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 using ASSIST or an institutional system-to-system solution; 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.

It is critical that applicants follow the Multi-Project (M) 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

The National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) encourages applications for Center Core Grants (P30) to support an HIV/AIDS Research Center (ARC). These Research Centers are intended to provide infrastructural support that facilitates the development of high impact science in HIV/AIDS relevant to the NIMH mission. The ARC supports innovative, interdisciplinary research in several areas, including basic, neuro-HIV, behavioral and social, integrated biobehavioral, clinical, translational, and implementation science.

In both behaviorally-focused and neuro-HIV Centers, the intent is to support research that addresses the most current research priorities in the field. The proposed Center priorities should align with the National HIV/AIDS Strategy, and international research directions outlined in guidance from the Office of AIDS Research (OAR) at the NIH. ARC awards permit the centralized coordination of affiliated research activities, foster the development of scientific innovations and new collaborations, encourage interdisciplinary research, and facilitate the dissemination of public health advances to implementing agencies, academia, affected communities, and policymakers. These Centers must have the potential to support studies in a variety of areas including biological, biomedical, behavioral, neuroscience, mental health, prevention, clinical sciences, and implementation science research.

Potential research areas that may serve as organizing themes or key areas of interest for the overall research strategy of the Center include but are not limited to:

• Identification of mutable multi-level risk and resilience factors that are associated with HIV infection, including individual, contextual, systemic, and structural factors which can facilitate or impede optimal access and use of effective HIV prevention and treatment. Mental health factors are an important subset of this constellation of potential areas for inquiry that is a high priority to DAR.
• Development and testing of feasible and cost-effective interventions to modify the risk and protective multi-level factors, in order to determine the most effective combination of interventions for HIV prevention and to improve HIV care continuum outcomes.
• Development and testing of methods and strategies to aid HIV-infected individuals and their families to cope with HIV infection; engage in HIV/AIDS care and other services to enhance quality of life and improve health outcomes; prevent complications and reduce the impact of co-morbidities (especially mental disorders); and avoid new sexually transmitted illnesses and the onward transmission of HIV.
• Identification of the effects of HIV infection of the central nervous system (CNS).
• Identification of the cellular and molecular mechanisms underlying HIV-induced CNS dysfunction.
• Development and testing of potential therapeutics to prevent or treat HIV/CNS disease.
• Identification of latent HIV/CNS reservoirs and testing of novel eradication strategies targeting the brain.
• Examination of the issues influencing adherence and non-adherence to HIV prevention and treatment regimens, and development and testing of methods to improve sustained adherence to drug therapy regimens.
• Development and testing of strategies to translate effective prevention and HIV care continuum interventions into real world settings both domestically and internationally, and the use of implementation science approaches to achieve public health impact.
• Development of effective strategies to integrate behavioral science with biomedical advances in HIV prevention and treatment.

AIDS Research Centers are expected to make several important contributions. First, Centers should demonstrate excellence and leadership in thematic areas that capitalize on the expertise of affiliated investigators. In this way, ARC-affiliated scientists serve as thought leaders who can guide the field in new directions in HIV/AIDS prevention and treatment research based on the accumulating evidence. Second, given infrastructural support, ARCs are expected to compete successfully for funding from NIH and other sources and, in doing so, address key scientific questions relevant to their thematic areas of interest.

Applicants are strongly encouraged to develop and maintain collaborations with industry, government, community, implementing agencies, and other scientific networks and institutions, to optimize the impact of Center-supported scientific advances and activities. In all potential thematic areas, Center programs are expected to address the key disparities that are evident in HIV prevention and treatment. For example, progress through the HIV care continuum is quite variable there are stark differences in subpopulations that do not progress to controlled viral load. To address these continuing research to service gaps, informed by local needs, there should be strong emphasis on potential collaborations with entities funded by the Centers for Disease Control and Prevention (CDC), the Human Resource Services Administration (HRSA), other implementing agencies, and/or local (e.g., city, state) health departments.

