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

This Funding Opportunity Announcement (FOA) encourages applications to establish Collaborative Hubs to conduct research focused on reducing the burden of suicide and promoting resilience among American Indian and Alaska Native (AI/AN) youth. This program aims to establish three collaborative research hubs to increase the reach and research base for effective, culturally relevant, preventive interventions that will increase resilience and reduce suicide in tribal communities. The goal of this program is to develop and test preventive strategies that could sustainably reduce the burden of youth suicide in AI/AN communities. Since each community has different strengths and challenges, cultural practices, and approaches, strong community and tribal partnerships will be essential to meeting this goal.

Native youth suffer disproportionately from suicide. From 2009-2012, the age-adjusted suicide rate for AI/AN youth ages 10-24 was 14.66/100,000, which is significantly higher than the overall suicide rate for that U.S. age group (e.g. 8.25/100,000). Male Alaska Native youth ages 10-24, in particular, suffer from the highest rate of suicide of all demographic groups, 109/100,000 (2009-2012). However, not all AI/AN communities experience the same challenges with suicide. Rates can vary considerably among communities, even within the same region. While the causes for this variation are poorly understood, suggested explanations for resilience in certain individuals and communities include increased adherence to cultural spirituality, meaningful community participation, and participation in traditional practices. Culturally sensitive, public health approaches to suicide prevention have yielded some successes; however, a systematic review of the literature concluded there is insufficient evidence to know which strategies are most effective in preventing suicide among indigenous populations. Creating strong partnerships between the communities, local tribal governments and researchers to rigorously evaluate current programs; developing community-based strategies that keep in mind the preferences of Native communities; and developing interventions that can be delivered in low resource settings will enhance current efforts to address this public health issue.

The objective of this FOA is to establish and support regional collaborative hubs whose research teams will (a) conduct preventive interventions research, including strengths-based/resilience-focused approaches, with the goal of reducing suicide in AI/AN youth, and (b) conduct outreach and dissemination activities to promote community engagement in research activities and enable community decision-makers to use science-based information to develop and assess mental health policies and programs.

NIMH encourages research approaches that answer questions about the mediators, moderators and mechanisms of interventions that prevent suicide, consistent with the NIMH experimental therapeutics approach. Research focused on resilience should specify the conceptual model(s) linking youth resilience to suicide risk and identify and test levers for intervention. The funded hubs will serve as a network of investigators and partners whose activities will aim to reduce the burden of youth suicide in AI/AN youth.

Areas of interest include:

• Research to develop culturally congruent preventive interventions that reduce suicide;
• Research to develop models for sustainable use of task-shifting (a process of delegation whereby tasks are moved, where appropriate, to less specialized health workers) for culturally congruent delivery of treatment engagement strategies, as well as training and supervision of a variety of health workers for delivery of mental health interventions;
• Research to identify effective, feasible approaches to reducing access to lethal means for suicidal individuals through community partnership agreements;
• Research on prevention strategies that take into account mechanisms of risk and resilience in youth for suicidal behavior outcomes, including comorbid factors related to alcohol and drug abuse;
• Research to determine how to improve the adoption, fidelity of implementation, and sustainability of effective youth suicide prevention programs, including strengths-based and resilience-focused approaches;
• Implementation research to identify appropriate application of technology to extend mental health human resources in remote rural settings;
• Research to identify suicide prevention approaches that relate to reducing environmental exposures and climate change impacts that may serve as mediators and/or moderators of suicide risk (via disruption of cultural traditions, traditional food sources, and sustainability of tribal lands).

A hub is defined as a multidisciplinary research group of investigators and their collaborators focused on a common research topic. Hubs are expected to serve as a focal point for all research and collaborative activities supported under this FOA and are expected to be located in the United States and involve local/regional researchers in study design, development, implementation and interpretation.

