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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 Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov

Title: Centers for Research to Reduce Disparities in Oral Health (U54)

Announcement Type
This is a reissue of RFA-DE-99-003 that was previously released September 30, 1999.

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

Request For Applications (RFA) Number: RFA-DE-08-008

Catalog of Federal Domestic Assistance Number(s)
93.121

Key Dates
Release Date: May 3, 2007
Letters of Intent Receipt Date(s): October 15, 2007
Application Receipt Date(s): November 15, 2007
Peer Review Date(s): March 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): August 2008
Expiration Date: November 16, 2007

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
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. Overall Program Objectives

The National Institute of Dental and Craniofacial Research (NIDCR) invites applications for Centers for Research to Reduce Disparities in Oral Health (CRRDOH) using the Specialized Center-Cooperative Agreement (U54) mechanism. This FOA is open to the existing NIDCR Centers for Research to Reduce Oral Health Disparities as well as to new applicants. These Centers will provide a venue for the interaction between scientists from a wide array of disciplines and the community to collaborate in research directed at reducing oral health disparities in vulnerable populations. The Centers should also provide training and career development for new health disparity scientists, particularly those from diverse backgrounds; and for the dissemination of research findings to benefit health disparity populations.

The NIDCR is committed to reducing the disproportionate burden of oral diseases experienced by vulnerable segments of society. Therefore the CRRDOHs will focus on intervention research related to oral diseases where there are known disparities caries, oral and pharyngeal cancer, and periodontal diseases. For the purpose of this FOA, vulnerable populations include African Americans; American Indians; Alaska Natives; Asians, Native Hawaiians and other Pacific Islanders; Hispanics/Latinos; subpopulations of all of the above (e.g. Puerto Ricans, Cubans, Dominicans, Haitians, Central, South and Mexican Americans) and those living in medically/dentally underserved rural and urban areas (i.e., socio-economically disadvantaged individuals, the elderly, and those with developmental or acquired disabilities). These groups are hereafter referred to as health disparity populations.

Collaborations between institution(s) and the community(s) are a requirement of this FOA any application that fails to document such collaborations will be deemed non-responsive.

Background

The U.S. Surgeon General’s Report: Oral Health in America and recent epidemiologic studies document that health disparity populations experience disproportionate burdens of dental caries, oral and pharyngeal cancer, and periodontal diseases. Rectifying this situation is the focus of the Centers for Research to Reduce Disparities in Oral Health (CRRDOH).

Dental Caries

Dental caries, an infectious disease that affects quality of life, is one of the most prevalent health conditions in the U.S. The distribution of dental caries in primary teeth by race/ethnicity is uneven, with 55% of Mexican American and 43% of black children aged 2-11 experiencing this disease compared with 38% of whites according to the National Health and Nutrition Examination Survey (NHANES), 1999-2002. Comparable differences are seen between poor and more affluent children (55% versus 31%, respectively). Two-thirds of eight-year old children in regions of Appalachia have experienced tooth decay.

Early Childhood Caries is a particularly devastating form of dental caries in young children. General anesthesia is often required for treatment of Early Childhood Caries, making it an expensive and traumatic condition to treat. Disparities in the prevalence of Early Childhood Caries have been reported with 18% of white children compared with 40% of Mexican-American and 29% of black children experiencing the disease (NHANES, 1988-1994). The Indian Health Service Survey of Oral Health (1999) reported an even higher prevalence of dental caries for both preschool and school age children (79% and 87%, respectively).

Disparities in dental caries echo across the life span. Root caries is increasingly prevalent as more people retain their teeth as they age, and is particularly significant in black non-Hispanics (41%) and Mexican Americans (36%) compared with 18% for white non-Hispanics (NHANES, 1999-2002).

Oral and Pharyngeal Cancers

The American Cancer Society recently estimated that approximately 31,000 new cases and 7,320 deaths per year were attributable to oral cavity and pharyngeal cancer. The prognosis of these cancers is poor especially when they are detected at a late stage. African American males and subgroups of Hispanic male populations are known to be at increased risk for late-stage malignancies that are less amenable to treatment and have poorer survival. Recent Surveillance Epidemiology and End Results (SEER) data also indicates that the rates of oral and pharyngeal cancer are considerably higher than the national average in some rural regions of the U.S. for both men and women. Recent research findings also suggest that determinants of oral cancer may vary among population subgroups and by region.

Periodontal Diseases

Periodontal diseases range from mild forms of gingivitis to severe forms of periodontitis. Health disparity populations are more likely to experience periodontal disease. For example, blacks are about twice as likely as whites to have periodontitis (NHANES, 1988-1994). Inequalities in periodontal disease also exist by education level and other socio demographic characteristics. Furthermore, periodontal health is of particular importance to people with diabetes since it has been documented that they suffer from more widespread or severe periodontal disease than non-diabetics. For instance, 30% of American Indian/Alaska Native dentate adults with diabetes were reported to have advanced periodontal disease compared to 22% for those without diabetes (Indian Health Service, 1999).

Research Objectives and Scope

The purpose of this initiative is to support interventional research to improve oral health and ultimately eliminate disparities in vulnerable subgroups of the U.S. population with the primary goal of testing sustainable approaches to prevent, reduce and ultimately eliminate the disproportionate burden of caries, oral and pharyngeal cancer, and periodontal diseases experienced by health disparity populations. The research must have a clinically meaningful impact that will influence clinical practice, health policy, community and/or individual action. Applicants are required to propose at least two intervention research projects one of which must be demonstration and/or dissemination/implementation type research. These studies should use the strongest research design possible. Randomized trial designs are encouraged where appropriate. Applicants may also propose other types of intervention studies.

Considerable progress has been made in the prevention, diagnosis and treatment of oral diseases in some segments of society. Randomized clinical trials have and will continue to provide important evidence to inform clinical practice and public health policy and advance the use of innovative technologies. Several clinical trials have verified the efficacy of preventing oral diseases in some settings, but replication and tailored/targeted studies designed for specific health disparity populations are needed. Few effectiveness trials have been conducted with specific health disparity populations in defined clinical or community settings. Moreover, the implementation of preventive oral disease programs by clinical providers, individuals, communities, and decision makers has been slow despite compelling evidence for their efficacy. Few demonstration and/or dissemination/implementation studies have explored the reasons for this, and fewer still have explored innovative approaches, such as the use of technology for translation, implementation, adoption, adherence and acceptance of oral disease preventive programs in defined, diverse populations, clinics, and communities. Such studies are critically needed if the findings from clinical trials are to result in sustainable and wide-spread improvements in oral health.

Not all health disparities intervention research is amenable to randomized clinical trials. Other intervention designs can provide essential information that informs clinical practice, public health policy, health care provision and community and individual action. Examples include:

As new areas of science emerge and as our country faces new challenges, the capacity of the CRRDOH to conduct a wide array of research with interdisciplinary teams should provide a flexible and important research infrastructure. The commitment of the CRRDOH to attract and mentor new scientists, and to develop and maintain community partnerships is essential.

Data that document disease prevalence are readily available for some health disparity populations, but not for others. Homogeneity in subgroups of health disparity populations cannot be assumed. For instance, the NHANES provides data for Mexican Americans, but not for the numerous other Hispanic subgroups such as Puerto Ricans, Dominicans, Cubans, Haitians, and Central and South Americans. Similarly, data regarding the oral health status of various American Indian/Alaska Natives tribes are unavailable. Limited information is available for rural Americans and special needs populations. Moreover, available data provide little insight into the etiology or determinants of the diseases beyond a few measures of socioeconomic status and race/ethnicity. This paucity of quality data concerning the broad array of determinants and risk-factors has inhibited progress. Researchers who wish to investigate these critical epidemiologic questions should utilize other NIDCR funding opportunities. These other mechanisms include R01 investigator-initiated applications and funding opportunities listed on the NIDCR website (http://www.nidcr.nih.gov/Funding/CurrentFundingOpportunities/default.htm) under Health Disparities Research. Accordingly, except for developmental research projects, Center applications that propose observational or epidemiologic studies will be considered non-responsive to this FOA.

