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: National Dental Practice-Based Research Network Limited Competition (U19)

Announcement Type
New

Request For Applications (RFA) Number: RFA-DE-12-002

Catalog of Federal Domestic Assistance Number(s)
93.121

Key Dates
Release Date: November 12, 2010
Letters of Intent Receipt Date: April 4, 2011
Application Receipt Date: May 3,2011
Peer Review Date(s): September-November 2011
Council Review Date: January 2012
Earliest Anticipated Start Date: April 2012
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: May 4, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose: This FOA issued by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), is a limited competition opportunity which invites applications from the incumbent NIDCR regional practice-based research networks to establish and support a National Dental Practice-Based Research Network (NDPBRN). The NIDCR will support one National DPBRN led by a National Network Director who will be responsible for assembling the infrastructure components to support this endeavor. The main goals of the cooperative agreement funded under this FOA are to support the infrastructure and conduct of national oral health research studies in dental practices on topics of importance to practitioners, to provide evidence useful in daily patient care, and to facilitate the translation of research findings into clinical practice.
• Mechanism of Support. This FOA will use the NIH Research Program Cooperative Agreement (U19) award mechanism.
• Funds Available and Anticipated Number of Awards. The NIDCR intends to commit up to approximately $70 million in total costs to fund one cooperative agreement for up to seven years in response to this FOA.
• Budget and Project Period. The total project period can be up to seven years.
• Application Research Strategy Length: In the U19 application, the Research Strategy section of the Overview and Administrative Core each may not exceed 12 pages, and the Research Strategy sections for individual Cores and for each individual Research Project may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits. See Section IV. Application and Submission Information
• Eligible Institutions/Organizations. Competition is limited. Only the currently funded NIDCR regional practice-based research networks (RFA-DE-05-006) are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of Applications. Applicants may submit only one application.
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Renewal applications are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
  Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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. Research Objectives

PURPOSE

The National Institute of Dental and Craniofacial Research (NIDCR) invites applications to establish and support a National Dental Practice-Based Research Network (NDPBRN). The NDPBRN will build on the significant investment to date by the NIDCR and only currently NIDCR-funded regional practice-based research networks (RFA-DE-05-006) are eligible to apply. The NIDCR will support one National DPBRN led by a National Network Director who will be responsible for the overall scientific leadership and fiscal management of National DPBRN activities. The main goals of the NDPBRN cooperative agreement funded under this FOA are to support the infrastructure and conduct of national oral health research studies in dental practices on topics of importance to practitioners, to provide evidence useful in daily patient care, and to facilitate the translation of research findings into clinical practice. While the initial focus of the NDPBRN is on forming a national network of primary care general dentists, the National Network Director should be prepared to recruit and coordinate networks of dental specialists to answer specific research questions.

BACKGROUND

The NIDCR defines the NDPBRN as a geographically diverse group of practices and clinics devoted principally to the oral health care of patients, and whose members are affiliated through their interests in investigating questions related to dental practice and in improving the quality of oral health care. This definition includes an ongoing commitment to network activities and an organizational structure that transcends a single research project. Similar to primary-care medical PBRNs, dental PBRNs link practicing clinicians with investigators experienced in clinical and health services research while at the same time enhancing the research skills of the network members. The NDPBRN will support a variety of clinical studies with clear and easily defined outcome measures, and will typically draw on the experience and insight of practicing clinicians to help identify and formulate research questions. Because the research will be conducted in the real-world environment of dental practice, results are more likely to be readily accepted and adopted by practitioners and translated into daily practice. Moreover, because practice-based research uses the existing personnel and infrastructure of established dental practices, certain types of clinical research can be conducted rapidly.

Research Objectives

The overall objective of this FOA is to develop a National DPBRN that builds upon the strengths of the currently NIDCR-funded regional dental PBRN system and to coordinate the efforts of the regional practices and clinics, or Regional Nodes , into a network to conduct national oral health research studies. The NDPBRN will initiate and perform a variety of clinical studies, with an emphasis on comparing the effectiveness of oral health treatments and preventive regimens. The primary objective of each study carried out by the NDPBRN is to strengthen the knowledge base for clinical decision-making by evaluating particular clinical approaches and evaluating the effectiveness of strategies for the prevention, management and treatment of oral diseases and conditions.

