NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Diabetes is a common chronic disease that imposes considerable demands on the individual as well as the U.S. healthcare system. People with diabetes have a higher rate of cardiovascular disease than those without diabetes and are at increased risk for kidney failure, lower limb amputation, and blindness. Diabetes currently affects an estimated 29.1 million people in the United States. Another 86 million Americans are estimated to be at greatly increased risk of developing diabetes. Type 1 and type 2 diabetes in youth are also on the rise. The CDC estimates that one in three American children born in 2000 will develop diabetes at some point in their lives. Although diabetes occurs in all populations in the U.S., many minority racial and ethnic groups and individuals in underserved areas are at higher risk for type 2 diabetes and its complications. The estimated current annual cost of diabetes in the U.S. is $245 billion dollars per year, with $176 billion in direct medical costs and the remainder related to reduced productivity.

Large clinical trials clearly demonstrate that glycemic control and cardiovascular risk factor modification can reduce the risk of complications in both type 1 and type 2 diabetes. Although there have been considerable improvements in diabetes treatment options and in risk-factor control over the past three decades, research demonstrates that many individuals with diabetes (youth and adults) do not meet the recommended goals for diabetes care. It is also well established that behavioral lifestyle interventions, with modest (5-7%) weight loss, can prevent or delay development of type 2 diabetes in individuals at high risk for the disorder and, in individuals who already have type 2 diabetes, can decrease sleep apnea, reduce the need for diabetes medications, help maintain physical mobility, and improve quality of life.

Despite these advances, there remains a gap between the evidence and real-world diabetes prevention and treatment. This gap is particularly evident in many racial and ethnic minority populations and for individuals living in poverty or low resource environments. Closing this gap in care and reducing health disparities will require type II translation research (e.g., bedside to practice and the community) testing innovative adaptations of evidence based approaches to prevent and treat diabetes in ways that can be disseminated and sustained (behaviorally and economically) in routine clinical health care practice and community settings.

The mission of the CDTRs will be to serve as a key component of the NIDDK-supported research program to translate efficacious research findings into practice and the community to improve the health of Americans with, or at risk for, diabetes. CDTRs will enhance scientific progress and improve the uptake of research through support of rigorous translation research aimed at prevention and improved treatment of diabetes and related conditions. An emphasis on type II translational research to reduce or eliminate the health disparities in diabetes is encouraged. To meet these goals, CDTRs will provide core services and consultation locally, regionally, and nationally in areas relevant to the NIDDK translation research agenda. Activities supported by CDTRs should enhance the efficiency, productivity, effectiveness and multidisciplinary nature of diabetes translation research.

For the purpose of this FOA, type II translation is defined as research focused on translating interventions/approaches that have clearly demonstrated efficacy into real world health care settings, communities, and populations at risk with an emphasis on reach, sustainability, and potential for widespread implementation. Type II translational research is distinct from type I translational research. Type I translational research (bench to bedside) builds on basic science findings and focuses on early phase research to translate these findings into potential interventions or therapeutics that might ultimately be tested in clinical trials. While type I translational research is a critically important piece of the research continuum, it is not the focus of this Funding Opportunity Announcement for the Centers for Diabetes Translation research (CDTR). Type II translational research supported by a CDTR might include effectiveness, dissemination, implementation, and comparative effectiveness research. The target of this type of the research can be varied to include individuals, families, healthcare practitioners or systems, communities, and/or policy makers. Examples of CDTR expertise that would be relevant to conducting diabetes translation research might include design and analysis issues in translational research (e.g., quasi-experimental designs, evaluation of natural experiments, adaptive or practical/pragmatic clinical trials, modeling, analyses for complex designs and data systems, health economic analysis), methodologies such as community engagement or Community Based Participatory Research, measurement at various levels (e.g., individual, family, system, community, healthcare practitioner) and dissemination and implementation science. Topic level expertise might include, but is not limited to, adherence, use of technology (eHealth, mHealth, health information technology, and diabetes management technologies), health disparities, health literacy and/or numeracy, diabetes self-management, prevention, lifestyle change, and health communication. These examples are not intended to represent a comprehensive list of areas of focus for a CDTR.

CDTRs are part of an integrated program of research support designed to enhance multidisciplinary cutting-edge research in diabetes. The focus of the CDTRs should complement and enhance the NIDDK translational research program such as those supported by these funding announcements:

PAR-13-365, Evaluating Natural Experiments in Healthcare to Improve Diabetes Prevention and Treatment (R18)

PAR-15-157, Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care (R18)

PAR-15-158, Planning Grants for Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care (R34)

PA-13-352, Translational Research to Improve Diabetes and Obesity Outcomes (R01)

To learn more about the NIDDK type II translation research priorities in diabetes, please see the Clinical Research to Practice: Translational Research chapter in the current draft of the Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the DMICC: http://www2.niddk.nih.gov/AboutNIDDK/ReportsAndStrategicPlanning/DiabetesPlan/PlanPosting.htm.