In a related vein, D-ARCs have the potential to assemble the evidence base critical to health policy decision-making pertaining to resource allocation, strategic priorities, and best practices for improving health outcomes. Those ARCs with an intervention science emphasis are also expected to advance the science of dissemination and implementation of evidence-based interventions that have the potential to lower HIV incidence and prevalence and improve health outcomes when delivered as part of full-scale programs. In these ways, ARCs are expected to serve as local, regional, national, and global resources for rigorous HIV/AIDS prevention, treatment, and implementation science.

Applicants are strongly encouraged to consult with the Scientific/Research Contacts listed in Section VII with regard to questions concerning research areas that are of highest priority.

See Section VIII. Other Informationfor award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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.
• o 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.

The ARC application institution must have a minimum of 4 active NIMH research project awards (R-series) and 2 additional NIH awards at the time of application and over the project period of the award. Centers unable to maintain the minimum required number of awards may be phased out.

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).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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	12 pages
Admin Core (use for Administrative Core)	6 pages
Development Core	6 pages
Research Core	6 pages

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.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; maximum of 1
• Developmental Core: required; maximum of 1
• Research Core: required; minimum of 3

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.

Descriptive Title of Applicant's Project: Applicants should clearly indicate in the application title that the application is for an ARC award.

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

Follow standard instructions.

Applications should describe the institutional commitment to the Center. A strong commitment of the parent institution can be demonstrated by providing sufficient resources and space to ensure organizational stability and fulfillment of Center objectives.

Collaborations with community-based organizations (CBOs) can be included in descriptions of the research environment.

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.

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

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.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe thematic aims of the overall Center and outline how the different Cores will contribute to these aims.

Research Strategy: The Research Strategy section of the application must include an overall description of the proposed Center, including objectives and integrating theme; justification of Center goals and proposed organization; and a diagram illustrating the organization and function of the programmatic and advisory structure of the Center.

Organize the Research Strategy into sections on Significance, Innovation, and Approach. The Overall Research Strategy should describe the impact that a Center could have to enhance HIV/AIDS research at the applicant institution(s) and exert a sustained influence on the HIV/AIDS research field. Use this section to describe the proposed Overall Research Strategy and the Strategic Plan of the Center and how it will contribute to meeting the goals and objectives of the Center Program. Also, explain the rationale for selection of the strategies, opportunities, action plans and outcome measurements proposed to accomplish the specific aims.

Significance: Describe the effect that a Center award would have on Center investigators' HIV/AIDS research efforts. Summarize HIV/AIDS science at the institution that justifies the need for Center support. Describe how the proposed Center provides added value to HIV/AIDS research conducted at the institution. Demonstrate the Center's ability to support the research base, foster synergy, and enhance HIV/AIDS research collaborations.

Innovation: Describe how Center resources will be utilized in unique ways to achieve the scientific goals of HIV/AIDS investigators at the institution. Provide the degree of variety across the disciplines involved in HIV/AIDS research projects within the Center structure. Illustrate unique ways to incorporate community involvement, collaboration, and outreach in the Center.

Approach: Describe the Center scientific planning process. Describe the leadership plan for the Center. The roles and responsibilities of the Center Director and Core Directors should be described.

A strategic plan must be outlined that identifies the immediate and long-term research goals of the Center. A process for implementing the activities to achieve the goals set by the Center should be clearly defined. Center applications should identify the highest priority goals with a detailed plan of activities to meet those goals for each year of the award. The application should define specific milestones that the Center expects to meet, and a process for evaluating their progress and making changes if course correction is needed. Goals for each successive year should build on those identified for the first year of funding.

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

Renewal applications should describe the overall accomplishments of the Center during the last funding period including a brief synopsis of progress in achieving the major aims of the Center. Identify the most significant findings that were facilitated or supported directly through Center infrastructure and resources. Describe the major successes of the previous funding periods and how continued funding will build on those successes. Highlight establishment of new collaborations and the effectiveness of the Core resources and facilities. Changes in structure or focus that have taken place over the previous funding period that have been done to strengthen or broaden the efforts of the Center should be clearly described. Provide examples of how the presence of the Center has brought new investigators into the field and stimulated HIV/AIDS research in the last funding period.

Letters of Support: The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) that describes resource support for the Center that will be provided by the applicant institution.

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:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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.