Regions: This FOA uses IHS Service areas to define regions. A hub may cover more than one region. Priority will be given to applications that significantly involve IHS regions with the highest suicide rates. Here is the complete list of IHS Service Regions https://www.ihs.gov/locations/:

• Alaska
• Albuquerque
• Bemidji
• Billings
• California
• Great Plains (Aberdeen)
• Nashville
• Navajo
• Oklahoma City
• Phoenix
• Portland
• Tucson

Partnerships: To be considered responsive, applications should include partnerships within the hub’s selected geographic region(s) with at least one element from each of the bullets below:

• 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 institutions/organizations
• Faith-based or Community-based organizations
• Tribal or urban Indian organizations
• One or more tribal or urban Indian leaders, tribal or urban Indian community health care workers, tribal government leaders or others who have a policy-making, evaluation or research role within the community. Given that many AI/AN communities are small, applicants may propose to include multiple tribal communities. If multiple tribal communities are involved, each should have representation.
• One or more tribal, urban Indian organization, community health or other organizations that provide access to service user and service provider viewpoints.

Applications must demonstrate that a research partnership currently exists (or can be developed and maintained) between the applicant and the partnership entities listed above via official documentation of the partnership (i.e., letter of support). The partnership is intended to ensure that the viewpoints of multiple stakeholders (i.e., researchers, service providers, service users, and policymakers) contribute to the development and conduct of the research and research capacity-building efforts, thereby increasing the likelihood of public health-relevant research findings, and ultimately, the uptake of research findings by service systems. Partnerships are expected to be integral to the conduct of the research proposed in the application and the application should describe the activities and responsibilities of each of the partners.

NOTE: Examples of studies that are not responsive to this FOA and will not be reviewed include the following:

• Animal model research or the development of new/improved animal models;
• Genetic studies;
• Research that does not require access to data sets or human subjects;
• Research primarily focused on HIV prevention or care;
• Stand-alone basic research;
• Hubs that do not involve at least one project focused on suicide preventive in AI/AN youth.

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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not 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:
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	6
Suicide Prevention	12

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: 1 required; maximum of 1
• Administrative Core: 1 required; maximum of 1
• Suicide Prevention Study: 1 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 support of a research hub that will (a) conduct research to reduce suicidal thoughts and behaviors as well as promote resilience in AI/AN youth, and (b) build and sustain local/tribal/regional research capacity to conduct research and to use science-based methods and information to develop and assess mental health policies and programs and programs relevant to suicide prevention.

Research Strategy: This narrative 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 it describes the conceptual wholeness of the overall project by giving a statement of the general problem area and by laying out a broad strategy for attacking the problem. As the strategy develops, each component (i.e., Administrative Core, Suicide Prevention Study) 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. This section should include a synopsis of the plans to establish or enhance and maintain a research partnership designed to (a) conduct a study that aligns with local tribal and community efforts and (b) build and sustain capacity to conduct research and use science-based methods and information to develop and assess mental health policies and programs.

This section should also discuss how the project governance structure and processes will address logistical challenges for a successful collaborative research hub for conducting suicide prevention research.

Significance: Describe the public health and scientific significance of the overall project. Describe how the significance of individual components (i.e., Administrative Core, Suicide Prevention Study) are enhanced by their integration into a single project.

Innovation: Highlight how the research collaborative hub and project components address key challenges of reducing suicidal thoughts and behaviors in AI/AN youth. 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 hub:

• Description of the existing tribal organizations or urban Indian organizations who will be partnering on the research initiatives.
• Evidence of local tribal and community support for the suicide prevention efforts.
• Evidence of an on-site administrative structure in the tribal community or urban Indian organization, along with scientific and outreach capacity to perform the proposed research at time of award.
• Evidence of an existing partnership and plans for 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.
• 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.

Note that letters detailing resource contributions are to be placed under their respective individual components. 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 care committed to providing these resources to the project.

If a data sharing agreement is in place with tribes/Tribal governments regarding ownership or control of data and biological samples, the applicant(s) should provide the letter of such an agreement with the application. Letters of Support should also explicitly stipulate that Tribes agree to respond to requests for approval of the protocol, protocol modifications, approval of abstracts for presentation to scientific meetings, and approval of manuscripts for submission for publication in scientific journals. The time required for approving each of these (protocol, abstracts, manuscripts): 1) must be proposed and stated within the resolution of support, 2) may differ for each of these activities, 3) may be modified by study investigators only in consultation with the tribal/community leadership, and 4) should also include the identification of an individual or entity within the tribe or community to whom a request for waiver of the time requirement can be directed if circumstances arise. PD/PI(s) and tribes/communities are expected to publish scientific papers, present at scientific conferences/associations/meetings; and may also be expected to develop fact sheets/materials for dissemination to the tribe/community.

