Part I Overview Information

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Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov)

Title: Recovery Act Limited Competition: NCMHD Exploratory Centers of Excellence (P20)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-MD-06-003, which was previously released July 7, 2006.

Request For Applications (RFA) Number: RFA-MD-09-007

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release Date: May 12, 2009
Letters of Intent Receipt Date: June 1, 2009
Application Receipt Date: July 1, 2009
Peer Review Date: July/August, 2009
Council Review Date: August, 2009
Earliest Anticipated Start Date: September 30, 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: July 2, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The NIH has received new funds for Fiscal Years (FYs) 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ). This is one of a number of NIH initiatives supported by that Recovery Act funding. This NIH Funding Opportunity Announcement (FOA), issued by the National Center on Minority Health and Health Disparities (NCMHD), NIH, invites grant applications from eligible institutions/organizations that propose to establish an Exploratory NCMHD Center of Excellence (COE). NCMHD COE awards provide funding for hiring staff, researchers, community members, and trainees with the goal of augmenting and expanding the capacity and infrastructure of the institution and community to engage in research improving the health of nation and for preparing the next generation of researchers. Activities should be proposed that will benefit from significant 2-year funds without the expectation of continued NIH funding beyond two years. The activities supported by these NCMHD COE grants should have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery. Applications are invited from institutions seeking support to 1) establish novel partnerships for community engagement/outreach efforts to eliminate health disparities, 2) establish new or enhance current research training infrastructure and capacity, including pipeline training programs, to prepare future biomedical, biobehavioral, and clinical researchers from minority, rural or low social and low economic status populations, and 3) to hire newly-recruited faculty to develop a research project within the context of the NCMHD Centers of Excellence program. To be eligible for the COE in this FOA, applicant institutions are expected to have existing federal research support and/or research infrastructure as reflected in a level of NIH institutional funding of less than $80 million for the year 2008. Mandatory Cores: Each NCMHD Exploratory COE (P20) must contain two cores: a mandatory Administrative Core, and one additional core selected from the following: Community Engagement/Outreach Core or Research Training/Education Core or a Research Core. If a Research Core is proposed, a single research project must be proposed. NCMHD will only support a single research project.
• Mechanism of Support. This FOA will utilize the Exploratory Center (P20) grant mechanism
• Funds Available and Anticipated Number of Awards. It is anticipated that approximately $6.0 million will be available in FY 2009 and FY 2010 to support up to 5 awards.
• Budget and Project Period. Direct costs may not exceed $450,000 per year. The total project period for an application submitted in response to this FOA may not exceed two years.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.
• Number of Applications. An eligible applicant institution may submit only one application in response to this FOA. Only one application from the same institution will be reviewed.
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Renewal applications are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

Table of Contents

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Part I Overview Information

Part II 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 Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Objectives

Nature of the Research Opportunity

With funding under the American Recovery and Reinvestment Act, the National Center on Minority Health and Health Disparities (NCMHD), National Institutes of Health invites grant applications from eligible institutions of higher education to establish an Exploratory NCMHD Center of Excellence to support accelerated research infrastructure and capacity building efforts that will make a measurable and significant contribution to NCMHD’s short and long term efforts to reduce and eliminate health disparities and stimulate the local economy by 1) establishing, building and sustaining novel partnerships; 2) hiring faculty from health disparity populations, 3) designing and launching new or expanding existing training programs within academe and the community for engaging academic health disparity researchers and community members in health disparity reduction or elimination research efforts or activities; 3) accelerating the recruitment of minorities into interventions and trials, and 4) rapidly initiating or expanding focused research training programs, research activities or intervention and prevention studies likely to enable improvements in minority health, reductions in existing health disparities and growth of the local economy.

There are clear and pressing needs for increasing the Nation’s infrastructure and capacity for addressing health disparities, for developing innovative research training/education programs, partnerships for community engagement/outreach activities and innovative biomedical and biobehavioral research with a high likelihood for promoting minority health and eliminating health disparities. An NCMHD COE funded under this FOA is limited to two cores: a mandatory Administrative Core, and one additional core selected from the following: a Community Engagement/Outreach Core or a Research Training/Education Core or a Research Core. If a Research Core is proposed, it must contain a single research project. The two core requirement for the NCMHD COE coupled with two years of funding requires applicants to identify and develop effective and efficient cores, administration practices, and to select and support ideas and activities with high short-term impact and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery. The required design allows applicants to either engage in building infrastructure and capacity, conducting innovative health disparities research, establishing novel partnerships for community engagement and outreach, providing research training/education experiences or all of the above depending on the existing resources, project aims, and the creativity of the applicant. Within this structure, applicants can select how best to establish a NCMHD COE for exploring the multiple and complex factors contributing to the promotion of minority health or to the reduction and elimination of health disparities. These factors are expected to include community level and individual social factors, biological, genetic, environmental, and behavioral factors acting independently or dependently, across multiple social contexts, and across multiple social levels. The Exploratory NCMHD COE established under this FOA is expected to contribute to the Department of Health and Human Services initiative for eliminating health disparities.

