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Part I Overview Information

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: NCMHD Exploratory Centers of Excellence (P20)

Announcement Type
This is a reissue of RFA-MD-06-003.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-MD-08-004

Catalog of Federal Domestic Assistance Number(s)
93.307

Key Dates
Release Date: May 29, 2008
Letters of Intent Receipt Date: July 1, 2008
Application Receipt Date: July 31, 2008
Peer Review Date(s): November-December 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 1, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Nature of the Research Opportunity

The National Center on Minority Health and Health Disparities (NCMHD) invites applications for establishing Exploratory NCMHD COE (P20). The Minority Health and Health Disparities Research and Education Act of 2000 authorized the NCMHD to establish COE. The first NCMHD COE were focused on partnerships for community outreach, research on health disparities, and training. The NCMHD now seeks to expand the number of active NCMHD COE and accelerate extramural efforts to improve minority health and to eliminate health disparities. There are clear and pressing needs for continued research, research training/education, and community engagement/outreach activities with a high likelihood for improving minority health and eliminating health disparities. An NCMHD COE funded under this FOA must establish an administrative core and cores for research, research training, and community engagement/outreach. This NCMHD COE program will support research, research training/education, and community engagement/outreach activities exploring the multiple and complex factors contributing to minority health and health disparities. These factors are expected to include biological, genetic, environmental, behavioral and social 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.

An Exploratory NCMHD COE should propose to conduct original and innovative basic laboratory, 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 disease 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 research studies and intervention trials exploring multiple factors that cut across a single or multiple diseases or conditions are of interest.

Pilot research or feasibility projects/studies are not supported under this FOA.

The P20 grant award provides a means through which an institution or consortium of institutions can: 1) integrate and centralize ongoing minority health and health disparities research and related research-based activities into a single interdisciplinary and trans-disciplinary research enterprise; 2) establish novel effective partnerships with organizations and communities for conducting original and innovative cutting-edge research leading to improvements in minority health, the elimination of health disparities, or both; 3) 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; and 4) establish, enhance or strengthen community engagement/outreach and institutional partnerships for improving minority health and the health of health disparity populations.

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 establishing centers of excellence, 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 Center of Excellence Program

The NCMHD COE Program has supported a total of 88 institutions in establishing resource related-centers (R24), exploratory centers (P20), and comprehensive centers (P60) since its inception in FY 2002. The NCMHD COE conduct research independently and in formal partnership with one or more institutional partners, provide training opportunities to 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 continuing to support: 1) original, innovative, leading-edge multi- and trans-disciplinary research to improve minority health and to eliminate health disparities; 2) establishing or strengthening of exemplary research training/education activities for increasing the numbers of well trained researchers from minority and health disparity populations; and 3) 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.

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. New knowledge is also expected to result from continuing research initiated under previous NCMHD COE support.

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 biopsychosocial interventions and strategies 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.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the P20 award mechanism(s).
The PD/PI will be solely responsible for planning, directing, and executing the proposed project.

Each application and subsequent NCMHD COE P20 award must contain an Administrative Core, a Research Core, a Research Training/Education Core, and a Community Engagement/Outreach Core. These cores are to be organized as outlined in this FOA. In the Research Core, at least one research project must be proposed, and a maximum of three research projects can be proposed. To receive an NCMHD COE award, at least one research project must be assessed meritorious by the scientific review group and subsequently recommended for funding by NCMHD. A maximum of three research projects can be supported. Support can be requested for up to five years. Pilot research projects or feasibility projects/studies are not supported under this FOA.

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

The estimated amount of funds available for support of four projects awarded as a result of this announcement is approximately five million dollars for fiscal year 2009 with a maximum of $950,000 direct costs. An applicant may request a project period of up to five years. Future year amounts will depend on annual appropriations and acceptable progress.

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. Although the financial plans of the IC(s) provide support for this program, 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

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply.

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

To be eligible for the COE in this FOA, applicant institutions must 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 2007. If your NIH institutional level exceeds this figure, your institution should consider applying for the Comprehensive NCMHD COE (P60) award. 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.

Additionally, there are specific eligibility criteria established by law that must 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, and retention, and promotion of racial and ethnic minority faculty and staff is also a priority at such institutions. In previous FOAs establishing exploratory 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:

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 necessary documentation prior to submission of an application.

An eligible institution may only submit a single application as the sole or lead institution. If more than one application is received identifying the same institution as the sole applicant or as the lead applicant in a partnership or consortium, all applications from this institution may be returned without review. In such cases, NCMHD will contact the appropriate institutional official to identify which application is to be accepted. The NCMHD strongly encourages collaboration of various schools of multi-component institutions by joining together in the submission of a single application. There are no limitations on the number of inter-institutional partnerships an institution may establish. An applicant may be the lead institution on one application and be a non-leading partner or consortium member on another. However, duplicative costs are not allowed. Applicants will be required declare and resolve any real or potential overlap issues prior to the making of an award.

