address logistical challenges for a successful research partnership and for conducting implementation research and research capacity-building activities.

Significance: Describe the significance of the overall project for reducing the mental health treatment gap. Describe how the significance of individual components (i.e., Administrative Core, Scale-Up Study, Capacity Building) is enhanced by their integration into a single program.

Innovation: Highlight how the research partnership and components address key challenges of scaling up evidence-based mental health interventions in low-resource settings. Describe the unique advantages, capabilities, and synergies the partnership will provide beyond what could be achieved through a traditional research project.

Approach: Include the following information to demonstrate the feasibility and appropriateness of the proposed research partnership:

• Description of existing or imminent policies and activities to scale up evidence-based mental health interventions within the designated LMIC, including the numbers of individuals and/or geographic region(s) to be involved in the scale-up effort; the national or regional entities involved; funding commitments; and timeline for implementation.
• Evidence of adequate funding and other material public and/or private support to ensure that the LMIC's existing or imminent scale-up efforts will proceed or continue to proceed as planned.
• Evidence of an on-site administrative structure in the designated LMIC or region, along with scientific and outreach capacity to perform the proposed research and the research partnership and capacity-building activities at time of award.

Letters of Support: Note that letters detailing resource contributions are to be placed under

their respective individual components.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Administrative Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

The Administrative Core Lead must commit a minimum effort of 3 calendar months per year overall to the program conducting research and related activities specified in the application on site where the research is based. In the case of multiple PDs/PIs, one must be the Administrative Core Lead, and the combined fulltime professional effort for all overall PDs/PIs together must equal a minimum of 3 person months (25% of full-time professional effort).

Start Up Meeting: In the first year of the award, proposed budgets in the Administrative Core must include funds for travel by the PD(s)/PI(s) and two additional Key Personnel (e.g., Component Leaders) to participate in a start-up meeting at a non-US location in a LMIC of one of the awardee projects, to be determined by NIMH staff.

Annual Meetings: Two annual meetings will take place throughout the duration of the award period.

An annual Scale-up Hubs meeting will take place in a LMIC of one of the awardees each year on a rotating basis. Each awardee should plan to host up to two annual Scale-up Hubs meetings and to attend all other annual Scale-up Hubs meetings during the life of the award. Annual Scale-up Hubs meetings will involve 3 representatives from each awardee project (i.e., the PD(s)/PI(s) and two additional Key Personnel), selected experts, and appropriate NIMH staff. These meetings are intended to identify areas of collaboration among awardees. The focus of the Scale-up Hubs meetings will include determining how the expertise, facilities, and other resources of the awarded projects can contribute to ongoing or new projects; sharing of data; and identifying opportunities for research involving participating projects. Investigators will also be expected to present their scientific progress and future plans. For planning purposes, applicants should request funds to host two annual Scale-up Hubs meetings and to attend this meeting in the other 3 years. At the time of award, budgets may be reduced to reflect the number of awardee sites and the funds needed to host annual Scale-up Hubs meetings.

NIMH hosts an annual Global Mental Health workshop in collaboration with Grand Challenges Canada. The Global Mental Health workshop is held in Washington, DC, or in a city in Canada, on a rotating basis. The 2017 meeting will be held in Canada. Each awardee (i.e., all PIs at a minimum) should plan to attend the annual Global Mental Health workshop during the life of the award. For planning purposes, applicants should request funds to attend this workshop for all years of the award.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Provide a concise description of Administrative Core aims.

Research Strategy: The Administrative Core is responsible for the overall administration, coordination, and management of all activities, including fiscal accountability, communication and coordination among program components, problem identification and resolution, establishment of a strong collaborative environment, monitoring of progress, effective implementation, and meeting project milestones. This section should include a discussion of the structure of the Administrative Core, roles of administrative staff within the Core, lines of authority within the Core, and how the project will ensure effective and timely communications among program components and with NIMH staff. The Administrative Core's organizational and administrative structure should facilitate collaboration and interaction among the service provider organizations, the Ministry of Health or other health-related government agency, and the project team.

Significance: Describe how the Administrative Core will contribute to the goals of the overall project.

