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 on Minority Health and Health Disparities (NIMHD) leads scientific research to improve minority health and reduce health disparities. NIMHD recognizes the unique and important role that institutions with historical commitment to training and serving diverse individuals have played in supporting scientific research and providing health care in underserved communities. These institutions are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes, but often lack the research infrastructure and capacity to conduct cutting edge health-related research. There is a compelling need to address this issue. The Research Centers in Minority Institutions (RCMI) program was originally established by NIH in 1985 as a result of congressional interest in the development of a program to expand the national capability for research in the health sciences.

The purpose of the RCMI Program is to expand the national capacity for research in the health sciences by providing cooperative agreement support to institutions that offer doctorate degrees in the health professions or in a health-related science and have a historical and current commitment to educating underrepresented students, and for institutions that deliver health care services, that provide clinical services to medically underserved communities. The primary goals of the RCMI specialized centers are to: (1) enhance institutional research capacity within the areas of basic biomedical, behavioral, and/or clinical research; (2) enable all levels of investigators to become more successful in obtaining competitive extramural support, especially from NIH, particularly on diseases that disproportionately impact minority and other health disparity populations; (3) foster environments conducive to career enhancement with a special emphasis on development of new and early career investigators; (4) enhance the quality of all scientific inquiry and promote research on minority health and health disparities; and (5) establish sustainable relationships with community-based organizations that will partner with the RCMI Institution.

The RCMI Research Coordination Network (RRCN), formerly known as the RCMI Translational Research Network (RTRN), was originally established in 2007 to enhance collaboration across RCMI institutions. The network is designed to engage all stakeholders in the RCMI institutions, increase the quality and efficiency of basic biomedical, behavioral, and clinical research, facilitate study participant recruitment and retention, and increase the efficiency of the implementation and dissemination of research advances to improved health outcomes among minority and health disparity populations.

The NIMHD's mission is to conduct and support research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to facilitate the development of research capacity in diverse institutions and research education of students/faculty to pursue basic biomedical, behavioral, and/or clinical research, particularly on diseases that disproportionately impact racial/ethnic minorities and other health disparity populations.

Every facet of the United States' scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. See NOT-OD-15-053.

The purpose of this funding opportunity announcement (FOA) is to provide infrastructure and research funding to support overall network coordination and collaboration, and to expand the Research Coordinating Center (RCC) and Data Coordinating Center (DCC) functions of the RRCN. The objective of the RRCN is to function as a Coordinating Center for all RCMI institutions. RRCN is not specific to one disease, but rather shares expertise and infrastructure across diseases and disciplines, leverages research resources at RCMI sites, and enables the flexibility to take advantage of research opportunities and address research needs as they arise in different disease areas. RRCN is a resource to support basic biomedical, behavioral, and clinical research. Of particular importance is to ensure continuation of the existing infrastructure and established research networks and data coordinating activities.

In addition, RRCN is a resource for engaging a broader spectrum of scientists and community partners in the minority health and health disparities research process, in the dissemination of research findings, and in the development and adoption of best practices to improve health outcomes. RRCN encourages collaborations with other NIH programs that could provide synergy with RCMI Institutions such as the NIMHD-funded COEs (

Specialized Centers of Excellence on Minority Health and Health Disparities) and TCCs (Transdisciplinary Collaborative Centers for Health Disparities Research Program), NCATS-funded CTSAs (Clinical and Translational Science Awards Program), the National Research Mentoring Network (NRMN), NIA's Resource Centers for Minority Aging Research (RCMAR) program and Alzheimer's Disease Research Centers, NIDDK's Network of Minority Health Research Investigators (NMRI), the NHLBI minority cohorts (Strong Heart Study, Jackson Heart Study, Hispanic Community Health Study[HCHS]/Study of Latinos [SOL], Multi-Ethnic Study of Atherosclerosis [MESA]), Cancer Centers, and others that would apply.

The activities described for this FOA must include the organization and management of the RRCN and infrastructure for overall network coordination (administrative core), research study coordination, data coordination, and overall evaluation of RCMI programs (evaluation core). Shared network infrastructure will consist of Research Coordinating Center (RCC) and Data Coordinating Center (DCC) to support all RCMI institutions.

