Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Minority Health and Health Disparities (NIMHD)
Funding Opportunity Title	Limited Competition: Transdisciplinary Collaborative Centers for Health Disparities Research Coordination Center (U54)
Activity Code	U54 Specialized Center- Cooperative Agreements
Announcement Type	New
Related Notices	May 7, 2014 - See Notice NOT-MD-14-002. Notice of Cancellation.
Funding Opportunity Announcement (FOA) Number	RFA-MD-14-002
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.307
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) invites applications to establish a Coordination Center to facilitate and support consortium-wide activities for NIMHD Transdisciplinary Collaborative Centers (TCCs) for Health Disparities Research. The TCC Coordination Center will serve as the focal point for disseminating TCC consortium information to the broader research community and public, including research results, scientific data, and methods to assess the impact of consortium activities on health disparities locally, regionally and nationally.

Posted Date	April 16, 2014
Open Date (Earliest Submission Date)	May 19, 2014
Letter of Intent Due Date(s)	May 19, 2014
Application Due Date(s)	(New Date May 7, 2014 per NOT-MD-14-002), Originally June 19, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July 2014
Advisory Council Review	August 2014
Earliest Start Date	September 2014
Expiration Date	(Now Expired May 8, 2014 per NOT-MD-14-002), Originally June 20, 2014
Due Dates for E.O. 12372	Not Applicable

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

Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIMHD Transdisciplinary Collaborative Centers (TCC) for Health Disparities Research program supports regional coalitions of academic institutions, community organizations, service providers and systems, government agencies and other stakeholders focused on priority areas in minority health and health disparities. The goals of the TCC program are to (1) develop centers that break organizational barriers between multiple systems and pursue a systems change approach to improve health or decrease disparities; (2) create new partnerships and research hubs that accelerate translation of research advances to improve health outcomes; (3) innovate comprehensive cross-systems solutions in the field of health; (4) develop scientific evidence to inform policy change; and (5) coordinate efforts of leaders from many fields to address social determinants of health and health policy with more robust networks.

Collaboration at the regional and national levels enables institutions and organizations to achieve a much broader reach than is possible with isolated local efforts, while fostering applied research that is uniquely responsive to specific factors that influence health within a particular region. To ensure that TCCs contribute optimally and effectively to national minority health and health disparities research efforts, the overall direction and scope of activities supported by the TCC program will be coordinated and monitored by an TCC Program Coordinating Committee consisting of TCC PDs/PIs and NIMHD program staff. A major function of this committee is to periodically assess progress toward program goals and promote information exchange across regions and nationally through the TCC consortium.

Establishment of a TCC Coordination Center (TCC-CC) is intended to support TCC consortium activities and increase the efficiency of translational health disparities research by leveraging expertise, infrastructure, and research resources across the TCC sites. This includes promoting the flexibility for TCC sites to take advantage of opportunities for multi-site collaborations that address research needs as they arise in the various areas. The TCC-CC will also serve as a resource to promote broad dissemination of TCC research advances and implementation of best practices to improve health outcomes. TCC-CC activities will emphasize consensus building with significant involvement of all TCC PDs/PIs in priority setting and process development.

The TCC-CC will consist of an Administrative Core for management of coordination activities, a Research Coordination Core (RCC), and a Data Coordination Core (DCC).

The Administrative Core will provide both an organizational and an administrative structure that is conducive for ensuring collaborative efforts and interaction among all TCC PDs/PIs, research and community investigators, and other stakeholders. Essential functions include, but are not limited to:

• Project management support for collaborative consortium projects involving two or more TCCs;
• Leadership and project management of RCC and DCC activities;
• Administrative support for collaborative consortium activities including, but not limited to scheduling, hosting, and providing minutes of consortium teleconferences, web meetings, and face-to-face meetings, including TCC Program Coordinating Committee meetings;
• Preparation of TCC-CC activity reports to NIMHD;
• Providing evaluation support and statistical data resources for each TCC as needed;
• Coordinating and enhancing communication, marketing and outreach of the TCC consortium, including hosting and maintaining a public TCC-CC website.