Innovation: Highlight novel features of the Administrative Core that will enhance the partnership effort, including optimizing communication, decision-making and sharing among the administrative, scientific, and capacity-building team members.

Approach: Describe how fiscal and other resources will be prioritized, allocated, and managed. Indicate the facilities, resources, services, and professional skills that the Core will provide and how the Core will be coordinated in a coherent manner. Describe how the Scale-Up Study and the Capacity-Building components will draw upon the Administrative Core and how it in turn will address component needs. Describe how Core activities will facilitate communications among partner organizations and individuals, research rigor, transparency of reporting, research capacity building, and dissemination of findings.

A Timeline and Milestones section must be included for the Administrative Core, describing the expected progression of activities and milestones specific to the Administrative Core. The milestones should be regarded as criteria for evaluating the progress and direction of the Administrative Core and should not be just a restatement of the specific aims. During the project period, the applicant will be expected to refer to these milestones in annual progress reports. Milestones must specify the outcome(s) for each activity and should be presented via a Gantt chart or equivalent. Applicants should include plans for periodically revisiting and revising the timeline and milestones, if needed, as new information becomes available, challenges are encountered, and research outside the Project goals modifies the science proposed. The timeline and milestones should be placed at the end of the Research Strategy for the Administrative Core and fall within the page limitations for the section.

Include the following information to demonstrate the feasibility and appropriateness of the proposed research partnership:

• Evidence of an existing partnership or plans for establishing and maintaining such a partnership for the duration of the award. Describe major tasks each partner organization will complete, and the benefits each brings to this alliance to enhance prospects for completing project aims. Include evidence that partners and the partnership as a whole will have facilities and resources necessary for achieving their goals.
• Plans to ensure that partner organizations collaborate on the proposed goals in ways that will enable the entire enterprise to proceed in a unified manner. Each partner organization should have sufficient scientific involvement, and at least one participant with qualifications to lead and/or share authority and responsibility for the overall effort, including authority to allocate resources to ensure successful completion of tasks.
• A plan to foster and ensure effective communication among partner organizations (e.g., scheduling meetings, notifying partners, documenting and disseminating meeting proceedings, etc.). Include plans for acknowledging and respecting partners' contributions, including publications.
• A description of the steps that will be taken to ensure successful completion of the scale-up study should a key member leave the partnership.
• A statement that awardees will agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Letters of Support: Include individual letters of commitment to the partnership and agreement to the stated communication plan (described in the Research Strategy) by all partner organizations. Include letters of resource support specific to the Administrative Core, including support from the applicant institution and partner organizations that will enhance the potential for overall project success. Examples of such support would include, but are not limited to: institution-funded staff time and effort; donated equipment and space; free and open access to tools, databases, workflow processes; logistical resources; or other resource investments. Include specific descriptions of these contributions plus assurances that the partner organizations are committed to providing these resources to the project. Include individual letters of commitment to the partnership specific to the Administrative Core by all other partners and consultants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Scale Up Component.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scale-Up Study Component)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scale-Up Study Component)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scale- Up Study Component)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? Note that providers are considered to be human subjects if they are the focus of an intervention and/or if data are gathered from them.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Scale- Up Study Component)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scale-Up Study Component)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Scale-Up Study Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scale-Up Study Component)

Budget forms appropriate for the specific component will be included in the application package.

Applicants should budget appropriately to comply with data sharing described in the Resource Sharing Plan instructions.

While this FOA strongly encourages applicant and partner organizations to contribute resources to this effort, such resources should be detailed in the Letters of Support section for this component and not be part of the Budget or Budget Justification.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Scale-Up Study Component)

Specific Aims: Provide a concise description of the aims for the Scale-Up Study.

Research Strategy: This important section describes the implementation research component. The focus and design of the Scale-Up Study should reflect the viewpoints of multiple LMIC stakeholders (i.e., investigators, service users, service providers, policymakers), thereby maximizing the study's potential public health impact and policy relevance for the designated LMIC. Accordingly, this section should describe the designated LMIC's effort to scale up evidence-based mental health interventions at the national or regional level, the funding and other commitments in place to ensure that the scale-up effort will proceed or continue to proceed as planned, the knowledge gap that the LMIC partners have identified as impeding their scale-up effort, and how the Scale-Up Study will fill that gap. The geographic region and population to be studied should be justified in terms of potential for substantially closing or eliminating the treatment gap in the designated LMIC.

