Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title

NIMHD Transdisciplinary Collaborative Centers for Research on Men's Health (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MD-13-004

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.307

Funding Opportunity Purpose

The National Institute on Minority Health and Health Disparities (NIMHD) seeks to establish specialized Transdisciplinary Collaborative Centers (TCCs) for Health Disparities Research comprising regional coalitions of academic institutions, community organizations, service providers and systems, government agencies and other stakeholders focused on priority research areas in minority health and health disparities. This initiative is intended to support coordinated research, implementation and dissemination activities that transcend customary approaches and “silo” organizational structures to address critical questions at multiple levels in innovative ways. The purpose of this funding opportunity is to support the development of TCCs focused specifically on research on men's health.

Key Dates
Posted Date

December 5, 2012

Letter of Intent Due Date(s)

January 6, 2013

Application Due Date(s)

February 6, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2013

Advisory Council Review

June 2013

Earliest Start Date

July 1, 2013

Expiration Date

February 7, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background and Overview

Addressing health disparities requires a transdisciplinary framework that cuts across organizational silos to foster an integrated approach involving multiple disciplines– biology, behavioral and social sciences, environmental science, public health, health care, economics, public policy and many other disciplines. It also requires strong collaborations between researchers and community organizations, service providers and systems, government agencies and other stakeholders to ensure that contextually appropriate and relevant research is conducted and that findings can translate into sustainable individual-, community- and systems-level changes that improve population health.

Collaboration at the regional level is particularly important and timely because it provides opportunities for institutions and organizations to achieve a broader reach than is possible with isolated local efforts while combining expertise and resources in an era of constrained budgets. At the same time, it fosters applied research that is uniquely responsive to specific population-based, environmental, sociocultural, and political factors that influence health within a particular region.

Recognizing these opportunities, the National Institute on Minority Health and Health Disparities (NIMHD) seeks to establish Transdisciplinary Collaborative Centers (TCCs) for Health Disparities Research specialized in several priority topic areas. The concept of regional collaborative centers is structured around an overarching goal in the NIH Health Disparities Strategic Plan 2009-2013 integrating research, capacity building and outreach/dissemination to (1) develop a coordinated interdisciplinary approach to reduce and ultimately eliminate health disparities; and (2) develop opportunities to leverage resources and enhance collaboration.

TCCs will support partnerships and collaborations between a broad range of stakeholders to develop a uniquely transformative and novel infrastructure for coordinated research, implementation and dissemination activities. Dissemination of research findings based primarily on publication of scientific manuscripts and conference presentations is not sufficient. The goal of this program is to translate research advances into practical applications in real-world settings. It is expected that the transdisciplinary teams established under the proposed TCC will develop new and integrative ways to explore the many complex interactions that influence health disparities within a defined region, and will use the knowledge gained to produce sustainable change within the region and beyond.

TCCs funded in response to this FOA will involve a one-year planning phase followed by a four-year implementation phase. Each TCC will support 2-4 collaborative research sub-projects, to begin during year 1, and a pilot project program designed to further encourage and sustain active participation of consortium partners in the full range of TCC activities by providing sub-awards to partner organizations during years 2 through 4.

Men's Health Research Theme

On average, males in the United States have poorer health outcomes and lower life expectancies compared to their female counterparts. This pattern in particularly pronounced in health disparity populations, including racial/ethnic minority, low-income, and rural populations. Reducing and ultimately eliminating this pervasive sex/gender disparity within and across health disparity populations requires better understanding of the complex interplay between myriad factors that disproportionaltely influence the health and wellbeing of men and boys. These include access to and utilization of male-specific preventive health services, exposure to workplace hazards, propensity for risk-taking behavior, exposure to violence and incarceration, and many other independent and interdependent factors. Applications must focus on one or more areas in men’s health research, defined in this FOA as research that involves a focus on at least one of the following:

Applications must address men's health within one or more health disparity populations, which include African Americans, Latinos/Hispanics, Asian Americans, American Indians/Alaska Natives, Native Hawaiians/Other Pacific Islanders, low-income populations, and rural populations. Applications involving research with multiple health disparity populations are particularly encouraged.

Topics of specific interest include but are not limited to:

Applications that involve research with men or boys but do not articulate an explicit focus on sex- or gender-specific factors will be considered nonresponsive to this FOA.