RESEARCH SCOPE

Consistent with the overall goals of the NDPBRN, the objective of this FOA is to support multiple clinical studies during a 7-year project period with a focus on general dental practice, but also incorporating projects of interest to dental specialists and other dental professionals. The projects must be feasible to conduct in a dental practice or similar clinical setting and designed to best answer the research question. To be responsive to this Funding Opportunity Announcement (FOA), applicants will be required to include two clinical study research projects. Examples of research topics relevant to national oral health that could be addressed in well-designed clinical studies and would be appropriate for the NDPBRN include, but are not limited to:

• Effectiveness of various strategies for the diagnosis of dental caries, periodontal disease, and oral cancer;
• Effectiveness of interventions for preventing, treating, and managing periodontal disease and caries;
• Effectiveness of various strategies for managing acute and chronic orofacial pain;
• Natural history of oral conditions;
• Assessing variation associated with the delivery of dental health care;
• Assessing patient compliance with treatment recommendations; or
• Assessing the outcomes of various treatments such as endodontic therapy, dental implants, and other prosthetics and restorative modalities.

It is anticipated that dental practitioners will generate the majority of study ideas; however, members of other organizations, such as academic institutions, professional dental organizations, or government agencies may submit research ideas for consideration by the NDPBRN. In addition, anonymous chart reviews may be conducted, as allowed by HIPPA, to provide data on disease and treatment trends and to obtain estimates of the prevalence of less common conditions.

NDPBRN ORGANIZATIONAL STRUCTURE

The National Network Director is the PD/PI of the U19 cooperative agreement and is responsible for the overall conduct of the network. Each Regional Node will be managed by a Regional Node Director who is responsible to the National Network Director. The NDPBRN application must include plans for an Administrative Core (AC), a Data Coordinating Core (DCC), and for infrastructure to undertake national Practitioner Recruitment, Practitioner Training and Education, Practitioner and Patient Reimbursement, Communications and Dissemination, and Independent Scientific Review and Oversight. Governance structures for the NDPBRN must provide for the direction, oversight, coordination, and involvement of the Regional Node Directors, the practitioners, and the AC and DCC investigators. The NIDCR will be responsible for providing support for the NDPBRN and will be substantially involved with the awardee as a partner in providing overall scientific guidance, consistent with the Cooperative Agreement mechanism.

The funding of the NDPBRN Regional Nodes, Regional Node Directors, the DCC and components of the NDPBRN infrastructure is to be accomplished through subcontracts from the parent grant to commercial or not-for-profit expert entities.

National Network Director

The National Network Director is the PD/PI of the U19 and is responsible for the overall scientific, technical, and administrative leadership for the Network. She/he will have lead responsibility for planning and directing all phases of the network s studies and for managing the network's operations and fiscal resources. In carrying out these responsibilities, the National Network Director should actively seek advice from all of the network's investigators and representatives of the NIDCR.

The National Network Director is also the Director of the NDPBRN Administrative Core (AC) and will oversee and coordinate research activities among the regional research nodes and the Data Coordinating Core (DCC). As such, the National Network Director will appoint Regional Node Directors.

Other responsibilities include: oversight of protocol development; building community awareness and participation in the network; assisting in obtaining Institutional Review Board (IRB) and approval of NDPBRN protocols; assisting investigator-practitioners and participating practices in obtaining a Federal Wide Assurance from the Office of Human Research Protection (http://www.hhs.gov/ohrp); and preparing budgets and annual reports.

In concert with the NIDCR and the Regional Node Directors, the National Network Director will: 1) stimulate and solicit ideas for new studies from practitioner-investigators; 2) develop requirements for participation of practitioner-investigators; 3) recruit and select practitioner-investigators; 4) develop clinical research training procedures and materials for practitioner-investigators; 4) conduct clinical research training and certification of practitioner-investigators and their staff; 5) monitor the performance of practitioner-investigators; 6) develop systems to assist practitioner-investigators in maintaining high rates of patient recruitment and retention; 7) arrange meetings of the governance and oversight committees; 8) host an annual research meeting for participating practitioner-investigators; 9) inform network participants of progress in protocol development and study-related issues; and 10) assume a leadership role in manuscript preparation and administrative issues related to the network.

The National Network Director will also establish and Chair relevant oversight committees, including the Practitioner Steering Committee (PSC), and a Regional Directors Meeting. The Director will also strive to establish a Central Institutional Review Board (Central IRB) in concert with IRBs of record affiliated with each of the Regional Nodes.

Administrative Core

The Administrative Core (AC) will provide the governance and administrative structure of the NDPBRN. As Director of the AC, the National Network Director will select a team of Regional Node Directors who will work with her/him to provide scientific leadership, infrastructure support, and coordination of the network activities, including coordination with a Data Coordinating Core (see below).