Applicants holding a NCMHD P20 or P60 award funded in fiscal year 2002, 2003, 0r 2004 are not required to submit the above requested documentation. They are deemed eligible by having previously received an NCMHD Project EXPORT award.

This competition is open to all eligible institutions as described herein. NCMHD COE grantees funded in 2002, 2003, and 2004 are eligible. NCMHD COE grantees that received NCMHD COE interim support funds in FY 2007 or FY2008 are also eligible. Institutions holding a Research Infrastructure In Minority Institutions (RIMI) grant may apply. If successful, plans for phasing out the RIMI grant must be negotiated.

Competing renewal applications will be permitted for this FOA.

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.

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

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: [email protected].

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.

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). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: July 1, 2008
Application Receipt Date: July 31, 2008
Peer Review Date(s): November-December 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 2009

3.A.1. Letter of Intent

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

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:

Derrick Tabor, PhD
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard
Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]

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 five 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).

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.

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 or renewal 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 or renewal 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.)

Pilot research projects or feasibility projects/studies are not supported under this FOA. 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 and approved for funding by NCMHD at the time of award.

6. Other Submission Requirements and Information

Modify the PHS 398, starting with the Table of Contents, to include the following and in the following order:

Supplemental instructions for major areas:

I. Description of the Proposed Exploratory NCMHD Center of Excellence (15-page maximum)

Provide and discuss the documentation submitted to meet the eligibility requirements for establishing a center independently or as the lead applicant in a partnership or consortium. 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 director; the status of the 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 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, 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. Specifically address and justify the proposed distribution of essential resources and administrative responsibilities between the partnering institutions, organizations, faculty and staff. Describe any official letters of understanding established between the partnering institutions and any 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. Summary Progress Report (required for competing renewals only and grantees receiving interim support funding)

Previously funded NCMHD COE must include in this section a summary progress report generally describing how the success of the center has been measured, what the center considers its most important successes and accomplishments and how these accomplishments have contributed to realizing the funded goals and objectives of the center. For example, describe recent scientific discoveries and successes, awards and additional grant funding obtained by NCMHD funded investigators, accomplishments in community outreach, dissemination, dissemination, and efforts towards the development of new and future health disparity researchers.

Describe improvements in the infrastructure for conducting minority health or health disparities research established at the institution or in the community using NCMHD funding. Discuss how this infrastructure is sufficient for accomplishing the proposed goals and objectives to be supported under this FOA. If a significant decrease in a health disparity or a significant improvement in minority health has been realized, provide the baseline data supporting such results. While the page count of the progress report does not count against the 15 page maximum, applicants should be as succinct as possible, utilize tables and graphs, and report on only the most significant accomplishments to be assessed by reviewers.

Include a table listing the title of all research projects, including pilot projects, funded with the NCMHD dollars to date. List the PI, title of projects, health disparity population studied, and a listing of all publications resulting from each project. Indicate whether NCMHD was acknowledged in the publications listed.

Given the differences in grant awards, goals and objectives, funding levels, and the number and types of personnel supported by the NCMHD Center of Excellence, applicants should provide a table summarizing the total man-hours, and dollars, contributing to the outcomes and progress of the center.

III. Administrative Core (mandatory) -- 10-page maximum

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 to be conducted within the center, 4) establishing and overseeing the process for the initial solicitation, review, and selection and justification of the research 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.

All exploratory NCMHD COE are expected to establish and maintain a website.

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.

IV. Research Core (mandatory, 10 page maximum for the narrative description of the core) and Research Projects (mandatory, items 2-5 of research plans for individual research projects cannot exceed 25 pages)

Within the research core narrative describe the overall purpose, structure, function, and the qualifications of the core director. Provide a brief description of the proposed research projects. An exploratory NCMHD COE application must propose at least one research project and may propose a maximum of three research projects. To be funded as an NCMHD COE, at least one research project must be judged meritorious by peer review and be recommended and approved for funding by NCMHD.

Each 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, with the exception of the page limit for the research plan. The research plan, items 2-5, should not exceed 25 pages. Include the title and page number for each project in the table of contents for the COE and provide in the proposal a face page for each project. The face page should include the title, name(s) and affiliation of the PI(s), disease/conditions, factors, and minority or health disparity or health disparity targeted and whether human subjects or vertebrate animals will be used. Provide a project description (PHS 398, form page 2). Do not exceed 25 pages for the research plan (items 2-5) of a given project. Include detailed budget pages for each project in the composite budget section and within each 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 a continuing project and previously funded by the NCMHD, provide a progress report. If multiple PD/PI will be designated, include a multiple PD/PI Leadership Plan.

