NIMHD Transdisciplinary Collaborative Centers for Health Disparities Research Focused on Precision Medicine (U54)

NIMHD Transdisciplinary Collaborative Centers for Health Disparities Research Focused on Precision Medicine (U54) is sponsored by National Institute on Minority Health and Health Disparities (NIMHD/NIH). This funding opportunity invites applications for Transdisciplinary Collaborative Centers (TCCs) for health disparities research exploring the potential for precision medicine to promote health equity and reduce health disparities.

Expired RFA-MD-15-013: NIMHD Transdisciplinary Collaborative Centers for Health Disparities Research Focused on Precision Medicine (U54) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute on Minority Health and Health Funding Opportunity Title NIMHD Transdisciplinary Collaborative Centers for Health Disparities Research Focused on Precision Medicine (U54) U54 Specialized Center- Cooperative Agreements July 7, 2015 - Notice of Correction to Award Information for RFA-MD-15-013.

See Notice NOT-MD-15-015 . June 17, 2015 - Notice of Correction to Eligible Organizations for RFA-MD-15-013. See Notice NOT-MD-15-011 .

June 12, 2015 - Notice of Technical Assistance Webinar for RFA-MD-15-013. See Notice NOT-MD-15-010 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity 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) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites applications for Transdisciplinary Collaborative Centers (TCCs) for health disparities research exploring the potential for precision medicine - an emerging approach that takes into account individual variability in genes, environment, and lifestyle - to promote health equity and reduce health disparities.

Priorities include: 1) development of new tools and analytic methods for integrating patient data with information about contextual factors acting at the community or population level to influence health; 2) development of pharmacogenomic and other precision medicine tools to identify critical biomarkers for disease progression and drug responses in diverse populations; 3) translation of pharmacogenomic discoveries into effective treatment or clinical practice; and 4) investigation of facilitators and barriers to implementing precision medicine approaches in disadvantaged populations.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) September 17, 2015 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity 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) September 17, 2015, by 5:00 PM local time of applicant AIDS-related applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement. 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.

** ELECTRONIC APPLICATION SUBMISSION REQUIRED** 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 (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 I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description Although scientific and technological advances have improved the health of the U.S. population overall, racial/ethnic minority populations, socioeconomically disadvantaged populations and rural populations continue to experience a disproportionate share of many diseases and adverse health conditions.

As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resources to characterize the root causes of health disparities, uncovering complex webs of interconnected factors (e.g., biological, behavioral, social and environmental factors) acting at multiple levels across the life course.

As an important next step, research is needed that capitalizes on this knowledge to develop interventions that reduce or eliminate health Tackling the complex drivers of health disparities requires a transdisciplinary framework that cuts across scientific and organizational silos to integrate multiple disciplines biology, behavioral and social sciences, environmental science, public health, health care, economics, public policy, etc. It also requires strong collaborations between researchers, community organizations, health service providers, public health agencies, policymakers and other stakeholders to ensure that relevant, contextually appropriate research is conducted and, more importantly, that findings can be translated into sustainable community and system-level changes that promote health equity.

NIMHD Transdisciplinary Collaborative Centers (TCCs) for health disparities research comprise regional coalitions of research institutions and consortium partners focused on priority research areas in minority health and health disparities. The TCC program's overarching goal is to develop and disseminate effective interventions that can be implemented in real-world settings.

The program is not intended to support activities targeting a single neighborhood, municipal jurisdiction, or service provider site in isolation; rather, TCC projects are expected to be regional in scope, population based, and placed in the context of regional or national efforts to Benefits from medical advances are not always distributed equitably, often because structural or systemic factors limit the effectiveness of new diagnostic or therapeutic approaches in disadvantaged populations.

Precision medicine ( http://www. nih. gov/precisionmedicine/ ) is an emerging approach for disease prevention, early detection and treatment that takes into account individual variability in genes, environment, and lifestyle.

While it holds great promise for improving patient care, its potential for reducing health disparities hinges on (1) better understanding of the dynamic interplay between biological, behavioral, social and environmental health risk and protective factors experienced across the life course, and (2) greater inclusion of health disparity populations in research aimed at developing precision medicine interventions.

An integrative, inclusive approach toward the development of precision medicine is vital for improving health risk assessment and using that information to predict optimal interventions that not only benefit individual patients but also extend health benefits equitably within and across patient populations.

