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

Although scientific and technological advances have improved the health of the U.S. population overall, racial/ethnic minority populations, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations continue to experience a disproportionate share of many chronic diseases and adverse health conditions. As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resources to characterize the root causes of health disparities, uncovering complex webs of interconnected factors (e.g., biological, behavioral, social and environmental factors) acting at multiple levels across the life course.

Tackling the complex drivers of health disparities requires a diverse, well-trained scientific workforce and a transdisciplinary framework that cuts across scientific and organizational silos to integrate multiple disciplines biology, behavioral and social sciences, epidemiology, data science, public health, health services, economics, clinical science, and public policy. It also requires strong collaborations between researchers, community organizations, health service providers, public health agencies, policymakers and other stakeholders to ensure that relevant, contextually appropriate research is conducted and, more importantly, that findings can be translated into sustainable community and system-level changes that promote health equity.

The NIMHD Centers of Excellence program, established by Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525), has played a vital role in realizing NIMHD’s mission to support research in minority health and health disparities, promote the training of a diverse research workforce, disseminate research findings, and foster innovative collaborations and partnerships. The purpose of this FOA is to further advance NIMHD’s mission by supporting Centers of Excellence to conduct transdisciplinary, multi-level research and to provide research opportunities for post-doctoral fellows, junior faculty, and other early stage investigators to engage in this type of research.

Research Objectives

NIMHD Minority Health and Health Disparities Research Framework communicates NIMHD’s conceptualization of factors relevant to the understanding and promotion of minority health and to the understanding and elimination of health disparities (www.nimhd.nih.gov). The thematic focus chosen should address the intersection of domains of influence (biological, behavioral, physical environment, sociocultural environment, healthcare system) and levels of influence (individual, interpersonal, community, societal) in the Framework in some way and that research activities will embrace a multi-domain, multi-level perspective. The thematic focus should map onto the Framework, but the Framework is not intended to substitute for theoretical or conceptual models that underlie proposed research activities.

Each Center of Excellence is expected to have a unifying thematic focus. The thematic focus should be at a level of specificity such that it is reasonable to expect that center activities can have a direct and demonstrable impact on addressing minority health and health disparities in that topic area. All center activities, including research projects, pilot projects, and community dissemination activities, should be designed to contribute to this impact.

• The thematic focus may involve:

(a) Specific disease areas that disproportionately affect disparity populations and contribute substantially to health outcomes (e.g., cardiovascular disease, cancer, diabetes mellitus, asthma, HIV/AIDS, chronic lung disease, chronic liver disease/cirrhosis, accidents, depression, osteoarthritis, inflammatory arthritis, chronic kidney disease, specific cancers)

(b) Prevention topics that cut across health conditions and populations (e.g., physical activity, tobacco use and cessation, healthy nutrition, obtaining recommended screening tests, immunizations, pre-natal care, breast feeding, adherence to medications and behavioral recommendations)

(c) Life course groups that incorporate selected components from above (e.g., children, women, older adults, men)

• This thematic focus may also involve:

(a) Understanding the etiology and mechanisms of diseases and health conditions in health disparity populations (e.g., how poverty creates and sustains health disparities, how structural racism/discrimination affects biological processes, why rural populations are disproportionately affected by opioid dependence);

(b) Evaluating intervention approaches to improve minority health or reduce health disparities (e.g., neighborhood-level interventions to reduce obesity in racial/ethnic minority populations, interventions to address provider bias towards sexual and gender minority patients); and/or

(c) Developing methodological approaches or addressing measurement issues (e.g., systems science methods to understand structural drivers of health disparities; measurement of neighborhood level effects on health disparities; methods for assessing the impact of policies on local, regional, or statewide population health).

• The thematic focus must revolve around one or more NIH-designated health disparity populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. This focus may include multiple health disparity populations, a single health disparity population, or a subgroup within a health disparity population.