The proposed governance structure should address the functions of leadership, direction, and oversight of the NDPBRN. This will include solicitation of input from the Regional Node Directors, the practitioners, the Data Coordination Core investigators, and NIDCR staff. The AC should provide the infrastructure to support the following required components of the NDPBRN: 1) Regional Nodes/Regional Directors; 2) Practitioner Steering Committee: 3) Practitioner Training and Education; 4) Practitioner Compensation System 5) Communication and Dissemination; and 6) Independent Scientific Review and Data Monitoring (see below). The components may be coordinated and/or managed under the AC or DCC, as appropriate, for the infrastructure and governance being proposed in the U19 application. The National Network Director will be responsible for ensuring that these shared scientific and technical resources are efficiently configured and utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research teams.

Regional Nodes/Regional Node Directors

The NDPBRN is expected to include representation from approximately 4-6 diverse geographical regions (Regional Nodes) of the country, and those regions should encompass more than one state and one population center. Each region will have a Regional Node Director who will be appointed by the National Network Director to provide leadership and management of each Regional DPBRN Node. Each Regional Node Director is responsible to the NDPBRN Network Director. The Regional Node Directors will be expected to: 1) propose, stimulate and solicit research ideas; 2) assist with protocol development; 3) recruit practitioner-investigators; 4) assure that practitioner-investigators are appropriately trained and certified; 5) coordinate IRB approval; 6) coordinate protocol deployment and study recruitment; 7) arrange for regional meetings; 8) facilitate regional dissemination of research findings; and 9) provide regional fiscal and operational management under the provisions of subcontracts from the National Network Director’s institution.

The U19 application should address the rationale for division of the country into the proposed geographic regions, and should identify Regional Node Directors as Senior/Key Personnel for at least half of the proposed regions. The application should provide evidence that the Regional Node Directors have demonstrated leadership potential and the ability to productively engage and participate in a large research network.

Practitioner-Investigators and the Practitioner Steering Committee (PSC)

Practitioner-Investigators are defined in the NDPBRN as dentists, dental hygienists, and other dental professionals who are engaged in the daily practice of dentistry and dental hygiene in participating practices of the NDPBRN. For the national network, the participating practices are to be drawn from a region encompassing more than one state and one population center. Practitioners or networks from the United States Federal Services including the Public Health Service, the Indian Health Service, the Veterans Health Administration, Health Resources Services Administration, and the Department of Defense are also encouraged to participate in the NDPBRN. It is anticipated that the enrolled practices will be within the United States unless there is a compelling reason to include practices outside the United States. The U19 application should describe the plans and criteria for selection of Practitioner-Investigators.

The Practitioner Steering Committee (PSC) is composed of Practitioner-Investigators. The role of this committee is to prioritize research topics for protocol development and to review protocols prior to submission to a Protocol Review Committee (described below). The U19 application should address plans for regional, gender, and racial/ethnic representation on the PSC for staggered 3-year terms. The practitioner-investigators should be representative of the gender and racial/ethnic distribution of the dentists in the region from which the network is formed.

Practitioner Training and Education Component (PTEC)

This component will provide the oversight for practitioner training on general research principles, Good Clinical Practice (GCP), the protection of human subjects, data management and security, and other areas deemed essential for the compliance of federal and other guidelines and regulations pertaining to the conduct of clinical research. The PTEC will also be responsible for all continuing medical education (CME) provided to members of the NDPBRN and if appropriate, will provide for the award of continuing education credits. The PTEC will work in concert with other interested parties and stakeholders in the development of educational programs for members of the NDPBRN.

Practitioner Compensation System (PCS)

The PSC should provide timely and accurate compensation to practitioners and patients engaged in NDPBRN projects. The U19 application should propose an efficient and contemporary system that is linked to predetermined deliverables obtained from data collected by the Data Coordinating Core (DCC). The system is expected to include an adjudication functionality to address disputes associated with compensation claims.

Communication and Dissemination Component (CDC)

The CDC will provide oversight of communication operations. The CDC should provide internal and external communications to ensure that knowledge gained through the network is shared quickly with the public and practitioners who can use the knowledge to inform decisions about oral health care. Internal communications among all Network members should include audio and video conferencing. Communications with external audiences, including health care professionals, patients, the general public, and the research community should include messages, materials and dissemination channels appropriate for the target audiences. These communications may include for example, print media, digital media, mobile web, text messaging, RSS feeds, and social networking.

Independent Scientific Review and Data Monitoring

An important principle of the NDPBRN is inclusion of independent scientific evaluation of proposed clinical NDPBRN protocols. This component will include a Protocol Consultants Group (PCG) organized by the NIDCR with input from the National Network Director. Expertise will include clinical research, dental research, biostatistics, PBRNs, clinical trial design and methodology, and experience as a practicing dental clinician. The National Network Director will serve as the non-voting Executive Secretary of the PCG. It will include an NIDCR representative as well as extramural scientists independent of the network. Protocols will be open for patient accrual only after independent scientific review and approval, NIDCR approval, and subsequent Institutional Review Board (IRB) approval. Additional independent safety and data monitoring entities will be convened by NIDCR to provide an increased level of oversight as needed.