TCCs supported through this initiative are expected to focus on at least one priority research area outlined below, each combining expertise in precision medicine, population health disparities, and the science of translation, implementation and dissemination to address one or more documented health disparities.

The proposed work must focus on one or more health disparities populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations and rural Each center will support 2-3 multidisciplinary research projects examining complementary aspects of precision medicine, focusing on interactions between biological, behavioral, and contextual predictors of disease vulnerability, resilience, and response to therapies in patients from disadvantaged communities.

For the purposes of this FOA, biological predictors can include but are not limited to genomic, epigenomic, proteomic, metabolomic, and microbiomic variations as well as standard clinical laboratory markers (e.g., blood lipids, inflammatory markers, HbA1c, vitamin D3, etc.), behavioral measures, and other quantitative or qualitative indicators of health status in Applications are expected to demonstrate substantive community input into the identification of research questions to be addressed by the proposed TCC and relevant contextual predictors to be examined in conjunction with biological predictors.

For the purpose of this FOA, community refers to a group or population that may be defined by geography, race, ethnicity, culture, gender, disease or other health condition, or a common health-related interest or concern. In addition to the required collaborative research projects, each TCC award will support an Administrative Core, a Consortium Core, and an Implementation Core.

The Administrative Core will manage and coordinate implementation of proposed TCC activities, including project evaluation; ensure that component plans are implemented according to proposed timelines; coordinate TCC Steering Committee activities and submission of annual progress reports; monitor progress on research sub-projects and ensure that TCC-supported research, including pilot projects, is carried out in compliance with applicable federal regulations and policies.

The Consortium Core will serve as a focal point for organizing and nurturing productive working relationships with consortium partners. Research shows that diverse teams working together to capitalize on innovative ideas and distinct perspectives outperform homogenous teams.

Moreover, involving community stakeholders in needs assessment, project planning and design, implementation, and dissemination of results enhances their participation in research and facilitates development of workable interventions. Consortium Core leadership is expected to include members of consortium partner organizations.

The Consortium Core will administer a pilot project program designed to encourage and sustain active participation of consortium partners in the full range of TCC activities by providing sub-awards of limited scope and duration to partner organizations.

Pilot projects may serve as a means to seed emerging research areas, explore new methodologies or approaches, conduct demonstration projects to test implementation of promising interventions in community settings, and generate preliminary data to support development of independently funded projects.

The Implementation Core will promote research and related activities aimed at implementing, disseminating and evaluating evidence-based interventions in community settings, working in close collaboration with community partners, health service providers, public health agencies, policymakers and other stakeholders as appropriate.

Teams should include individuals or organizations that are likely to be critical to the intervention process and able to use knowledge generated through research to make informed decisions about policies, programs and/or practices.

Ethical standards that promote values essential to collaborative community-engaged research, such as mutual respect, trust, accountability, fairness and protection of individuals and communities from unintended harms, are critically important.

Applications are expected to address ethical considerations in the development and/or utilization of precision medicine variables and measures in study populations (e.g., biological variables, clinical data, behavioral measures, socioeconomic variables, environmental exposures, other contextual variables) and in communicating research results to the scientific community and the lay public.

Applications may propose additional (optional) technical cores to help support the proposed research projects.

Examples include but are not limited to clinical research cores, bioinformatics cores, genomics cores, biostatistics/study design cores, bioethics and regulatory knowledge cores, biospecimen repositories, data warehouses, etc. NOTE: TCC awards will not support cores that duplicate institutional resources or cores supported by other federal funding if such cores/resources are already available for use by A top priority for this initiative is the development of better tools and analytic methods for integrating different types of data obtained from individuals ("omics" data, clinical data, behavioral survey data, etc.) with structured information about key contextual factors (social stratification, racism and discrimination, community ecological context, cultural factors, environmental factors, health-related policies, etc.) that act at the community or population level to influence the health of individuals.

Approaches that leverage public and private-sector investments in health information technology, public health reporting systems, clinical data research networks, and informatics tools to identify patients from diverse populations with specific clinical characteristics for cohort studies are strongly encouraged.