This NCMHD COE grant award provides a means through which an institution or consortium of institutions can:

• Establish an entity responsible for administrative and scientific oversight, coordination, and global reporting and evaluation of all minority health and health disparity research, research training, community outreach/engagement, etc., and related awards made under the American Recovery and Reinvestment Act. This includes but is not limited to the Recovery Act Limited Competition: NIH Challenge Grants in Health and Science Research (RC1), RFA-OD-09-003, Administrative Supplements Providing Summer Research Experience for Students and Science Educators, NOT-OD-09-060; Administrative Supplements, NOT-OD-09-056; Competitive Revision Applications, NOT-OD-09-058, etc.;
• Develop an infrastructure at the institution and within a minority, rural, or low social and economic status community for conducting minority health and other health disparities research, community engagement/ outreach, and research training;
• Establish a single interdisciplinary and trans-disciplinary center at the institution for coordinating and facilitating single, multi-site or regional minority health and health disparities efforts and activities;
• Establish, enhance or strengthen community engagement/outreach and institutional partnerships for addressing minority health, the elimination of health disparities, or both;
• Develop, enhance or strengthen existing research training activities that prepare researchers from minority and health disparity populations to conduct meritorious minority health and health disparities research.

The proposed or existing projects and activities that are administered, coordinated, or housed under the NCMHD COE must address or be related to minority health, health disparities, or both but need not be thematic or focused on a single specific disease or condition. Research training activities may be provided for students, post-docs, faculty, community organizations, lay community workers, etc. The adaptation of training programs proven to increase quality, retention, and competitiveness of minorities and individuals from health disparity populations are of interest.

An exploratory NCMHD COE may propose to conduct innovative basic, behavioral, clinical, or population based research directed toward improving minority health, eliminating health disparities, or both, in any of the following diseases or conditions: cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, mental health, and obesity or other diseases or conditions of major public health importance. Research associated with lung and liver diseases, psoriasis, scleroderma, and glomerular injury is also encouraged when significant disparities for racial and ethnic populations and medically underserved populations are known to exist. Intervention and prevention research studies and trials exploring multiple risk factors that cut across a single or multiple diseases or conditions are of interest.

Background

The mission of the NCMHD is to promote minority health and to eliminate health disparities. The NIH defines health disparities as differences in the incidence, prevalence, morbidity, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups (See, http://ncmhd.nih.gov/about_ncmhd/index2.asp , page 7). The specific population groups are African Americans, American Indians, Alaska Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, subpopulations of all of the above, and medically underserved populations (i.e., socio-economically disadvantaged individuals in rural and urban areas). These populations are hereafter referred to as health disparity populations. Additional background information can be found in previous NCMHD RFAs and FOAs, see RFA MD-02-003, http://grants.nih.gov/grants/guide/rfa-files/RFA-MD-02-003.html, and MD-03-003, http://grants.nih.gov/grants/guide/rfa-files/RFA-MD-03-003.html.

I. The NCMHD Centers of Excellence Program

Grantees in the NCMHD COE program conduct research independently or in formal partnership with one or more institutional partners, provide training opportunities to students, researchers and junior faculty from health disparity populations, engage in health promotion and health information dissemination activities, and have established partnerships with community based organizations. According to published research findings, these centers are conducting research involving all health disparity populations and all of the priority diseases and conditions identified by the Department of Health and Human Services. This initiative provides opportunities to accelerate these and other efforts by providing support for 1) engaging minority and health disparity communities in effective and sustainable NCMHD COE community partnerships and activities for improving the health of their communities, increasing the numbers of individuals from minority and health disparity populations engaged in clinical research activities, including clinical trials, and for increasing health literacy and knowledge of health disparities, 2) infrastructure and capacity building, 3) establishing or strengthening of exemplary research training/education activities for increasing the numbers of well trained researchers from minority and health disparity populations and 4) innovative multi- and trans-disciplinary research to promote minority health and to eliminate health disparities.

II. Scientific Knowledge to be Gained through the NCMHD COE Program

It is expected that this program will produce advances in biomedical and behavioral knowledge that will be invaluable for improving minority health and for eliminating health disparities within and across the priority areas of cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, mental health, and obesity, as well as lung and liver diseases, psoriasis, scleroderma, and glomerular injury, and other diseases and conditions of public health importance.