The goal of the NIDDK CDTRs (http://www.diabetes-translation.org/) is to improve prevention and treatment of diabetes by promoting research that supports rapid dissemination, implementation, and sustained use of effective interventions/approaches; particularly in high risk populations. The CDTRs should improve the efficiency and collaborative nature of type II translational research in diabetes by providing shared access to specialized technical resources and expertise and a framework for fostering synergy between disciplines relevant to translating evidence based approaches to real world adoption and practice.

The Centers for Diabetes Translation Research will:

• Create an environment that supports important and innovative type II translation research;
• Raise awareness of and interest in type II translational diabetes research at their institutions as well as locally, regionally, and nationally;
• Enhance translational diabetes research education and training opportunities for patients, students, scientists, and clinicians;
• Attract and retain new and junior investigators;
• Develop cores that enhance and leverage other funding resources such as grants and other NIH Centers
• Provide core services based on skills, knowledge, and expertise that are unique to type II translational research;
• Foster interdisciplinary collaborations required to advance type II translational research;
• Promote the translation of scientific discoveries from bedside to practice and the community to improve public health; particularly in high risk populations.

Institution and Research Base

A CDTR must be an identifiable unit within a single institution such as a university medical center or a consortium of cooperating institutions. CDTR applications must demonstrate a strong base of successful external research funding (NIH or non-NIH) that is related to type II translational research in diabetes. Program excellence includes a consistent and outstanding record of publications and peer-reviewed research funding in related areas. Multi-disciplinary collaborations are also encouraged. Centers should identify one or more central themes or focus areas that link Center investigators and their research programs.

Where possible and applicable, CDTRS are encouraged to leverage relevant skills and collaborations with other institutions (e.g., academic, health departments, healthcare systems, and community organizations) or NIH funded centers (e.g., Diabetes Research Centers, Nutrition Obesity Research Centers, and Clinical and Translational Science Awards). The goal of the Diabetes Center program is to make type II translational science resources readily accessible to a broad spectrum of investigators who are pursuing research in relevant topic areas.

Administrative Core

CDTRs applications must include an administrative core that will be responsible for allocation and oversight of Center resources. In addition, each CDTR will be required to create and maintain a Center website, with the administrative core taking primary responsibility for its curation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website (http://www.diabetes-translation.org/).

Translational Research Core

A Core should address how they will support and foster diabetes translational research. A core should focus on activities that support research focused on enhancing translation of evidence into broader or higher risk populations and into routine clinical or community practice setting. Core services can support research to identify and test approaches to overcome barriers to widespread dissemination and implementation of evidence-based approaches Cores should be designed to provide specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of the type II translational research performed by Center-affiliated investigators. In addition, applicants are encouraged to focus on underserved and high risk populations that may be disproportionately affected by diabetes.

Each research core should provide state-of-the art expertise to multiple funded research projects. A Center may support research at a single or set of cooperating institutions through an Institutional Core, or may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core (see below for more information). With a regional or national core, the Center will service a specific research base that is expanded beyond investigators at the Center-affiliated institution. If relevant, applicants should consider and propose opportunities to share core services or functions with other NIH funded Centers in order to expand, enhance, or increase the cost-effectiveness of research activities of the Center.

Applicants are encouraged to propose cores that address specific research areas or objectives based on the unique skills and expertise of investigators at the applicant institution. Particular emphasis should be placed on services that support and foster interdisciplinary translational approaches to research.

Optional Opportunities for Translational Resource Cores

The principal goal of the opportunities listed below is to provide NIDDK CDTR research core services (and pilot and feasibility grant opportunities) to diabetes researchers at institutions that are not currently served by an NIDDK CDTR.

• Regional/National Resource Core: A CDTR may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Resource Core. This core can be located at the applicant institution or an affiliated institution but any funds requested above the cap must be used to support national/regional activities outside the applicant institution(s) and its affiliated hospitals.
  
  Support for the expansion of the Center Pilot and Feasibility (P and F) program to investigators at the institution where the Regional/National Resource Core is located may also be requested but is not sufficient to be considered a Regional/National program for purposes of expanding the allowable requested funds.
  