Strategic Planning for this FOA

Applicants who expect to be competitive for this FOA will find it necessary to conduct collaborative strategic planning activities to develop a conceptual framework for the specific areas of health disparities research proposed in their applications. Such a process is key to identifying the most important research gaps and opportunities, identifying the expertise needed to address these gaps, developing a plan of action, policies and procedures, identifying outcome measures and plans for monitoring progress, developing an administrative structure for efficient management and research implementation, developing specific research projects, and maximizing synergy among community partners, the investigators, and the research projects. This planning is a critical first step in developing essential communication and collaborations among researchers from many disciplines and stakeholders, including the populations and community(s) at risk for health disparities. The planning activities should also include developing training and career development plans for future oral health disparities investigators, plans for disseminating research findings, and for developing management strategies for implementation of research that will ultimately result in improved oral health for disparities populations. The resulting strategic plan should include short and long term goals that can be used to help monitor progress. The health disparities population(s)/community(s) that is the focus of the CRRDOH must be given opportunities to provide input and collaborate with the research team throughout the planning process. The ways in which input is obtained must be documented in the application. Applications failing to do so will be considered non-responsive to the FOA.

Applicants are encouraged to consider the following elements of a strategic planning process as they prepare to respond to this FOA.

This includes a collaborative process to identify and prioritize research gaps in order to have an impact on clinical practice, inform public health policy, and empower individuals and communities so that oral disease is reduced or eliminated in targeted health disparities populations.

This involves development and adoption of an overall conceptual framework for addressing the selected disease(s) in the specific health disparity population.

This involves identification of strengths in terms of the experience, expertise and resources of the proposed consortium of institutions, organizations, agencies, researchers and community partners. A realistic assessment should be made of the available experience and appropriate facilities for CRRDOH research, and for the training of oral health disparities researchers, the dissemination of research findings, and the development of the infrastructure for sustainable community-based participatory research.

This involves identification of opportunities to conduct community-based intervention research with health disparity populations and to identify opportunities for the training and career development of researchers new to oral health disparities. Applicants should explore potential for collaborations with a variety of organizations, such as federal agencies, state and local health departments, private sector organizations, foundations, and health facilities, with particular emphasis on networks of Federally Qualified Health Centers (Community and Migrant Health Centers).

A focused research theme for the CRRDOH must be identified to assure that the proposed studies produce synergy and maximize the body of evidence needed to influence health policy, clinical practice, community and individual actions. The CRRDOH program must not be simply a collection of independent and unrelated research projects. Rather, the CRRDOH application must clearly delineate how the research projects, consortium, and stakeholders will synergistically collaborate to address the research theme that is identified in the strategic planning process.

While the CRRDOH is expected to bring together experts from multiple disciplines to form interdisciplinary collaborations and is expected to undertake a wide range of types of intervention research, it is not expected to address the entire spectrum of health disparities research. The theme and range of research, training and career development, community participation, and research dissemination activities proposed must emerge from the strategic planning process. This theme should be used by the CRRDOH to focus its activities throughout the funding period.

These elements of the strategic planning process should result in the following RPAC, research projects, and S&DCC components.

The RPAC component of the application must include the following:

The research component of the application must include the following R01-level intervention studies:

The S&DCC component of the application must include the following:

The overall goals of the RPAC and the specific studies that are planned must be developed in the overall context of the theme and conceptual framework of the proposed CRRDOH and must be clearly described in the application. The applicant CRRDOH must identify the studies and activities that it will undertake under this FOA to reduce caries, oral and pharyngeal cancer, and/or periodontal diseases in one or more defined health disparities populations/communities. Intervention research and studies that are ready for field work will be given precedence in this FOA. During the development of an application, the need for future cores and additional expertise may emerge and be identified for inclusion in the application.

It is integral to successful collaborative initiatives that policies and procedures for the management of the CRRDOH be agreed upon and established. These should be developed during the strategic planning process in full collaboration and partnership among research team members, consortium members and community partners. Programs of research and activities may emerge from the strategic planning process and must be related to the overarching research theme of the CRRDOH and its conceptual framework.

CRRDOHs that seek to enhance collaboration with researchers of other disciplines may consider the use of multiple PD/PIs. The use of the multiple PD/PI option must comply with the requirements as described in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html. This includes the development of a Multiple PD/PI Leadership Plan (Section I of the Research Plan in the PHS 398).

The active and substantial participation of community partners is essential to developing and implementing intervention research that will eventually improve oral health in disparity populations and communities. Detailed, complete and substantive plans for ensuring the meaningful involvement of community partners must be included in applications responsive to this FOA. In addition to a Community Advisory Committee (CAC) and a community liaison function, the successful CRRDOH will substantively involve community partners in the both development and implementation of each research project. The successful applicant will fully delineate the roles of each partner and provide evidence of equitable and sustainable community participation.

In order to advance the science of oral health disparities, it is imperative that the CRRDOH 1) actively identify and train a cadre of new health disparities researchers and 2) provide career development activities to assure that existing health disparities researchers will be knowledgeable and focused on oral health issues. Applicants must submit detailed plans for training and career development. In addition, CRRDOH must provide a plan for the dissemination of research findings to stakeholders and change agents. The expertise of the entire consortium must be engaged in training and career development and in the dissemination of research findings. In addition, outcome measures for successful training and career development and for the dissemination of research findings must be described in the application.

Consensus must be reached as to how progress will be monitored in meeting the goals of the CRRDOH. A section must be included in the application that describes the qualitative and quantitative criteria that will be used to help monitor the CRRDOH’s progress. These criteria must incorporate how the CRRDOH will provide added value compared to other types of research mechanisms. Measurable criteria for helping to assess the progress of the CRRDOH toward its goals for the entire funding period must be provided in the application.

2. Organization of the CRRDOH

The CRRDOH will be composed of an RPAC, an S&DCC, an Executive Committee (EC), a Community Advisory Committee (CAC), an External Scientific Advisory Committee (ESAC), and designated NIDCR staff. If multiple PD/PIs are designated on a RPAC and/or S&DCC component that are submitted as a package in response to this FOA, they will share responsibility for ensuring that their respective Centers meet all goals, objectives and measurements for success proposed in the application and in all subsequent activities of the CRRDOH. In addition, an Oral Health Disparities Collaborative Working Group (CWG) composed of the ECs of all of the CRRDOHs will be formed.

The NIDCR will be substantially involved with the awardees as a partner in providing overall scientific guidance and support consistent with the U54 cooperative agreement mechanism. A designated NIDCR staff person will monitor study progress, and serve on the Executive and External Scientific Advisory Committees. The NIDCR staff person, together with the NIDCR Grants Management Specialist, will provide fiscal oversight of the Center. The NIDCR, in collaboration with the RPAC and S&DCC PIs, will appoint Data and Safety Monitoring Boards (DSMBs) for clinical trials. In addition to ongoing monitoring by program staff, the NIDCR plans to conduct a prospective and comprehensive evaluation of the research portfolio in oral health disparities, which includes (but is not limited to) Centers funded under this announcement. Awardees are hereby notified that they may be contacted during or after the completion of this award for information and assistance in assessing the overall impact of the program.

3. Research Program and Administrative Center (RPAC)

Description of Center Overall

In the RPAC component of the application, each CRRDOH will provide a detailed description of the conceptual framework for the Center and a focused research theme that developed from strategic planning. The conceptual framework and theme will be used throughout the life of the Center to assure that the proposed studies produce synergy beyond the value of the individual research projects. True synergy among the Center’s interdisciplinary team members is needed to maximize the body of evidence that will influence health policy, clinical practice, health care delivery, and community and individual actions.

The RPAC will be responsible for the management and supervision of the entire range of CRRDOH activities. The RPAC, in collaboration with NIDCR, will provide overall administrative and scientific leadership for the CRRDOH. The PI(s) of the RPAC will have overall responsibility for the following activities of the RPAC:

With the assistance from the S&DCC and in consultation with the NIDCR, the RPAC will also:

The RPAC PI will serve as the overall CRRDOH Director, will chair the EC, and will have overall administrative and scientific responsibility for the research design, implementation, and timely dissemination of results. Additionally, under the NIH Cooperative Agreement mechanism, NIDCR staff member(s) will be substantially involved in overseeing CRRDOH research.