Be sure to highlight scale-up and research activities that (a) build on the demonstrated successes of other service delivery systems/platforms in the LMIC; (b) use and enhance existing research infrastructure in the LMIC or region, where possible, in the proposed project; and (c) use and enhance existing, sustainable data bases, where possible, in answering study questions.

Significance: Describe the potential effect of the designated LMIC's scale-up effort for reducing the mental health treatment gap, the knowledge gap that the LMIC partners have identified as a substantial obstacle to their scale-up effort, and how the Scale-Up Study will fill that knowledge gap. Describe the potential for the proposed study to inform future attempts to scale up and improve mental health care and policy in other LMICs.

Innovation: Highlight any novel features of the Scale-up Study that relate to the FOA goals to stimulate and conduct implementation research to close the mental health treatment gap, and to build and sustain capacity to conduct implementation research and use science-based methods and information to develop mental health policies and programs. Describe the unique advantages and capabilities that the partnership will provide to the Scale-Up Study, such as shaping the study design to local needs, resources, and expertise, and how this synergizes beyond what could be achieved through a traditional research study.

Approach: Describe the proposed study design and method, the study's feasibility, the advantages of any innovative methods, the potential pitfalls, and alternative approaches. Illustrate how the study addresses the needs for rapid scale up of evidence-based mental health interventions in resource-poor settings. Describe how the study design will inform understanding of key mediators/mechanisms of action of the scale-up effort and/or the interventions being scaled up. Describe any features of the study design that will permit other LMICs to use data, methods, procedures, or results generated by this study in their own scale-up efforts.

A Timeline and Milestones section must be included for the Scale-Up Study, describing the expected progression of activities and milestones specific to the Scale-Up Study. The milestones should be regarded as criteria for evaluating the progress and direction of the Scale-Up Study and should not be just a restatement of the specific aims. During the project period, the applicant will be expected to refer to these milestones in annual progress reports. Milestones must specify the outcome(s) for each activity and should be presented via a Gantt chart or equivalent. Applicants should include plans for periodically revisiting and revising the timeline and milestones, if needed, as new information becomes available, challenges are encountered, and research outside the Project goals modifies the science proposed. The timeline and milestones should be placed at the end of the Research Strategy for the Scale-Up Study and fall within the page limitations for the section.

Letters of Support: Include letters of resource support specific to the Scale-Up Study, including support provided by the applicant institution and partner organizations and which will enhance the potential for success. Examples of such support would include (but are not limited to): institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as assurances that the partner organizations are committed to providing these resources to the Scale-Up Study, should be included in this section. Also include individual letters of commitment to the partnership specific to the Scale-Up Study by all other partners and consultants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Scale Up Study Component)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Capacity Building.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Capacity Building)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Capacity Building)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Capacity Building)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Capacity Building)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Capacity Building)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Capacity Building Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

Budget (Capacity Building)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Capacity Building)

Specific Aims: The Capacity-Building component is to build sustainable capacity to conduct and apply mental health research in two or more LMICs, including the designated, or lead, LMIC where the Scale-Up Study is to be conducted. Provide a concise description of the aims for building sustainable capacity to (a) conduct mental health care implementation research, and (b) use science-based methods and information for developing mental health policies and programs.

Research Strategy: One goal of this FOA is to establish resources and infrastructure that will benefit the lead LMIC plus one or more regional LMIC partners in conducting and using/applying mental health research. Applications should propose partnerships among investigators, service users, service providers, and policymakers for building regional capacity to (a) conduct implementation research involving mental health care, and (b) use science-based methods for developing mental health policies and programs. Applicants must articulate a plan for outreach, engagement, and collaboration amongst partners. Given that different LMICs may have different levels of research capacity, readiness for research participation, and willingness among policy makers to apply research in policy and program development, an application's capacity-building component should clearly describe a principled approach to engagement and subsequent activities relevant to the participating LMICs.