Healthy People 2010 identified the following six critical determinants of health: biology, behaviors, the social environment, the physical environment, policies, and access to care. It is expected that research conducted at an NCMHD Center of Excellence will discover knowledge on the interactions of significant biological factors with behavioral and social variables, how they affect each other, and how these interactions influence and contribute to minority health conditions and health disparities. This new knowledge is expected to lead to the development of new interventions, strategies, polices and practices for improving minority health and eliminating health disparities.

In addition to the above, NCMHD anticipates that this program will contribute to increasing the number of individuals from racial and ethnic health disparity populations 1) trained to conduct minority health and health disparities research, 2) enrolling in clinical trials, and 3) engaged in improving the health of their communities though sustained partnerships and programs with NCMHD COE institutions.

III. Examples of Research, Research Training/Education, and Community Engagement/Outreach Activities

Applicants may want to consider the following when developing activities for the COE. These are examples and are not meant to suggest priority areas, nor are they comprehensive or restrictive.

Research Themes, Areas, Scope

• Interdisciplinary minority health and health disparities research, including basic, clinical, and behavioral and social sciences research to advance understanding of disease development and progression and the development of interventions for preventing or delaying the onset and progression of one or more diseases or conditions.
• The biological and biomedical bases of diseases/conditions affecting minority health and the factors (biological, behavioral, environmental, social, etc.) contributing to or influencing minority health and health disparities.
• Approaches for improvement of techniques for diagnosis, prevention, and treatment.
• Development of methodological tools, measures, validated instruments, and novel research designs for disentangling the contribution of biologic factors, behaviors, and social factors to health disparities.
• Translational research successfully translating research into interventions, health promotion/prevention programs or policy or behavioral changes in communities, schools, businesses, families, prisons, etc.
• The pathways and mechanisms by which biologic and non-biologic determinants contribute to or influence minority health or health disparities.
• Examination of potential pathways and mechanisms leading to disparities in health outcomes, including but not limited to behaviors and social factors, policy, genetic variations and/or other underlying biological, gender, ethnic and familial factors, and environmental exposures, including, exposure of children or adults to abuse, bias, discrimination or other potential stressors; in particular, studies identifying the biological underpinnings of differential responses to stressors, and to therapies (i.e., hypertension, diabetes, renal transplantation, depression), and the differential prevalence of disease, and co-morbidities.
• Population-based studies for reducing the incidence and prevalence of health disparities among individuals living in different geographical regions of the US, in particular, the top 10 unhealthiest states according to America’s Health Ranking Report 2008, the Mississippi Delta, Appalachia, U.S.-Mexico Border region, and Tribal Communities, and studies designed to eliminate or decrease the impact of factors, including natural disasters, contributing to the excess risks, morbidity and mortality associated with living in such regions. The top 10 unhealthiest states in 2008 were Alabama, Georgia, Nevada, Arkansas, Oklahoma, Florida, Texas, Tennessee, Mississippi, and Louisiana.
• Developmental influences across the life span; specific health behaviors; discrimination in health processes; psychosocial and socio-cultural influences, and socioeconomic factors (such as, differential access to health care) that have shaped the health care outcomes of the targeted populations. Health processes include the technical and interpersonal activities pertaining to disease prevention, diagnosis, and treatment that occur between the patient and practitioner, and other health care providers, and consideration of the linguistic abilities of patients and practitioner and its impact on communications between the patient and the practitioner.
• Cultural sensitivity/competency and its role in health promotion/disease prevention.

Capacity Building and Infrastructure Development/Research Training

• Establishing programs for the development of new and future investigators.
• Establishing novel or enhancing existing training programs and curricula for enriching the biomedical and behavioral research training and competence of researchers and health care providers, especially those engaged in or likely to conduct research on minority health or health disparities.
• Establishing or sustaining novel partnerships for promoting minority health or reducing health disparities within minority and health disparity communities

Community Engagement/Outreach Objectives

• Establishing innovative partnerships between academic institutions and community groups/organizations.
• Information Dissemination and Education - How to reach minority and health disparity populations and health care provider communities serving these populations with information that will lead to positive changes in behaviors, practices, and health.
• Interaction of culture and other variables on recruitment into research studies and clinical trials, utilization of services, adherence to lifestyle and behavioral changes; and understanding individual cultural beliefs and expressions within a multicultural setting.
• The efficacy of a full range of health promotion, health services, communication, and information dissemination approaches for improving minority health or eliminating health disparities.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

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1. Mechanism of Support

This funding opportunity will use the Exploratory Center (P20) award mechanism.

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

Each NCMHD Exploratory COE P20 application must contain an Administrative Core and one other core selected from the following: a Research Training Core or a Community Engagement/Outreach Core or a Research Core. If proposing a Research Core, one single research project must be proposed. Support for only one research project will be provided for up to 2 years and can not exceed the project period of the award.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5.The estimated amount of funds available to support up to 5 projects awarded as a result of this announcement is approximately $6.0 million.