Data Coordinating Core

The Data Coordinating Core (DCC) has both scientific and administrative functions. The Director of the DCC will manage all the functions of the Core and serve on relevant governance and oversight committees. Scientifically, the DCC will be responsible for the design of studies to ensure they yield scientifically sound results. Activities include: assisting with protocol design, study protocols, and Manuals of Procedures; providing analytical support for all studies; and reviewing all manuscripts for statistical considerations. Administrative functions include deploying a sophisticated database management system, an informed consent process, and a quality assurance program. Additionally, the DCC will assist the National Network Director in the establishment of an IRB that will meet all federal requirements and regulations and will serve as the IRB of record for all of the participating practices.

Additional functions of the DCC include: assisting in developing materials to aid recruitment of practitioner-investigators and patients; coordinating site visits, preparing site visit agendas; preparing site visit reports; reviewing performance of all participating practices; coordinating activities involving independent study oversight; developing and implementing a system for adverse event reporting; creating/maintaining modular standardized protocols for study procedures; and conducting data analyses required for independent data oversight and monitoring. The DCC will implement flexible and innovative technologies to capture research data with the capability to accomplish research participant follow-up independent of practitioner offices. Finally, the DCC will manage the Information Technology Component.

Information Technology Component

The Information Technology Component (ITC) will provide the oversight of the planning, implementation, and deployment of network systems and software services to support and enhance all NDPBRN activities. By integrating various information systems across organizational and network boundaries, the information technology (IT) resources should support maximum productivity, efficiency and effectiveness at all levels of information processing. The ITC should provide all of the resources required to meet these commitments. All NDPBRN patient treatment and research record systems are to be appropriately certified in accordance with appropriate government policies and regulations. The IT component will employ IT industry best practices with regard to project management, configuration management, security management, systems administration, application development, change management, IT program governance, and establishment of end user service levels and support procedures.

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 U19 cooperative agreement award mechanism(s).

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

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

In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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 Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

This FOA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The earliest anticipated start date is May 2012. This FOA uses just-in-time concepts.

2. Funds Available

Applicants may request a project period of up to 7 years. The NIDCR intends to commit up to approximately $10 M (total costs) each year of the funding period to support this FOA.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a meritorious application.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only the currently funded NIDCR regional practice-based research networks are eligible to apply.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit only one application.

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

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

Section IV. Application and Submission Information

1. Address to Request Application Information

The current 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 Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: April 4, 2011
Application Receipt Date: May 3, 2011
Peer Review Date(s): September-November 2011
Council Review Date: January 2012
Earliest Anticipated Start Date(s): April 2012

3.A.1. Letter of Intent

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

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

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

The letter of intent is to be sent by April 4, 2011.

The letter of intent should be sent to:

Lynn Mertens King, PhD
Chief, Scientific Review Branch
NIDCR-NIH
6701 Democracy Blvd., Rm. 662
Bethesda, MD 20892-4878 (20817 for express deliveries)
Phone: (301) 594-5006
FAX: (301) 480-8303
Email: Lynn.King@nih.gov

3.B. Sending an Application to the NIH

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

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

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Lynn Mertens King, PhD
Chief, Scientific Review Branch
NIDCR-NIH
6701 Democracy Blvd., Rm. 662
Bethesda, MD 20892-4878 (20817 for express deliveries)
Phone: (301) 594-5006
FAX: (301) 480-8303
Email: Lynn.King@nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

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

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

6. Other Submission Requirements

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Supplemental Instructions for the Preparation of the U19 Multi-Project Applications

The following section supplements the instructions found in the PHS 398 application instructions for preparing a multi-project grant application (U19). Additional instructions are required because the PHS 398 is designed primarily for individual, free-standing research project grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects and cores interrelated by a common theme.

The supplemental instructions for multi-project applications below are divided as follows:

A. General Instructions for the Overall Network and the Administrative Core Instructions supplement the PHS 398 to address the administrative and organizational structure, address integration and collaborative efforts among cores and research projects as well as the overall facilities and environment, and the overall budget. Include section or component subheadings, when appropriate, in bold text.

B. Specific Instructions for the Data Coordinating Core and Individual Clinical ResearchProjects describes modifications to the PHS 398 instructions.

For Sections A and B, the page limits for the Specific Aims and Research Strategy sections of the PHS 398 Research Plan are shown in the following table. The clinical studies should be prepared as separate Research Project applications. Include section or component subheadings, when appropriate, in bold text.