Be sure to highlight the use of existing LMIC systems, platforms, or data bases, where possible, for building capacity to conduct implementation research and to foster evidence-based mental health policy and program development.

Significance: Describe the role of the Capacity-Building component in achieving the overall long-term aim of closing the mental health treatment gap through development of regional capacity to conduct mental health care implementation research and to use science-based procedures and information in developing mental health programs and policies.

Innovation: Highlight any novel features of the Capacity-Building component for building regional capacity to conduct mental health care implementation research or fostering the use of research for developing mental health policies and programs.

Approach: The research Capacity-Building component is intended to (a) enhance the skills of LMIC researchers for conducting mental health implementation research, and (b) enhance LMIC policymakers' skill in using science to inform policy and program development. Applicants should describe the feasibility of the proposed Capacity-Building activities to achieve these ends, the advantages of any innovative features, and the potential pitfalls and alternative approaches.

Applicants are encouraged to develop innovative models for enhancing the skills of researchers and technical personnel to conduct implementation research in mental health. Activities may include but are not limited to implementation research methods seminars, webinars, or short courses in implementation research; research-practice communities focused on implementation science; distance-learning courses in implementation research methods; etc. Applicants are also encouraged to develop innovative models for enhancing the skills of LMIC policymakers and technical personnel in using science-based methods and information to develop mental health policies and programs. Activities may include but are not limited to seminars or webinars on evidence-based mental health policy and program development; short courses in the application of research in developing mental health policies and programs; research-policy communities focused on closing the mental health treatment gap; distance-learning courses in research interpretation and use for policy and program development; etc.

In summary, applications should propose educational activities for (a) researchers and technical personnel who wish to enhance their implementation research skills in the area of mental health care; and (b) policymakers or technical personnel in governmental or non-governmental organizations who wish to become informed consumers of research and facile in applying scientific evidence in developing policies and programs aimed at closing the mental health treatment gap. Funds may not be used to support formal training or an academic degree program.

A Timeline and Milestones section must be included for the Capacity-Building component, describing the expected progression of activities and milestones specific to the Capacity-Building component. The milestones should be regarded as criteria for evaluating the progress and direction of the Capacity-Building component and should not be just a restatement of the specific aims. During the project period, the applicant will be expected to refer to these milestones in annual progress reports. Milestones must specify the outcome(s) for each activity and should be presented via a Gantt chart or equivalent. Applicants should include plans for periodically revisiting and revising the timeline and milestones, if needed, as new information becomes available, challenges are encountered, and research outside the project goals modifies the science proposed. The timeline and milestones should be placed at the end of the Research Strategy for the Capacity-Building component and fall within the page limitations for the section.

Letters of Support: Include letters of resource support specific to the Capacity-Building component, including support provided by the applicant institution and partner organizations and which will enhance the potential for success. Examples of such support would include (but are not limited to): institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as assurances that the partner organizations are committed to providing these resources to the project, should be included in this section. Also include individual letters of commitment to the partnership specific to the Capacity-Building component by all other partners and consultants.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Capacity Building)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the NIMH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the grant-funded program 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 research and capacity-building activities proposed).

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 program that by its nature is not innovative may be essential to advance a field.

Does the proposed program of research and capacity-building activities address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the program 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? Are the results of the proposed program (i.e., research and capacity building) likely to inform future attempts to scale up and improve mental health care and policy in other LMICs? Is the program focused on (a) conducting implementation research that increases the evidence base for scaling up mental health interventions, and (b) building capacity in LMICs to conduct implementation research and apply research to developing mental health policies and programs? Are the program goals important in the geographic region in which the Scale-Up Study and Capacity-Building component will take place? Will the Scale-Up Study and Capacity-Building component involve collaboration with appropriate LMIC government agencies and nongovernmental organizations? Are there coordination and synergy of the Scale-Up Study, Capacity-Building component, and Administrative Core towards the achievement of the overall program aims?