Regional Collaborative Approach

Each TCC will establish and support a collaborative research program consisting of regional research sub-projects designed to significantly advance understanding of key factors influencing men's health and health disparities in communities and populations within a defined region. Applications must describe the region on which the proposed work will focus. The TCC initiative is not intended to support activities that target a single neighborhood, municipal jurisdiction, or service provider site in isolation; rather, research projects and implementation and dissemination efforts must be regional in scope and placed in the context of consortium efforts to establish and sustain effective interventions on a regional or national level. Applications must provide a scientifically sound and compelling conceptual justification for selecting the identified region and population(s) to be included e.g., based on shared population characteristics, environmental factors, health policies, etc.

Although delineation of the region and populations(s) involved is determined by the applicant, applicants must specify in which of the 10 established HHS regions their work will occur (http://www.hhs.gov/about/regions/). Applicant-defined regions of focus 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

Applications must identify collaborating partners within and across the proposed region. In addition to academic institutions, the proposed TCC must involve a broad cross-section of partner organizations, such as community-based organizations, health care provider organizations, for-profit or non-profit organizations, government agencies and other key stakeholders. Each TCC will have a Consortium Steering Committee composed of the PD(s)/PI(s), one or more members representing consortium partner organizations, two external members selected by the PD(s)/PI(s), an NIMHD Program Official, and one or more NIMHD Project Scientists. The Consortium Steering Committee will oversee the management and direction of the TCC and each major component.

TCCs are strongly encouraged to identify and collaborate with other NIMHD grantees in the target region who have expertise and/or interest in research on men's health or other resources that could be leveraged to help achieve TCC objectives. Along the same lines, TCCs are encouraged to collaborate with other federally-funded investigators within and outside the identified region as appropriate to promote optimal use of TCC resources for advancing the aims of the center.

To ensure that TCCs collectively contribute to national minority health and health disparities research efforts in optimal ways, the overall direction and scope of activities supported by this initiative will be coordinated and monitored by a TCC Program Coordinating Committee consisting of all TCC PIs/PDs and program representatives from NIMHD. The TCC Program Coordinating Committee will meet at least annually to assess progress toward program goals and promote information exchange across regions.

Planning Phase and Program Implementation Phase

The goal of the planning phase is to: a) solidify collaborative relationships with all partners for a regional organizational structure that will support research, implementation and dissemination activities; b) fully assess existing research and outreach/dissemination capacity for the proposed activities, including scientific and administrative resources and needs; c) identify and engage additional partners needed to fill identified gaps; d) finalize procedures for soliciting, selecting and overseeing pilot research projects and identify initial projects to be supported during the implementation phase, and e) develop a detailed plan for executing the implementation phase.

The NIMHD will post answers to Frequently Asked Questions (FAQs) about this FOA on its website at www.nimhd.nih.gov.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIMHD anticipates committing up to $3,000,000 in FY 2013 to fund up to two awards, contingent on availability of funds and receipt of a sufficient number of meritorious applications..

Award Budget

Application budgets are limited to $1,500,000 in total costs during the 1st year (planning phase) and $3,000,000 per year in total costs for years 2-5 (implementation phase).

Award Project Period

The maximum project period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Other

Institutions cannot have more than a single NIMHD TCC award at any one time. Institutions that have an active TCC award are not eligible to apply to this FOA.

Foreign Institutions

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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 PHS 398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

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:

The letter of intent should be sent to:

Robert Nettey, M.D.
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: 301-496-3996
Email: netteyr@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Robert Nettey, MD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
6707 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: 301-496-3996
Email: netteyr@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following additional requirements for the Research Strategy section of each component in this multi-component application:

Application Format

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

The application should be assembled as follows:

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells

A PD/PI must serve as director of the Administrative Core and commit at least three person months to that position, in addition to any involvement in other TCC activities or components. For multi-PD/PI applications, the sum of PD/PI efforts on the Administrative Core must be at least 3 person months per year.

Research Plan - Overall Component

Specific Aims

Describe the overall objectives, specific aims and expected outcomes of the proposed TCC, including key short- and long-term goals addressing one or more topics in men's health. Delineate the geographic region to be covered, including the HHS region(s) where the proposed work will occur..

Research Strategy

Identify consortium partner organizations and describe their respective roles and contributions. Explain the scientific rationale for selecting the proposed region, consortium partners and population(s) to be included. Summarize the strengths of the proposed consortium, including participants’ relevant expertise and their experience in productive regional collaborations and partnerships. Describe institutional commitment and organizational 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 grants should describe center expertise and resources available to support the proposed regional activities, as well as how TCC activities are distinct from those of the existing center(s).

