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

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 disparities.

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 promote health equity.

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 populations.

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 the study population(s).

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 TCC participants.

1. Data Integration

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.

2. 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 populations.

3. 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 disparity populations;
• 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.

4. Implementation research

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 not limited to:

• 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 stigma;
• 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 objectives.

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 multiple regions.

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 Pacific jurisdictions

REGION X: AK, ID, OR, WA

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.

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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

Only one application per 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 not accept:

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

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, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Maryline Laude-Sharpe, PhD
Telephone: 301-451-9536
Fax: 301-480-4049
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
Core (use for Consortium Core, Implementation Core, and Technical Core)	6
Project (use for Research Project)	12 (per project)

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• 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 Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

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

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

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

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

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

Specific Aims: Describe the 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 therapies.

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 course.

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 the United States.

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 matures.

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 proposed activities.

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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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.

Specific Aims: Describe aims to ensure effective management, coordination and support of the TCC's precision medicine research program and related consortium activities.

Research Strategy: Describe the TCC’s organizational and governance structure and explain the roles and responsibilities of Administrative Core personnel. Describe the processes to be used to allocate and prioritize fiscal and other resources, as well as procedures for ensuring timely and effective communication between TCC consortium participants. Include a management plan that describes the composition and roles of the Steering Committee, as well as any community advisory boards or other committees proposed to help manage TCC activities. Do not name potential members of the Steering Committee in the application.

Describe how the Administrative Core will manage, coordinate and supervise the entire range of proposed TCC activities, monitor progress on research projects, and ensure that component plans are implemented according to proposed timelines.

Include an evaluation plan to monitor progress on proposed TCC activities. The evaluation plan is intended to facilitate ongoing TCC project management to ensure successful completion of the stated aims. Describe how the evaluation will be conducted, logic models for the TCC as a whole and for each proposed core, principal measures and metrics to be used to assess achievement of short- and long-term goals, and potential sources of data. The plan should address administrative functioning (process) as well as scientific accomplishments (outcomes) in the following key areas: translational activities; scope and impact of research; innovation; collaboration and communication; integration and synergy; and funds management. Describe key milestones and expected outcomes for each area as appropriate.

NOTE: Under the cooperative agreement mechanism, NIMHD staff will work with TCC award recipients to develop complementary evaluation methods and measures addressing the scientific impact of the TCC program at regional and national levels.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

Not Applicable

Not Applicable

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

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

SF424 (R&R) Cover (Consortium 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 (Consortium Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

List all performance sites that apply to the specific component.

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

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

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

Pilot Project Program (see Research Strategy below): Each pilot project's budget should not exceed $50,000 in direct costs per year for a project period not to exceed two years.

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 (Consortium Core) Specific Aims: Describe the aims and objectives that will be pursued to establish the Consortium Core as a regional focal point for organizing and nurturing productive working relationships with a broad cross-section of community organizations, health disparity populations, health service providers, public health agencies and other stakeholders with an interest in eliminating health disparities.

Research Strategy: Explain the scientific rationale for including the consortium partners in research involving the proposed study population(s). Summarize the strengths of the proposed consortium, including relevant expertise, relationships with the study population(s), and experience participating in productive regional collaborations and partnerships.

Describe specific opportunities to establish or strengthen associations with federal agencies, state and local health departments and other relevant agencies with expertise and/or interest in the proposed research, implementation and dissemination activities. Describe strategies and procedures for assessing the effectiveness of partnerships on an ongoing basis and resolving disputes or misunderstandings between partner organizations.

Describe how the pilot project program to be administered by Consortium Core will encourage and sustain active participation of consortium partners in the full range of TCC activities. Explain how the program will complement and enhance other TCC research, implementation and dissemination activities. Do not propose specific pilot projects in the application; instead, describe the overall scope and objectives of the pilot project program, eligibility requirements for project leaders, solicitation, review, and selection processes, and plans for oversight and evaluation. Also describe resources in place, either at the applicant organization or within the prospective pilot project recipient organizations, to ensure sound research design, including appropriate statistical analyses, and compliance with all applicable Federal research regulations, policies and guidelines.

Plans for overseeing pilot projects must include provisions for supervision when appropriate. If new and early-stage investigators (as defined by NIH) at consortium partner organizations will be eligible to serve as pilot project leaders, describe the supervision activities to be provided, the qualifications of proposed supervisors, plans for monitoring progress on the project and steps to be taken if problems arise, and plans for evaluating the effectiveness of proposed supervision activities. Supervisors may be affiliated with the applicant organization or with other organizations as appropriate for the research topic.