The Research Coordination Core (RCC) will be responsible for working with TCC PDs/PIs and key investigators to facilitate consortium projects and ensure that collaborative activities address TCC program goals and objectives. The RCC will also provide support and guidance as needed to help investigators develop feasible study designs, e.g., consultation on project work scope and timeline, protocol design and schedule of activities, assessing numbers of potentially eligible participants at proposed sites, and inclusion of community representatives' perspective in the conceptual process. Essential RCC functions include, but are not limited to:

• Facilitating collaboration and resource sharing among TCCs, other academic institutions, community-based organizations, government agencies or programs, and industry partners engaged in multi-site consortium projects;
• Coordinating, documenting, and tracking all communication and reporting of NIMHD-approved activities involving human subjects or live vertebrate animals, between the RCC, consortium study sites, central Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) of record, and local IRBs and IACUCs as applicable, along with documentation of adverse event reports, Good Clinical Practice (GCP) and training certifications, and other reports as needed to support consortium projects;
• Providing coordination and resource support for recruitment efforts at TCC study sites to ensure tracking of enrollment efforts and adequate inclusion of racial and ethnic minorities for valid analysis.
• Registering multi-site Phase III trials with http://www.clinicaltrials.gov

The Data Coordination Core (DCC) will collaborate with TCC PDs/PIs and the RCC to develop data management standard operating procedures (SOPs) for multi-site consortium projects, including support for reviewing study protocols, scope of work, budget and timelines for database building, and related services. During the planning phase of approved projects, the DCC will work with project investigators and the RCC to develop plans for data management, data quality assurance, and data monitoring. During project implementation, the DCC will provide support for all aspects of data management. The DCC team is expected to include an experienced programmer and project manager. Essential DCC functions include, but are not limited to:

• Developing and maintaining communication platforms/websites for recruitment and outreach efforts, and for storing/sharing study documents, protocols and amendments, manuals of procedures, case report forms, etc.;
• Providing statistical consultation and analytical services as needed during development and execution of consortium projects;
• Establishing and maintaining secure databases and providing staff training as needed;
• Working with the RCC to report and track study status, including participant enrollment and retention and reporting of adverse events;
• Overseeing data quality control, including but not limited to regular data queries and data monitoring and cleaning to assure data completeness and quality;
• Ensuring that human subjects data is handled securely to ensure privacy and confidentiality;
• Supporting and promoting data sharing after study completion by preparing final data sets for submission to a secure data repository after publication of primary study results as appropriate and consistent with achieving the goals of the program;

The RCC and DCC will work in a collaborative manner. Development of their respective SOPs will require close collaboration with TCC PDs/PIs based on jointly developed plans. It is essential that the tasks required in planning and executing complex, multi-site studies be clearly defined, and that the responsibilities of the RCC and DCC be clearly delineated.

The TCC-CC is expected to enhance consortium functions as evidenced by measurable advances based on metrics that will include, but are not limited to:

• Increased TCC translational research capacity to address minority health and health disparities through implementation of multi-site pilot/developmental studies, coordinating activities, dissemination activities and efforts to promote inclusion of health disparity populations in studies funded by NIH and other agencies and the private sector;
• Increased efficiency of collaborative clinical and translational research involving TCC institutions, e.g., by implementation of material transfer agreements, central IRBs and/or other collaborative agreements;
• Engagement of a broader spectrum of scientists, community partners and stakeholders in the translational research process, dissemination of research findings and development and adoption of best practices to improve health outcomes;
• Development of consortium-wide approaches and metrics to assess local and regional impact of individual TCC programs on health disparities and the national impact of the consortium.

The TCC-CC will facilitate broad dissemination of TCC research advances in three current priority areas: social determinants of health, health policy research, and men's health. Consortium-wide dissemination activities are expected to complement and extend ongoing dissemination efforts at individual TCC sites and enhance targeted delivery of new knowledge, evidence-based interventions, and best practices to relevant stakeholders, particularly TCC community partners and service agencies, to achieve greater use and impact of effective interventions.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIMHD intends to commit $2 million in FY 2014 to fund one award.
Award Budget	The award budget may not exceed $2 million in annual total costs.
Award Project Period	The maximum award project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

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

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

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

Eligible applicant organizations are limited to active NIMHD Transdisciplinary Collaborative Center (TCC) U54 awardees.

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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
• Number and title of this funding opportunity announcement

The letter of intent should be sent to:

Maryline Laude-Sharp, PhD
National Institute on Minority Health & Health Disparities
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465
Telephone: 301-451-9536
Fax: 301-480-4049
Email: mlaudesharp@mail.nih.gov

Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
Core (use for Research Coordination Core and Data Coordination Core)	12

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

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

The application should consist of the following components:

Overall Component: required
Administrative Core: required
Research Coordination Core: required
Data Coordination 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.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities and Other Resources: Describe the TCC-CC environment and existing resources that will be utilized or leveraged to implement the proposed plan.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Specific Aims: Concisely state the specific aims for the TCC-CC and explain how the proposed activities will enhance the overall goals of the TCC Program, facilitate and enhance local TCC activities, and increase the efficiency of translational health disparities research focused on improving minority health and eliminating health disparities in the United States.