Budget requests are limited to $450,000 direct costs per year. The total project period for an application submitted in response to this FOA may not exceed two years.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. However, the duration of the awards issued under this FOA will be limited to two years.

Awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

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

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• 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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. An eligible applicant institution may only submit a single application as the sole or lead institution. Only one application from the same institution will be reviewed.

This competition is open to all eligible institutions and to NCMHD grantees operating a previously funded NCMHD COE (P20), including R24 EXPORT recipients, under a no-cost extension or with bridging funds. Institutions holding a Research Infrastructure In Minority Institutions (RIMI) grant or a currently funded NCMHD COE may not apply.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

To be eligible for establishing a COE in this FOA, applicant institutions are expected to have existing federal research support and/or research infrastructure as reflected in a level of NIH institutional funding of less than $80 million dollars for the year 2008. See the following link maintained by the NIH Office of Extramural Research for determining the level of NIH funding for your institution, http://grants.nih.gov/grants/award/trends/FindOrg.cfm. Applicant institutions having an NIH institutional funding level greater than or equal to this figure may not apply to be the lead institution on this FOA.

Additionally, there are specific eligibility criteria established by law that are expected to be satisfied in order to receive an award under this FOA. Pursuant to Public Law 106-525, awards under this program may only be made to institutions of higher learning having a history of enrolling and graduating racial and ethnic minority and socioeconomically disadvantaged students from their degree programs. The recruitment, retention, and promotion of racial and ethnic minority faculty and staff are also priorities at such institutions. In previous FOAs establishing an NCMHD COE, institutions having the above priorities were referred to as designated institutions. In this FOA, designated institutions are now referred to as eligible institutions, meaning these institutions are eligible to establish an NCMHD COE independently as the sole applicant or as the lead applicant in a partnership or consortium. Four operational characteristics previously set forth for designated institutions have been restated as eligibility criteria. Responsive applicants must be able to document that, for the past four years, they have:

• Had a significant number of members of health disparity populations enrolled as students in the institution, including individuals accepted for enrollment in the institution.
• Been effective in assisting students from health disparity populations to complete a program of study or training and receive the advanced degree(s) offered.
• Made significant efforts to recruit and enroll health disparity population students into and graduate from the institution, which may include providing means-tested scholarships and other financial assistance as appropriate.
• Made significant recruitment efforts to increase the number of members of health disparity populations serving in full-time faculty or administrative positions at the institutions.

Applicants that are unable to provide documentation that satisfies all of the above criteria should establish a partnership or consortium with an eligible institution serving as the lead applicant. Applicants unable to meet all of the above eligibility criteria, or those lacking sufficient documentation to establish eligibility, will be considered non-responsive and will be returned without peer review. Applicants are invited to contact the program official listed in this FOA for assistance in identifying the possible documentation prior to submission of an application.

Definitions

The definitions below are intended to clarify concepts that are expressed in this FOA.

APPLICANT INSTITUTION: The applicant institution is the entity at which the NCMHD center will be physically located and/or integrated into its administrative structure. The Project Director/Principal Investigator must have his/her primary appointment at the applicant institution.

COLLABORATING INSTITUTION: The collaborating institution is the institution with which the applicant institution has partnered. The following are examples of potential collaborators or partners.

• 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)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations

PREDOMINANTLY MINORITY SERVING INSTITUTION: A predominantly minority serving institution is an academic, health care, or research institution with an enrollment and/or faculty that consists predominantly of racial and ethnic minorities.

HEALTH DISPARITY POPULATIONS: African Americans, Alaskan Natives, American Indians, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific Islanders, and other medically underserved populations, which includes socioeconomically disadvantaged individuals in rural and urban areas. (P.L. 106-525)

PARTNERSHIP AND CONSORTIUM ARRANGEMENTS: A formalized arrangement whereby a research project is carried out by the grantee and one or more other organizations that are separate legal entities. Such activities are encouraged in this FOA.

HISPANIC-SERVING INSTITUTION: A Hispanic-Serving Institution (HSI) is defined as an institution that has at least 25% Hispanic full-time equivalent (FTE) enrollment, and of the Hispanic student enrollment at least 50% are low income. Low income is defined as 100 and 199% of the poverty threshold as determined by the Bureau of the Census. (See U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 1975-2007.)

DESIGNATED INSTITUTION: See Public Law 106-525.

Section IV. Application and Submission Information

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1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: June 1, 2009
Application Receipt Date: July 1, 2009
Peer Review Date: June/July, 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Prabha Atreya, PhD
Chief, Office of Scientific Review
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8676
FAX: (301) 480-4049
Email: atreyapr@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application must be sent to:

Prabha Atreya, PhD
Chief, Office of Scientific Review
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8676
FAX: (301) 480-4049
Email: atreyapr@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review as indicated in the NIH Grants Policy Statement.