Because the application represents collaboration(s) between tribe(s)/community(ies) and research organization(s), the letters of support should also describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The letter(s) of support should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects.

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.

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.

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.
• At least one participant from each partner organization should have the qualifications to lead and/or share authority and responsibility for the overall effort, including authority to allocate resources to ensure successful completion of tasks.

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

PDs/PIs must commit a minimum of 3 person months (25% of full time professional effort) conducting research and related activities specified in the application on-site where the research is based. In the case of multiple PDs/PIs, the PDs/PIs combined full time professional effort must be a minimum of 3 person months (25% of full-time professional effort)

PDs/PIs are encouraged to involve community members in the research as outreach coordinators, research assistants and other staff roles.

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 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 meeting of the Suicide Prevention Hubs will take place throughout the duration of the grant period and will take place at the activity site of one of the grantee projects each year on a rotating basis. Each awardee should plan to host up to two annual meetings and to attend all other annual meetings during the life of the grant. Annual meetings will involve 3 representatives from each awardee project (i.e., the PD(s)/PI(s) and two additional Key Personnel), selected experts, members of the Network Scientific Advisory Group (defined in the Terms and Conditions, see Section VI.2.A.3), and appropriate NIMH staff. These meetings are intended to identify areas of collaboration among awardees. The focus of the 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 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 meetings.

NIMH convenes its diverse set of Collaborative Hub programs annually at its Global Mental Health Workshop. This workshop is held in Washington D.C. or a city in Canada on a rotating basis. 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.

Community Engagement: In order to engage the local tribal or urban Indian community(ies) in the research, PI(s)/PD(s) should budget for local community meetings or other culturally-appropriate activities.

Dissemination Meeting(s): Understanding research findings is important for communities and policy makers. The PI/PD is expected to communicate research findings to the community and relevant policy makers in consultation with tribal or urban Indian leaders.

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 monitoring progress; ensuring that the project is implemented effectively within the proposed timeline; and meeting project milestones. This section should include a discussion of the structure of the Administrative Core, roles of administrative staff within the Administrative Core, and lines of authority within the Administrative Core. This description should include the functions to be performed, as well as a discussion of how the project will ensure effective and timely communications with NIMH staff. The Administrative Core's organizational and administrative structure should facilitate collaboration and interaction among the service provider organizations, the tribal organizations, and the project team.

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

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

Approach: Clearly identify Administrative Core personnel and resources for overseeing the entire project, including the Suicide Prevention Study.. Administrative Core personnel should include an administrator who will be responsible for daily administration and fiscal management. Describe how fiscal and other resources will be prioritized, allocated, and managed. Indicate the facilities, resources, services, and professional skills that the Administrative Core will provide and how the Administrative Core will be managed in a coherent manner. Describe how the Suicide Prevention Study will draw upon the Administrative Core and how it in turn will respond to project component needs. Describe how Administrative Core activities will facilitate communications among partner organizations and individuals, research rigor, transparency of reporting, research capacity building, and dissemination of findings. Describe 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 Describe plans 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 in publications. Describe the steps that will be taken to ensure successful completion of the suicide prevention study should a key member leave the partnership. Describe how the Administrative Core will facilitate community engagement with the research and other team members, as well as with the Suicide Prevention Study. Understanding research findings is important for communities and policy makers. Describe a dissemination plan to communicate research findings to the community and relevant policy makers in consultation with tribal or urban Indian leaders.

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.

Letters of Support: 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, with the following modification:

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

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.

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

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

When preparing your application in ASSIST, use Component Type Suicide Prevention.

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

SF424 (R&R) Cover (Suicide Prevention Study)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Suicide Prevention Study
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Suicide Prevention Study)

Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information

Research & Related Other Project Information (Suicide Prevention Study)

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) (Suicide Prevention Study)

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 (Suicide Prevention Study)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Suicide Prevention 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.