Specific Areas of Research Interest

Areas of specific interest regarding the thematic focus include, but are not limited to, the following:

• Projects that encompass multiple health disparity populations and/or the intersectionality of multiple health disparity populations (e.g., race/ethnicity and SES, SGM status and rural vs. urban residence, etc.)
• Understanding or addressing risk factors or mechanisms that are common to multiple diseases or conditions.
• The pathways and mechanisms by which biologic or non-biologic determinants contribute to or influence minority health or health disparities.
• Development of methodological tools, measures, validated instruments, and novel research designs for disentangling the contribution of biologic factors, behaviors, and social factors to health disparities.
• Multi-sectoral collaborations and/or interventions, i.e., those that involve other service sectors in addition to health, such as education, housing, justice, transportation, labor, etc.
• Interaction of culture and other factors on recruitment into research studies and clinical trials, utilization of health services, adherence to lifestyle and behavioral changes; and understanding individual cultural beliefs and expressions within a multicultural setting.
• Communications research how to reach minority and health disparity populations and clinicians serving these populations with information that will lead to positive changes in behaviors, practices, and health.
• Understanding the dynamics governing the successful translation of minority health and health disparities research into multilevel interventions, health promotion/prevention programs or sustained behavioral changes and practices in communities, schools, businesses, families, prisons, etc.

Required Components:

The Center must include the following required components:

• Administrative Core
• Investigator Development Core
• Community Engagement and Dissemination Core
• Research Project(s)

Descriptions of Required Components

• The Administrative Core will provide overall project oversight and evaluation, ensuring that component plans are implemented per proposed timelines, submitting annual progress reports, monitoring progress on research projects and pilot projects, and ensuring that Center-supported research is carried out in compliance with applicable federal regulations and policies. The core will also develop a standard set of common data elements and measures to be used across research and pilot projects, as appropriate. Further, the Core will offer career enhancement activities for investigators at the applicant institution, including post-doctoral fellows and junior investigators. Resources may be requested to support seminars, workshops, and/or other activities that promote the recruitment, advancement, and retention of investigators in biomedical, behavioral, social, and clinical research. The Administrative Core must be directed by the PD(s)/PI(s) of the Center.
• The Investigator Development Core will develop a pilot project program that provides opportunities for the applicant institution's post-doctoral fellows, junior faculty, and other early stage investigators to generate preliminary data in the thematic focus area of the Center for subsequent submission of grant applications. Core personnel will develop a program to solicit and select pilot projects, provide necessary guidance for the development of pilot projects as well as to support awardees to ensure successful completion of projects to publication of results and submission of subsequent grant applications. Annual funding for the pilot project program should be a minimum of $150,000 with at least three new pilot projects awarded each year. Pilot projects, whether observational or intervention studies, are expected to use a multi-level, multi-domain approach. Eligibility to receive a pilot project award is limited to the recipient institution's post-doctoral fellows, junior faculty and other early stage investigators as defined by NIH (see https://grants.nih.gov/policy/new_investigators/index.htm#definition). Recruitment of early career investigators from groups underrepresented in science (http://www.nsf.gov/statistics/wmpd/) is encouraged.

The Research Project(s) will address research questions relevant to the thematic focus of the COE. One to three research projects may be proposed that vary in scale and scope, with the caveat that all research projects together should comprise no more than $500,000 annual direct costs. Research projects, which may be observational or intervention studies, are expected to use a transdisciplinary, multi-level, multi-domain perspective. Projects are also expected to engage collaborators from relevant organizations and stakeholders as appropriate, which may include but are not limited toacademic institutions, clinicians, health systems, state and local public health agencies, school systems, community-based organizations, and faith-based organizations. Projects may be full-scale projects or more exploratory/developmental projects. However, all projects must have fully developed and specified research plans at the time of application. Planning-phase studies, in which the topic area or study design is determined after award as the result of community and stakeholder input processes, will not be supported. There should be synergy between the research projects such that there is added value to conducting them as interrelated rather than independent projects. Examples of synergy include but are not limited to the pooling of data across studies; sharing of resources, tools, or data analytic strategies; or the testing of different components of the same conceptual or theoretical models.

• The Community Engagement and Dissemination Core will facilitate equitable collaborative and sustainable relationships with community and other stakeholders. The Core will coordinate dissemination activities with community members, partner organizations, and relevant service organizations or policymakers, as well as the scientific community. Dissemination activities include the presentation of findings from research projects and pilot projects and strategic planning about how to translate findings into sustainable community and system-level changes at the local level and beyond.