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

Except under extenuating circumstances as discussed below, NCMHD funds may not be used to support any research project (regardless of the size of the budget or the length of the project period) that was not requested in the application, peer reviewed by NIH, and approved for funding by NCMHD at the time of award

For example, a grantee may seek to replace a research project due to the departure of a PI from the institution. The institution must submit a written request, with sufficient justification, seeking to replace the current research project with a new research project and PI. Prior approval from NCMHD ensures that any applicable requirements for a change in scope or aims or deviation from award terms and conditions have been met. In such cases grantees are advised to discuss pending developments with the designated program official and grants management specialist.

6. Other Submission Requirements and Information

Modify the PHS 398, starting with the Table of Contents, to include the following items in the following order and using the page limits below when provided:

• Composite Detailed Budget for Initial Budget Period (Entire Project, 398 Form Page 4)
• Composite Budget for Entire Proposed Period (398-Form Page 5)
• Budgets Pertaining to Consortium/Contractual Arrangements
• Detailed Budgets (Initial and Entire Period) and Budget Justification (by Core, and for each Research project or Activity within a Core)
• Biographical Sketch COE PD/PI
• Other Biographic Sketches Key Personnel, etc.
• Resources
• Checklist
• Summary Description of the Proposed NCMHD COE (A total of 4-8 pages recommended including the subsections below.)
• Provide documentation requested for satisfying the eligibility criteria bulleted in Section III.3 for establishing an NCMHD COE (1-3 pages recommended).
• Describe the COE, its scientific focus, for example, minority health, health disparities, or both, its goals and specific aims/objectives, its cores, the type of research to be conducted, disciplines involved, disease/conditions, determinants, etc., and dedicated facilities to be utilized by the center. Describe expected outcomes: increases in infrastructure and capacity, partnerships, etc. at the institution and within the community; minority or health disparity research faculty hired or community health workers hired or trained; training programs established; and, if applicable, expected research advances in minority health and health disparity research; (3-5 pages recommended).
• Description of Administrative Core (This is a required core, select at least one additional core from those listed in bullets below; 4-6 pages recommended.)
• Description of the Research Training/Education Core or Description of the Community Engagement/Outreach Core or Description of the Research Core (4-6 pages recommended, one of the three cores must be selected as the second core)
• Research Project Title Page and Project Description (PHS Form Pages 1 and 2) (Include this and the following bullets if the Research Core is selected as the second core. NCMHD will provide funding for a single research project. Use the modified PHS 398 format suggested below. Include a detailed budget for the research project as per guidance in the PHS 398.)
• Research Plan Specific Aims (one page is recommended)
• Background and Significance (1 page recommended)
• Preliminary Studies (omit)
• Research Design and Methods (Limited to 12 pages)
• Research Topic (must be clearly within the area of minority health or health disparities)
• Potential Impact
• The Approach
• Timeline and Milestones

(Note: the following 10 bullets are omitted from the 12 page limit for the research plan)

• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted Planned Enrollment Table
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• Multiple Principal Investigator (MPI) Plan
• Consortium/Contractual Agreements/MOUs
• Letters of Support
• Resource Sharing Plans

Supplemental instructions for major areas:

I. Description of the Proposed Exploratory NCMHD Center of Excellence (4-8 pages recommended)

Applicants should describe the center, its scientific focus, for example, minority health, health disparities, or both, its goals and objectives, its cores, the type of research to be conducted, disciplines involved, disease/conditions, determinants, etc. In addition, assuming baseline data are available, the applicant should provide the expected improvement over the relevant baseline for any given disease, condition, or significant activity. Describe the dedicated facilities to be utilized by the center. If requesting a shared resources core or additional center components provide the appropriate rationale.

The NCMHD, through this FOA, will make a substantial investment in these exploratory NCMHD COE and expects similar commitments of the institution(s) to the center. Discuss and provide evidence (for example, a letter from the provost) of the institutional commitments to the center, including the recognition of the center as a formal organizational component, the provision of space, administrative, faculty and staff positions and discretionary resources, the authorities of the NCMHD COE director; the status of the NCMHD COE director in comparison to department chairs; institutional lines of authority, and responsibilities of institutional leaders to ensure the long-term stability (viability) of the center, and the plans for assuring the continued commitment of the center in the event of a NCMHD approved change in directorship.