NDPBRN U19 Application	Research Plan	Page Limit
Section A
Overall Network and Administrative Core	Specific Aims	1
	Research Strategy: Overall Network and Administrative Core	12
Section B
Data Coordinating Center	Specific Aims	1
	Research Strategy
		6
Individual Research Project 1	Specific Aims	1
Individual Research Project 2	Research Strategy	6
	Specific Aims	1
	Research Strategy	6

A. General Instructions

All applications must be submitted using PHS 398 Forms.

The multi-project grant application should be assembled and paginated as one complete document.

PHS 398 Form Page 1- Face Page for the overall NDPBRN; Name of the PD/PI for the overall Network. Multiple PD/PIs may not be proposed.

PHS 398 Form Page 2- Provide a succinct but accurate description of the overall Network project application addressing the major, common theme of the program. Describe the relevance of the Network to public health.

List the performance sites where the research will be conducted.

Senior/Key Personnel. List the PD/PI of the Network followed by the Overall and Administrative Core leaders, the Regional Node Directors, the project leaders of the Data Coordinating Core and clinical study projects, and then other key personnel and then other significant contributors.

Do not repeat biosketches if an individual has multiple roles. Potential members of the Protocol Consultants Group and any other advisory committee members must not be contacted or named in the application; however, the (scientific) expertise required for these positions should be described

PHS 398 Form Page 3- Do not use Form Page 3 of the PHS 398; a more comprehensive Table of Contents is needed for a multi-project application. Bearing in mind that the application will be scientifically reviewed core by core and project by project and; prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component core and clinical study project. Further, each Core should be identified by name (e.g., Data Coordinating Core) and responsible Core Director, and each clinical study should be identified by number (e.g. Project 1), title, and responsible Project PD/PI. The page location of the overall budget should be indicated in the Table of Contents.

PHS 398 Form Pages 4-5- This overall Network budget should include the Network Administrative Core at the institution of PD/PI and subcontracts to the Data Coordinating Core, the Regional Nodes and the clinical studies. Budget justifications should be included.

Biographical Sketches- Biographical sketches of all professional personnel for all components of the Network should be included with the PD/PI first, followed by those of other key personnel in alphabetical order.

Resources - For the Overall network and Administrative Core, Specialized (Overall) Network and Administrative Core resources may include laboratory facilities, equipment, and services. For each specialized resource, describe in detail the resource(s) that it will provide to the NDPBRN. In addition, describe its role in the overall functioning of the U19, including how each resource will enhance the Network, and a description of the projects that will be supported by the specialized resource.

(Other essential Resources information is to be presented in the individual core and research project sections of the application.

Checklist - One Checklist, placed at the end of the application, is to be submitted for the entire application.

Research Plan for the Overall Network and Administrative Core

Specific Aims- (1page limit)

Describe the overall network and administrative goals, specific aims, and expected impact of the proposed network on oral health care.

Research Strategy (Limited to 12 pages)

Describe the Overall Network and Administrative Core and your ability to build upon your previous network experience to develop and sustain a robust and effective organization.

Describe how the proposed Network and Administrative Core (AC), headed by the National Network Director, will be integrated to address the overall goals and aims of the NDPBRN. This should be supported by a discussion of the past accomplishments of the currently NIDCR funded regional PBRN(s). Describe the process for selection of the Regional Nodes and Regional Node Directors and the overall potential for the proposed NDPBRN Director to organize and manage a national research Network. Explain the plans for relevant governance and oversight committees, organizational and administrative management of the overall Network, and coordination and communication within the Network. Describe how the administrative structure would be organized to foster interactions among Regional Node Directors, Practitioner-Investigators and the Data Coordinating Core. Include information on the chain of responsibility, specific managerial responsibilities, and consortium arrangements. Describe the process for forming, maintaining and coordinating the Regional Nodes. Explain how the AC will be involved in the oversight of the Data Coordinating Core and all the Network components. Describe the process for selecting, promoting, monitoring and terminating research projects. Describe the plans to monitor the progress of the overall Network. Describe approaches to create a Network with diverse national representation of practitioners and subjects. Describe the relationship of the AC with the Practitioner Steering Committee. Describe the function of the AC in subject recruitment and retention plans. Describe the Network succession plans, including the designation of replacements for Regional Node Directors, if needed.

Regional Nodes/Region Directors: Describe the plan for establishing Regional Nodes and recruiting qualified Regional Directors for each respective region.

Practitioner Recruitment/Practitioner Steering Committee: Describe a strategy for recruiting practitioners from diverse backgrounds located in dispersed geographic regions and the plan for engaging them in the governance process of the Network.

(Depending on how the applicant chooses to structure the NDPBRN, the following components may function in the Administrative Core or the Data Coordinating Core)

Practitioner Training and Education Component: Describe the plans for practitioner training and education and the function of the Administrative Core in managing this component. Describe the training of practitioners in human subjects research.