The organization and management functions (administrative core) must include, but are not limited to:

• Leadership and project management for the administrative, research coordinating, data coordinating, and evaluation functions;
• An Administrative Core that provides both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among all RCMI institutions;
• Administrative support for RRCN activities including, but not limited to scheduling and hosting teleconferences, web meetings, and face-to-face meetings; especially monthly telephone meetings of the RCMI institutions organized around the three themes - basic biomedical, behavioral, and clinical research;
• Coordination of Steering Committee (SC) and External Advisory Committee activities including, but not limited to organizing teleconferences and in-person meetings, and maintaining documentation such as meeting minutes;
• Coordinating the activities of Steering Sub-committees and Working Groups as needed;
• Preparation of reports to NIH and other funding or regulatory agencies;
• Coordinating and enhancing communication, marketing and outreach of the RCMI/ RRCN activities and research findings including management of the public RRCN website content (with information of all RCMI institutions), newsletter, and other social media;
• Planning an annual RRCN meeting with RCMI network investigators.

RCC functions must include, but are not limited to:

• Engaging RCMI Institutions and scientists in basic biomedical, behavioral, and clinical research;
• Facilitating collaboration and resource sharing within the RCMI network;
• Facilitating collaboration of the RCMI/ RRCN with other academic institutions, community-based organizations, federal agencies or programs, and industry partners who are engaged in research, training and educational activities focused on reducing disparities and improving the health status of minority populations;
• Coordinating IRB and other human subject issues for the multi-site studies and providing IRB consultation for RCMI institutions;
• Providing methodological consultation on research design or other content experts to RCMI institutions;
• Coordinating, documenting, and tracking all communication, and reporting between the RCC, multi-site network study sites, single IRB or IACUC of record, which includes but is not limited to maintaining documentation of initial approvals, amendment approvals, and adverse event reports, Good Clinical Practice (GCP) and training certifications, and other reports;
• Working closely with the DCC in a collaborative and interactive manner and developing RCC standard operating procedures (SOPs);
• Soliciting, selecting, and conducting at least 3 multi-site network projects over the 5 years with one each in basic biomedical, behavioral, and clinical research. The projects will be led by principal investigators from one of the sites. RRCN will provide support to the study sites, including potential ad-hoc sites with respect to performance monitoring and potential interventions, and clinical coordination and project management.

DCC functions must include, but are not limited to:

• Providing DCC Standard Operating Procedures (SOPs) including, but not limited to all aspects of data management and data quality control;
• Providing statistical and other analytical support to multi-site network projects; providing statistical, informatics, and data management expertise to RCMI institutions;
• Establishing a secured, centralized web-based, user-friendly data hub for all multi-site network studies and other RCMI data; promoting standardization of data collection across multi-site network studies; preparing and releasing data sets for public use;
• Ensuring all human subjects data is handled securely to ensure privacy and confidentiality; resolving final queries, finalizing reporting to the DSMB and other boards as applicable;
• Providing staff training and certification, answering database questions and resolving technical issues for database users;
• Working with the RCC, Administrative Core, study sites, and network members, to create a public website as platform for recruitment and outreach efforts for all multi-site network projects.
• Working with the RCC and network investigators in the publication of the primary and, if applicable, secondary manuscripts.
• Overseeing data quality control, including but not limited to regular data queries and data monitoring and cleaning to assure data completeness and quality.

The Evaluation Core functions must include, but are not limited to:

• Supporting and coordinating the ongoing evaluation of RRCN and all RCMI activities;
• Setting up a tracking system to collect standardized metrics of RCMI NIH-funded studies and studies funded by other government agencies, industry or foundations; RCMI publications; scholar training and pilot project support; and other contributions made by investigators at RCMI institutions that address the health of minorities and health disparities in general;
• Evaluating increased efficiency of collaborative basic biomedical, behavioral, and clinical research involving RCMI institutions by implementation of biological and research material transfer agreements, single IRBs and/or other collaborative agreements;
• Assessing RRCN/RCMI engagement of a broader spectrum of scientists and community partners in the minority health and health disparities research, dissemination of research findings and development and adoption of best practices to improve health outcomes.

The findings of this evaluation will determine whether the RRCN is continued as configured, continued with modifications, or discontinued. Should the findings indicate that the program is no longer needed or is ineffective, then NIMHD may consider terminating the program.

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.

Eligibility for this FOA is limited to grantees currently funded via the RCMI program through PAR-11-132, PAR-13-279 and RFA-MD-17-003

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.