If establishing a partnership, discuss briefly the history of previous partnerships with the proposed partners if any, and the rationale, scientific and geodemographic, for partnering. Describe how the partnership was established, and describe the complementary institutional strengths and expertise; for example, strengths and expertise in basic, clinical, or population-based research, research training, community engagement, partnership building with minority or health disparity communities, trust, etc, as appropriate, that contribute to the likelihood that this partnership will achieve the proposed scientific goals and objectives and thereby make significant contributions to improving minority health or eliminating health disparities. Describe efforts that have been taken to ensure the success of the partnership generally and the steps taken to ensure that it is and will remain a true partnership throughout the course of the award. Provide a plan for ensuring the solvency of the proposed partnership(s) once an award has been made and for resolving conflicts within the COE, especially among different organization units. Specifically address and justify the proposed distribution of essential resources and administrative responsibilities between the partnering institutions, organizations, faculty and staff. Provide an official signed letter of understanding establishing the partnership between the partnering institutions or organizational components and document all significant inter-institutional commitments. Applicants should decide what and how much is appropriate to include about the partnership in this section versus the administrative core.

II. Administrative Core (mandatory, 4-6 pages recommended, select at least one additional core from those listed below,)

Applicants should describe the administrative structure of the center and the roles and responsibilities of all key personnel. The administrative core is responsible for 1) the allocation and oversight of all COE resources, 2) establishing and maintaining all partnerships, advisory and executive boards, cores, and training and community activities essential to the success of the COE, 3) the selection of key personnel and the minority health or health disparities research and other activities to be conducted within the center, 4) establishing and overseeing the process for the initial solicitation, review, and selection and justification of all projects and activities included in the application, and 5) for working with the local IRB(s) to ensure that all projects involving human subjects or vertebrate animal subjects are in full compliance at all times and that appropriate measures and safe guards are in place and utilized for ongoing data safety and data monitoring.

Additionally, through the efforts of the administrative core, each NCMHD COE is expected to become a valued, trusted, institution-wide resource for expanding the capacity and competence of the institution, and that of NIH funded researchers and students in conducting minority health and health disparities research. The center director is also expected to interact with the administrative leadership of the institution to enhance the success of the center.

III. Research Training/Education Core (4-6 pages recommended)

Training activities may be provided at the undergraduate, graduate, post-doctoral, or junior faculty level.

Undergraduate/Graduate Students. Training components for students may include establishing academic term and/or summer training opportunities. The enhancement of existing curricula to include subjects related to minority health and health disparities may be proposed. The development of curricula for preparing students to conduct research on minority health or health disparities is of special interest. For consortia arrangements, new research training programs might provide students the opportunity to fulfill their research requirements in research laboratories at the partner institution or to take courses not offered at the student s home institution.

Post-Doctoral Training. Training components may also support post-doctoral training for individuals that have earned the doctorate degree or equivalent and who are from health disparity populations.

Faculty Support). With respect to faculty at HBCUs and Minority Serving Institutions (MSI), mentored research components may be developed to provide assistance in learning new methodologies or to encourage faculty participation in research. Support for new faculty research positions to build capacity in biomedical and behavioral research and research training can be requested. Applicants must justify the position(s) relative to the goals and objective of the proposed COE. Up to 50% support (time and effort) may be requested for HBCU or MSI faculty at a partnering institution to engage in research.

The applicant institution and its partners must demonstrate or give reasonable assurances that it has the capacity to train predoctoral and/or postdoctoral students for careers in biomedical, behavioral, epidemiological or health services research. For partnerships and consortia, training initiatives should represent true collaborations that function across institutional boundaries.

Training in the Responsible Conduct of Research. Every trainee supported by the COE grant should receive instruction in the responsible conduct of research (http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the predoctoral trainees appointed to the program. Plans must address the subject matter of the instruction, the format of the instruction, the degree of training faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

IV. Community Engagement/Outreach Core (4-6-pages recommended)

The mission of each Community Engagement/Outreach Core is expected to vary depending on the overall goals of the COE, the proposed research, and the needs and capabilities of the community and of the applicant institution. Ideally, activities within this core should contribute to improvements within the community and not simply provide a service. Improvements can be, for example, in health literacy, including knowledge of health disparities and ways to recognize, prevent, reduce or eliminate them. Activities that are service only will not be supported. All proposed activities must include a means of assessing the effectiveness and or efficacy of the activities. In disseminating health information to a minority or health disparities community, an applicant might seek to determine what dissemination methods are most effective in preventing, reducing or eliminating health disparities associated with a given disease and or condition. Is it important to disseminate health science research information in a culturally sensitive way? What fraction of the community actually uses the information? What are the expected outcomes? Applicants should describe how the use and effectiveness of the disseminated information would be measured. Accordingly, this core may focus on 1) how to access and build public trust; 2) training of lay community workers, etc.; 3) how to engage the community for potential participation in clinical studies and clinical trials and for eventual partnering in the conduct of community-based health disparity interventions; and 4) how to engage the community in science education activities (e.g., K-12 science programs within area middle schools, high schools, or adult community groups) and assessing the effectiveness of these activities in contributing to improving minority health or the elimination of health disparities, or increasing the pool of researchers from health disparity and minority populations.