Practitioner Compensation System: Describe the plans for the compensation system and the function of the Administrative Core in managing practitioner and patient compensation.

Communication and Dissemination Component: Describe the plans for communication and dissemination within the Network and with external audiences and the function of the Administrative Core in managing this component.

Independent Scientific Review and Data Monitoring Component: Describe the plans for independent scientific review and data monitoring and the function of the Administrative Core in implementing this component.

B. Specific Instructions for the Data Coordinating Core (DCC) and Individual Clinic Study Projects

Cover Page- The section must begin with a cover page identifying the title of the Core or clinical study project, the PD/PI, key personnel, institution affiliation, and the contact information of the PD/PI.

PHS 398 Form Page 2- Provide a description (Project Summary) of the Core/ clinical study . In addition, the summary should contain a brief description of how the Core/clinical study will contribute towards attainment of the Network goals.

List the performance sites where the Core/ clinical study research will be conducted.

Under Key Personnel, list the Core/ clinical study Research Project PD/PI, followed by other senior/key personnel, and then other significant contributors.

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5)- Budget of Research Project with budget justifications.

Resources Provide information on resources available for the core/clinical study Research Project Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.)

Research Plan

Specific Aims (Limited to 1 page)

For the DCC, Describe the overall goals of core, specific aims, and expected impact of the proposed core on the network and national oral health care.

For the clinical study research projects, state concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the practice of dentistry and the oral health of the public.

Research Strategy (Limited to 6 pages)

Data Coordinating Core (DCC): Describe the management and coordination of the scientific and administrative functions of the Data Coordinating Core (DCC), including the proposed database management system, and processes for informed consent and quality assurance programs. Describe how the DCC will guide study design, the preparation of study protocols and relevant documents, and provide analytical support for studies. Describe plans for data acquisition and research participant follow-up in diverse regions of a national network displaying significant variation in research site capability and functionality. Describe how the DCC interfaces with the AC and how the DCC will establish the IRB of record for all of the participating practices.

Information Technology Component: Describe the information technology plans and the function of the Data Coordinating in managing this component. Describe how information technology can be leveraged to improve the functionality, efficiency, oversight, and communications in this widely dispersed Network.

Clinical Study Research Projects

Each application must include two individual research projects, each of which is responsive to the FOA and the overall goals of the NDPBRN. Each individual project should be an independent research effort. Projects proposing practitioner or patient surveys are not responsive to this FOA.

Provide pertinent background information and the relevance of the proposed project to national oral health and oral health practitioners. Describe the design, the method for implementing the study in the NDPBRN including the plan to develop and initiate the final protocol, method(s) to collect data from subjects, the method for conducting the study in the diverse practice setting anticipated in the Network and a brief analytical plan. Describe the plan for recruitment and retention, the study timeline, the process for monitoring progress and additional resources to conduct the project.

Describe how this research project integrates with the Network as a whole, including the administrative core, the data coordinating core and the other research project. Finally describe a dissemination and implementation strategy that will enhance the incorporation of research findings into clinical practice.

Checklist- One Checklist, placed at the end of the application, is to be submitted for the entire application.

Appendix Materials- Refer to Section IV.6. Appendix Materials below, for instructions on submitting appendix materials. For each project or core in the multi-project application, 3 publications plus other approved material are allowed.

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

• Specific Aims is limited to 1 page.
• In the U19 application, the Research Strategy section of the Overview and Administrative Core may not exceed 12 pages, and the Research Strategy sections for the Data Coordinating Core and each individual clinical study Project may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.

Budget

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

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process. For each project or core in the multi-project application, 3 publications plus other approved material are allowed.

Resource Sharing Plan(s)

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

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

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

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to be responsive will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Dental and Craniofacial Research Council.

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

For the NIDCR U19 multicomponent cooperative agreement applications, peer review of scientific and technical merit focuses on three areas: (1) review of the individual Core units; 2) review of the individual clinical research study projects; and (3) review of the overall merit of the U19 network and the program as an integrated effort.

Review Criteria for the Overall NDPBRN Application

Overall Impact

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

Scored Review Criteria

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

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

How significant are the overall goals of the Network? Is the significance of the individual clinical study research projects enhanced by conducting them in a National Network?

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

Does the National Network Director have the experience and expertise to plan, direct and administer a network of this scope? Do the Regional Node, DCC and other Directors/Leaders have the ability, expertise and accomplishments to support the multiple functions of the Network? Do the senior/key personnel plan to commit sufficient time to the program to ensure its success?

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

Is the innovation of the individual clinical study projects enhanced by conducting them in a national Network?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is the proposed approach likely to create a Network with a diverse national representation of practitioners and subjects? How feasible are the plans to monitor the progress of the overall Network?