If multiple PD/PIs are designated on the RPAC component of the application, the contact PI will serve as the overall Director of the CRRDOH. Other PIs should also serve on the EC and CWG on a rotating basis and the schedule for such rotation must be included in the application as part of the RPAC Multiple PD/PI Leadership Plan.

The RPAC component must also provide a detailed description of the administrative functions, its staffing, function and responsibilities. The CRRDOH Director must commit at least 30% effort to these responsibilities in addition to any effort that he/she may have for their own CRRDOH research. A co-Director must be identified and must commit at least 10% effort to the RPAC in addition to his/her CRRDOH research and must be fully informed of all aspects of the Center’s activities. This section must describe the process that would be used to recommend a successor to the Director, if needed. In addition, a Center Administrator must be designated with a minimum commitment of 50% effort.

Health disparities research is complex and requires expertise from diverse areas of science. Applicants must demonstrate that academic collaboration with research experts from disciplines outside of the oral health field will be integral partners in the CRRDOH. These individuals must be committed to CRRDOH research, training and career development activities, and research dissemination enterprises. These research experts are expected to be from various colleges and universities. The CRRDOH may use the multiple PD/PI option to involve these academic partners. Letters of commitment from all the collaborating department heads or deans (e.g., dentistry, public health, nursing, medicine, social work, sociology, communications, political science/public affairs/public policy, law, anthropology, psychology, business, economics, epidemiology, etc.) must be included in the appendix for the RPAC component.

Management Plan

The Management Plan must include the structure and roles of the RPAC personnel. This includes: 1) identification of specific key personnel among the Center leadership who are responsible for each major CRRDOH activity, 2) how fiscal and other resources will be allocated and prioritized, 3) how communications throughout the Center will be facilitated, 4) how synergy among the research projects will be enhanced, 5) what principles of multi- and interdisciplinary team building will be employed, and 6) the role of any major committees that will help mange the Center’s business.

Clear organizational charts for the RPAC as a whole must be provided. The Management Plan must include procedures for continual evaluation and selection of the most promising new research approaches for interventions that will be initiated through the developmental research program or through other research funding mechanisms including investigator-initiated awards. The NIDCR anticipates that successful developmental projects may mature into major projects and be submitted for funding as separate investigator-initiated research grants. Successful developmental projects might also replace some of the Center’s full R01 level projects that do not merit further continuation or have been completed.

Support for Center leadership and appropriate research team members to attend the annual meeting of the CRRDOH grantees can be provided through the award as part of the RPAC budget. The expenses of the annual meetings of the EC, ESAC, CAC, CWG and any DSMB(s) must be included in the RPAC budget.

Future developmental or other research projects must initially be reviewed and approved by the ESAC to assure appropriateness with the CRRDOH theme, conceptual model and merit. The proposals should be prepared in SF424 R01 or R21 format. Following ESAC approval, meritorious applications will be submitted to the NIDCR for program review and approval. Addition of any new projects or termination of existing projects must be approved by NIDCR program staff prior to implementation. No additional funds will be awarded by the NIDCR for new projects but the Center PI will have authority to reallocate funds within a Center’s existing budget.

Leadership Plan for Multiple PD/PIs

CRRDOHs that seek to enhance collaboration with researchers of other disciplines may consider the use of the multiple PD/PIs option. The use of this option must comply with the requirements described in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html including the development of an RPAC Multiple PD/PI Leadership Plan (Section I of the Research Plan in the PHS 398). A rationale for choosing a multiple PD/PI approach; the governance and organizational structure of the leadership team and the research projects including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts must be described in the RPAC Leadership Plan. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs must be delineated in the RPAC Leadership Plan. The RPAC Leadership Plan must be provided in addition to the Management Plan.

Executive Committee (EC)

If multiple PD/PIs are designated in the RPAC and/or S&DCC components of the application, the EC will be composed of four individuals: 1) the CRRDOH Director who serves as the Chair of the EC, 2) one PI from the RPAC who serves on the EC on a rotating basis with other PIs from the RPAC, 3) a PI from the S&DCC who serves on the EC on a rotating basis, and 4) an NIDCR staff person.

If the CCRDOH Director is also the sole PI of the RPAC, the EC will be composed of three individuals: 1) the CRRDOH Director who is also PI of RPAC and who chairs the EC, 2) a PI from the S&DCC, and 3) an NIDCR staff person.

The EC will make decisions on operational issues; consider and adopt changes in study procedures as necessary; review and implement recommendations from the IRB(s), ESAC and DSMB(s); review the progress of studies in achieving their main goals and take steps required to enhance likelihood of success; and review data collection practices and procedures as summarized in performance monitoring reports from the S&DCC to identify and correct remediable deficiencies. The EC will prioritize research topics for subsequent proposals for developmental research projects and submission of manuscripts. The EC will convene monthly meetings of the investigators and other key personnel for a discussion of CRRDOH progress on all aspects of the Center. The EC will meet immediately following each of the CRRDOH meetings. The CRRDOH and EC will meet, at a minimum, in person at the beginning of the award and once per year in person thereafter. Other monthly CRRDOH and EC meetings may take place via teleconference as necessary. The NIDCR staff person will participate in both the CRRDOH and EC meetings. The EC will regularly meet with representatives of the CAC. The EC of each Center will serve on the CWG.

Oral Health Disparities Collaborative Working Group (CWG)

The goal of the Health Disparities Collaborative Working Group is to foster activities that will advance oral health disparities science within and beyond the CRRDOH initiative through collaboration between the individual CRRDOHs. This will be achieved by the formation of a working group comprised of the EC of each CRRDOH including NIDCR staff. This group is expected to initiate activities that may advance oral health disparities research and will include:

Guidelines for monthly teleconferences and an annual meeting will be established by the NIDCR after awards under this FOA are made. Each CRRDOH will provide evidence of commitment to working collaboratively with CRRDOH colleagues.

Plan to Monitor Center Progress

The CRRDOH must develop a clear and concise plan for how progress will be monitored in meeting its goals. A section must be included that describes the qualitative and quantitative criteria that will be used to help monitor the CRRDOH s progress. These criteria must incorporate how the CRRDOH will provide added value compared to other types of research mechanisms. Measurable criteria for helping to assess the progress of every component of the CRRDOH toward its goals for the entire funding period must be provided. One component of the Center monitoring plan must address the ESAC. The ESAC will conduct at a minimum an annual review of the: 1) goals of the CRRDOH including goals related to training and career development, implementation of community-based research infrastructure, and dissemination of research findings; 2) accomplishments and progress towards meeting the CRRDOH s goals for the Center as a whole; 3) interim progress of all research projects; 4) adherence to the CRRDOH conceptual framework and theme; 5) progress toward measurements of success of the CRRDOH overall and all RPAC components and the S&DCC; 6) collaboration with the community with reports directly from the CAC annually; and 7) identification, prioritization and review of proposed research projects that emerge during the course of the award period. The ESAC will also conduct a concept review of all developmental projects proposed by the CRRDOH to assure appropriateness with the theme and conceptual framework of the CRRDOH. The reports of the ESAC are advisory to the CRRDOH and to the NIDCR.

The NIDCR will select the members of the ESAC with input from the RPAC and the S&DCC Center PIs following the award. The RPAC will provide all support for all ESAC meetings. The ESAC will be composed of approximately six individuals with expertise appropriate for research conducted by the CRRDOH (for example, intervention and other clinical research, dental research, health disparities research, biostatistics, and clinical trial design and methodology, and other areas as appropriate). An NIDCR staff person will serve as an ex officio member of the ESAC. The ESAC will meet at least annually and will submit a written report to the NIDCR that summarizes its evaluations and recommendations. The application must not list potential ESAC members nor are applicants to contact any potential members in advance of the award.