NCMHD COE may request support for disseminating health information, as well as sponsor activities that encourage community participation in research as study participants or that equip community-based organizations for partnering in and/or conducting disease prevention and/or intervention activities. In particular, for information dissemination purposes, the audiences should include health care students and professionals, community-based organizations and researchers at the host institution as well as investigators at partnering institutions. Information transfer activities may include, but are not limited to activities such as training programs, short courses, telemedicine, presentations at professional meetings and publications. Applicants should address the expected effectiveness of the proposed activities and describe how the actual effectiveness of these activities will be measured and documented.

With respect to equipping health disparity communities to develop and manage their own culturally sensitive programs for educating their populations and/or participating in prevention and intervention activities, the focus could be, for example, on addressing community level and individual risk factors for priority diseases and conditions, chronic disease management, screening, prevention, and decision making with respect to available therapeutics and behavioral interventions. Plans to evaluate the success and/or effectiveness of the proposed community outreach/information dissemination should be described. Activities for engaging the health provider community in improving minority health or eliminating health disparities at the local, regional or state levels should also be considered.

V. Research Core (4-6 pages recommended)

This core is composed of a section describing the core and a section for the single project. Four to six pages are recommended for the description of the research core. If this optional core is proposed, NCMHD will provide support for only a single research project. Include a research plan for the research project and follow the format suggested above, which is a modification of the PHS 398 program project format.

Items 2-5 of the research plan are limited to 12 pages.

Within the research core section describe the overall purpose, structure, function, and the qualifications of the core director. Provide a brief description of the proposed research projects. If a research core is proposed, the application must include a research project. Only one research project will be supported.

The sole research project will be reviewed on its own merit and must include all of the components (face page, see below, project description, table of contents, etc.) described in the PHS 398 guidelines for research projects and adhere to all of the PHS 398 page limits and guidelines within, except where provided above. For this FOA the research plan, items 2-5, are limited to a total of 12 pages. Include the title and page number for the project in the table of contents for the COE and provide in the proposal a face page for the research project. The face page should include the title, name(s) and affiliation of the PI(s). Include detailed budget pages for the project in the composite budget section and in the research project (do not use modular budgets) along with a narrative budget justification. Also include the role and responsibilities of all of the members of the research team. If research using human subjects is proposed, provide a human subjects section as directed in the PHS 398 guidelines. If multiple PD/PIs will be designated, include a multiple PD/PI Leadership Plan. Include, as applicable in the research plan, the other sections listed in the PHS 398 (see below):

The following sections or items are excluded from the above page limits of the research plan but should be included in the research plan for each research project as applicable:

• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted Planned Enrollment Table
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• Multiple Principal Investigator (MPI) Plan
• Consortium/Contractual Agreements/MOUs
• Letters of Support
• Resource Sharing Plans

Each proposed research project must address a significant issue in minority health or health disparities. A single principal investigator or multiple co-investigators from the same or different institutions may conduct the proposed research. The research team can include senior and junior faculty, post-doctoral or other trainees, as well as community members, all with the appropriate justification. Expected improvements in health relative to an existing baseline measure for the health disparity population(s) under study should be provided when possible. For example, if the proposed research involves an intervention documented to be effective for only 50% of a given population, the applicant should make the case for increasing the effectiveness to 75%, and address the basis for the expected improvement.

No NCMHD funds may be used to support any research project (regardless of the size of the budget or the length of the project period) that was not peer reviewed by NIH or NCMHD and approved for funding by NCMHD at the time of award, unless written prior approval from NCMHD has been provided.

Research Plan Page Limitations

Items 2-5 of the research plan are limited to a total of 12 pages.

Appendix Materials

Appendices are not permitted.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

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1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCMHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below. Responsiveness will be evaluated by NCMHD program staff using the criteria listed in this FOA. Incomplete and/or non-responsive applications will not be reviewed.

As part of the scientific peer review, all applications will:

• 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 a priority score.
• Receive a written critique.
• Receive a second level of review by the NCMHD’s National Advisory Council

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

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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?

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

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

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 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?

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? Is institutional commitment to the pursuit of minority health and health disparities research and other proposed activities, including provision of resources, administrative authority and recognition, convincing?

In addition to the above review criteria, NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program (using the above five criteria);
• The qualifications and experience of the center director and other key personnel;
• The statutory and program purposes to be accomplished;
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
• The extent to which the center's activities would be coordinated with similar efforts by other organizations;
• The administrative and managerial capability of the applicant; and
• Other factors which NCMHD considers appropriate in light of its particular statutory mission: The extent to which the center activities are focused on improving minority health, eliminating health disparities, or both, and its potential to favorably establish or enhance and sustain the fields of minority health or health disparities research at the institution and its engagement and partnerships with the community past the project period.