Budget (Suicide Prevention Study)

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 (Suicide Prevention Study)

Specific Aims: Provide a concise description of the aims for the Suicide Prevention Study.

Research Strategy: The focus and design of the Suicide Prevention Study should reflect the viewpoints of multiple stakeholders (i.e., researchers, tribal organizations and governance, service users, service providers, policymakers), thereby maximizing the study's potential public health impact and policy relevance for the designated tribal or urban Indian community. Accordingly, this section should describe the local community's efforts to promote resilience with its youth or its efforts to reduce suicidal thoughts or behaviors.

Significance: Describe how the potential Suicide Prevention Study will reduce suicidal thoughts or behaviors in AI/AN youth. The application should describe how the study could potentially address issues related to personal or historical trauma, self-esteem, depression, alcohol misuse, substance abuse or other factors that impact youth resilience. The application should describe how the study will fill knowledge gaps related to research on youth suicide and resilience promotion among tribal youth. NIMH encourages research approaches that answer questions about the mediators, moderators and mechanisms of interventions that prevent suicide. Research focused on resilience should specify the conceptual model(s) linking youth resilience to suicide risk and identify and test levers for intervention. If the research is successful, describe how it might be scaled up or adapted for the benefit of other tribal groups.

Innovation: Highlight any novel features of the Suicide Prevention Study that relate to the FOA goals to reduce suicidal thoughts and behaviors and promote resilience among AI/AN youth. Describe how tribal knowledge and community participation in the research will shape the study design to meet local needs.

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 (a) reducing suicidal thoughts and behavior and increasing resilience among AI/AN youth, and (b) how these evidence-based and culturally congruent methods will potentially affect local policies and programs. Describe how the study design will inform understanding of key mediators/mechanisms of action of the suicide preventive interventions. Describe any features of the study design that will permit other tribal groups to use data, methods, procedures, or results generated by this study in their own suicide prevention efforts. Describe the tribal/urban Indian community's involvement in the design and implementation of the research.

Applications that propose a clinical trial should follow NIMH's experimental medicine approach to intervention development and testing. Under this approach, projects should specify the presumed intervention target/mechanism (e.g., a mutable risk or resilience factor) and be designed to assess whether the intervention engages the target/mechanism that is presumed to underlie clinical benefit (e.g., reductions in suicidal thoughts and behaviors). Information on NIMH Clinical Trials can be found at http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml.

A Timeline and Milestones section must be included for the Suicide Prevention Study, describing the expected progression of activities and milestones specific to the study. The milestones should be regarded as criteria for evaluating the progress and direction of the Suicide Prevention 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 Suicide Prevention Study and fall within the page limitations for the section.

Letters of Support: Include letters of resource support specific to the Suicide Prevention 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 Suicide Prevention Study, should be included in this section. Also include individual letters of commitment to the partnership specific to the Suicide Prevention 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, must include a Data Sharing Plan.

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.

Planned Enrollment Report (Suicide Prevention Study)

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

PHS 398 Cumulative Inclusion Enrollment Report (Suicide Prevention Study)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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 Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

NIMH 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 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 set of 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 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 PD(s)/PI(s), collaborators, and other researchers well suited to the proposed tasks? 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? Do(es) the PD(s)/PI(s) have experience leading a multidisciplinary team and demonstrate the ability to manage administrative functions in which the research activities will take place? Is there substantial and appropriate integration of partner investigators into the research plans? Do the investigators commit adequate effort to successfully fulfill the program needs? Does the research team include adequate community and tribal representation that can ensure that the research will be acceptable and relevant 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 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? Are the overarching project milestones applicable to the overall program, feasible within the proposed timeframes, and integrated with the milestones for the Administrative Core and Suicide Prevention Study component? Do the milestones present quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner? Are there coordination and synergy of the Suicide Prevention Study, and Administrative Core towards the achievement of the overall program aims?

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?

As applicable for the overall collaborative hub 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.

Additional Review Criteria (Administrative Core)

Is the administrative and organizational structure of the Administrative Core appropriate and adequate? Is the management plan for fiscal accountability and communication among the program components appropriate? 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? Are plans adequate for coordination, communications, problem identification and resolution, and the establishment of a strong collaborative environment?