Describe plans and timelines for accomplishing the following objectives during the first-year planning phase: a) solidify collaborative relationships with all partners to create a regional framework that will support the proposed research, implementation and dissemination activities; b) fully assess existing research and outreach/dissemination capacity for the specified area of emphasis, as well as scientific and administrative resources and needs; c) identify and engage additional partners needed to fill identified gaps; d) finalize procedures for soliciting, selecting and overseeing pilot research projects and identify initial projects to be supported, and e) develop a detailed plan and timelines for the program implementation phase (years 2-5). The planning phase is not intended as a vehicle to identify TCC topic areas, overall objectives or specific aims; these should be developed prior to submission and specified in the application.

Research Plan - Administrative Core

Specific Aims

Describe how the Administrative Core will manage, coordinate and supervise the entire range of proposed TCC activities, monitor progress, and ensure that component plans are implemented and that TCC-supported research is carried out in compliance with applicable federal regulations and policies. .

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 participants. Include a management plan that describes the composition and roles of any committees proposed to help manage TCC activities, including the required Consortium Steering Committee.

Also provide a comprehensive Evaluation Plan to be used to monitor the conduct and track the progress of proposed TCC research, implementation and dissemination activities. Describe how the evaluation will be conducted, the principal measures and metrics to be used, and the potential sources of data. Also include a detailed self-evaluation plan to assess achievement of short- and long-term TCC goals. Since the major purpose of the evaluation is to provide information to assist with TCC planning and management, the plan should address both administrative and scientific functioning and accomplishments. The Evaluation Plan should address the following areas of particular importance: translational activities; scope and impact of research; innovation; collaboration and communication; integration and synergy; and funds management. Describe timelines, key milestones and expected outcomes for each area as appropriate.

While evaluation should be a continuous process, a formal evaluation by an outside, independent group selected by TCC leadership and approved by NIMHD staff should be conducted at least every two years. TCCs may also be called upon to gather data and participate in the development of a national TCC Program evaluation.

Research Plan - Collaborations and Partnerships Core

Specific Aims

Describe the aims and objectives that will be pursued to establish the TCC as a regional focal point for organizing and nurturing productive working relationships with a broad cross-section of community organizations, minority and health disparity populations, health care provider organizations, for-profit or non-profit organizations and other stakeholders with an interest in reducing and ultimately eliminating health disparities.

Research Strategy

Describe strategies and procedures for identifying partners and engaging in formal relationships, e.g., through Memoranda of Understanding and/or other mutual agreements, as well as assessing the effectiveness of those relationships on an ongoing basis and resolving disputes or misunderstandings. Also 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.

Applicants are strongly encouraged to identify and work with NIMHD grantees in their respective regions who have expertise and/or interest in areas related to men's health research or other relevant resources that could be leveraged to help achieve TCC goals and objectives and avoid unnecessary duplication. Along the same lines, TCC researchers are encouraged to collaborate with other federally-funded investigators within and outside the Center’s region as appropriate to achieve efficiencies while advancing the aims of the center.

Research Plan - Research Core

Specific Aims

Describe aims to ensure effective management, coordination and support of the TCC's regional collaborative men's health research program. . ..

Research Strategy

Provide an overview of the proposed Collaborative Research Sub-projects and plans to promote synergy among the various research activities. Describe the scientific rationale and the process used by TCC organizers to select the proposed  Sub-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. Also describe any existing shared core facilities or other research resources that are available to support the proposed research activities.

Research Plan - Collaborative Research Sub-Project

Specific Aims

TCC applications must include descriptions of two to four collaborative research sub-projects, each of which addresses an important problem within the TCC theme. Each sub-project must be regional in scope, meaning that it encompasses more than one site or setting within the region.

Research Strategy

Each sub-project must be conducted by a team of investigators that includes, in addition to investigators at academic institutions, individuals from consortium partner organizations identified as PD/PIs, senior/key personnel, and/or co-investigators with specified levels of effort. Clearly describe the roles and responsibilities of all members of the research team. Expected improvements in health relative to an existing baseline measure for the health disparity population(s) under study should be provided when possible.

Research Plan - Pilot Project Program

Specific Aims

Describe the aims and objectives that will be pursued to encourage and sustain active participation of TCC partners in the full range of research, implementation and dissemination efforts. Pilot projects may be used to seed emerging research areas, explore new methodologies or approaches, or develop new regional partnerships and collaborations that could evolve into independently funded research and/or demonstration projects.