NOTE: Recipient-selected pilot projects are subject to NIMHD prior approval. It is expected that pilot project awards will be made to consortium partner organizations, and that projects will be led by personnel from those organizations. Projects that do not meet these expectations will not be approved. No more than two pilot projects may be submitted to NIMHD for prior approval during any given budget period. Pilot projects are expected to commence at the beginning of the second year. A pilot project performance period cannot extend beyond the TCC award project period.

Letters of Support: Letters or memoranda of agreement/understanding signed by authorized representatives of consortium partner organizations are to be included in the application's Overall Component and should not be duplicated in the Consortium Core component.

When preparing your application in ASSIST, use Component Type Project

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

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

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Project)

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

Budget (Research Project)

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

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

PHS 398 Research Plan (Research Project)

Specific Aims: State concisely the overall goals of the proposed research project. Identify the health disparity population(s) to be included and the disease(s) or condition(s) under study. List succinctly the specific objectives, e.g., to test a stated hypothesis, create a novel design, solve a specific problem relating to health disparities, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field of precision medicine as it relates to health disparities, or develop new technology.

Research Strategy: For research involving human subjects, describe steps taken prior to and/or during the development of the application to obtain substantive community input into (1) identification of research topics of importance to the proposed study population(s), and (2) identification of relevant contextual factors (e.g., social stratification, racism and discrimination, community ecological context, cultural factors, environmental factors, health-related policies, etc.) that mediate the effects of interventions targeting individual patients.

Explain how the proposed collaborations will serve to advance scientific knowledge of the interplay between biological, behavioral, social and environmental risk and protective factors experienced across the life course. If the project involves implementation or dissemination of an existing intervention, describe expected improvements in health relative to an existing baseline measure for the health disparity population(s) under study.

Explain how the project will complement and synergize with other research sub-projects included in the application, and how its successful completion will advance the TCC's overall aims and objectives. Also address plans for leveraging TCC infrastructure and resources to ensure successful completion of the project's stated aims.

For projects focused on data integration, describe plans and approaches for collecting and integrating different types of data pertaining to the proposed individual-level and contextual factors under study. Explain how the proposed work will improve the predictive power of precision medicine as applied to health disparity populations.

For projects examining population differences in pharmaceutical therapy outcomes and correlations with various biological and contextual predictors, describe how the proposed work will advance our understanding of variability in drug responses across different racial/ethnic groups. Also describe how the proposed work may lead toward improved strategies to enhance therapeutic outcomes in patients from health disparity populations. Such projects may include discovery and validation of novel biological and contextual predictors of variations in drug response, assessing the relevance of pharmacogenomic data derived primarily from European-ancestry populations to racial/ethnic minority populations, and efforts to tailor treatment strategies for particular health disparity populations.

For implementation research projects, describe how the proposed work will advance our understanding of facilitators and barriers to the implementation, uptake and diffusion of precision medicine approaches in health care organizations and systems that serve disadvantaged communities.

Planned Enrollment Report (Research Project)

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 Project)

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 (Implementation 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 (Implementation Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Implementation 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.
• Core leadership should include individuals from organizations that are likely to be critical to the intervention implementation process and able to use knowledge generated through research to make informed decisions about policies, programs and/or practices.

Budget (Implementation 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 (Implementation Core)

Specific Aims: Describe the aims and objectives that will be pursued to support regional implementation, diffusion, adoption and evaluation of evidence-based interventions, including new interventions developed through collaborative research sub-projects and pilot projects, in collaboration with relevant communities, service providers, other partner organizations and policy makers. This may include pilot testing of interventions developed in one health disparity community or population to assess their effectiveness and sustainability in other communities or populations in the region.

Research Strategy: Describe any collaboration with health service providers, public health agencies, policymakers and other relevant stakeholders.

Describe strategies to use research findings to inform policy and to promote diffusion, adoption and sustainability of effective interventions in relevant settings within the proposed region. Address ethical considerations for (1) development and/or utilization of precision medicine variables and measures in study populations, and (2) communicating research results to the scientific community and the lay public. Describe plans to ensure protection of study participants and communities from unintended harms, including risks associated with stigma.

Describe strategies to keep various stakeholders informed, on an ongoing basis, of needs and capacity assessments, as well as results from research projects and pilot projects. Describe steps to assess the effectiveness of community- or service system-level implementation and dissemination of interventions and/or health education efforts.

Planned Enrollment Report (Implementation 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 (Implementation 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 (Technical 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 (Technical Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

List all performance sites that apply to the specific component.

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

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

Specific Aims: Describe the overall purpose and scope of the proposed core and explain how it will serve the proposed collaborative research projects and/or pilot projects.