Each 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.

Pilot research projects or feasibility projects/studies are not supported under this FOA. No NCMHD funds may be used to support any research project (regardless of the budget or length of the project period) that was not peer reviewed and approved for funding by NCMHD at the time of award.

In case of extenuating circumstances, such as the departure of a research project PD/PI from the institution, the grantee may submit a written request to NCMHD for the re-budgeting of allocated funds. When submitting such requests, the instructions specified in NOT-MD-08-002 must be followed.

V. Research Training/Education Core (mandatory) --10-page maximum

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 at Minority Serving Institutions (MSI). With respect to faculty at MSIs, 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 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.

VI. Community Engagement/Outreach Core (mandatory) -- 10-page maximum

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? 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) 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 3) 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.

Research Plan Page Limitations

Items 2-5 of the Research Plan for each research project must not exceed 25 pages.

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

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 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

1. Criteria

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

2. Review and Selection Process

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 the CSR 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:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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 original and 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 the PD/PI(s) and other 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?

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

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 PROJECTS 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 original and 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, 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?

The CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:

Significance: Do the Center s research goals address an important problem? Is there potential for favorably impacting the fields of minority health and health disparities research?

Approach: Does the Center demonstrate a multidisciplinary approach appropriate for its goals? Is the coordination among the administrative and other cores adequately explained? Is there synergistic potential among the Center’s research components? Is there justification for each research and core component in terms of the overall goals of the Center? Does the Center have the potential to achieve a whole greater than the sum of its parts? For Renewal Applications: Has adequate progress been made in achieving the stated goals of the previously funded Center and its concomitant research projects and activities?

Innovation: Will the Center make a unique contribution or fill a significant gap in the areas of minority health and health disparities research?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Do the investigators bring complementary and integrated expertise to the project? Is the Center Director capable of providing the scientific leadership and administrative oversight required to lead a Center?

Environment: Is the academic and physical environment, including availability of space, equipment and materials well defined? Is there evidence of institutional commitment to the pursuit of improving minority health and eliminating health disparities for the long-term? Is there evidence of prior institutional commitment to establishing and sustaining lasting relationships with the local minority and health disparity communities essential for the success of this Center of Excellence and the mission of the NCMHD? Is the environment within and around the institution suitable for the advancement of minority health research and health disparities research? Is there evidence of true collaboration with institutional and community partners if applicable?

The initial review for scientific and technical merit of applications will emphasize three major aspects: (1) the review of each mandatory core: administrative, research, research training/education, and community engagement/outreach; (2) the quality of the research projects within the research core; and (3) the review of the proposed Center as an effectively integrated whole working together to focus on improving minority health, eliminating health disparities, or both, and its potential to favorably establish or enhance the fields of minority health or health disparities research at the institution.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The reasonableness of the detailed budgets for each proposed Core, each research project or activity within a Core, and any consortium/contractual arrangements. The priority score should not be affected by the evaluation of the budget.

Training in Responsible Conduct of Research: Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

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 Notice of Award 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.

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.

As part of the Continuation Progress Report include the following:

Overall Summary for the Center. Summarize the progress made for the entire Center of Excellence over the past year (narrative part limited to six pages, include tables and graphs as needed). State the originally funded specific aims or objective for the Center. Indicate the aims for which progress will be presented in this report. The PHS 2590 subsections A-F may not be relevant for preparing the overall summary of progress. Do not feel compelled to use them if other headings are more suitable

Summary for each Core. Using the PHS 2590 subsection headings A-F, as relevant, summarize the progress in each Center Core (two-page limit per Core). Do not include a section for the Administrative Core if its activities were sufficiently covered in the overall summary above.

Summary for each Research Project. Using the PHS 2590 subsection headings A-F summarize the progress for each funded research project (two-page limit per research project). Generally, report on what is new since the last progress report. When reporting on the progress for a new or continuing research project, include the name of the project PI(s), the project title and a project description or abstract. If the project or study includes human subjects include an updated inclusion enrollment report.

Summary for each Subcontractors/Partners. Provide a narrative summary of the progress made by subcontractors or partners in achieving particular specific aims or objectives of the Center (two page limit per subcontractor/partner).

When meeting page limits, do not include the list of publications, the inclusion enrollment report or scientific highlights in the page count.

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

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
6707 Democracy Boulevard
Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]

2. Peer Review Contacts:

Dr. Sooja Kim
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Telephone:301-435-1780
E-mail: [email protected]

3. Financial or Grants Management Contacts:

Priscilla Grant, JD, CRA
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard
Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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 Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) 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 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/.

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 public 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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. 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 (DHHS) 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 DHHS 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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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.health.gov/healthypeople.

Authority and Regulations:
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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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:
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.

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NIH Funding Opportunities and Notices


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