Research Strategy

Describe the overall scope of the pilot project program; expected number of projects to be supported each year; eligibility requirements; solicitation, submission, review, and selection criteria and processes; procedures for program oversight and evaluation; limits on dollars available and number of years of support per project. Also describe the support and resources in place to ensure sound research design, including appropriate statistical analyses. Do not include detailed proposals or descriptions of specific pilot projects.

Describe the internal institutional plans and procedures to ensure that TCC-funded pilot projects will comply fully with all applicable Federal regulations, policies and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for data and safety monitoring for clinical trials, if applicable

Plans for soliciting pilot projects must include provisions for mentoring when appropriate. If new and early-stage investigators (as defined by NIH) are eligible to serve as pilot project leaders, describe mentoring activities to be provided during the pilot project planning, execution, and post-completion phases; how mentors for such investigators will be selected; and how mentoring activities will be evaluated. If a suitable mentor is not available within the applicant institution, appropriate mentors may be enlisted from outside institutions.

PHS398 Research Plan - Intervention Implementation/Diffusion Core

Specific Aims

Describe the aims and objectives that will be pursued to support regional implementation, diffusion, adoption and evaluation of evidence-based health disparity 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 strategies to keep various stakeholders informed, on an ongoing basis, of needs and capacity assessments and results from collaborative research projects and pilot research projects. Describe steps to assess the effectiveness of community- or service system-level implementation and dissemination of interventions and/or health education efforts. Describe strategies to use research findings to inform policy change and to promote diffusion, adoption and sustainability of effective interventions in relevant settings within the region.

PHS398 Research Plan - Optional Technical Core(s)

Specific Aims

Applications may include one or more shared core facilities to help support the proposed research projects. Examples include but are not limited to biospecimen repositories, regional data warehouses, biostatistics/study design core, bioethics and regulatory knowledge core, etc.

Research Strategy

Explain how each core will serve the proposed collaborative research sub-projects and pilot project program, the role each core will play in the overall research plan, and its value added to the TCC and the region as a whole. 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).

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. Cores whose sole mission is to support clinical research activities will not be supported; clinical research, where appropriate, will be supported as collaborative research sub-projects.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

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

Is the proposed Center likely to create an inclusive and integrative regional infrastructure for conducting comprehensive research on minority health and health disparities and applying the resulting knowledge in practical ways in community settings to promote health equity?

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 PD(s)/PI(s) and other members of the leadership team highly qualified to successfully lead and manage the proposed Center? Are the administrative structure, lines of authority and plans for alternate lines of authority in the PD(s)/PI(s) absence appropriate and clear? Is documentation provided to demonstrate that project leaders have the aptitude and volition to function as part of an integrated team? Are the training, qualifications, experience, and accomplishments of core directors appropriate to provide the proposed core services? 

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? 

Are the proposed goals of the Center and plans to achieve those goals innovative? Do the proposed research, implementation and dissemination/translation activities transcend customary approaches and “silo” organizational structures to address critical questions at multiple levels in innovative ways? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the TCC? 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 TCC involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are plans and timelines for solidifying collaborative relationships, assessing current capacity, engaging additional partners to fill identified gaps, and finalizing procedures for the pilot project program during the first year of support clearly described and feasible?

Is an effective strategy evident for selecting approaches and technologies within the TCC to address the proposed research questions? Are plans to incorporate new research projects and/or cores in response to emerging opportunities and to eliminate unproductive projects or cores appropriate, feasible, and equitable for all participating organizations? 

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 the documented capability and interest of the proposed institution(s) to aid in regional health disparities research and community engagement efforts meritorious and feasible? If optional research cores are proposed, are their roles in the overall research plan and value added to the TCC and region clearly described and adequately justified? Are plans in place for ensuring equitable access to core facilities, adequate staffing, and appropriate management?   

Additional Review Criteria - Overall

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.

Administrative Core

Collaboration and Partnerships Core

Research Core

Collaborative Research Sub-Projects

Reviewers will consider the following questions for each sub-project:

Pilot Project Program

Intervention Implementation/Diffusion Core

Optional Technical Cores (if proposed)

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned  to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected pilot research projects require prior approval by NIMHD prior to initiation. For research projects that involve human subjects:

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

Awardees must actively seek, and as appropriate, form partnerships with other NIMHD grantees in their respective regions with expertise and/or interest in health policy or social determinants of health and other relevant resources that could be leveraged to facilitate achievement of TCC goals and objectives.

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

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

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. NIH Project Scientists(s) will:

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

Additionally, the NIH Program Official(s) may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility:

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 Consortium Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Robert Nettey, MD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: netteyr@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, JD
Office of Extramural Research Administration
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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


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