Topics of interest include but are not limited to: Variations in biomarkers and their interactions with relevant contextual predictors in clinical research cohorts and/or patient registries involving multiple chronic diseases or co-morbid conditions; Feasibility of pooling and augmenting diverse datasets from multiple existing clinical research cohorts (observational studies, population studies, clinical trials) to enhance predictive power and enable examination of differences between sub-populations; Development and testing of risk prediction models that incorporate cultural practices and other contextual factors that support healthful behavior and resilience and resistance to disease.

Population differences in pharmaceutical therapy outcomes Striking differences in health outcomes related to obesity, infant mortality, cancer, cardiovascular disease, hypertension, asthma, diabetes and HIV infection in disparity populations are well established. Significant differences also exist among various health disparity populations in responses to therapeutic drugs.

This initiative will support research examining population differences in pharmaceutical therapy outcomes and correlations with biological and contextual predictors (see examples above) to better understand variability in drug responses and identify effective patient-specific treatments that enhance therapeutic outcomes in patients from health disparity populations.

Topics of interest include but are not limited to: Differential response to drug treatments; Relative efficacy and effective dosage; Differential side effects and toxicity, including genetic sequencing of known drug metabolizing enzymes to better understand variability associated with risks for toxicity; Differential rate and mechanisms of relapse; Novel therapeutics or device strategies that optimize or modulate existing therapies to enhance clinical outcomes in health disparities Translating pharmacogenomic discoveries to health disparity populations A major limitation of existing pharmacogenomic-based therapies is that most of the data informing clinical guidelines are derived from populations of European descent.

This initiative encourages clinical and translational research to study genomic variations that impact the specificity and response of drugs in patients from diverse racial/ethnic populations and evaluate other factors that may contribute to variability of responses across different populations.

Topics of interest include but are not limited to: Clinical validity and utility of predictive testing based on genomic information, particularly for disease screening, prevention and/or treatment for complex diseases and co-morbid conditions in one or more health Foundational studies in pharmacogenomics to incorporate whole and partial genome sequence and other deep resequencing efforts (e.g., selected regions of the genome) towards predicting drug actions and patient responses among various health disparity populations; Data-driven approaches utilizing patient-derived specimens to move beyond genome sequence (and sequence variation), integrating and modeling multidimensional datasets (e.g., transcriptome, proteome, epigenome, metabolome, etc.) to better predict drug response and adverse reactions.

Research on potential facilitators and barriers to implementation and adoption of precision medicine approaches in health disparity populations is also encouraged.

Topics of interest include but are Acceptability of comprehensive genetic testing and phenotypic profiling in clinical settings, both for patients and healthy individuals; Potential individual-level factors that influence patient attitudes toward precision medicine approaches, such as age, gender, family history, severity of adverse health conditions, issues surrounding doctor/patient communication, concerns about privacy and confidentiality, etc.; Community-level and/or cultural or societal factors that affect implementation and adoption, including but not limited to risks associated with Acceptability among health service providers and systems that serve health disparity populations, including but not limited to issues surrounding access, cost, and reimbursement for clinical services; Development of culturally consistent and acceptable approaches to overcoming barriers and enhancing facilitators.

To promote optimal use of TCC resources, TCC investigators are strongly encouraged to collaborate with other federally-funded investigators who have expertise and/or interest in precision medicine and health disparities or other resources that can be leveraged to help achieve TCC Although delineation of the region and populations(s) under study is determined by the applicant, applications must specify in which of the 10 established HHS regions the proposed work will occur ( http://www.

hhs. gov/about/regions/ ). Applicant-defined regions may fall within a single HHS region or across REGION I: CT, ME, MA, NH, RI, VT REGION II: NJ, NY, PR, VI REGION III: DE, D.

C.

, MD, PA, VA, WV REGION IV: KY, MS NC, TN, AL, FL, GA, SC REGION V: IL, IN, MI, MN, OH, WI REGION VI: AR, LA, NM, OK, TX REGION VII: IA, KS, MO, NE REGION VIII: CO, MT, ND, SD, UT, WY REGION IX: AZ, CA, HI, NV, and the six U.S. Associated 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 this initiative will be coordinated and monitored by a TCC Program Coordinating Committee consisting of TCC PDs/PIs and NIMHD program staff.

The TCC Program Coordinating Committee will meet at least annually to assess progress toward program goals and promote information exchange across regions. The NIMHD will conduct a Technical Assistance webinar for prospective applicants in June 2015 at a date and time to be determined. Information about the webinar will be published in the NIH Guide to Grants and Contracts and posted on the NIMHD website at www.

nimhd. nih. gov .

