Source: http://grants2.nih.gov/grants/guide/rfa-files/RFA-DE-12-002.html
Timestamp: 2014-09-19 06:06:11
Document Index: 106525568

Matched Legal Cases: ['art6', 'art4', 'art9', 'arts 74', 'art 92', 'art 50', 'art\n16']

RFA-DE-12-002: National Dental Practice-Based Research Network Limited Competition (U19) Part I
Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
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
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
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
racial and ethnic groups as well as individuals with disabilities are always encouraged to
apply for NIH support. Number of
may submit only one application. Resubmissions. Resubmission
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
available at: TTY: (301)
451-5936 Table
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.
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
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
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
strategies for managing acute and chronic orofacial pain; Natural history of oral
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.
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
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.
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 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.
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.
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 (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).
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
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)
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.
Compensation System (PCS)
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
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
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 (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
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,
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
funds and the receipt of a meritorious application. Facilities
in the direct cost limitation; see NOT-OD-05-004. NIH
Statement will apply to the applications submitted and awards made in response to this
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
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
applications are not permitted in response to this FOA. Section
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)
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
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
Review Date(s): September-November
Review Date: January 2012
Earliest Anticipated Start Date(s): April 2012
title of proposed research.
Name, address,
and telephone number of the PD(s)/PI(s).
Names of other
title of this funding opportunity.
Although a letter of intent is
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
Lynn Mertens King, PhD
NIDCR-NIH
6701 Democracy Blvd., Rm. 662
Bethesda, MD 20892-4878 (20817
for express deliveries)
Phone: (301) 594-5006
Sending an Application to the NIH Applications
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
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
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/.
period of a new award. The
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
Administration Information". Supplemental
Instructions for the Preparation of the U19 Multi-Project Applications
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
projects and cores interrelated by a common theme.
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.
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.
U19 Application
Network and Administrative Core
Strategy: Overall Network and Administrative Core
Coordinating Center Specific
Research Project 1 Specific
All applications must be submitted using PHS
398 Forms.
multi-project grant application should be assembled and paginated as one
complete document.
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.
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.
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.
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
Checklist - One Checklist, placed at the end of the application, is to
Plan for the Overall Network and Administrative Core
Aims- (1page limit)
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)
the Overall Network and Administrative Core and your ability to build
upon your previous network experience to develop and sustain a robust and effective
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.
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
on how the applicant chooses to structure the NDPBRN, the following components
may function in the Administrative Core or the Data Coordinating Core)
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’
Compensation System: Describe the plans for the compensation system and
the function of the Administrative Core in managing practitioner and patient
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.
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.
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.
Key Personnel, list the Core/ clinical study Research Project PD/PI, followed
by other senior/key personnel, and then other significant contributors.
of Contents (PHS 398 Form Page 3)
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
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.
Strategy (Limited to 6 pages)
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.
Study Research Projects
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.
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
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.
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
(see http://grants.nih.gov/grants/funding/phs398/phs398.html). Appendix Materials
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.
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.
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.
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
identify genetic associations with observable traits (such as blood pressure or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
group convened by the NIDCR and in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
a selection process in which only those applications deemed to be
responsive will be discussed and assigned an impact/priority score. Receive
a second level of review by the National
Advisory Dental and Craniofacial Research Council.
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
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?
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
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
of minorities and members of both sexes/genders, as well as the inclusion of
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?
scientific environment, subject populations, or collaborative arrangements? Review Criteria for Evaluating the Administrative Core within the NDPBRN
Application Overall Evaluation
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
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?
Criteria for Evaluating the Data Coordinating Core within the NDPBRN
Application Overall
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?
Criteria for Evaluating the Individual Clinical Study Projects within the
NDPBRN Application Overall Evaluation Reviewers
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
presented? Additional
additional items in the determination of scientific and technical merit but
subjects involvement and characteristics, and 3) sources of materials. For additional
well as the inclusion of children. For additional information on review of the
Inclusion section, please refer to the Human
3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress,
reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For
for Review of the Vertebrate Animal Section. Biohazards. Reviewers will assess whether materials or
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
from Foreign Organizations. Not
Applicable to this FOA.
following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
The following will be considered in making
of the proposed project to program priorities NIDCR considers the following in evaluating
NDPBRN cooperative agreement applications:
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.
access his or her Summary Statement (written critique) via the eRA Commons.
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
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.
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)
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
2.A. Cooperative Agreement Terms and Conditions of
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
administrative and funding instrument used for this program will be the
cooperative agreement an "assistance" mechanism (rather than an
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
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 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
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.
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
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
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
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.
VII. Agency Contacts We encourage your inquiries concerning this
peer review, and financial or grants management issues: 1. Scientific/Research Contacts: Center for Clinical 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
Rm. 662, MSC 4878
Bethesda, MD 20892-4878 (use 20817 for express deliveries)
3. Financial or Grants Management Contacts: Kevin
Institute of Dental And Craniofacial Research
Democracy Blvd, Room 654, MSC-4878
MD 20892-4878
(301) 594-4801 Fax:
(301) 480-3562
Email: Kevin.Crist@NIH.GOV
as applicable. Human Subjects Protection: Federal
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Data and Safety Monitoring Plan: Data
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
laws and regulations, including the Privacy Rule. Policy for Genome-Wide Association Studies
(GWAS):
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
use of data collected under this award. Sharing of Model Organisms: 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
Research: The
in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm). Required Education on the Protection of Human Subject
Participants: NIH
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
"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
Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm. The
protect and advance the physical and mental health of the American people. Loan Repayment Programs: NIH