Research Strategy: Describe the core's role in the overall TCC project and explain its value added to the TCC and the region as a whole. TCC awards will not support institutional cores that duplicate resources supported by other federal funding if those resources are already available for use by TCC participants. Address potential overlap with existing shared core facilities and explain why this core is essential for conducting the proposed TCC activities. Describe plans for ensuring equitable access to core resources for all TCC participants, and plans for staffing, managing, and prioritizing core utilization and charging user fees (if any).

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete, non-compliant and/or non-responsive to program requirements stated in the FOA will not be reviewed. Applications with foreign components that involve data collection in foreign sites must state how the proposed activities will help improve minority health or reduce health disparities in the United States; applications that do not include this information will be considered incomplete.

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 center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the center proposed).

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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How likely is the project to yield new insights into the complex interactions between biological, behavioral, and contextual predictors of disease vulnerability, resilience, and response to clinical therapies in one or more health disparity populations?

How and to what extent are the proposed activities likely to enhance inclusion of health disparities populations in precision medicine research and development?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partner organizations raise confidence that each partner is actively engaged and committed to achieving the project's stated aims?

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

Does the proposed team include people with demonstrated expertise in precision medicine, population health disparities, and the science of translation, implementation and dissemination? Have the PD(s)/PI(s) demonstrated a history of productive working relationships as scientific collaborators, both in academic settings and in consortia that include community-based organizations and other stakeholders?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partner organizations adequately describe the qualifications, roles and responsibilities of senior/key personnel and other significant contributors at those organizations?

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

Does the application propose an innovative conceptual framework, novel strategies or approaches for integrating individual patient data with community and population-level data such that precision medicine interventions are appropriately informed by contextual factors that influence health outcomes?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Taken together as a whole, are the proposed TCC activities likely to promote integration of precision medicine interventions with community or population-level interventions that take into account the dynamic interplay between biological, behavioral, social and environmental health risk and protective factors experienced across the life course?

Is there convincing evidence of substantive community input into the selection of proposed research topics and the identification of relevant community and/or population-level contextual factors to be examined alongside biological factors?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partner organizations adequately describe the roles and responsibilities of each organization in carrying out the proposed TCC activities? Do they raise confidence that each organization is actively engaged and committed to achieving the project's stated aims?

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 applicant organization describe its commitment to the establishment and maintenance of the proposed center in terms that raise confidence in the prospects for success?

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

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

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

Review Criteria - Administrative Core

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

Are strategies to ensure effective management, coordination and support of the TCC's precision medicine research program and related consortium activities well described and likely to succeed? Do the proposed approaches for coordinating and supervising TCC activities raise confidence that each component's aims will be achieved within the project period?

Is the TCC organizational and governance structure adequately described and appropriate for supporting the stated aims? Does the management plan adequately describe the composition and roles of the TCC Steering Committee and any other committees proposed to help manage TCC activities? Are appropriate resources and processes in place to ensure that TCC-supported research will be carried out in compliance with applicable federal regulations and policies?

Is the proposed evaluation plan well-conceived and described in sufficient detail to judge its utility for ongoing project management? Is its execution likely to facilitate successful completion of the TCC's stated aims?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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) Genomic Data Sharing Plan .

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.

Review Criteria - Consortium Core

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

Are the aims and objectives of the Consortium Core well described as a regional focal point for organizing and nurturing productive working relationships with community organizations, minority and health disparity populations, health care provider organizations, for-profit or non-profit organizations and other stakeholders with an interest in using precision medicine approaches to improve health equity? Are the proposed strategies to keep consortium partners and other stakeholders informed on an ongoing basis of TCC activities adequately described and likely to be effective?

Are consortium partner organizations and their respective roles and contributions clearly articulated? Is the scientific rationale for including the consortium partners in research involving the proposed study population(s) clear and consistent with the overall objectives of the proposed TCC? Do consortium participants have relevant expertise, working relationships with the study population(s), and experience participating in productive collaborations and partnerships? Does the Consortium Core leadership include qualified representatives from consortium partner organizations?

Is the proposed pilot project program appropriately designed to encourage and sustain active participation of consortium partners in the full range of TCC activities? How and to what extent will it complement and enhance other TCC research, implementation and dissemination activities? If new and early-stage investigators (as defined by NIH) are eligible to serve as pilot project leaders, are provisions for supervising them adequately described and likely to be effective?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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) Genomic Data Sharing Plan.

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.

Scored Review Criteria - Research Project

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 sub-project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How and to what extent does the project complement and synergize with the other research sub-projects included in the application, and how will its successful completion advance the TCC's overall aims and objectives?