Section II. Award Information 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 Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards NIMHD intends to commit $6,000,000 in FY 2016 to fund approximately 3 awards, contingent on receipt of a sufficient number of scientifically meritorious Application budgets are limited to $1,500,000 in direct costs annually, excluding consortium/contractual facilities and administrative costs.

The maximum project period is 5 years. 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 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

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 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 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. 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.

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 must have an active DUNS number and SAM registration in order to complete the 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.

Eligible Individuals (Program Director/Principal 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Only one application per organization (normally identified by having a unique DUNS number or NIH IPF number) is allowed. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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 ). Section IV. Application and Submission Information 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. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in (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 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 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: Maryline Laude-Sharpe, PhD Types Available in ASSIST Strategy/Program Plan Page Limits Core (use for Consortium Core, Implementation Core, and Project (use for Research Project) Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component 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: Administrative Core: required Consortium Core: required Research Projects: required, minimum of two, maximum of three Implementation Core: required Technical Cores: optional, maximum of two When preparing your application in ASSIST, use Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall Project Information (Overall) Follow standard instructions.

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 Senior/Key Person Profile (Overall) Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of 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: Describe the overall composition, objectives, specific aims and expected outcomes of the proposed TCC. Identify the health disparity population(s) to be included in the proposed project and describe the topic areas (diseases/conditions) of focus. Delineate the geographic region to be covered, including the HHS region(s) where the proposed work will occur.

Research Strategy: Identify and delineate the roles of consortium partners. Provide the scientific rationale for selecting the partners and the population(s) to be included.

Describe how the proposed TCC structure and activities will facilitate productive collaborations, bringing together people with expertise in precision medicine, population health disparities, and the science of translation, implementation and dissemination, to investigate interactions between biological, behavioral, and contextual predictors of disease vulnerability, resilience, and response to Describe steps taken prior to or during the development of the application to gain substantive community input on (1) identification of research topics of importance to the study population(s), and (2) identification of relevant contextual factors (e.g., social stratification, racism/discrimination, community ecological context, cultural factors, environmental factors, health-related policies, etc.) to be considered alongside biological factors.

Explain how the various TCC activities taken together as a whole will significantly contribute to the integration of precision medicine interventions with community or population-level interventions, taking into account the dynamic interplay between biological, behavioral, social and environmental health risk and protective factors experienced across the life Also explain how the proposed TCC activities will enhance inclusion of health disparity populations in precision medicine research and development.

If foreign components are included that involve data collection at foreign sites, the application must describe how the proposed activities will help improve minority health or reduce health disparities in Provide an overview of the proposed collaborative research projects and describe plans to promote synergy among them.

Describe the scientific rationale and the process used to select the proposed research projects, as well as plans and procedures to monitor and assess progress on those projects.

It is expected that under-performing projects will be discontinued and replaced by new projects with greater potential as the program evolves and Identify collaborating NIMHD-supported investigators in the region (if any) who have expertise in precision medicine or other relevant resources that could be leveraged to help achieve TCC goals and objectives and avoid unnecessary duplication.

Describe plans for leveraging any existing core facilities or other shared research resources that are available to support the Describe the applicant organization's commitment and capabilities for regional coordination and collaboration, particularly with community-based organizations, federal, state and local agencies and private sector partners.

Applicant organizations that currently hold federally-funded center awards should describe center expertise and resources available to support the proposed TCC activities, as well as how TCC activities are distinct from those of the existing center(s).

Letters of Support: Provide a letter or memorandum of agreement/understanding (MOA/U) for each proposed consortium partner organization, signed by an authorized official of that organization, describing its expectations for the partnership and its roles and responsibilities on the project.

The application should also include a detailed statement from the applicant organization's leadership describing its commitment to the establishment and maintenance of the proposed center. Support may include but is not limited to provision of professional release time, support staff, facilities, and other resources that will contribute to the proposed TCC activities.

Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) 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 All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Complete only the following fields: Title of Applicant’s Project Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Enter Human Embryonic Stem Cells in Project Information (Administrative Core) Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal 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 Project /Performance Site Location(s) (Administrative 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 Research & Related Senior/Key Person Profile (Administrative Core) 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 additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

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. than 100 Senior/Key persons are included in a component, the