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 Director 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.
• Co-Center Directors are not permitted. The Administrative Core Director must be the Center Director.

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

The Administrative Core Director is expected to devote a minimum of 3.6 person months to their role.

The Administrative Core may include a limited number of administrative and clerical personnel, with a detailed description of their responsibilities for the Center, only if all the following conditions are met: 1) the administrative or clerical services are integral to a project or activity; 2) individuals involved can be specifically identified with the project or activity; and 3) the costs are not also recovered as indirect costs. Rent may be allowed only in unusual and exceptional circumstances whereby the applicant institution has a documented shortage of space on campus.

Travel expenses for key personnel to attend annual NIMH AIDS Research Center Directors meetings in Washington DC should be budgeted. Limited support is available to cover travel of the Administrative Core Director and other investigators to scientific meetings that are justified as essential to the conduct of research supported by the Center. Travel of technical staff for training that is justified as essential to enhancing the quality of the research projects is also an allowable expense.

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.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: All Centers must have an Administrative Core that provides scientific direction and administrative leadership, performs key decision-making functions, develops and implements strategic plans, monitors and evaluates progress toward Center goals and objectives, and ensures efficient fiscal operations. The Specific Aims should describe how the Core administration will coordinate and manage activities across the Center and have an impact on the research infrastructure and strategies.

Research Strategy:

Organize the Research Strategy into sections on Significance, Innovation, and Approach.

Significance: Explain the role of the Administrative Core in the Center as a whole and the responsibility of the Core for the overall administration, coordination and management of the Center.

Innovation: Explain the unique utilization of Core resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institutions.

Approach: A well-developed administrative plan is integral to the success of the Center and must be clearly defined in the application. The plan should include a discussion of the structure, referencing, as necessary, the roles of administrative staff, including the functions to be performed.

The Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of the Cores. The Core must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed.

The process for implementing the activities to achieve the goals set by the Center should be clearly defined. Mechanisms for internal review, decision-making, and priority-setting processes appropriate to planned activities must be defined. Appropriate criteria and review processes for evaluating affiliated investigators' ongoing participation in the Center should be established and include such factors as productivity, research direction, and overall contribution.

Centers should articulate a plan to measure progress toward strengthening the research capacity of the home institution. Evidence of such impacts may include broad dissemination of research products, citations by other published materials, or other indicators of scientific advancement.

The administrative structure must include an external advisory committee charged with providing objective advice and evaluation of Centers' strategic directions, research programs, community engagement, capacity building, and other key activities. A plan for meeting with the advisory committee should be outlined and a process for responding to its recommendations should be delineated. Information from this advisory committee meeting should become part of the annual progress report, including the date/s of the meeting; a brief, written report from the advisory committee; and the Administrative Core Director's written responses to the advisory committee's recommendations, if any. This should be included as an attachment to item G.1 of the RPPR

The Administrative Core will also manage interactions with the Advisory Committee. Describe the plans and procedures for nominating and selecting members of this committee. Describe the expected composition of the Advisory Committee (number of members, types of expertise, etc.), but do NOT name the members of the committee who are not from the Center Institution in the application so as not to limit the pool of potential reviewers. The Advisory Committee should include both users of the Cores and investigators external to the Center who may have expertise in the design and management of other core facilities or expertise in the technologies, services, and/or resources offered by the Cores or expertise in the research fields covered by the research community.

Procedures should be outlined for a set of specific actions used to conduct the affairs of the Center, and how various tasks will be accomplished within the Center. Policies and procedures should describe, for example:

• The proposed roles of the Administrative Core Director, Core Directors, Center investigators, advisory boards, and institutional officials in the decision-making process
• The annual strategic planning process; examples of issues Center members should consider
• How funds will be allocated to all types of Cores and activities
• Procedures for changes in support of any Cores
• How Center-sponsored conferences, seminars, workshops, and other activities will be identified
• How priorities for communication, outreach and additional Center activities will be established
• The authority and responsibility of internal and external advisory committees

Renewal applications should also describe the overall accomplishments of the Core during the last funding period, including a brief synopsis of progress in achieving the major aims of the Core.