Is the proposed timeline for the Administrative Core tasks and milestones appropriate and feasible? Are there adequate plans for community engagement with the research team and Suicide Prevention Study? Is there an adequate plan for dissemination of results back to the community?

Additional Review Criteria (Suicide Prevention Study)

Is the Suicide Prevention Study designed to facilitate existing tribal or local community efforts? Is there evidence of support for the study by tribal leaders, depending on the study location?

Are the scientific questions to be answered by the proposed Suicide Prevention Study relevant and important to the community where the study is taking place? Will the research findings inform the public health system or mental health policy of the community and tribal partners?

Will the study inform understanding of key mediators/mechanisms of action of the suicide prevention intervention being tested? Does the study engage the target/mechanism that is presumed to underlie clinical benefit (e.g., reduces the incidence or prevalence of suicidal thoughts and behaviors)? Will the Suicide Prevention Study substantially involve tribal community members in study design, development, implementation, and interpretation, with the goal of engaging local and regional expertise?

Are the proposed resources for the Suicide Prevention Study adequate and justified?

Will the Suicide Prevention Study substantially involve tribal community members in study design, development, implementation, and interpretation, with the goal of engaging local and regional expertise?

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

Are plans adequate for coordination, communications, problem identification and resolution, and the establishment of a strong collaborative environment? Do plans for the Suicide Prevention Study propose adequate methodological expertise and data management support?

Is the proposed timeline for the Suicide Prevention Study tasks and milestones appropriate and feasible?

Are the sites and/or facilities where the Suicide Prevention Study 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 community? Will the Research component involve collaboration with appropriate tribal community and local health care organizations?

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 collaborative hub 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 collaborative hub 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.

Not Applicable

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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.
• Priority will be given to applications that significantly involved IHS Regions with the highest suicide rates.

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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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 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:

• Defining the research objectives, approaches, and details of the projects and core within the guidelines of the FOA and retain primary responsibility for the performance of all U19 supported research activities.
• Planning, directing, and executing of the proposed research 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.
• Comply 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.
• 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.

The regional collaborative hub's research activities must be conducted in the United States. The hub must provide for significant involvement of local/regional researchers in study design, development, implementation and interpretation.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, as negotiated with their tribal partners, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The role of the NIMH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIMH Project Scientist will offer advisory input. The NIMH Project Scientist will:

• Facilitate liaison activities for partnerships, and provide assistance with access to NIH-supported resources and services
• Provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct
• 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 the interactions among the awardees under this initiative
• Participate as a voting member in Steering Committee meetings of the network of hubs
• Facilitate collaboration with other NIMH-supported research resources
• Serve as a resource for all major transitional changes that the awardees might propose (e.g., a change in partnership organization) and advise on their appropriateness prior to implementation to assure consistency with the goals of this FOA
• Assist in avoiding unwarranted duplication of effort with other NIH efforts
• Provide technical assistance and advice to the awardees as appropriate

Additionally, an agency program official will be responsible for the normal 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 Hub awardees. All awardees in the Hub 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/PI of each Hub U19 award, or a designated representative in the case of Multiple PI award. The NIMH Project Scientist will be a voting member of the Steering Committee. Each member (one member per hub and the one NIMH Project Scientist) will have one vote. The NIMH Project Collaborator will be a non-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:

• Evaluating, reviewing, and recommending new collaborations among the Hub researchers and resource allocations for collaborative activities across the Hub network.
• Coordinating research resource sharing among Hubs (e.g., measures, consultations with staff across hubs) as appropriate.

The Steering Committee Chair will arrange regular Steering Committee meetings via teleconferences, and annual Steering Committee meetings in conjunction with the annual Hub meeting. The annual meeting is a forum for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among members of the Hub. Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance the Hub's overall goals. The PD/PI of each Hub (or a designated representative for multiple PI awards) is required to make an oral presentation on current and planned activities and projects at each annual meeting. Each hub 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Catherine Roca, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: [email protected]

Catherine Roca, MD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: [email protected]

Dorothy Castille, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9411
Email: [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected].

Rebecca Claycamp
National Institute of Mental (NIMH)
Telephone: 301-443-2811
Email: [email protected]

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.