  
• Core to Support Underserved or Health Disparity Populations: CDTRs may propose partnerships that establish a research core and/or Pilot and Feasibility programs at institutions of higher education (i.e., rural institutions, historically black colleges and universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-serving Institutions (HSIs), Alaska Native and Native Hawaiian Serving Institutions), or other agencies that focus on underserved or populations with health disparities in diabetes outcomes. The primary goal of such partnerships is to foster scientific collaborations and to provide access to the CDTR infrastructure to investigators at these institutions or organizations in order to foster health disparities research in populations disproportionately affected by diabetes.

Pilot and Feasibility Program

The CDTR P and F program provides seed support (typically $25,000-$50,000) for new and innovative research relevant to translational diabetes research. P and F Programs are intended to provide support for investigators to collect preliminary data sufficient to support a grant application for independent research support and/or to test a novel hypothesis. The P and F program is particularly directed at new investigators and established investigators new to diabetes translational research. Established diabetes investigators pursuing timely or highly significant projects are also eligible for support under the CDTR P and F program but this should be the exception rather than the primary focus of the P and F program. Pilot and feasibility support is not intended for large projects by established investigators that should be submitted as separate research grant applications, nor is it intended to provide bridging support. Pilot and feasibility funds are also not intended to support or supplement ongoing funded research of an investigator.

To be considered a viable P and F program, the Center must support a minimum of two pilot projects.

Enrichment Program

The CDTR Enrichment Program should advance type II translational diabetes research, promote scientific exchange among investigators with related research interests, and enhance interactions between diabetes researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops..

Additional Features

Cooperation, Coordination and Integration: Applicants from institutions with an NIH Clinical and Translational Science Award (CTSA) program (http://www.ctsaweb.org/) funded by the NIH National Center for Research Resources or an NIDDK funded Center such as a Diabetes Research Center or Nutritional Obesity Research Center, are strongly encouraged to partner with these Centers, where applicable, to maximize resources for enhancing translational research programs within the CDTR.

Research Base: Successful CDTR applications require an existing program of excellence in type II translational research either in diabetes or in areas directly related to diabetes. To justify Center support, the CDTR must serve a large research base of NIH-funded investigators pursuing research activities in Center topic areas. The research base of the CDTR must also include investigators with an established track record of productivity and funding support in prevention and control research that is directed toward translating current diabetes research findings into clinical and/or community practice.

CDTR Directors' Meeting: Every year, all CDTR Directors and other key personnel are expected to attend a meeting in the Bethesda area to foster shared scientific projects, communicate with NIDDK staff, and highlight key Center activities.

Applications that propose cores to significantly support type I translation research (bench to bedside), or biomedical, behavioral or clinical research other than research to practice translation (type II translational research), are not responsive to this funding opportunity.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent, preferably electronically, should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall (use for Center Overview)	12
Admin Core	6
Core (use for Translational Research Core, Regional/National Resource Core, and Core to Support Underserved or Health Disparity Populations	12
P and F (Use for Pilot and Feasibility Program)	12
Enrichment Program	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Center Overview: Required
• Administrative Core: Required
• Translational Research Core: at least one required
• National/Regional Research Core: Optional
• Core to Support Underserved or Health Disparity Populations: Optional
• Pilot and Feasibility (P and F) Program: Required
• Enrichment Program: Required

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in the cell line table in Overall component.

Follow standard instructions.

Project Summary/Abstract: Describe the scientific theme(s) of the CDTR and the need for a Center to support the investigators in the research base. Provide a brief overview of the research base as it relates to the theme(s) of the Center, as well as an overview of the translational research cores, and the pilot and feasibility and enrichment programs.

Project Narrative: In 1-3 sentences describe the relevance of the research to be supported and facilitated by Center activities (Core services; P and F and Enrichment programs) on public health.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use existing access, space, and usage; include space maps as needed. Scientific personnel and institutional resources capable of supporting the research base must be available.

Other Attachments: The following attachments should be included with the Overall Component to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Grant Support: Please title this attachment "Grant Support" and include all Federal and non-federal grant support for Center members. Complete and organize alphabetically by the last name of the Center Investigator who is listed as the PD/PI on the grant. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs, and Identify Other NIDDK Centers (if the grant listed is also included in its research base). The attachment should include, in order: Current Diabetes Translation Research Grant Support (Table A.1), Other Diabetes Translation Research Grant Support (Table A.2) and Pending Diabetes Translation Research Grant Support (Table A.3). An Example of Table A is provided at this link for applicant assistance with this requirement.

Biographical Sketches of Center Research Base Investigators: Please title this attachment "Center Member Biographical Sketches." Provide biographical sketches for all Center members, as defined by the Center within the application, and organize them alphabetically by the last name of the Research Base Investigator. Do not include biographical sketches for Senior/Key Personnel since those are included with the appropriate component of the application and should not be duplicated here.