Community Liaison Program and Infrastructure for Community-based Research

In order to develop and implement intervention research in health disparity populations, it is essential to involve the community in the research as a substantial partner. The assistance of community leaders and organizations is vital to the implementation of the research projects and to their design. Community organizations often provide assistance in recruiting research subjects and in promoting retention. However, their importance stretches well beyond this function. Community leaders can inform the research design by providing valuable perspective and key information about the social, economic, and cultural factors specific to the community. For example, community leaders can share information about the types of interventions that would be acceptable and practical for the specific population. In return, it is important for researchers to give back to the community and to these organizations in some way. The CRRDOH is expected to include multiple community partners, from multiple types of organizations that will participate in the full range of the Center's activities. Simply having an advisory committee will not be sufficient to ensure meaningful community collaboration for the individual research projects. Such collaboration is necessary to promote the success of the individual research projects and to create the infrastructure needed for sustainable community-based research partnerships in the future.

Each CRRDOH applicant must include a detailed description of how the Center plans to manage and coordinate its partnerships with community leaders and organizations. This includes: (1) identification of specific key personnel, both among Center leadership and in each individual research project, who are responsible for coordination with community partners; (2) how communication with the partners will be facilitated; and (3) how joint activities will be chosen and conducted. Moreover, the ways in which the researchers are integrated into the community(s) and community organizations must be provided in detail. Furthermore, each major research project in the CRRDOH must include a section that describes a collaborative working relationship with the specific health disparities community(s) and how this collaboration will result in successfully achieving the specific aims of the proposed research project. Letters of commitment from the collaborating institution(s), community partners and community organizations must accompany the complete application as a whole and for each research project, as appropriate. Applications without this documentation will be considered non-responsive.

Within the RPAC component of the application, each Center will also provide evidence that a CAC has been formed and has guided the development of the component. A description of the role of the CRRDOH CAC as it pertains to the work of the CRRDOH must be provided. The CAC is expected to have substantial input into the design and implementation of the Center's research projects and overall activities. The CAC is expected to include not only leaders and organizations involved directly in the research projects, but others with pertinent information and community expertise as well. The CAC is expected to have a diverse membership of a cross-section of community representatives, rather than include only members with ties to one particular type of organization (community health centers, for example).

Training and Career Development Program

The Centers must develop and implement a Training and Career Development Plan to increase the cadre of oral health disparities investigators. Particular attention must be given to attracting and mentoring those from diverse backgrounds and disciplines. As part of the plan, applicants must describe how they would integrate a full range of existing NIDCR or NIH training and career development mechanisms, such as NIDCR institutional training awards and NIH Clinical and Translational Science Awards (CTSAs). In addition, the application should describe plans to encourage, support, and mentor individual trainees to apply for individual awards such as fellowships (Fs), career development awards (Ks), and health disparity loan repayment programs (Ls). Plans to identify suitable candidates for diversity and disability supplements should also be described. While a training and career development program is a requirement for Centers, funds may not be requested for supporting this activity under this FOA.

If the applicant institution does not have a current NIH CTSA or does not plan to apply for a future NIH CTSA, plans to identify and encourage future oral health clinical investigators to apply for clinical and translational research training at other NIH CTSA institutions must be described.

Dissemination or Research Findings Program

The application must describe how the Center will implement a dissemination plan to assure that research findings will be communicated in a timely, meaningful and appropriate manner to key stakeholders. The expertise of communications specialists will be needed for this program. Dissemination activities could take many forms for example: seminars made widely available to researchers, health disparity populations, policy makers, clinicians and the media; web sites, community boards, newsletters; and the development of white papers and articles for lay audiences and clinicians. The use of technology that promotes the widest distribution of information is encouraged.

Developmental Research Program:

Health disparities research requires considerable preparatory work that may include the exploration and development of the research projects with community and other partners, pilot data gathering, feasibility studies and research planning. Developmental studies provide the CRRDOH with the flexibility to take advantage of evolving community-based partnerships, findings from anthropologic and epidemiologic studies, and emerging scientific approaches and technologies from basic, translational, and clinical research. Developmental studies will also facilitate collaboration with other institutions and organizations. Optional examples of developmental projects (R21-level studies) for the first two years of funding under this FOA may be identified and prioritized. Applicants may provide descriptions of not more than two developmental projects. The brief description should be not more than one-half page in length.

Applicants must provide a description of the developmental research program as part of the RPAC and describe in detail the process for: 1) soliciting applications for developmental research projects focused on the proposed CRRDOH theme, 2) selecting the most promising projects that contribute to the conceptual framework of the CRRDOH, 3) monitoring the progress and success of the projects, and 4) termination or promotion of developmental research investigations to full research projects. The ESAC will aid in the review of the developmental research projects to assure that the proposed research is consistent with the conceptual model and theme of the Center and are meritorious.

Some developmental research projects may begin during the first year, while others will be phased in during subsequent years. The long-term success of the CRRDOH will, in part, be determined by the choice of developmental research projects and their growth into new NIH investigator-initiated research grants to reduce oral health disparities through clinical and other research. The use of the developmental research program is at the discretion of the applicant and the number of such projects will be dependent upon the success of those submitted for consideration.

A maximum of two developmental projects may be supported by the CRRDOH in any given year. The total funding for each developmental research project may not exceed $200,000 in direct costs and two years in duration. A maximum of $125,000 in direct costs per year may be budgeted for each developmental research project. For example, $125,000 could be budgeted in the first year and $75,000 in the second year.

These studies when fully developed would be the equivalent of R21 studies used by the NIDCR for the following purposes:

The optional developmental project descriptions will receive a qualitative review during peer review with final approval of complete developmental project applications by NIDCR program staff post award. It is anticipated that the effective use of developmental research projects will provide maximum flexibility for the CRRDOH so that the most productive areas of health disparities science can be pursued. The NIDCR anticipates that successful developmental research projects may mature into major projects and replace full R01 type projects as they are completed or that do not merit further continuation. Developmental projects may also become investigator-initiated R01-type applications. These developmental research projects may not be used to support student research or ongoing funded research of an investigator and are not renewable. The proposed developmental studies must directly relate to the overall theme and conceptual framework of the Center.

Small clinical trials will not be funded as part of the developmental research program unless it can be unequivocally shown that such trials are essential to the development of subsequent full-scale randomized interventional clinical trials. Such small scale trials would involve a relatively few number of subjects (e.g. 10-50) and for example, might pilot test various methods of compliance or measurement of outcomes for possible implementation in a subsequent R01-level intervention study.

Research Program

Description of Research Program Overall

The overall goals of the RPAC and the specific studies that are planned must be developed in the overall context of the theme and conceptual framework of the proposed CRRDOH and must be clearly described in the application. The rationale for how and why the proposed intervention studies were selected, including the role of the community in the decision-making process, must be provided in the description of the research program overall. The Research Program component of the CRRDOH must include at least two major intervention studies (equivalent to R01-level research). The CRRDOH must maintain a minimum of two major intervention studies throughout its life course.

The intervention studies proposed must be designed to result in a clinically meaningful reduction in caries, oral cancers including premalignant lesions, and/or periodontal disease in specific health disparity populations. The qualitative and quantitative oral health outcomes must be objectively measured and must be of sufficient magnitude that they would likely change clinical practice, inform public health policy, result in community and/or individual action. Direct service programs intended solely to provide preventive or other care are not eligible under this FOA. Applications that include such programs will be deemed non-responsive and returned to the applicant.

Research Projects

Intervention Research (R01-level Studies, http://grants.nih.gov/grants/guide/pa-files/PA-07-070.html):

It is expected that for each of the intervention studies, research teams will be interdisciplinary and include experts in such areas as oral health, public health, epidemiology, behavioral and social sciences, health policy, economics, communications sciences, social work, health care financing, psychology, biostatistics, organizational management and those with experience in demonstration/dissemination/implementation-type research. Conceptual frameworks for the studies must be provided. In all cases, community stakeholders must be included as meaningful participants of the research team.

In keeping with the mission of the CRRDOH, the intervention research should be reasonably generalizable to a specific, targeted, health disparity population. To facilitate adequate enrollment and generalizability, intervention studies may be conducted at multiple sites in the specific, targeted population/community. These studies may also be conducted at a single site if enrollment is adequate and if sufficient numbers of participants are available to allow extrapolation of clinically meaningful results to the specific, targeted health disparity population/community. Studies may need to intervene at multiple levels.