How well does the coordination and synergy of the individual research projects, cores and components contribute towards the achievement of the central goal of the Network? To what extent will the integration of the individual cores, components and projects into a single Network be more beneficial than pursuing each independently? How well do the clinical studies relate to the central theme of the Network application and to other projects, components and cores within the application? Are the plans for communication among the individual parts of the Network appropriate and adequate?

What are the potential and ability to scale from a regional network to a national Network?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Review Criteria for Evaluating the Administrative Core within the NDPBRN Application

Overall Evaluation

Reviewers will provide an overall score to reflect their assessment of the scientific and technical merit in consideration of the following review criteria and additional review criteria (as applicable).

Evaluate whether the Administrative Core (AC) organizational structure will provide effective governance, management and communication among all components of the Network and be effective on a national scale. Are the plans for coordinating and communicating among all network components clear and likely to be effective? Are the scientific and administrative functions of the Data Coordinating Core well integrated with the AC? Do the proposed governance and management plans address potential problems, alternative strategies and leadership succession plans?

Are the roles and responsibilities of the senior/key personnel well defined and appropriate? Do they have the experience and ability to achieve the functions of the AC? Are they able to recruit and retain practitioners from geographically diverse regions of the country reflecting the national demographics of the dental profession? Are they able to establish and engage them in the governance process of the Network?

Are the processes for forming, maintaining and coordinating the regional nodes realistic and do they lead to strong leadership and national population representation? Are the quality control and oversight mechanisms appropriate and likely to function successfully on a national scale?

Will the process for selecting, promoting, monitoring and terminating research projects lead to robust clinical research studies with results that will meaningfully address national oral health? Are the proposed research participant recruitment strategies appropriate for national studies?

NOTE: the following required application components may be part of an application’s Administrative Core, or Data Coordinating Core. The Cores should be evaluated accordingly.

Practitioner Training and Education Component:

Evaluate the plans for practitioner training and education. To what extent can the education and training plans be achieved and measured? Are the plans to train practitioners in all aspects of human subjects research appropriate and adequate?

Practitioner Compensation System:

Does the practitioner and patient compensation component provide for timely and accurate compensation?

Communication and Dissemination Component:

Do the communication and dissemination plans demonstrate sufficient expertise in both internal and external communications?

Independent Scientific Review and Data Monitoring Component:

Is the proposed process for assisting NIDCR with the development an independent scientific review process for NDPBRN protocols appropriate and adequate?

Review Criteria for Evaluating the Data Coordinating Core within the NDPBRN Application

Overall Evaluation

Reviewers will provide an overall score to reflect their assessment of the scientific and technical merit in consideration of the following review criteria and additional review criteria (as applicable).

Will the structure of the Data Coordinating Center (DCC) contribute to the success of its scientific and administrative functions? Are the roles and responsibilities of the personnel in the DCC clear and appropriate? Are the proposed communication plans among all Network components appropriate and adequate? Are the clinical research functions of the DCC, including informed consent, clinical monitoring, calibration, and adverse event reporting appropriate?

Is the experience of the DCC Director in directing a DCC, coordinating national projects and studies, developing and managing clinical trials, managing interdisciplinary research teams, developing Manuals of Procedures, designing research studies and data analysis plans, managing and coordinating clinical trials and other clinical research studies, and preparing DSMB reports appropriate and adequate? Are the experience and ability of the key personnel to develop clinical trial protocols, design data analysis plans, and effectively manage and coordinate clinical trials and other clinical research studiesappropriate and adequate? Is the proposed effort of the Director and other key personnel sufficient?

Information Technology Component:

Are the information technology plans and the function of the Data Coordinating in managing this component appropriate and adequate? Can the DCC support and integrate multiple data entry systems?

Review Criteria for Evaluating the Individual Clinical Study Projects within the NDPBRN Application

Overall Evaluation

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on clinical dental practice and improving the health of the public, in consideration of the following review criteria, and additional review criteria (as applicable for the project proposed).

Will the proposed clinical research study significantly influence clinical practice and/or oral health policy. Is the rationale behind the proposed study Appropriate and adequate?

Is the proposed project feasible, including design, implementation method(s)for conducting the study in a private practice setting, protocol development and initiation, recruitment and retention, data collection methods, and analytical plans? Is the timeline realistic and will the processes for monitoring progress be appropriate? Are potential problems, alternative strategies, and benchmarks for success presented?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit but will not give separate scores for these items.

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

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

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

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

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

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

Revision Applications. Revision applications are not permitted in response to this FOA.

Additional Review Considerations for Evaluating the Overall NDPBRN Application

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

Applications from Foreign Organizations. Not Applicable to this FOA.