NIMHD will conduct a Technical Assistance webinar for prospective applicants. Information on the date and time of the webinar will be posted on the NIMHD website at www.nimhd.nih.gov.

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:

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)

Pursuant to Public Law 106-525, institutions of higher education must meet the following criteria to be eligible:

• Had a significant number of members of health disparity populations enrolled as students in the institution, including individuals accepted for enrollment in the institution. NIH-designated health disparity populations are Blacks or African Americans, American Indians or Alaska Natives, Asian Americans, Hispanics or Latinos, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.
• Been effective in assisting students from health disparity populations to complete a program of study or training and receive the advanced degree(s) offered.
• Made significant efforts to recruit and enroll health disparity population students into and graduate from the institution, which may include providing means-tested scholarships and other financial assistance as appropriate.
• Made significant recruitment efforts to increase the number of members of health disparity populations serving in full-time faculty or administrative positions at the institutions.

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 not 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.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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, 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:

Thomas Vollberg, Sr., PhD
Telephone: 301-594-8770
Fax: 301-480-4049
Email: vollbergt@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6 pages
Admin Core	12 pages
Core (Investigator Development Core and Community Engagement and Dissemination Core)	6 pages
Project (Research Projects)	12 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.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Investigator Development Core: required
• Research Project: required, maximum of 3
• Community Engagement and Dissemination Core: required

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.

Other Attachments: The application must include two separate attachments that provide: 1) a description and evidence of the institution's explicit accomplishments in meeting the special eligibility criteria regarding health disparity populations and 2) the institutional Maintenance of Effort attestations as described below.

Special Maintenance of Effort Attestation:

• With respect to authorized activities, the institution, or institutions in the consortium, as the case may be, must agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the institutions involved for the fiscal year preceding the fiscal year for which such institutions receive such an award.
• With respect to any Federal amounts received by the Center or consortium and available for carrying out authorized activities, the institutions involved agree that the institutions will, before expending the award, expend the Federal amounts obtained from sources other than the award.

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: Describe the specific aims for the Center, including the thematic focus of the center and how center activities will have a measurable impact on addressing minority health and health disparities in that area.

Research Strategy: Summarize the design, structure, and governance of the Center, its thematic focus, the features and functions of the proposed Cores, and how the Center will broadly: 1) advance the knowledge and science of minority health or health disparities, 2) contribute to expanding the development of a diverse workforce for conducting minority health and health disparities research in the thematic focus area, 3) facilitate equitable stakeholder collaborations. Describe plans and procedures to monitor and assess progress of the Center. Describe how the efforts of this Center will avoid duplicating institutional or national efforts.

Provide an overview of the proposed research projects and describe how they are synergistic with one another and with the pilot project program, as well as plans and procedures to monitor and assess progress on those projects.

Describe existing linkages with community stakeholders and the principles, policies, and practices that will guide when and how the Center will engage with communities and for what purposes.

Letters of Support: Applicants must provide a letter from the president, chancellor, dean, or provost:

• Indicate the commitment of the institution to the Center specific aims and how the Center activities will be integral to the broad institutional vision for minority health and health disparities research.
• Specify any institutional support, at the departmental and higher administrative levels, for example, financial support, support for developing early stage investigators to conduct Center research, i.e. access to core facilities, research design, data analyses, etc.) dedicated space, salary support for professional or administrative staff, interface with other grant funded programs, centers, and initiatives, etc.

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.

Appendix:

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

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

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

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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.
• The Administrative Core must be directed by the PD(s)/PI(s) of the Center.

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

The PD/PI is expected to attend an annual NIMHD Centers of Excellence grantees meeting, held at or near NIH, Bethesda, MD. Funded junior investigators, collaborators or other members of the project team may also attend as warranted. Funds for travel to this meeting should be included in the budget request.

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: Describe the specific aims for this core.

Research Strategy: Describe strategies for overseeing, managing and coordinating the entire range of proposed activities, establishing the appropriate measures for monitoring and accessing progress, and for ensuring that component plans are implemented. A Describe the roles and responsibilities of Administrative Core personnel including scientific leadership, and administrative management and coordination of the proposed activities.