A wide range of types of intervention studies would be responsive to the FOA, including both randomized clinical trials (RCTs) and other intervention research methods. Applicants are encouraged to use the strongest design appropriate for the intervention study. RCTs that are proposed as part of the CRRDOH will be subject to the same requirements as the Phase III RCTs funded through the NIDCR Clinical Trials Program. http://www.nidcr.nih.gov/ClinicalTrials/ClincalTrialsProgram/.

Specifically:

(1) Consistent with NIDCR Policy, small clinical trials will not be funded because it is unlikely that such trials will lead to a change clinical practice and/or inform public policy and/or community action and lead to a reduction in oral disease in health disparities populations.

(2) NIH defined Phase III clinical trials involve from several hundred to several thousand subjects. The definition of a NIH Phase III trial may be accessed at: http://grants2.nih.gov/grants/funding/phs398/instructions2/p2_human_subjects_definitions.htm.

(3) Applications that include RCTs must include sufficient resources for appropriate DSMB(s) that will be appointed by the NIDCR with input from the CRRDOH EC after the award is made.

(4) A fully developed MOP for each R01-level study must be developed and available for review by the ESAC within a time period defined at the time of the award. (See http://www.nidcr.nih.gov/ClinicalTrials/ClincalTrialsProgram/ for a model showing the detail required in a well-written MOP. Another example of a detailed MOP table of contents can be found in Meinert, CL, Clinical Trials Design, Conduct, and Analysis, Oxford University Press, 1986, pp. 417-419.)

(5) For clinical trials, the MOP must be approved by NIDCR and the DSMB(s) before implementation of a clinical trial. The MOP for other types of R01-level studies must be reviewed by the ESAC and approved by the NIDCR.

(6) All R01-level studies must be implemented within one year of the Notice of Award.

Center applications that include clinical trials that do not meet the requirements above will be considered unresponsive to this FOA and returned to the applicant. Researchers who are in the earlier planning stages for RCTs are encouraged to conduct this work as a developmental project of the CRRDOH or to submit applications for funding under the NIDCR Clinical Trials Program, which provides funding opportunities for pilot and planning grant. (For more information, see http://grants1.nih.gov/grants/guide/pa-files/PAR-06-245.html and http://grants1.nih.gov/grants/guide/pa-files/PAR-06-244.html.

For this FOA, applicants are to provide a detailed description of each research project in the format of the Research Plan (sections A-L) of an individual PHS 398 application, including specific aims, research methods, the target population, and letters of support. A cover page must identify the title of the research project, the names of the investigators and the contact information of the lead PI. If the multiple PI/PD approach is used, a research project specific Leadership Plan must be developed and submitted. Each study description must also include criteria for monitoring progress at quarterly intervals each year, with timelines including, participant recruitment and retention trajectories. A maximum of 15 pages may be devoted to describing sections A-D of the Research Plan of each of the R01-level studies. An appendix is allowed for each research project. All R01-level studies, including studies that do not involve a randomized clinical trial (RCT) design, must have a fully developed Manual of Procedures (MOP) prior to implementation that is reviewed and acceptable to the ESAC and the NIDCR. However, MOPs for the R01-type proposed studies must not be included in applications submitted under this FOA. Each R01-level project will be peer reviewed and scored.

Intervention Research Project # 1: Demonstration and/or Dissemination/Implementation

At least one of the intervention studies required by the FOA must be demonstration and/or dissemination/implementation type research that extends, replicates, implements, or adapts efficacious interventions to a specific health disparity population, community or clinical setting. As proposed under this FOA, such studies must be focused on prevention or treatment of caries, oral and pharyngeal cancer, and/or periodontal diseases. The research submitted under this FOA may also be focused on the promotion of healthy behaviors and environments in a defined health disparities population or community. Demonstration and/or dissemination/implementation research for oral cancer may include the enhancement or promotion of early diagnosis or prevention of lesions including those that are premalignant. Applicants are encouraged to use the most rigorous designs possible, including but not limited to RCTs.

The primary outcome of this research must be clinically meaningful improved oral health in the defined population, clinical or community setting. This improvement must be documented by reliable, objective and quantifiable measures of oral health. It is anticipated that this research will necessitate the use of multiple secondary outcomes such as the impact of the intervention on quality of life as well as its feasibility, acceptability, and sustainability (including cost analyses) in the defined population, clinical or community setting. The adherence to the intervention(s) must be documented and evaluated in the research design.

These research projects may include, but are not limited to:

This list is provided for illustration only, is not exhaustive, and is not prioritized. Applicants are encouraged to consider a full range of possibilities for proposed research.

Additional Intervention Research Projects:

Other intervention(s) proposed by the CRRDOH may take the form of additional demonstration and/or dissemination/implementation type research, efficacy or effectiveness trials, studies designed to modify determinants and/or risk factors of health disparities in specific populations, and/or health promotion studies. Combinations of approaches may be proposed.

This intervention study(s) must be designed to produce research results that, when appropriately implemented, will reduce or eliminate caries, periodontal disease and/or oral cancer by changing clinical practice, informing public policy, and/or community action. The intervention study(s) may focus on improving individual skills and/or the adoption of health services/technologies that are appropriate, acceptable and sustainable in health disparity populations. Oral health outcome measures may be added to already funded general health intervention studies particularly to those studies that intervene on determinants/risk factors that are also common to oral health.

Studies may be proposed to modify determinants and/or risk factors for oral diseases in a specific health disparities population/community. Applicants must provide a rationale for the selection of the targeted health disparity population/community and the specific determinants and/or risk factors that are selected for modification. Factors may be at the biological, social, psychological, behavioral, policy or environmental levels. For example, studies related to oral health behavior may be proposed that employ theory-based behavioral interventions or that modify social and psychological circumstances. Studies that address macro and intermediate level determinants such as ready access to community-based preventive approaches, establishment of healthy public policy in communities, schools, worksites; modes and methods of prevention and oral health care delivery and management that are tailored/targeted to the community, are appropriate. Population intervention research that is concerned with reducing oral health disparities through policy and/or program interventions that have the potential to impact health at the population level are responsive. These interventions may explore approaches at the population level that are either within or outside of the health sector and that may impact at the individual, community and/or population levels.

Intervention studies may test emerging technology to improve oral health in specific, targeted disparity populations, such as methods of diagnosing or identifying the oral diseases of caries, periodontal disease, and oral cancer including premalignant lesions in individuals and communities using salivary diagnostics, imaging, electronic communication systems, telehealth, and electronic medical/dental records. Studies may test ways to enhance early detection by providers.

Health promotion research that tests ways to enable people/communities to exert control over the determinants of oral health and thereby improve their oral health status is responsive to this FOA. This research may take the form of a combination of educational, organizational, political and economic interventions designed to facilitate behavioral and environmental changes conducive to reducing oral health disparities. The following examples of health promotion research that would be responsive to this FOA are given as examples only and investigators are encouraged to consider other possible areas of research. Health promotion studies may test, in a targeted health disparity population/community, ways to:

4. Statistics and Data Coordinating Center (S&DCC)

Each CRRDOH application must include a separate and complete S&DCC component. The S&DCC will have both scientific and administrative functions including:

Other functions may be housed in the S&DCC as appropriate to each center. For example, the S&DCC could be involved in such activities as developing and maintaining a center website to assist with dissemination efforts, training and career development, providing assistance to the community liaison and community partners, using technology to conduct and coordinate research activities, and others as appropriate. The S&DCC PI must commit a minimum of 20% effort to the CRRDOH and will be responsible for all aspects of the operations of the S&DCC and for the local implementation of clinical trials. The S&DCC PI will be a member of the EC and of the CWG. If multiple PD/PIs are designated in the S&DCC component, they will rotate as the PI member from the S&DCC on the EC and CWG. A schedule for such rotation must be included in the S&DCC component of the application and in the S&DCC multiple PD/PI Leadership Plan. A cover page must identify the title of the component, the names of the investigators and the contact information of the lead PI. If the multiple PD/PI option is used, a S&DCC Leadership Plan must be developed and submitted. The description of the S&DCC cannot exceed 10 pages.

5. Progress Reviews and Evaluations

The annual progress report will have two parts. The first will be the standard NIH progress report (form PHS 2590). The second will be a more specialized report that should be included as an attachment to the standard report and will go the NIDCR Program Official. The content and format of this specialized report will be defined by the NIDCR Program Official, the NIDCR Evaluation Officer, and other NIDCR officials.