Description of Center Research Base Investigators: Please title this attachment Description of Center Research Base Investigators and organize alphabetically by Center Member (last name). Provide a narrative description of no more than one page per research base investigator. These narratives should include: the active grant number(s), title(s), and a few descriptive sentences of the investigator’s research projects, as well as a brief description regarding what aspect of the investigator’s research justifies the use of Center core facilities. In the description of the research base, include ONLY those grants awarded, or subcontracted, to investigators at the applicant institution or consortium, not to investigators at other locations. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to diabetes translational research, and to the theme of the CDTR, when this is not readily apparent from the project title of the grant.

Core Use by Center Members: Please title this attachment "Core Use by Center Members" and organize alphabetically by Center Member (last name, first name). List all CDTR Members including Membership Category (only if more than one category of Membership is designated by the Center), and for each Center Member indicate those Center Core Facilities that will be used. Table B is provided at this link, which is provided for applicant assistance at this requirement.

For renewal applications: Provide an additional table with the same information for the "Actual Core Use by Center Members". Applicants are strongly encouraged to use Table B (link above), which is provided for applicant assistance.

Center Collaborations: Please title this attachment Center Collaborations and organize alphabetically by Center Member (last name, first name). List all Center Members. Provide primary Department Affiliation, key words for research interests, names of other Center members who are collaborators (through publications, grants or research projects), and the number of collaborative publications (only those relevant to the CDTR). Table C is provided at this link, for applicant assistance with this requirement.

Optional: Provide Charts and Tables to illustrate the structure, interactions, and leadership of the institution and the CDTR. Title this attachment "Relation to Overall Center".

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Describe the broad, long-term objectives of the proposed CDTR. A strategic vision, theme and set of goals must be developed and described in the application. The plan should summarize the existing expertise and resources available in the research base as well as other resources at the institution(s). This plan should delineate how the Center will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations toward developing new and/or improved prevention and treatment approaches for diabetes.

Research Strategy: The Research Strategy should include the following sections.

Research Base: The Center Core grant provides a mechanism for fostering interdisciplinary cooperation within a group of established investigators conducting high quality type II translational research in diabetes. Therefore, existence of a strong, substantial research base in this area is a fundamental requirement for, and the most important aspect of, the establishment of a Center.

Applicants should include an overview of current research in diabetes and related areas being conducted at their institution in sufficient detail to allow reviewers to judge its extent and the interrelationship of ongoing research. Applicants should indicate how the establishment of a Center will provide added dimensions, such as greater focus and increased cooperation, communication and collaboration that would not likely occur without Center resources.

A high level of integration and close collaboration among Center personnel from diverse scientific disciplines are important features of a successful CDTR. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Criteria for becoming a CDTR member should be clearly defined. Each Center, however, is expected to formulate these definitions based on its own situation. Center membership and affiliation are often open to those individuals who would like to promote the mission of the Center. Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined in order to better organize and facilitate the focus of the Center’s mission. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Applicants should provide clear guidelines for a) how Center membership(s) is (are) defined; b) the application and selection processes for Center membership; and c) the obligations of Center membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in diabetes-related type II translational research, and the need for the use of core facilities. All research base investigators should be Center members. Designation as a Center member without the need for the use of core facilities must be well justified.

Presentation of the research base in the application should be done in two ways: (1) by completing a Table like the one shown in "Grant Support" in "Other Attachments"; and (2) by providing a full narrative description of the diabetes related research activities at the applicant institution and any collaborating institutions. This presentation should be organized into several areas of emphasis that demonstrate the research focus of the Center. The research of each Center participant should be discussed and interrelationships of research being conducted by Center participants should be highlighted. Since most, if not all, of the research base will have undergone separate peer review, the quality of the individual funded projects is already established. The more important aspects are: (a) interactions and interrelationships of the research efforts; (b) uses and benefits of core services; and (c) plans to develop productive collaborations among Center investigators.

Center Organization: Summarize the services, resources, and expertise provided by the proposed Translational Research Cores, emphasizing the support they will provide for the thematic areas of the research base. Point out novel expertise and resources available in the cores and describe the potential for interdisciplinary collaborations among Center Investigators.

Indicate if any of the proposed cores will utilize or expand Cores already existing at the institution. Describe how the proposed Center will leverage existing resources and fill gaps in the services available. Leveraging existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available.

Provide a plan to determine the need for new expertise or resources for CDTR members. Include information on the process of re-evaluating the needs of Center members and how evolving needs will be met.

Describe how the Center will enhance the research base and foster the careers of its junior investigators through enrichment activities and the use of Core services/expertise.