PDs/PIs should be experienced with the RCMI program, working with RCMI investigators and have the ability to forge new and continuing collaborations.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

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

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

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 M. Vollberg, Sr., Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8770
Fax: 301-480-4049
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits (per core)
Overall	6
Admin Core (use for Administrative Core)	12
Res Coord Ctr Core (use for Research Coordinating Center Core)	12
Data Coord Ctr Core (use for Data Coordinating Center Core)	6
Evaluation Core	6

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required; maximum of 1
• Research Coordinating Center Core:required; maximum of 1
• Data Coordinating Center Core: required; maximum of 1
• Evaluation Core: required; maximum of 1

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

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

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

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

Biographical Sketch

The PD/PI should highlight their experience related to RCMI and experience working

with RCMI investigators.

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. The amount of effort for the PD(s)/PI(s) must be commensurate with the requirements of the position and not less than 20% (two person months) each and sum to not less than 50% (six person months). For PD(s)/PI(s) of an eligible RCMI, a decrease of commitment from the level approved at the start of the last non-competing continuation type 5 award is not allowable and should be indicated in the application. This level of effort is required whether or not salary is requested.

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 RRCN and summarize how the proposed components and activities will provide infrastructure and research funding to support overall network coordination and collaboration, expand RCC functions and DCC functions

of the network, and overall evaluation of RCMI activities.

Research Strategy: Each applicant must assess and plan a program to address its own research needs and vision. The applicant must describe and justify how existing and requested resources will be utilized and leveraged to implement the institutional plan to

develop, expand, and maintain an environment and framework suitable for achieving the objectives of RRCN.

The overall Research Strategy section must include a Program Overview that describes:

• The significance of the minority health and health disparities research efforts that are a part of its institutional priorities.
• An analysis of organizational, educational, and scientific strengths and weaknesses.
• How the proposed activities will address research infrastructure need.
• Goals for the RRCN during proposed project period.
• A summary of the key activities that will be conducted to achieve each of the proposed goals.
• Innovation of the proposed activities.
• Specific institutional commitments that will be made to support the RRCN goals.

The governance and organizational structure of the leadership team should be described, including communication plans, process for making decisions regarding the RRCN, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities should be delineated for the leadership team.

Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) that:

• Indicate the commitment of the institution to the RRCN goals and how the network activities will be integral to the broad institutional vision for minority health and health disparities research.
• Specify any institutional support if available, for example financial support, dedicated space, salary support for professional or administrative staff, interface with other grants, centers, and initiatives, etc.
• Indicate the commitment of the institution to participate in the RRCN consortia and other national consortia working towards developing, adopting and implementing best practices in minority health and health disparities research.

Multiple PD/PI Plan: If Multiple PDs/PIs are proposed, and a budget allocation is proposed, the distribution of resources to specific components of the project or the individual PD(s)/PI(s) must be delineated in the Leadership Plan.

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 '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 forms appropriate for the specific component will be included in the application package. The amount of effort for the PD(s)/PI(s) must be commensurate with the requirements of the position. The sum of each PD/PI's effort on all components must be not less than 20% (2.4 person months) each and sum to not less than 50% (six person months). For PD(s)/PI(s) of an eligible RCMI, a decrease of commitment from the level approved at the start of the last non-competing continuation type 5 award is not allowable and should be indicated in the application. This level of effort is required whether or not salary is requested.

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 the Administrative Core.

Research Strategy: Applicants must describe how the Administrative Core will manage, coordinate and supervise the entire range of proposed activities; monitor progress; and ensure that component plans are implemented. Applicants must explain the roles and responsibilities of Administrative Core personnel including scientific leadership, and administrative management and coordination of the proposed activities.

Applicants must also provide proposed programmatic activities (e.g., annual RRCN meeting, monthly conference calls with RCMI institutions organized around the three themes, seminars, workshops or other activities) to support the network, as appropriate. Applicants must provide evidence of how the proposed activities will be integrated across the RCMI institutions.

A management plan describing the RRCN's organizational and governance structure must be included. Plans to manage and, where necessary, reassign institutional resources among the schools and/or departments should be described.

The management plan should describe the composition and roles of any committees proposed to help manage the RRCN activities. RRCN must have a Steering Committee and an External Advisory Committee (EAC). EAC should include representatives from the target communities, external scientific advisors, and institutional scientists not directly supported by the RCMI. External scientific advisors should be named only in those instances where they were consulted and provided input on this application and/or in the case of renewal for the past award. Other potential members for future advisory meetings must not be named but should be described for their qualifications. Applicants must describe the type of expertise of the members that will be recruited for the EAC. Meetings should occur at least every year. The EAC should review structure and progress and offer recommendations to the PD/PI(s) on an annual basis.