In addition to ongoing monitoring by program staff, the NIDCR plans to conduct a prospective and comprehensive evaluation of the research portfolio in oral health disparities, which includes (but is not limited to) centers funded under this announcement. The goal of this national evaluation will be to assess the effectiveness of the oral health disparities research portfolio in meeting the research objectives of the NIDCR health disparities plan. Accordingly, areas of interest to the national evaluation effort will include increasing the productivity of disparities research; enhancing research capacity (especially through training and career development); improving capacity for community-based research; and translating research results into improved prevention and treatment. To support this effort, the NIDCR will request that grantees participate in the design and conduct of the national evaluation. In addition, awardees are hereby notified that they may be contacted during or after the completion of this award for information helpful in assessing the overall impact of the program. 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 U54 award mechanism.

The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the PI(s) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PI, as described under the Section VI.2. Administrative and National Policy "Cooperative Agreement Terms and Conditions of Award". As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (See (http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application (additional instructions below). Similarly for each component a separate detail budget of the first year and the entire 7 year proposed period of support should be included.

2. Funds Available

Applicants may request a project period of up to seven years. The NIDCR intends to commit approximately $10 million (total costs) each year of the funding period through FY2015 to fund this FOA. The available funds will be used to support the RPAC and the S&DCC of each CRRDOH. Applicants should include funds in the budget for the annual meetings of the CRRDOH, the ESAC meeting and DSMB. It is anticipated that up to four Centers will be funded but will depend on: 1) the merit of submitted applications as evaluated by peer review, 2) secondary review by the National Advisory Dental and Craniofacial Research Council, 3) budgetary requirements of submitted applications, and 4) programmatic priorities of the NIDCR. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

This RFA is a one-time solicitation, and plans for this initiative beyond the current funding opportunity are indefinite.

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

You may submit an application(s) if your institution is an academic institution. It is anticipated that consortia with other types of institutions, organizations and agencies will be formed.

1.B. Eligible Individuals

Individuals Eligible to become RPAC or S&DCC PIs

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

Multiple PDs/PIs for the RPAC and/or for the S&DCC

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The standard NIH review criteria 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 PD/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.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

This funding opportunity is open to all eligible institutions. New applicants as well as those from existing Centers for Research to Reduce Oral Health Disparities are welcomed.

The same institution may apply for both the RPAC and the S&DCC, but the RPAC and the S&DCC PD/PI must be different.

An eligible institution may submit more than one application on which it proposes to be the lead institution, provided each application is scientifically distinct and focuses on a different disease and/or population. An individual cannot be the Center Director/ PI on more than one such application. There are no limitations on the number of 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. The NIDCR will fund only one competitive CRRDOH application per institution.

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 on line 2 of the face page of the application form and the YES box must be checked.

Supplemental Instructions:

Overall Center Information:

PHS 398 Form Pages 1. Face page for entire CRRDOH application - Name of PD/PI for the overall Center.

PHS 398 Form Pages 2. Key personnel

List of all participating institutions and key investigators/personnel in alphabetical order. When multiple PIs are proposed, list the Contact PI first, then all additional PIs in alphabetical order. Then, list all Key Personnel, giving name and organization.

PHS 398 Form Pages 3. Overall table of contents

PHS 398 Form Pages 4-5. Budgets

The budgets should include:

a) A detailed composite budget for the entire CRRDOH

b) Separate budgets for the RPAC component, the individual research projects, and the S&DCC component. Additional pages for budget justification are to be used as necessary.

Biographical Sketch Principal investigator/Program Director

Other Biographical Sketches all key personnel and other significant contributors, including consultants, following the order listed on Form Page 2.

Resources

RPAC Component of the Application:

The RPAC component of the application must begin with a cover page identifying this component, the PD(s)/PI(s), key personnel, institution affiliation, and contact information of the contact PD/PI. Applicants should keep their applications as concise as possible, adhere to the specified page limits, and assemble the application as follows:

  • Description of Center Overall

7 page
  • Management Plan

3 pages
  • Leadership Plan (if the Multiple PD/PI option is used)

3 pages
  • Plans to Monitor Center Progress

3 pages
  • Plans for Community Liaison Program and Infrastructure for
  • Community-based Research

5 pages
  • Plans for Training and Career Development

5 pages
  • Plans for Dissemination of Research Findings

3 pages
  • Description of Developmental Research Program

2 pages
  • Optional examples of not more than 2 developmental research projects

page each
  • Description of Overall Research Program

3 pages
  • Letters of commitment from each institution and community partners

  • Appendix

Research Projects Component of the Application:

Each research project must begin with a cover page identifying the title of the research project, the PD(s)/PI(s), key personnel, institution affiliation, and contact information of the contact PD/PI. The research projects must use the format of the Research Plan (sections A-L) of the PHS 398 individual application. (http://grants1.nih.gov/grants/funding/phs398/phs398.doc Applicants should keep their applications as concise as possible, adhere to the specified page limits, and assemble the application as follows:

Research Project #1: Demonstration and/or Dissemination/Implementation Research Project (R01-level)

Additional Intervention Research Project (s): (R01-level) repeat as for Research Project # 1

S&DCC Component of the Application:

The S&DCC component of the application must begin with a cover page identifying this component, the PD(s)/PI(s), key personnel, institution affiliation, and contact information of the contact PD/PI. Applicants should keep their applications as concise as possible, adhere to the specified page limits, and assemble the application as follows:

Description of the S&DCC 10 pages

Leadership Plan (if the Multiple PD/PI option is used) 3 pages

Letters of commitment from each institution and community partners

Appendix

Multiple PD/PI Leadership Plans: For each component (RPAC, S&DCC and/or each research project) designating multiple PD/PIs, a new section entitled Multiple PD/PI Leadership Plan (Section I of the Research Plan in the PHS 398), 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, including 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 PD/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs must be delineated in the Leadership Plan. In the event of an award, the requested allocation may be reflected in a footnote on the NoA. For detailed information regarding the requirement of the multiple PD/PI option including the required Multiple PD/PI Leadership Plan refer to: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html

The CRRDOH application should conclude with:

Progress Report (if applicable) - Centers for Research to Reduce Oral Health Disparities funded under RFA-DE-99-003 must submit a progress report following PHS 398 instructions and include information on progress and accomplishments. http://grants1.nih.gov/grants/funding/phs398/phs398.doc

Checklist - Checklist form for entire CRRDOH application.

Appendix Materials

IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applicants to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

As noted above, a separate appendix may be submitted for the following components of the Center application: 1) the RPAC, 2) each R01-level project, and 3) the S&DCC. Appendices must conform to established limitations. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

Manuals of Procedures are NOT permitted.

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

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
Letters of Intent Receipt Date(s): October 15, 2007
Application Receipt Date(s): November 15, 2007
Peer Review Date(s): March 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): August 2008

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 should be sent to:

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms 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, the entire Center application (including appendices) is encouraged to be submitted on a CD to the following address. It is required that two additional copies of the CRRDOH application and all copies of the appendix materials be sent to:

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDCR. Incomplete and 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 PI 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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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.

6. Other Submission Requirements

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

In the scientific and technical merit peer review of a Center application, individual priority scores will be assigned to the overall Center as an integrated effort, the Research Program and Administrative Center (RPAC), each of the R01-level intervention projects, and the Statistics and Data Coordinating Center (S&DCC).

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 a major scientific impact and thus deserve a high 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 the field forward or have a significant impact on oral heath in a health disparity population.

Overall Center Review Criteria

Significance: Does this application address an important problem? If the aims of the application are achieved, will the findings change clinical practice or public health practice and policies? 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? Does the investigator acknowledge potential problem areas and consider alternative approaches? For applications designating multiple PD/PIs, is the leadership approach, including designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project and the expertise of each of the PD/PIs?

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 of health disparities research in the selected population?

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 PD/PI(s) and other researchers? Do the PD/PI(s) and the 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Research Program and Administrative Core Review Criteria (RPAC)

Management Plan: Is the organizational structure adequately developed, well integrated, well reasoned, and appropriate for the CRRDOH?