The ADMINISTRATIVE CORE will be evaluated with the following criteria:

Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the project? Does the application describe how day-to-day management will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate? Are contractual and consortium arrangements adequately described, if applicable? What is proposed for long-term management and periodic evaluation of goal attainment? If a partnership is involved, are the resources and responsibilities appropriately distributed and justified given the goal and objectives of the proposed COE? Does the grantee describe an effective process for resolving conflicts between the partners? Are plans in place to sustain efforts, partnerships, and relationships with engaged communities and community organizations past the proposed project period?

Investigator: Are the qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate, if different than the PI? Is there an appropriate time and effort commitment made by the Administrative Core Director? If applicable, is there evidence that the researchers and faculty of the partnering institutions have worked closely together in the preparation of the application or will do so in meeting the proposed objectives?

Environment: Is institutional commitment to the pursuit of minority health and health disparities research and other proposed activities, including provision of resources, administrative authority and recognition, convincing?

The RESEARCH CORE will be evaluated with the following criteria:

Approach: Are the goals of the Research Core significant and explained in the context of potential to contribute to improving minority health, the elimination of health disparities, or both? Is there evidence that the applicant utilized an effective process for selecting the research projects submitted in the application? What are the quality control and oversight mechanisms in place for the proposed projects?

Investigator: Are the qualifications, experience, commitment and administrative competence of the Research Core Director appropriate? Is there an appropriate time and effort commitment made by the Research Core Director? Are there adequate plans for communication and cooperation among investigators?

Environment: Are there appropriate plans for resource allocation? Does the scientific environment in which the work will be done contribute to the probability of success? If the research sites are not all located on a single campus, do the additional sites contribute to the probability of success?

The RESEARCH PROJECT within the RESEARCH CORE will be evaluated with the following criteria:

Significance: Does this study address an important minority health or health disparity problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? How will minority health be improved? Will a disparity be eliminated or significantly reduced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? For a continuing research project, has adequate progress been made in achieving the stated goals of the previously funded research?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Has the applicant appropriately recognized, designed, and considered the role of culture and ethnicity for all proposed research and activities?

The RESEARCH TRAINING/EDUCATION and COMMUNITY ENGAGEMENT/OUTREACH cores will be evaluated with the following criteria:

Significance: Is there evidence that these cores will make significant contributions to the goals/specific aims of the COE? Will the proposed activities of the community engagement/outreach core contribute to the translation of research findings to the community? What is the potential impact of the core on improving minority health and eliminating health disparities? Does the community engagement core contribute increased health literacy, increased enrollment in clinical trials, and increased knowledge of health disparities and ways to identify, prevent, reduce, or eliminate them? Does the training core contribute to increasing the number of individuals from health disparity populations engaged in research? Will it contribute to improved research training in minority health and health disparities all participating institutions? Will it contribute significantly to the development of future researchers?

Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the program? Do the proposed cores benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?

Investigator: Are the qualifications, experience, commitment and administrative competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Are there adequate plans for communication and cooperation among core participants?

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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.

2.B. Additional Review Considerations

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

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

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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm);

2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and

3) Genome-Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

The following will be considered in making funding decisions:

• Existing federal research support and/or research infrastructure as reflected in a level of NIH institutional funding of less than $80 million dollars for the most recent fiscal year as documented at http://grants.nih.gov/grants/awards/trends/findOrg.cfm
• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed COE to NCMHD program priorities: 1) The types of diseases(s) and condition(s) - ensuring that NCMHD COE resources are appropriately distributed in breadth and depth of diseases and conditions; 2) Diversity in geographic locations within the NCMHD Exploratory COE portfolio, for example, rural areas, border regions, and urban and other areas with significant numbers of minority and health disparity populations - ensuring that the NCMHD COE portfolio is diversified geographically; and 3) Diversity in the minority and health disparity populations and subpopulations within the NCMHD Exploratory COE portfolio - ensuring that the NCMHD Exploratory COE portfolio is diversified with respect to the inclusion of minority and health disparity populations and subpopulations in NIH supported research.

Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

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1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Derrick Tabor, PhD
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8950
FAX: (301) 480-4049
Email: tabord@mail.nih.gov

2. Peer Review Contacts:

Prabha Atreya, PhD
Chief, Office of Scientific Review
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8676
FAX: (301) 480-4049
Email: atreyapr@mail.nih.gov

3. Financial or Grants Management Contacts:

Priscilla Grant, JD, CRA
Chief Grants Management Officer
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-8412
FAX: (301) 480-4049
Email: grantp@mail.nih.gov

Section VIII. Other Information

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Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Act and Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

Authority and Regulations:
This FOA is supported by funds provided to the NIH under the Recovery Act, Pub. L. No. 111-5.

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 211 and 284) and under 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs (LRP):
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.