Applicants must describe plans of communication, marketing and outreach of the RCMI/ RRCN activities and research findings including management of the public RRCN website content (with information on all RCMI institutions), newsletter, and other social media.

The Program Director(s)/Principal Investigator(s) should provide plans that support an annual RRCN meeting with network investigators and NIMHD staff. These meetings will provide a forum for the exchange of ideas, and to address any concerns, needs, and problems that arise. In addition, NIH staff will provide updates on policies and regulations that relate to the conduct of minority health and health disparities research. The emphasis of these meetings is to present research by investigators at RCMI institutions including scholars who receive pilot projects/funds, provide common NIH support and review the multi-site network studies.

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)

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 'Res Coord Ctr 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 Coordinating Center 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 Coordinating Center Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Coordinating Center 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) (Research Coordinating Center 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 Coordinating Center Core)

• 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 Coordinating Center Core)

Budget forms appropriate for the specific component will be included in the application package. The amount of effort for the PD(s)/PI(s) must be commensurate with the requirements of the position. The sum of each PD/PI's effort on all components must be not less than 20% (2.4 person months) each and sum to not less than 50% (six person months). For PD(s)/PI(s) of an eligible RCMI, a decrease of commitment from the level approved at the start of the last non-competing continuation type 5 award is not allowable and should be indicated in the application. This level of effort is required whether or not salary is requested.

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 Coordinating Center Core)

Specific Aims: Describe the specific aims for the Research Coordinating Center Core

Research Strategy: The applicants must describe how they plan to engage scientists across RCMI institutions and other stakeholders in the minority health and health disparities research. They should include plans to reach out to and engage scientists across the RCMI institutions in RRCN activities. Plans are also needed in outreach to investigators outside of the RCMI institutions.

The applicants must include a plan to increase the quality and efficiency of basic biomedical, behavioral, and clinical research. The proposed plan should optimize minority recruitment in clinical studies. The applicants must describe plans to coordinate IRB and other human subject issues for the multi-site studies and providing IRB consultation for RCMI institutions.

The applicant must describe plans to provide methodological consultation on research design or other content experts to RCMI institutions;

The applicants must include research objectives of potential multi-site network studies (at least three over 5 years with one each in basic biomedical, behavioral, and clinical research). The applicants must describe how multi-site studies will be facilitated and implemented by the network. Applicants must specify the objectives of the multi-site research projects that account for not less than 30% of direct costs per year (not including consortium direct costs). A subset or all of the RCMI Sites will participate in a given multi-site project, depending on their capacity, interest, and patient population relevant to the specific protocol. It is also possible that non-network sites may be added ad-hoc for a specific project, for their expertise and/or patient population to complement network sites. The applicants must explain how the proposed network studies will serve to advance scientific knowledge to improve minority health and/or reduce health disparities. The multi-site studies can include the following three phases: Conceptual and Planning Phase (1st year), Implementation Phase (2nd -4th years), and Analysis and Publication Phase (5th year).

The applicants must include a performance monitoring and potential interventions implementation plan. The applicants must describe a research coordination and project management plan with standard operating procedures (SOPs) or workflows that can lead to successful coordination and project management.

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 Human Subjects and Clinical Trials Information (Research Coordinating Center Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for in the SR424 (R&R) Application Guide

Data Coordinating Center Core

When preparing your application in ASSIST, use Component Type 'Data Coord Ctr Core.'

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

SF424 (R&R) Cover (Data Coordinating Center 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 (Data Coordinating Center Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Coordinating Center 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.

Application guide states that Project Narrative is required

Project /Performance Site Location(s) (Data Coordinating Center 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 (Data Coordinating Center Core)

ASSIST will default to "Project Lead". If you would like to use a different category, then replace "Project Lead" below with a different Category (e.g., Core Lead).

• 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 (Data Coordinating Center Core)

Budget forms appropriate for the specific component will be included in the application package. The amount of effort for the PD(s)/PI(s) must be commensurate with the requirements of the position. The sum of each PD/PI's effort on all components must be not less than 20% (2.4 person months) each and sum to not less than 50% (six person months). For PD(s)/PI(s) of an eligible RCMI, a decrease of commitment from the level approved at the start of the last non-competing continuation type 5 award is not allowable and should be indicated in the application. This level of effort is required whether or not salary is requested.