Research Strategy: Describe the general approach proposed for coordinated activities to enhance translational research across the consortium and to develop solutions to address any barrier(s) for coordination of multi-site research activities. Address innovation in the proposed coordination center functions and activities and describe how they will add value to the individual TCCs and the consortium as a whole. Include a timeline with milestones for collaborative development of consortium priorities and initiation of consortium-wide projects. Describe how the TCC-CC will work with the TCC Program Coordinating Committee to support periodic assessment of progress toward program goals and promote information exchange across regions and nationally through the TCC consortium.

Letters of Support: Applications must include letters from the appropriate high-ranking institutional official(s) from TCC institutions/organizations and other key partners, including all TCC PDs/PIs, that commit the institution(s) or organization to the TCC-CC's goals and objectives, indicating how the program will be integral to their broad vision of translational research efforts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

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.

SF424 (R&R) Cover (Administrative 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 (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

List all performance sites that apply to the specific component

Research & Related Senior/Key Person Profile (Administrative 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 (Administrative 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 (Administrative Core)

Specific Aims: Concisely state the specific aims of the Administrative Core and describe how they relate to and support the overall aims of the TCC-CC.

Research Strategy: Describe the management functions and governance structure of the administrative core, along with plans for supporting management of collaborative consortium activities. Describe how the core will coordinate and support the work of the TCC Program Coordinating Committee. Describe how the core will provide leadership and oversight for the Research Coordination Core (RCC) and the Data Coordination Core (DCC). Describe plans for coordinating and supporting consortium-wide dissemination activities, collaborations and partnerships, communication, and outreach.

Evaluation Plan: Applications must provide detailed performance milestones and a timeline that will be used to measure progress in each budget period toward the goals of each core activity. Clearly describe (1) an overall detailed process and outcome evaluation plan for coordinating center activities, including milestones for each RCC and DCC activity, and milestones for the overall coordination; (2) plans for coordination of the evaluation resource support activities; (3) a clear description of interim objectives to be achieved for each activity during the course of the project; (4) potential impediments that could require a revision of the milestones with a discussion of possible solutions; (5) detailed quantitative and/or concrete criteria by which milestone achievement will be assessed; and (6) detailed schedules or timelines for the anticipated attainment of each milestone in each TCC-CC component and overall goals with alternatives should milestones not be reached. Where appropriate, applicants are encouraged to include plans to obtain feedback from the TCC PDs/PIs and investigators to help identify weaknesses and provide suggestions for improvement of coordinating center activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

When preparing your application in ASSIST, use Component Type 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 Coordination 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 Coordination Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Research Coordination 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.

Budget (Research Coordination Core)

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

PHS 398 Research Plan (Research Coordination Core)

Specific Aims: Concisely state the specific aims of the Research Coordination Core (RCC) and describe how they relate to and support the overall aims of the TCC-CC and the research priority areas being addressed by the TCCs.

Research Strategy: Describe the overall approach and clearly delineate how the RCC will involve the various TCC sites in the implementation of ongoing and proposed research activities. Include a timeline for planning and implementation of consortium projects and plans for dissemination of results across the consortium. Describe how the RCC will work with the TCC PDs/PIs and other TCC investigators in facilitating their research and collaborative activities to ensure the overall TCC consortium goals and objectives are met. Outline leadership plans for coordinating and tracking research and related collaborative activities, including resource sharing as appropriate. Describe coordination services and activities to provide resource support and information necessary to facilitate TCC pilot project programs and potential pilot projects for TCC investigators.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Research Coordination Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Coordination Core)

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

When preparing your application in ASSIST, use Component Type 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 Coordination Core)

Complete only the following fields:

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

Research & Related Other Project Information (Data Coordination 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) (Data Coordination Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Data Coordination 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 (Data Coordination Core)

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

PHS 398 Research Plan (Data Coordination Core)

Specific Aims: Concisely state the specific aims of the Data Coordination Core and describe how they relate to and support the overall aims of the TCC-CC.