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:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

SF424 (R&R) Cover (Developmental Core)

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 (Developmental Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental Core)

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.

Project /Performance Site Location(s) (Developmental Core)

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 (Developmental Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Developmental Core Director' and provide a valid eRA Commons ID in the Credential field.
• Developmental Core Directors must have the appropriate scientific training, mentoring experience, organizational skills, and administrative qualifications appropriate to the position. The Developmental Core Director assumes responsibility for the scientific, administrative, and operational aspects of the Core.
• 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 (Developmental Core)

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

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

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 (Developmental Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe briefly how the Core will expand and promote the research priorities of the Center and how it will support the next generation of HIV/AIDS researchers.

Research Strategy: Organize the Research Strategy into sections on Significance, Innovation, and Approach. Describe how the proposed activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section also should indicate the relevance of the Developmental Core to the Overall Research Strategy of the Center application.

Significance: Describe the effect that the Developmental Core would have on Center investigators' HIV/AIDS research efforts. Describe how the Core provides added value to HIV/AIDS research conducted at the institution, and describe the Core's ability to support the next generation of HIV/AIDS researchers.

Innovation: Explain the unique utilization of Core resources to achieve the scientific goals of HIV/AIDS investigators at the institution.

Approach: The Developmental Core can serve a range of Center functions, such as capacity building, providing internal peer review and support services, funding pilot or preliminary research, facilitating science generation, education in grant and manuscript writing, organizing seminars and conferences, and establishing new interdisciplinary collaborations that address emerging scientific priorities.

A Developmental Core can support 1 2 year, formative or feasibility studies proposed by new or established investigators, including the research activities of newly recruited faculty. These pilot award projects are expected to be innovative, interdisciplinary research that addresses the highest priority HIV prevention and treatment science that will position the investigator(s) for subsequent research that aligns with NIMH DAR priorities.

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

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:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Developmental Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

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

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

SF424 (R&R) Cover (Research Core)

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 (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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.

Project /Performance Site Location(s) (Research Core)

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 (Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Research Core Director' and provide a valid eRA Commons ID in the Credential field.
• Research Core Directors must be recognized scientists and skilled administrators who are well qualified to lead the Core to achieve its goals and objectives. Each Research Core Director must be experienced in the relevant scientific area and assume responsibility for the scientific, administrative, and operational aspects of the Core.
• 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 (Research Core)

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

The time commitment of a Research Core Director should be based on the breadth and complexity of the Core and the effort needed to administer it but should not fall below 2.4 person months.

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 (Research Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Core will contribute to the goals of the Center, how this Core will provide services to HIV/AIDS research beyond what is currently available, and/or increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or provide user training to new investigators.

Research Strategy:

Organize the Research Strategy into sections on Significance, Innovation, and Approach. Describe how the proposed activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. This section should also indicate the relevance of the Core to the Overall Research Strategy of the Center application. Applicants should describe the operation of the Core.

Significance: Describe the effect that a Core would have on Center investigators' HIV/AIDS research efforts. Describe how the Core provides added value to HIV/AIDS research conducted at the institutions. Describe the strengths of the Core.

Innovation: Describe how Core resources are utilized in unique ways to achieve the scientific goals of HIV/AIDS investigators at the participating institution.

Approach: A Research Core can be developed around any research activity that can provide resources to Center investigators. A Research Core is expected to be used as a shared resource and service and is intended to provide access to knowledge and technology that enhances the research productivity of the Center, scientific interaction within the Center and consultation being provided by the Center. A Research Core also provides access to services that facilitate the research and strengthens the administrative and organizational cohesion of the Center. A Research Core should clearly describe a plan for identifying new or expanded services that it provides. In addition, a Research Core should clearly describe a plan for identifying potential users of the shared resources, and for providing the resources to investigators who may request them. The potential benefits of these resources and a mechanism to evaluate these benefits must be detailed in the description of a Research Core.

Renewal applicants should describe previous utilization of the Core resources.

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:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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, NIH. 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 [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center 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 project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the application provide a compelling rationale that describes the benefit that a Center award would have for Center investigators' HIV/AIDS research efforts?