Are the PD(s)/PI(s), 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? Does the PD/PI have experience leading a multidisciplinary team and demonstrate the ability to manage administrative functions in the LMICs in which the research and capacity-building activities will take place? Is there substantial and appropriate integration of partner investigators into the research and capacity-building plans? Do the investigators commit adequate effort to successfully fulfill the program needs? Does the research team include a representative from the appropriate government agency that can ensure uptake of research findings and ensure public health relevance for that setting?

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? Are innovative models proposed for (a) enhancing the skills of researchers and technical personnel to conduct implementation research in mental health, and (b) enhancing the skills of LMIC policymakers and technical personnel in using science-based methods and information to develop mental health policies and programs?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the program involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the applicant's overall approaches to overcoming obstacles and limitations sound and feasible?

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? Are the sites and/or facilities where the Scale-Up Study and Capacity-Building component will be conducted appropriate for the proposed activities? Is there a process to identify, evaluate the capabilities of, and add new sites based on the emerging needs within the geographic region?

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 score, but will not give separate scores for these items.

Administrative Core

Is the administrative and organizational structure of the Administrative Core appropriate and adequate?

Are management plans for fiscal accountability, communication and coordination among program components, problem identification and resolution, and the establishment of a strong collaborative environment appropriate and adequate?

Are the proposed resources for the Administrative Core adequate and justified?

Are the qualifications, competence, experience, level of commitment, and availability of the Administrative Core Lead and administrative staff adequate? Does the Administrative Core Lead have the capabilities and demonstrated expertise to support the research and research capacity-building activities proposed?

Is the proposed timeline for the Administrative Core tasks and milestones appropriate and feasible?

Are the overarching project milestones applicable to the overall program, feasible within the proposed timeframes, and integrated with the milestones for the Administrative Core, Scale-Up Study, and Capacity-Building component? Do the milestones present quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?

Scale-Up Study

Is the Scale-Up Study designed to facilitate existing efforts within the designated LMIC to scale up science-based mental health interventions?

Is there evidence of public and/or private support for the designated LMIC's scale-up efforts?

Are the scientific questions to be answered by the proposed Scale-Up Study relevant and important to the lead LMIC where the research will be conducted? To other partner LMICs? Will the research findings inform the public health system or mental health policy of the lead LMIC and regional LMIC partners?

Will the study inform understanding of key mediators/mechanisms of action of the scale-up effort and/or the interventions being scaled up?

Will the Scale-Up Study substantially involve LMIC researchers in study design, development, implementation, and interpretation, with the goal of engaging local and regional expertise?

Are the proposed resources for the Scale-Up Study adequate and justified?

Are the qualifications, competence, experience, level of commitment, and availability of the Scale-Up Study Lead and research staff adequate? Does the Scale-Up Study Lead have the capabilities and demonstrated expertise to guide the research activities proposed?

Do plans for the Scale-Up Study propose adequate methodological expertise and data management support?

Is the proposed timeline for the Scale-Up Study tasks and milestones appropriate and feasible?

Capacity Building

Does the Capacity-Building component involve compelling opportunities for building capacity (a) to conduct implementation research on scaling up mental health interventions in resource-poor settings, and (b) to apply science-based methods and information in developing mental health policies and programs?

Are the proposed capacity-building activities relevant and important to the LMICs where they will be conducted? How will the Capacity-Building component enhance the public health system or mental health policy of the lead LMIC and regional LMIC partner(s)?

Are the proposed resources for the Capacity-Building component adequate and justified?

Are the qualifications, competence, experience, level of commitment, and availability of the Capacity-Building Lead and other staff adequate? Does the Capacity-Building Lead have the capabilities and demonstrated expertise to guide the capacity-building activities proposed?

Is the proposed timeline for the Capacity-Building tasks and milestones appropriate and feasible?

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

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 score.