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 (Data Coordinating Center Core)

Specific Aims: Describe the specific aims for the Data Coordinating Center Core

Research Strategy: The applications must describe a data management, quality assurance and monitoring plan. A rigorous error and query resolution process is needed to monitor data quality throughout the collection process. The procedures for security and protection of personal health information should be described. The measures to facilitate data sharing and dissemination and data security and privacy need to be included.

The applicants must describe a statistical, informatics, and data management support plan. It should include how DCC will support the statistical aspects of studies from the conceptual and planning phase, to the implementation phase, and the analysis and publication phase.

The applicants must describe a plan to establish a secured RRCN data hub for multi-site studies and other RCMI data in a format (e.g., de-identified) appropriate and available to all RCMI awardees.

The applicants must describe a collaboration and communications plan. Strengths or special expertise to enhance collaborative efforts should be included.

The applicants must describe a project management and coordination plan. The SOPs and other documents used by the DCC in the implementation of multi-site network studies should foster effective project management and coordination.

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 Human Subjects and Clinical Trials Information (Data Coordinating Center Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for in the SR424 (R&R) Application Guide

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

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

SF424 (R&R) Cover (Evaluation 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 (Evaluation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Evaluation 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) (Evaluation 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 (Evaluation Core)

ASSIST will default to "Project Lead". If you would like to use a different category, then replace "Project Lead" below with a different Category (e.g., Core Lead).

• 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 (Evaluation Core)

Budget forms appropriate for the specific component will be included in the application package. The amount of effort for the PD(s)/PI(s) must be commensurate with the requirements of the position. The sum of each PD/PI's effort on all components must be not less than 20% (2.4 person months) each and sum to not less than 50% (six person months). For PD(s)/PI(s) of an eligible RCMI, a decrease of commitment from the level approved at the start of the last non-competing continuation type 5 award is not allowable and should be indicated in the application. This level of effort is required whether or not salary is requested.

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 (Evaluation Core)

Specific Aims: Describe the specific aims for the Evaluation Core

Research Strategy: Applicants must describe an evaluation plan that includes logic model and key milestones for the overall program and for RRCN and all RCMI activities. The plan should evaluate the short-term and long-term goals for each of the proposed activities. The milestones and timelines should provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed. Applicants should describe the measures for the program's goals to be assessed and how accessible and practical are the available data sources.

The applicants must describe a plan to set up a tracking system to collect standardized metrics of RCMI NIH-funded studies and studies funded by other federal government agencies, foundations, State government agencies and industry; RCMI-supported peer-reviewed publications and other publications (e.g., book chapters, editorials, and non-peer-reviewed articles); scholar pilot project support and outcomes in terms of future funding and publications; and other contributions made by investigators at RCMI institutions that address the health of minorities and health disparities in general.

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 Human Subjects and Clinical Trials Information (Evaluation Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for in the SR424 (R&R) Application Guide

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMHD, 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 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.

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? To what extent are the proposed RRCN components and activities likely to enhance network research capacity for basic biomedical, behavioral, and clinical research and to foster coordination and collaboration?

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

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

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

To what extent are the proposed RRCN components and activities likely to help all RCMI institutions become more successful in collaborations especially multi-site studies?

To what extent are the proposed RRCN components and activities likely to enhance and sustain productive collaborations and partnerships within and outside RCMI institutions?

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 RRCN components and activities likely to foster environments conducive to network coordination and collaboration?

To what extent do the institutional letters of support indicate that the applicant institution is fully committed to achieving the goals and objectives of the proposed RRCN, and that the network will be integral to achieving the broad institutional vision for minority heath and health disparities research?

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.

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

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

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

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

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

Not Applicable

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

Not Applicable

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

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:

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

Are the plans for the Steering Committee and External Advisory Committees indicative that they will be constituted to provide critical, stimulating, and thoughtful advice for the overall performance of RCC and DCC activities? Is the governance structure designed to ensure both accountability and integration of the components of the RCC and DCC into a coherent program? Are plans for leadership and management of specific RCC and DCC activities adequate? Are the plans for annual RRCN meeting and monthly conference calls with RCMI institutions adequate? Is there a well-formulated and developed plan for communication and outreach including RRCN website?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Coordinating Center Core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria:

How well do plans reach out to and engage scientists across the RCMI institutions in RRCN activities? To what extent and success, can the described plans be expected to result in outreach to investigators outside of the RRCN institutions? Are the outreach plans proposed likely to increase interest and participation in RRCN activities or studies?