If the project involves implementation or dissemination of an existing intervention, are expected improvements in health relative to an existing baseline measure for the study population(s) adequately described?

For projects focused on data integration, is the proposed work likely to improve the predictive power of precision medicine as applied to health disparity populations?

For projects examining population differences in pharmaceutical therapy outcomes and correlations with various biological and contextual predictors, is the proposed work likely to advance understanding of variability in drug responses across different racial/ethnic groups and lead to improved strategies to enhance therapeutic outcomes in patients from health disparity populations?

For implementation research projects, is the proposed work likely to advance understanding of facilitators and barriers to the implementation, uptake and diffusion of precision medicine approaches in health care organizations and systems that serve disadvantaged communities?

Investigator(s)

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

Are the proposed collaborations likely to advance scientific knowledge of the interplay between biological, behavioral, social and environmental risk and protective factors experienced across the life course? Are the roles and responsibilities of each research team member clearly described?

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?

Does the application propose an innovative conceptual framework, strategy or approach for integrating individual patient data with community and population-level data so that relevant contextual factors can inform the development of appropriate precision medicine interventions?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

For research involving human subjects, is there convincing evidence of substantive community input into the selection of the proposed research topic(s) and the identification of relevant community and/or population-level contextual factors to be examined alongside biological factors?

For projects focused on data integration, are plans and approaches for collecting, analyzing and integrating different types of data adequately described and appropriate for the individual-level and contextual factors under study? Is the proposed work likely to improve the predictive power of precision medicine as applied to health disparity populations?

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? Are plans for leveraging TCC infrastructure and resources adequately described and appropriate for the project?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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) Genomic Data Sharing Plan .

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.

Review Criteria - Implementation Core

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

Are the proposed activities likely to promote or enhance regional implementation, diffusion, adoption and evaluation of evidence-based interventions in collaboration with relevant communities, service providers, other partner organizations and policy makers? Are steps to assess the effectiveness of implementation and dissemination efforts adequately described and appropriate?

Are the roles and responsibilities of consortium partners and collaborators clearly described and adequately justified? Does the Core's leadership include qualified individuals from organizations that are likely to be critical to the intervention implementation process?

Does the application adequately address ethical considerations for (1) development and/or utilization of precision medicine variables and measures in study populations, and (2) communicating research results to the scientific community and the lay public? Are plans to ensure protection of participating communities or groups from unintended harms, including risks associated with stigma, adequately addressed?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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) Genomic Data Sharing Plan .

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.

Review Criteria - Technical Core

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

How and to what extent will the proposed Core serve the collaborative research sub-projects and/or pilot projects? What is the Core's utility to investigators? Do the proposed personnel have appropriate qualifications, experience and resources to carry out the Core's functions? Is potential overlap with existing shared core facilities adequately addressed? Are appropriate plans provided for ensuring equitable access to core resources for all TCC participants, as well as managing and prioritizing core utilization?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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) Genomic Data Sharing Plan.

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 National Advisory Council on Minority Health and Health Disparities. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution of award recipients.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Recipient-selected pilot projects that support clinical trials/studies involving human subjects or research with live vertebrate animals require prior approval by NIH prior to initiation.

• The recipient institution will provide NIMHD with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan, NOT-OD-12-129 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-129.html), and NOT-OD-12-130 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-130.html).
• The recipient institution will provide NIMHD with specific plans for data and safety monitoring, and will notify the IRB and NIMHD of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
• If live vertebrate animals are to be involved, follow NIMHD policy (NOT-MD-08-002).

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 Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the award recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

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

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

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

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

• Review and comment on critical stages in the program implementation;
• Assist in the interaction between the recipient and investigators at other institutions to promote collaborations;
• Assist in coordinating access to other resources available through statewide, regional, or national specialized cores or resources;
• 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.

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

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

Areas of Joint Responsibility include:

• Establishing a TCC Steering Committee consisting of: 1) the PD(s)/PI(s); 2) two or more members representing consortium partner organizations, with at least one representative from a non-research institution, 3) two external members selected by the PD(s)/PI(s); 4) the NIMHD Program Official; and 5) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH staff members, who will share one vote. The TCC Steering Committee will convene by telephone as needed and will meet in person at least once a year.
• Identifying and facilitating partnerships with other NIMHD award recipients in the respective regions with expertise and/or interest in precision medicine and health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of the TCC Program goals and objectives.
• Organizing and participating in the TCC Program Coordinating Committee meetings at least annually to discuss matters of mutual interest and promote information exchange across regions.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual award recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Nishadi Rajapakse, PhD, MHS
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-4338
Email: [email protected]

Maryline Laude-Sharpe, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-9536
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

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

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