A Management Plan describing the center s organizational and governance structure should be included. The plan should describe the composition and roles of the Steering Committee, as well as any community advisory boards or other committees proposed to help manage Center activities. Do not name potential members of the Steering Committee in the application.

If appropriate, describe plans to develop a standard set of common data elements and measures to be used across research and pilot projects. Describe activities the center will offer to promote the conduct of minority health and health disparities research within the thematic focus area for investigators at the applicant and collaborating institutions.

Include an Evaluation Plan to facilitate ongoing Center performance and project management to ensure successful completion of the stated aims and the achievement of the desired results and purpose of the NIMHD Centers of Excellence initiative. Describe how the evaluation will be conducted, principal performance measures and metrics to be used to assess achievement of short- and long-term goals of each core and project, and potential sources of data. The productivity of investigators, including those with pilot projects, should include monitoring related publications, grant applications and awards. The plan should address administrative functioning (process) as well as scientific and developing investigator accomplishments (outcomes). Describe key milestones and expected outcomes for each area, as appropriate.

Letters of Support: Include letters of support for any collaborative/cooperative arrangements, subcontracts, or consultants, including letters from community members and other stakeholders.

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.

Appendix:

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

PHS Inclusion Enrollment Report (Administrative Core)

Not applicable

When preparing your application in ASSIST, use Component Type Core

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

SF424 (R&R) Cover (Investigator Development 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 (Investigator Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Investigator Development 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. 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) (Investigator Development 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 (Investigator Development Core)

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

Budget (Investigator Development Core)

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

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

Applicants must support 3-10 pilot projects with a maximum $50,000 limit for an individual pilot project corresponding to $150,000-$500,000 per year in direct costs, exclusive of consortium indirect costs.

PHS 398 Research Plan (Investigator Development Core)

Specific Aims: Describe the specific aims of this core and how this core will contribute to expanding the scientific workforce for conducting minority health and health disparities research in the thematic focus area.

Research Strategy: Describe the plans to solicit and review applications, prioritize the pilot projects for funding, review their methodology and research performance, and provide support to recipients throughout the pilot project to publication of results and preparation of subsequent grant applications. Describe advisory and technical support resources in place to support rigorous research designs and appropriate statistical analysis.

Describe the scope, eligibility requirements, the limit on the dollars available and the number of years of support per pilot project, oversight and evaluation procedures, and assurances that all pilot projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects and vertebrate animals. Do not include detailed proposals or descriptions of specific pilot projects, as pilot projects should not be selected until after the center grant is awarded.

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.

Appendix:

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

PHS Inclusion Enrollment Report (Investigator Development Core)

Not Applicable.

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

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

SF424 (R&R) Cover (Research Project)

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 Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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) (Research Project)

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 Project)

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

Budget (Research Project)

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

The combined budget for all Research Projects should comprise no more than $500,000 in total annual direct costs.

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 Project)

Specific Aims: State the specific aims of the Research Project.

Research Strategy: Specify the objectives of the research project. Explain how the project will contribute to advancing the knowledge and science of minority health and health disparities within the specific thematic focus. Provide a conceptual model that specifies the determinants and mechanisms of health outcomes that will be examined in the project and guides the study design, selection of measures, and data analytic strategy. Describe how the project maps onto the NIMHD Minority Health and Health Disparities Research Framework, http://www.nimhd.nih.gov/. Describe the transdisciplinary aspects of the project and describe how relevant stakeholders will be engaged in the project. Describe how study findings can contribute to understanding or addressing minority health and health disparities on a broad scale, not just at the specific study sites or for local populations.

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.

Appendix:

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

PHS Inclusion Enrollment Report (Research Project)

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

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

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

SF424 (R&R) Cover (Community Engagement and Dissemination 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 (Community Engagement and Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement and Dissemination 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. 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) (Community Engagement and Dissemination 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 (Community Engagement and Dissemination Core)

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

Budget (Community Engagement and Dissemination Core)

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

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

PHS 398 Research Plan (Community Engagement and Dissemination Core)

Specific Aims: Describe the specific aims for the Dissemination Core.