Center Director/RPAC PI:

Leadership Plan for Multiple PD/PIs:

Plans to Monitor Center Progress:

Community Liaison Program and Infrastructure for Community-based Research:

Training and Career Development Plan:

Dissemination of Research Findings Plan:

Developmental Research Program and Project Review Criteria:

Overall Research Program Review Criteria:

Research Projects R01-level Review Criteria

Significance: Does this study address an important problem? If the aims of the study are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this study 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? For applications designating multiple PD/PIs, is the leadership approach, including designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project and the expertise of each of the PD/PIs?

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 of health disparities research?

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 PD/PI(s) and other researchers? Do the PD/PI(s) and the 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Statistics and Data Coordinating Center (S&DCC) Review Criteria

Organizational Structure and Implementation:

PD/PI:

Investigators:

Analysis Approach:

Electronic Communications Network/Platform:

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 priority score:

Applications with Multiple PDs/PIs

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project. The governance and organizational structure of the leadership team and the research project should be described, including 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.

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

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 priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing NIDCR program staff will be responsible for the administrative review of the plan for sharing research resources.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

N/A

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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.

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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the PI as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

General Considerations

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

The administrative and funding instrument used for this program will be the cooperative agreement U54, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The CRRDOH will be comprised of an RPAC, an S&DCC, an Executive Committee (EC), a Community Advisory Committee (CAC), an External Scientific Advisory Committee (ESAC) and the NIDCR Project Scientist. In instances where CRRDOHs designate multiple PDs/PIs for the RPAC and/or S&DCC, they will share responsibility for ensuring that their respective Centers meet all goals, objectives and measurements for success proposed in the application and in all subsequent activities of the CRRDOH. However one PI must be designated as the Director of the CRRDOH.

Research Program and Administrative Center (RPAC): The RPAC will be responsible for the management, coordination and supervision of the entire range of CRRDOH activities and for monitoring the progress and ensuring that goals and measurements for success are met. The RPAC, in collaboration with NIDCR, will provide overall administrative and scientific leadership for the CRRDOH.

Statistics and Data Coordinating Center (S&DCC): The S&DCC will have both scientific and administrative functions. The S&DCC will: 1) assist in the preparation of study protocols and Manuals of Procedures including the statistical design of each study, 2) develop data collection systems including the use of networked electronic medical/dental records, 3) develop a database management system, 4) assist with informed consent procedures, 5) develop a data quality assurance program, 6) assist with IRB approvals, 7) assist in developing materials to aid recruitment of subjects and communities, 8) assist in training and certification of CRRDOH staff, 9) analyze study results, 10) review all manuscripts for statistical considerations, coordinate site visits and prepare site visit reports, 12) coordinate activities and meetings of the DSMB(s) as needed for clinical trials, 13) develop and implement a system for adverse event reporting for clinical trials, 14) create and maintain standardized protocols for study procedures and conduct data analysis for DSMB(s) as needed, and 15) collaborate with other CRRDOH grantees to establish common data elements for health disparities studies conducted by CRRDOH grantees. The S&DCC will also play a leadership role in the training, career development and research findings dissemination components

The S&DCC Principal Investigator (PI) will be a member of the EC and will participate in the Annual Meeting of the CRRDOH. If multiple S&DCC PDs/PIs are designated in the application, they will rotate as the PI member from the S&DCC on the EC. A schedule for such rotation must be established.

Community Advisory Committee (CAC): The CAC will play an active role in the design and implementation of the Center's research projects and overall activities. The CAC is expected to include not only leaders and organizations involved directly in the research projects, but others with pertinent information and community expertise as well. The CAC is expected to have a diverse membership of a cross-section of community representatives, rather than include only members with ties to one particular organization type (health centers, for example). The CAC will prepare a report each year for the ESAC.

External Scientific Advisory Committee (ESAC): The ESAC will conduct, at a minimum, an annual review of the: (1) goals of the CRRDOH including goals related to training and career development, implementation of community-based research infrastructure, and dissemination of research findings; (2) accomplishments and progress towards meeting the CRRDOH s goals for the Center as a whole; 3) interim progress of all research projects; 4) adherence to the CRRDOH conceptual framework and theme, 5) progress toward measurements of success of the CRRDOH overall and all RPAC components and the S&DCC, and 6) collaboration with the community with reports directly from the CAC annually. The ESAC will also assist with the identification, prioritization and review of proposed research projects that emerge during the course of the award period. The ESAC will also conduct a concept review of all developmental projects proposed by the CRRDOH to assure appropriateness with the theme and conceptual framework of the CRRDOH. The reports of the ESAC are advisory to the CRRDOH and to the NIDCR.

The NIDCR will select the members of the ESAC with input from the RPAC and the S&DCC PIs. The RPAC will provide all support for all ESAC meetings. The ESAC will be comprised of approximately six individuals with expertise appropriate for research conducted by the CRRDOH (for example, intervention and other clinical research, dental research, health disparities research, biostatistics, and clinical trial design and methodology, and other areas as appropriate). The NIDCR Project Scientist is an ex officio member of the ESAC. The ESAC will meet at least annually and will submit a written report to the NIDCR that summarizes its evaluations and recommendations.

The NIDCR, in collaboration with the RPAC and S&DCC PIs, will appoint DSMB(s) for clinical trials. In addition to ongoing monitoring by program staff, the NIDCR plans to conduct a prospective and comprehensive evaluation of the research portfolio in oral health disparities, which includes (but is not limited to) Centers funded under this announcement. Awardees are hereby notified that they may be contacted during or after the completion of this award for information and assistance in assessing the overall impact of the program

Future year funding is contingent upon persistent satisfactory performance with respect to the goals of the Center. The NIDCR reserves the right to curtail, withhold, or terminate support for the Center overall, or for individual participating projects or allied participant recruitment centers in situations involving: a) inadequate recruitment, follow-up, data reporting, or quality control; b) a major breach of a study protocol; c) a substantive change in the agreed-upon protocol to which the NIDCR does not agree; d) statistical evidence that a major study endpoint has been reached ahead of schedule in a clinical trial or clinical study; or, e) human subject concerns or ethical issues that dictate a premature termination. Prior to taking such actions, NIDCR will consult with and receive recommendations from an advisory group.

Terms and Conditions for Clinical Trials: Clinical trials funded through cooperative agreements have special terms and conditions pertaining to the scope and nature of the interaction between NIDCR and the awardees incorporated into the Notice of Award. The Terms and Conditions of Award for Clinical Trials Funded through Cooperative Agreements are found at http://www.nidcr.nih.gov/ClinicalTrials/ClincalTrialsProgram/CoopAgrTermsCond.htm The terms and conditions of award for clinical trials will appear in the Notice of Award as appropriate for the CRRDOH structure.

As with all NIDCR-supported research, all publications and reports resulting from activities supported by this award must acknowledge support from the National Institute of Dental and Craniofacial Research, NIH, DHHS specifically referencing the cooperative agreement number.

Information obtained from the data under the cooperative agreement may be used by the NIDCR in preparation of internal reports on the CRRDOH activities. However, awardees will retain custody of and have primary rights to the data developed under the cooperative agreement.

2.A.1. Principal Investigator Rights and Responsibilities

The RPAC PI serves as the overall Director of the CRRDOH and will Chair the EC. If multiple RPAC PDs/PIs are designated in the application, one of the PIs will be designated as the overall Director of the CRRDOH. Additional PIs from the RPAC will serve on the EC on a rotating basis per a rotation schedule. The CRRDOH Director will have overall administrative and scientific responsibility for the overseeing the research design, implementation, and timely dissemination of results as well as for the proposed goals, community liaison program and infrastructure for community-based research; training, career development and dissemination program, management plan, and research program. The Director of the CRRDOH will assume responsibility and accountability to the applicant institution and to the NIDCR for the performance and proper conduct of the research in accordance with the Terms and Conditions of Award. The named co-Director of the CRRDOH will maintain substantive involvement with the overall CRRDOH. A plan for choosing a successor to the CRRDOH will be in place. Under the NIH Cooperative Agreement mechanism, NIDCR staff member(s) may be substantially involved in the performance of CRRDOH research.