How adequate and likely to be effective are plans to implement at least three multi-site network studies (basic biomedical, behavioral, and clinical research)? Are general plans of three phases described adequately in planning, implementing, and analyzing multi-site studies and are effective strategies to be employed? How well are the proposed network studies likely to serve to advance scientific knowledge to improve minority health and/or reduce health disparities?

Are the proposed plans likely to reduce start-up time of multi-site studies through the use of standardized master trial agreements? Are the proposed plans likely to optimize minority recruitment in clinical studies?

Are the plans to provide methodological consultation on research design or other content experts to RCMI institutions adequate and likely to be effective?

Are general plans for monitoring performance, study start-up, recruitment and retention and data quality adequate for assessing performance and implementing potential interventions?

Are the proposed list of standard operating procedures (SOPs) or workflows used by the RCC comprehensive and likely to lead to successful research coordination and project management?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Data Coordinating Center Core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria:

Will data be collected and presented in a user-friendly manner, with a user interface directed at the experience and knowledge of users? Will there be seamless integration of data from disparate sources? Are plans to validate data comprehensive? Is there a rigorous error and query resolution process, which monitors data quality throughout the collection process? Are procedures for security and protection of personal health information well-developed? Are measures to facilitate data sharing and dissemination appropriate? Will data security and privacy be safeguarded?

Is the plan on statistical, informatics, and data management support adequate?

Will the statistical aspects of studies from the conceptual and planning phase, the implementation phase and the analysis and publication phase be appropriately supported by the DCC?

Has the applicant demonstrated that multi-site network studies can be effectively supported? Are databases and other tools available to support multi-site studies? Will the list of SOPs and other documents used by the DCC to support the implementation of multi-site network studies foster effective project management and coordination?

Is there a plan to establish a secured RRCN data hub for multi-site studies and other RCMI data in a format (e.g., de-identified) appropriate and available to all RCMI awardees? Is there a collaboration and communications plan?

Are the DCC plans for communication with the RCC and study sites within the network appropriate? Are there unique strengths or special expertise to enhance collaborative efforts (e.g., established database tools, hardware, software, quality control tools, monitoring expertise, team leadership and training?)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Evaluation Core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria:

Does the application include an evaluation plan that includes logic model and key milestones for the overall RRCN and all RCMI activities? Is the plan to set up a tracking system adequate to evaluate contributions made by RCMI institutions that address the health of minorities and health disparities in general? Is the plan adequate to evaluate the short-term and long-term goals for each of the proposed activities? Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed? Are the measures valid for the program's goals to be assessed and how accessible and practical are the available data sources?

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 on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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
• History of successful interactions with the RCMI program.

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 {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 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:

• Supporting the Key Component Activities;
• Working towards developing, adopting and implementing the agreed-upon policies, procedures, best practices, or other measures;
• Providing information to the NIH Program Officer(s) and Project Scientist(s) concerning progress;
• Participating in the overall coordination of NIMHD efforts in minority health and health disparities research; this participation may include collaboration and consultation with other research awardees, and the sharing of information, data and research materials.
• 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, Project Scientist(s), and a Grants Management Specialist to the RRCN.

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

• assist in coordinating activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new clinically useful resources and methodologies;
• review and comment on critical stages in the program implementation;
• assist in the interaction between the awardee and investigators at other institutions to promote collaborations;
• assist in coordinating access to other resources available through statewide, regional, or national specialized technology cores;
• 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;
• retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
• convene meetings/workshops to address emerging areas of high priority.

An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The program official(s) will:

• assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
• 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;
• 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 RRCN activities prior to implementation to ensure consistency with the goals of this FOA;
• link the approaches developed from RRCN to other NIMHD supported networks to ensure that information is shared and utilized on the widest basis possible;
• monitor institutional commitments and resources to ensure that RRCN receives the maximum chance of stabilization and success;
• assist with financial oversight of the Program.

Additionally, the NIH Program Official(s) may recommend the termination or curtailment of an

activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:

Awardees agree to governance, through voting and decision making, of the RRCN through a Steering Committee. Steering Committee voting membership shall consist of the Principal Investigator(s), NIMHD Program staff [Program Official and Project Scientist(s)]. Quarterly meetings of the Steering Committee will be held in the first year of the award. One of these meetings must be an in-person meeting in Bethesda, MD. Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period. Each member of the Steering Committee will have one vote. The RRCN leadership will be required to accept and implement policies approved by the Steering Committee.

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 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

Xinzhi Zhang, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-6136
Email: [email protected]

Thomas M. Vollberg, Sr., Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8770
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD
Telephone: 301-594-8412
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.