Research Strategy: Describe how this core will contribute to the thematic focus of the Center. Describe the leadership of this core, and the principles, policies, and practices that will guide its operation. Describe the types of activities that will be conducted for the timely and appropriate dissemination of information generated by the Center, its research projects, pilot projects, and other activities for diverse audiences, including lay community audiences. Describe the expected outcomes of the proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed. Describe how the core will coordinate dissemination activities with community members, partner organizations, and relevant service organizations or policymakers. Describe how stakeholders will share in the decision making on what, when, how, and to whom findings from research and pilot projects will be presented. Describe strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond.

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.

Appendix:

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

PHS Inclusion Enrollment Report (Community Engagement and Dissemination Core)

Not Applicable

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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 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 Center 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?

To what extent has a clear and specific thematic area been identified? To what extent is it likely that the Center will have a measurable impact on addressing minority health and health disparities in the thematic area?

To what extent has the Center been structured to successfully integrate the theme throughout all cores and core activities?

Does the structure of the proposed Center make it likely to disseminate research findings from research projects and pilot projects in peer-reviewed and other journals in a timely and efficient manner?

Does the application make a compelling case that the presence of a Center at this institution will have a high likelihood to expand the scientific workforce for the conduct of research on minority heath and health disparities?

Will this Center conduct transdisciplinary, multi-level research that advances the understanding of minority health and health disparities and addresses the NIMHD Framework for Minority Health and Health Disparities Research?

Are the research studies, if successful, likely to produce findings that will inform policy or practice that may lead to sustainable community and system-level changes that promote health equity?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the training, experience, level of commitment, availability and qualifications of the PD(s)/PI(s) and key personnel of the leadership team adequate to successfully lead and manage the proposed Center?

Do the plans for governance provide adequate administrative structure and lines of authority? Do information and the biosketches for the Center leaders demonstrate aptitude and volition to function as part of a multidisciplinary, integrated, high functioning team of academicians and community stakeholders?

Are the training, qualifications, experience, and accomplishments of the Project Leaders and Core Directors appropriate, in terms of their abilities to accomplish the proposed projects and activities under the thematic area?

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 conceptual and theoretical frameworks, design, methods, and analyses for the aims of proposed research projects appropriate, and do they support the Center's thematic area?

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 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 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?

Are the proposed specific aims of the Center, as well as the plans to achieve them feasible?

To what extent are the proposed research projects synergistic with each other and the Center's thematic focus?

Are the plans for community engagement and dissemination activities likely to facilitate equitable and collaborative relationships with community and other stakeholders? To foster the translation of research findings into sustainable community and system-level changes?

Do the research projects, cores and overall goals focus to reduce/eliminate a particular minority health issue or health disparity and does the application clearly address relevant domains and levels?

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?

To what extent are the proposed Center components and activities likely to foster environments conducive to investigator development, particularly for post-doctoral fellows, junior faculty, and early stage investigators?

To what extent do the institutional letters of support indicate that the applicant institution is fully committed to achieving the specific aims of the proposed center?

For projects that include translational and clinical studies, are adequate support and expertise available for the successful pursuit of the proposed work?

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.

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 Center 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.

For Renewals, the committee will consider the progress made in the previous project period.

Not Applicable.

As applicable for the Center 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.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit:

Are strategies to ensure effective management, coordination, and support of the entire range of proposed activities well described and likely to succeed?

Do the proposed approaches for coordinating activities and monitoring progress adequately support the likelihood that each component's aims will be achieved within the project period?

Are the proposed programmatic activities appropriate for the support of career enhancement for post-doctoral level professionals and junior faculty from a variety of disciplines, as appropriate?

Are the Core Lead, collaborators, and other researchers well suited to the roles in the management and conduct of the Core's activities?

Is the organizational and governance structure adequately described and appropriate for supporting the stated aims? Does the management plan adequately describe the composition and roles of the Steering Committee (SC) and any other committees proposed to assist in managing the proposed activities?

Does the applicant include an evaluation plan that incorporates appropriate performance targets, objectives, and outcomes? Is the proposed evaluation plan well-conceived and described in sufficient detail to judge its utility for ongoing project management?

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

Reviewers will consider each of the review criteria below in the determination of scientific merit

Are the pilot project program and other activities in this core focused on minority health or other health disparities within the theme of the Center and likely to expand opportunities for post-doctoral fellows, junior faculty and early stage investigators to engage in multi-disciplinary and multi-level research?