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

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Use and enhancement of existing LMIC research infrastructure, where possible, in conducting the proposed research
• Use and enhancement of existing LMIC data, where possible, to answer the study questions
• Leveraging of existing LMIC systems, platforms, and data bases in building capacity to conduct mental health care implementation research and foster evidence-based mental health policy and program development.
• Global balance of all funded grants under this initiative.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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’s 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The overall program PD(s)/PI(s) will have the primary responsibility for the performance of all

U19 supported research activities, including the following:

• Defining the research objectives, approaches, and details of the project components and core within the guidelines of the FOA
• Planning, directing, and executing the proposed research and capacity-building activities;
• Assuring compliance with applicable Federal, State, Local regulations;
• Assuring compliance with all applicable DHHS/NIH/NIMH policies for conduct of research and clinical trials.
• Performing the duties of organizer and host of up to two annual meetings of all awardees under this initiative and NIMH staff.
• Participating in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIMH staff in accordance with the guidelines described here.
• Complying with Federal, State, and Local regulations regarding clinical research and monitoring of clinical trials, and oversee that all training requirements for the protection of human subjects are in compliance. All clinical research performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.
• Ensuring that the on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant.
• Ensuring that research and research capacity building activities conducted under this cooperative policy research to increase the research base for scaling up evidence-based mental health interventions in LMICs. The overall PD(s)/PI(s) will provide a process for assessing ongoing research and research capacity building projects and modifying, redirecting, and/or curtailing ongoing activities to reflect local changes/shifts based on emerging needs or changing conditions in the region.
• Being responsible for timely submission of all abstracts, manuscripts and reviews (co)authored by the program team and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to the NIH Program Official within two weeks of acceptance for publication and must comply with the NIH Public Access Policy (see http://publicaccess.nih.gov/). Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIMH support. Timely publication of major findings is encouraged.
• Retaining custody of and primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff members will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A NIMH Project Scientist will facilitate - not direct - project activities. It is anticipated that the NIMH Project Scientist will offer advisory input, facilitate liaison activities for partnerships, and provide assistance with access to NIH-supported resources and services. Other appropriate NIMH Program staff assistance will be coordinated by the NIMH Project Scientist, which may include Medical Officer(s), clinical operations and regulatory staff, and other expertise as required. The NIMH Project Scientist, with support of the appropriate staff and expertise, may provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct. The NIMH Project Scientist with substantial programmatic involvement may:

• Provide guidance and support in the design of research activities
• Serve as a resource for protocol design and development
• Advise in the selection of sources or resources
• Advise in management and technical performance
• Participate in scheduled meetings and teleconferences to discuss program coordination and/or progress
• Coordinate and facilitate interactions among the awardees under this initiative
• Participate as a voting member in Steering Committee meetings of the network of Projects
• Facilitate collaboration with other NIMH-supported research resources
• Assist in avoiding unwarranted duplication of effort with other NIH efforts
• Provide technical assistance and advice to the awardees as appropriate

In addition, an NIMH Program Official will be responsible for the scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility Include:

A Steering Committee will serve as the governing board for awardees. All awardees under this initiative program are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the Steering Committee.

Membership in the Steering Committee will include the PD(s)/PI(s) of each U19 award, or a designated representative in the case of Multiple PD/PI award. Each member will have one vote.

The NIMH Project Scientist will be a voting member of the Steering Committee.

The chair will be chosen by a majority vote of the Steering Committee, with years of service as chair determined by the committee. The chair is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to Steering Committee members within 30 days of the meeting. Virtual meetings are appropriate. The NIMH Project Scientist may not serve as the Chair of the Steering Committee.

Steering Committee responsibilities will include coordinating research resource sharing among awardees (e.g., measures, consultations with staff across projects).

The Steering Committee Chair will arrange regularly scheduled Steering Committee meetings via teleconferences, and annual Steering Committee meetings in conjunction with the annual project meeting.

The annual meeting is a forum for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations. Meeting participants will identify the group's tangible resources, capabilities, and needs to advance the initiative's overall goals. The PD/PI of each U19 grant (or a designated representative for multiple PD/PI awards) is required to make an oral presentation on current and planned activities and projects at each annual meeting. Each awardee will be responsible for hosting at least two annual workshops during the life of the grant.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Ishmael Amarreh, Ph.D., M.P.A.
National Institute of Mental Health (NIMH)
Telephone: 301-451-5132
Email:ish.amarreh@nih.gov

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstada@mail.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email:tkees@mail.nih.gov

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.

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 Part 75.