Research Strategy: Describe plans for data coordinating activities, including (1) data management; (2) data quality assurance; (3) data-sharing plans and data communication with the TCC sites; (4) data monitoring and tracking; and (5) statistical support for the TCC sites, as appropriate. Also describe how the DCC will work with the RCC in a collaborative manner to ensure successful execution of consortium-approved projects.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Research Coordination Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Coordination Core)

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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 by the Center for Scientific Review and responsiveness by NIMHD. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the TCC Coordination 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 TCC Coordination Center activities proposed).

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

Significance

Does the coordination center activity address an important problem or a critical barrier to progress in the field? If the aims of the coordination 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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the coordination 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?

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? Is the coordination center likely to develop and implement novel approaches to increasing the efficiency of translational health disparities research across the TCC sites to advance health disparities science?

Approach

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

If the coordination center activity 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?

Does the application clearly describe and justify how existing and requested resources will be utilized to implement plans to develop an environment and framework suitable for achieving the objectives of the TCC-CC? Do the proposed activities foster active and significant collaboration among TCC investigators? Does the application identify key obstacles to coordination activities and the performance of multi-site research, and then propose plans or means to overcome these? Is an implementation phase for all core components clearly described? Is the timeline for developing consortium priorities and implementing consortium projects feasible, and are specific goals and milestones appropriate to guide successful execution? Are alternatives proposed should the goals and milestones not be reached in a timely manner?

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? Does the application make efficient use of potentially unique resources at the individual TCC sites? Will the proposed activities enhance, complement, and extend the current resources for translational research at TCC institutions and partner organizations in the consortium?

As applicable for the coordination 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.

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 coordination center activities 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

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) Genome Wide Association Studies (GWAS).

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.

As applicable for the coordination 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.

Governance and Management

Is the Administrative Core component well suited to provide critical, stimulating, and thoughtful advice for the overall performance of the proposed TCC-CC and its 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?

Evaluation Plan

Does the application include an evaluation plan that includes key milestones for the overall coordinating center program and for each proposed activity? 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?

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

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) Genome Wide Association Studies (GWAS).

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.

As applicable for the coordination 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.

Consortium Research Coordination Activities

Are plans to actively engage members across the TCC consortium and partner institutions in the proposed TCC-CC activities likely to promote and facilitate collaborative translational research projects in priority areas being addressed by the individual TCCs? Are plans for collaborative development of protocols and monitoring protocol adherence and data quality at study sites adequate to ensure quality control and effective execution of consortium projects?

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 coordinating center activities 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

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) Genome Wide Association Studies (GWAS).

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.

As applicable for the coordination 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.

Consortium Data Coordination Activities

Are the proposed DCC plans for communication and collaboration with the RCC and the study sites within the TCC consortium appropriate and likely to facilitate achievement of consortium goals and objectives? 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, communications platforms, website design and management)? Will data be collected 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 the TCC consortium sites and other relevant 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? Are statistical support plans and other aspects well thought out and appropriately supported by the DCC?

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 coordinating center activities 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

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) Genome Wide Association Studies (GWAS).

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.

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 NIMHD 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.

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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 on 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 translational research; this participation may include collaboration and consultation with other translational 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 TCC-Coordinating Center.

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

The NIMHD Project Scientists(s) will:

• Coordinate 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;
• Coordinate 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 NIMHD 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:

• Enforce 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 TCC-CC activities prior to implementation to ensure consistency with the goals of this FOA;
• Link the approaches developed from TCC-CC 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 TCC-CC receives the maximum chance of stabilization and success;
• Provide financial oversight of the Program.

Additionally, the NIMHD 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:

The Awardee TCC-CC agrees to its governance, through voting and decision making, of the TCC-CC through a TCC Program Coordinating Committee. TCC Program Coordinating Committee membership shall consist of the Principal Investigators of the TCC-CC, the Principal Investigators of each active NIMHD TCC, NIMHD Program Official and the NIMHD Project Scientist. Quarterly meetings of the TCC Program Coordinating Committee will be held in the first year of the award and at least annually thereafter. One of these meetings must be an in-person meeting in Bethesda, MD. Frequency of meetings in succeeding years will be decided by the Program Coordinating Committee at the beginning of each budget period. The voting membership is restricted to one vote each per TCC award. The NIMHD Project Scientist will be the voting member and have one vote. The Program Official will be a non-voting member of the TCC Program Coordinating Committee. The TCC leadership will be expected to accept and implement policies approved by the TCC Program Coordinating 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 Program 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Irene Dankwa-Mullan, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8758
Email: dankwamullani@mail.nih.gov

Maryline Laude-Sharp, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-9536
Email: mlaudesharp@mail.nih.gov

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.