Are the procedures and criteria for soliciting, submitting, reviewing and selecting projects clearly described and adequately justified in the overall context of the Center’s proposed theme, goals and objectives?

Are appropriate advisory and technical support resources in place to support rigorous research design and appropriate statistical analyses?

Are details provided about the expected number, distribution, direct costs and duration of pilot projects sufficient to support the potential for success, as well as program scope and impact?

Are plans for ensuring compliance with applicable Federal laws, regulations and policies for research involving human subjects adequately described?

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Will the project advance the knowledge and science of minority health and health disparities within the thematic focus area? Does the project have the potential to contribute to understanding or addressing minority health and health disparities on a broad scale? Does the application clearly specify how the project maps onto the NIMHD Research Framework?

Investigator(s)

Are the Project Lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? To what extent does the research project support the thematic focus?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 project 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 clear and appropriate conceptual model provided that guides the study design, selection of measures, and data analytic strategy?

If this project involves multidisciplinary study, is there an investigator record for transdisciplinary research and does the project involve appropriate collaborators?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

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.

Biohazards

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

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.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources

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.

Budget and Period of Support

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

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

Reviewers will consider each of the review criteria below in the determination of scientific merit:

• Are the community and stakeholder organizations/members appropriate for the proposed activities of the Center?
• Are strategies identified to keep community members and all stakeholders informed about Center activities and research findings?
• Are there plans to assess the effectiveness of community- and stakeholder-level engagement and dissemination efforts?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIMHD 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 Council on Minority Health and Health Disparities. 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.
• Geographic location

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.

Awardee-selected projects that involve human subjects or live vertebrate animals 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, NOT-OD-15-129 and NOT-OD-15-128.
• 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.
• If live vertebrate animals are to be involved, follow NOT-MD-08-002 and NOT-OD-16-006

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.

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

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:

• Coordinating project activities technically, scientifically and administratively at the recipient institution and coordinating project activities at other sites that may be supported by the award.
• Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
• Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
• Selecting external members for and participating in the Steering Committee.
• Organizing annual meetings of the Steering Committee.
• Consulting with NIMHD to ensure compliance with relevant grant policies and regulations
• Provision of information to the NIH Program Official and NIH Project Scientists.
• Participating in the Steering Committee meetings and other PD/PI meetings convened by NIMHD.

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

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

NIMHD will assign a Program Official (see below) and Project Scientist(s) to the award. The Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination.

The Project Scientists(s) will:

• Review and comment on critical stages in the program implementation;
• Assist in the interaction between the recipient and investigators at other institutions to promote collaborations;
• Retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
• Assist in coordinating access to other resources available through statewide, regional, or national specialized cores or resources.
• Convene meetings/workshops to address emerging areas of high priority.

Additionally, the NIMHD program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The Program Official will:

• Assist with the NIMHD’s monitoring of compliance of award-supported activities;
• Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
• Help ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer-reviewed funding mechanisms;
• Provide assistance in reviewing and commenting on all major transitional changes of center activities prior to implementation to ensure consistency with the goals of this FOA;
• Link the approaches developed from the NIMHD Center of Excellence to other NIMHD-supported activities to ensure that information is shared and utilized on the widest basis possible;
• Monitor institutional commitments and resources to help ensure that the center receives the maximum chance of stabilization and success;
• Assist with the NIMHD’s monitoring of financial oversight of the NIMHD Center of Excellence.

Areas of Joint Responsibility include:

• Establishing a Steering Committee consisting of: 1) the PD(s)/PI(s); 2) up to six other members selected by the PD(s)/PI(s) and to include at least two non-academic community stakeholders; 3) the NIMHD Program Official; and 4) the NIMHD Project Scientist(s). Each committee member will have one vote except for the NIH staff members, who will share one vote. The Steering Committee will convene by telephone as needed and will meet in person at least once a year.
• Identifying and facilitating partnerships with other NIMHD award recipients with expertise and/or interest health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of the center goals and objectives.
• Organizing and participating in the Steering Committee meetings at least annually.

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.

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: support@grants.gov

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

Derrick Tabor, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8950
Email:Derrick.Tabor@nih.gov

Thomas Vollberg, Sr. PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8770
Email:vollbert@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.