Does the application describe how the proposed Center provides added value to HIV/AIDS research conducted at the institution, and demonstrate the Center's ability to foster synergy and enhance HIV/AIDS research collaborations?

Do the thematic framework and research agenda focus on a significant public-health topic consistent with the HIV/AIDS research priorities of NIMH?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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 Center 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 center?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

Does the application describe how the utilization of Center resources in unique ways will achieve the scientific goals of HIV/AIDS investigators at the institution?

Does the application provide the degree of variety across the disciplines involved in HIV/AIDS research projects within the Center structure, and illustrate unique ways to incorporate community involvement, collaboration, and outreach in the Center?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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 Center 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?

Is a strategic plan outlined which identifies the immediate and long-term goals of the Center, and a well-defined process for implementing the activities to achieve the goals set by the Center?

For the Center as a whole, is the coordination among the operations and research Cores adequately explained? Does the application describe each Core's essential function and aims, relevance to the Center's thematic area(s), and added-value to the HIV/AIDS science at the institution?

Is there synergistic potential among the Center research components? Is there justification for each research Core and pilot/developmental studies in terms of the central theme and the overall research goals of the Center?

Does the Center have the potential to achieve a whole greater than the sum of its parts? Are the plans for interactions with participating institutions and organizations adequately explained? Are the management plans and arrangements feasible?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the Center 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 Core Director an accomplished administrator capable of leading a complex, interdisciplinary organization to achieve its key aims and objectives?

Does the proposed Administrative Core have an appropriate and adequate administrative structure with an internal organization capable of planning, conducting, and evaluating Center activities?

Does the Core clearly delineate procedures and plans for Center administration, data management, and analysis?

Is there an adequate mechanism for internal review, decision-making, and priority-setting processes appropriate to conduct the activities of the Center?

Is a standing outside advisory committee proposed or established that can provide appropriate and objective advice and evaluation regularly to the Administrative Core Director, and is an appropriate process proposed for responding to recommendations of the committee?

Additional Review Criteria - Developmental Core

Are the Developmental Core leadership and personnel well suited to the project? If Early Stage Investigators or those 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 there is Core co-leadership, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is the proposed Developmental Core Director scientifically qualified to direct the activities of the Core, experienced in the scientific areas in which the Core proposes to develop pilot projects, as well as in the scientific process of developing ideas into applications?

Does the proposed Developmental Core Director demonstrate the ability to assume responsibility for the administrative and operational aspects of the Developmental Core?

Does the Core describe an adequate plan to recruit innovative pilot projects by independent investigators, with the goal of providing support for short term scientific studies in order to develop preliminary data for peer-reviewed research applications?

Is the mechanism for reviewing potential projects, making funding decisions and awards, and monitoring projects to ensure effective use of pilot project funds clearly described?

Is there an adequate process for assuring that pilot projects conducted under the Center's auspices comply with applicable NIH policies?

Additional Review Criteria - Research Cores

Are the Research Core leadership and personnel well suited to the Research Core? If Early Stage Investigators or those 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 there is Core co-leadership, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is the Research Core Director scientifically qualified to handle the nature and complexity of the research objectives of the Research Core, experienced in the scientific area in which the Core functions, and has demonstrated ability to assume responsibility for and manage the scientific, administrative, and operational aspects of the Research Core?

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

Is the Research Core structured around the proposed Center research activity capable of providing the necessary resources to meet the goals of the Center?

Is the proposed Research Core adequately structured for use as shared resources and services intended to provide access to knowledge and technology to facilitate and enhance the research productivity of the Center? Does the Core promote scientific interaction within the Center, and foster consultation with Center investigators?

Is the research that is proposed to be conducted within the Research Core directed toward improving and expanding the resource, and is there a well-defined plan for identifying new or expanded services that it could provide?

Is there adequate justification for the shared resource?

Are the potential benefits of these resources detailed, and is there a mechanism to evaluate these benefits?

Is the research Core structured to reflect the overall level of funding requested for the Center?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

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

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

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

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.

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.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Institute of Mental Health Advisory 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.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH's Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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 RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Christopher Gordon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3867
Email: [email protected]

Vinod Charles, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1606
Email: [email protected]

Jane Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
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.