The PI(s) of the RPAC will have overall responsibility for partnering with targeted populations/communities; providing oversight for development and implementation of protocols; assuring overall operational and fiscal management of the CRRDOH, with the NIDCR; and arranging meetings and conference calls of the EC and the ESAC. Furthermore with the assistance from the S&DCC and in consultation with the NIDCR, the RPAC PI will: 1) coordinate the overall activities of the CRRDOH, 2) develop, nurture and build upon existing community relationships to partner with the CRRDOH in research initiatives, integrate existing NIH Clinical Translational and Science awards and other research training programs into the CRRDOH for training new health disparities researchers, 3) monitor the overall progress of the CRRDOH, 4) ensure that all participants in the CRRDOH are regularly informed of progress in protocol development and study-related issues, 5) build community awareness and participation in the CRRDOH via the CAC, community liaison and other activities, 6) assist in obtaining Institutional Review Board (IRB) approval for CRRDOH protocols, 7) prepare budgets and annual reports, and 8) assume a leadership role in manuscript preparation and administrative issues related to the CRRDOH.

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

2.A.2. NIH Responsibilities

The NIDCR will be involved substantially with the awardees as a partner in providing overall scientific guidance and support consistent with the cooperative agreement mechanism. The NIDCR Program Official will review the scientific progress and may recommend to the NIDCR to withhold support, suspend, or terminate an award for lack of scientific progress. The NIDCR Program Official, together with the NIDCR Grants Management Specialist, will provide fiscal and administrative oversight of the Center.

The NIDCR Program Official whose name appears on the Notice of Award will be responsible for the normal stewardship responsibilities such as routine performance monitoring of the CRRDOH, including matters of quality control within and among various components, adherence to theme and conceptual framework, progress of studies and components, and in evaluating patient recruitment and compliance with protocol of studies conducted by the Center. The Program Official will have overall responsibility to assure the scientific and technical integrity of the CRRDOH on behalf of the Institute.

The NIDCR Project Scientist will have substantial scientific-programmatic involvement that is above and beyond the normal stewardship. It is the role of the NIDCR Project Scientist to act as a facilitator and partner and not to direct the activities of the study investigators. A representative from the Planning, Evaluation and Legislation Branch, OSPA, NIDCR will provide guidance with respect to the overall prospective evaluation of the Center’s activities but will participate with and assist, but not direct the activities of the Center.

The NIDCR Project Scientist will participate with and assist:

The NIDCR Project Scientist will have access to data generated under the cooperative agreement. Information obtained from the data may be used by NIDCR for the preparation of internal reports on research activities. However, awardees will retain custody of and have primary rights to the data developed under the cooperative agreement.

The NIDCR will approve all new projects prior to their initiation, major changes to existing projects (alterations in scope and effort), and termination of projects.

2.A.3. Collaborative Responsibilities

Executive Committee (EC):The EC will; 1) prioritize research topics for developmental research project proposals and submission of manuscripts; 2) make decisions on operational issues; 3) consider and adopt changes in study procedures as necessary; 4) review and implement recommendations from the IRB(s), ESAC and DSMB(s); 5) review the progress of studies in achieving their main goals and take steps required to enhance likelihood of success; and 6) review data collection practices and procedures as summarized in performance monitoring reports from the S&DCC to identify and correct remediable deficiencies.

The EC will convene monthly meetings of the CRRDOH investigators and other key personnel for a discussion of CRRDOH progress on all aspects of the Center. The EC will meet immediately following each of the CRRDOH meetings. The CRRDOH and EC will meet, at a minimum, in person at the beginning of the award and once per year in person thereafter. Other monthly CRRDOH and EC meetings may take place via teleconference as necessary. The NIDCR staff will participate in both the CRRDOH and EC meetings.

If multiple PDs/PIs are designated in the RPAC and/or S&DCC application, the EC will be composed of four individuals: 1) the CRRDOH Director who serves as the Chair of the EC, 2) one PD/PI from the RPAC who serves on the EC on a rotating basis with other PD/PIs from the RPAC, 3) a PD/PI from the S&DCC who serves on the EC on a rotating basis, and 4) the NIDCR Project Scientist. The EC will regularly meet with representatives of the CAC. However, if the CCRDOH Director is also the sole PI of the RPAC, the EC will be composed of three individuals: 1) the CRRDOH Director who is also PI of RPAC and who chairs the EC, 2) a PI from the S&DCC, and 3) the NIDCR Project Scientist.

The Executive Committee of each CRRDOH will serve on the Oral Health Disparities Collaborative Working Group, participate in monthly teleconferences and an annual meeting, and is expected to work collaboratively with other CRRDOHs and the NIH staff on issues that will advance oral health disparities research. Issues will include the development of common data elements; participation in common future research projects; collaboration on activities that advance the field of oral health disparities research such as the development of symposia or workshops, identification and training of investigators; and the development of flexible and adaptable electronic communications network/platforms. If multiple PIs are named, a rotation plan will be established. Guidelines for the monthly teleconferences and the annual meeting will be established by the NIDCR.

Annual CRRDOH Meeting: An annual meeting of CRRDOHs will be held at the National Institutes of Health to share scientific findings and identify and discuss emerging research opportunities; develop collaborative research activities amongst the Centers; discuss and resolve administrative issues in the Centers with participants invited by the Institute; obtain input from the NIDCR on the on-going formative evaluation of the Centers; and provide training experiences for developing members of the center’s research team. The PD/PIs of both the RPAC and the S&DCC are expected to participate in the development of the agenda and to serve as the representative of his/her center at the meeting. In addition to the Center PD/PIs it is anticipated that the co-Directors and other key team members will participate in the annual meeting.

The annual meeting is also a venue for the CRRDOHs to provide input into the design and implementation strategies for the evaluation of the oral health disparities research initiative. The NIDCR plans to conduct a prospective and comprehensive evaluation of the research portfolio in oral health disparities, which includes (but is not limited to) centers funded under this announcement. The goal of this national evaluation will be to assess the effectiveness of the oral health disparities research portfolio in meeting the research objectives of the NIDCR health disparities plan. Accordingly, areas of interest to the national evaluation will include increasing the productivity of disparities research; enhancing research capacity (especially through training and career development); improving capacity for community-based research; and translating research results into improved prevention and treatment. To support this effort, the NIDCR will request that grantees participate in the design and conduct of the national evaluation. In addition, awardees are hereby notified that they may be contacted during or after the completion of this award for information helpful in assessing the overall impact of the program.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Executive Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590.htm) and financial statements as required in the NIH Grants Policy Statement. The annual progress report for the U54 award will use the standard 2590 form as well as a supplementary report that will be more extensive and will go to the NIDCR Program Official. The content and format of this supplementary report will be defined by the NIDCR Program Official, the NIDCR Evaluation Officer, and other NIDCR officials.

In addition to ongoing monitoring by program staff, the NIDCR plans to conduct a prospective and comprehensive evaluation of the research portfolio in oral health disparities, which includes (but is not limited to) centers funded under this announcement. The goal of this national evaluation will be to assess the effectiveness of the oral health disparities research portfolio in meeting the research objectives of the NIDCR health disparities plan. Accordingly, areas of interest to the national evaluation will include increasing the productivity of disparities research; enhancing research capacity (especially through training and career development); improving capacity for community-based research; and translating research results into improved prevention and treatment. To support this effort, the NIDCR will request that grantees participate in the design and conduct of the national evaluation. In addition, awardees are hereby notified that they may be contacted during or after the completion of this award for information helpful in assessing the overall impact of the program.

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:

Ruth Nowjack-Raymer, M.P.H., Ph.D.
Director, Health Disparities Research Program
Center for Clinical Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS-43F
Bethesda, MD 20892-6402
Voice: (301) 594-5394
FAX: (301) 480-8322
Email: [email protected]

2. Peer Review Contacts:

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
Email: [email protected]

3. Financial or Grants Management Contacts:

Diana Rutberg, M.B.A.
Lead Grants Management Specialist
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44J
Bethesda, MD 20892-6402
Voice: (301) 594-4798
FAX: (301) 480-3562
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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.

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.

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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 RFA 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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