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities

NIDCR considers the following in evaluating NDPBRN cooperative agreement applications:

• The scientific and technical merit of the proposed Network.
• The qualifications and experience of the NDPBRN Director and other key personnel.
• The statutory and program purposes to be accomplished.
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the Network.
• The extent to which the Network's activities would be coordinated with similar efforts by other organizations.
• The leadership, managerial, and administrative capability of the applicant
• Other factors which the awarding IC considers appropriate in light of its particular statutory mission

3. Anticipated Announcement and Award Dates

It is anticipated that the award notification will be made March 2012.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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.

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

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 Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

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 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the FOA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIDCR staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to the award. The responsibility for the planning, direction, and execution of the proposed project will be solely that of the Principal Investigator. The Principal Investigator agrees to provide NIDCR with the design, methods, and procedures to be employed in the conduct of studies and to comply with requirements prescribed by NIDCR for study development, conduct, and independent scientific review.

Meetings

Meetings will be convened periodically to monitor and review progress of the awardee during which the Principal Investigator and appropriate Key Personnel will provide updates on network development and study progress. The NIDCR Project Scientist/Program Official and External Advisors (when applicable) will be present. A critical determinant of success will be the degree of communication between the Principal Investigator, Project Leaders, the Practitioners, and other significantly involved parties. Therefore additional meetings may be necessary for coordination of cooperative agreement activities. Regular telephone and written/email communication with the NIDCR Program Official is considered to be very important and is strongly encouraged.

Publications

The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the cooperative agreement award and supported in part or in total under this Agreement. Publications or oral presentations of work performed under this Agreement are the responsibility of the Principal Investigator and will require appropriate acknowledgement of NIDCR support. Timely publication of major findings is encouraged.

Data

While the NIDCR Project Scientist/Program Official has a right of access to the data (see NIDCR staff responsibilities below) the awardee will retain custody of and right to the data. 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

An NIDCR Project Scientist/Program Official will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NIDCR Project Scientist/Program Official will serve as a liaison/facilitator between the awardee and other government agencies (e.g., FDA, CDC, AHRQ), and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIDCR Project Scientist/Program Official will facilitate coordination of project activities during the course of the project. The NIDCR Project Scientist/Program Official will assist the awardee with access to other NIDCR-supported resources and services.

The NIDCR Project Scientist/Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. However the NIDCR Conflict of Interest Management strategy for Cooperative agreements will apply to this award. It is anticipated that the Project Scientist/Program Official will refrain from activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication. Should the extent and nature of staff involvement evolve to the level where conflicts of interest arise, NIDCR will carefully re-evaluate the alignment of duties among staff and implement specific strategies to manage the conflicts of interest.

2.A.3. Collaborative Responsibilities

The specific timelines, interim objectives and funding levels agreed to by the awardee and the NIDCR shall be included in the terms and conditions of award. Given the nature of practice-base research, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. The Principal Investigator and NIDCR must agree to all such revisions. Release of each funding increment by NIDCR will be based on a NIDCR review of progress towards achieving the previously agreed upon interim objectives. Where scientifically appropriate, NIDCR may ask the awardee to collaborate or cooperate with other NIDCR-funded projects and/or US government agencies, for example CDC, FDA, and/or AHRQ.

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

The awardee will be required to provide the NIDCR with periodic reports reflecting project recruitment and other measure of study progress. There will be an administrative review organized by the NIDCR after approximately four years of the project period to determine if the National PBRN and each of its components have been performing as envisioned in terms of patient recruitment and implementation of protocols of importance to the field. Based on this review, a decision will be made by the NIDCR about continuing research activities as planned, refocusing activities, or ending the research activities of the network.

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

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

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

Section VII. Agency Contacts

We encourage 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:

Center for Clinical Research
Division of Extramural Research
National Institute of Dental And Craniofacial Research/NIH
6701 Democracy Blvd.
Bethesda, MD 20892-4978
All inquiries should be sent to: nationalpbrn@mail.nih.gov

2. Peer Review Contacts:

Lynn Mertens King, PhD
Chief, Scientific Review Branch
NIDCR-NIH
6701 Democracy Blvd.
Rm. 662, MSC 4878
Bethesda, MD 20892-4878 (use 20817 for express deliveries)
Phone: (301) 594-5006
FAX: (301) 480-8303
Email: Lynn.King@nih.gov

3. Financial or Grants Management Contacts:

Kevin Crist
Grants Management Branch
National Institute of Dental And Craniofacial Research
6701 Democracy Blvd, Room 654, MSC-4878
Bethesda, MD 20892-4878
Phone: (301) 594-4801
Fax: (301) 480-3562
Email: Kevin.Crist@NIH.GOV

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide 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-09-116.html. Only research using HESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the HESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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.