For new applications: Emphasize the anticipated impact of the establishment of a CDTR on the research base. Include an indication of how the establishment of the Center will provide added dimensions and new opportunities for diabetes related research, along with increased cooperation, communication, and collaboration among investigators.

For renewal applications: Briefly discuss the progress and accomplishments of the research base as influenced by the CDTR; the development of multidisciplinary, collaborative, and cooperative interrelationships among Center members; and indicate any alteration in the original Center design that was instigated to meet the evolving needs of the research base. This should be described in a narrative fashion.

Progress Report Publication List: List publications related to or derived from CDTR support or assistance. Include PMCIDs. Table E is provided for assistance with this list. The Core most significantly contributing to the work should be assigned 'primary' (P) status. All other contributing Cores are designated 'secondary' (S). Group publications by Core used, so that the number of publications (not the list of publications) that resulted from the use of each Core can be cited in each Core narrative write-up. Portions of this table should NOT be duplicated in each Core, but the absolute number of publications from this main list should be cited.

Letters of Support: Include any letters of support for the proposed CDTR from appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the CDTR and its goals. The parent institution is expected to recognize the Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, staff recruitment, salary support for investigators or technical personnel, dedicated or shared equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the CDTR in the event of a change in directorship. A well-defined plan for this eventuality should be in place.

Where relevant, appropriate letters of support from the PD/PI of an NIH funded Center or CTSA at the applicant institution should be included with the application detailing plans for appropriate integration and synergy with the CDTR activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of CDTR activities through cooperation with other NIH supported core facilities at the applicant institution. Applicants are encouraged to suggest coordinated efforts, such as enrichment programs or pilot and feasibility programs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable to this component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Center Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each applicant institution must specify one or more Center Director(s) (PD(s)/PI(s)) to be responsible for the scientific and administrative leadership of the Center. If multiple Center Directors are proposed, the application must document their complementary expertise. The Director(s) should be an experienced and respected scientist with a proven track record for obtaining NIH funding. She/he must be able to coordinate, integrate, and provide guidance in the establishment of new programs in diabetes related translational research.
• One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and will serve as Acting Center Director in the absence of the Director.

Budget forms appropriate for the specific component will be included in the application package.

Personnel: The Center Director must devote a minimum of 2.4 person months to the Center, and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the Center. If a multiple-PD/PI application, the combined effort of the PD(s)/PIs must be 2.4 person months. If there is a need for a full or part-time program administrator, the salary support for this individual should be included in the Administrative Core. Center directors should indicate willingness to collaborate with other NIDDK funded CDTRs. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place and should be described in the application that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed. Again, where possible and applicable, CDTRs are encouraged to leverage administrative resources in other NIH funded centers (e.g. Diabetes Research Centers, Nutrition Obesity Research Centers, and Clinical and Translational Science Awards) to maximize efficiency of resources.

Equipment: If pieces of specialized equipment, or computers, costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on core service provided to CDTR investigators. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. This includes all equipment in future budget years as well as the initial budget period.

Supplies: Consumable supplies directly related to the operational aspects of the Administrative Core facilities are an allowable expense.

Other Expenses: Support for development/maintenance of the Center's website may be requested as well as funds for supporting regional Center meetings, if appropriate.

Consultants: Include costs associated with consultants (consultant fees, per diem, and travel) when their services are required by the CDTR, such as the members of the External Advisory Board.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the CDTR. Include travel costs for the CDTR Director and others as appropriate (i.e. co-Director, core Directors) to attend an annual CDTR Directors' meeting in the Bethesda, Maryland area.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the CDTR and outline plans for oversight/coordination of the research Cores, enrichment activities, and the P and F Program.

Research Strategy: The Administrative Core is key to the coordination and functioning of the Center. Therefore, describe the administrative structure of the CDTR, including: chain-of-command; committee structures, and Core oversight.

The CDTR Director(s), who is the PD(s)/PI(s) of the application, should be assisted by one or more Associate Directors who will be involved in the administrative, scientific, or enrichment efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place to recommend a successor to the Director, if a successor becomes necessary.

Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in setting the overall direction of the Center. In addition, direct lines of communication between the Administrative Core and Translational Research Cores as well as with the P and F Program should be delineated, as all of these cores/programs serve critical roles for Center integration. Procedures for reviewing the utilization, quality and necessity of Core services must be described.

Applicants should describe any ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on related T32 training programs at the Center institution(s), and describe how the CDTR will help to integrate, facilitate and enhance activities of T32-supported trainees.

It is expected that organization of the Administrative Core will provide a supportive structure sufficient to ensure accomplishment of the following:

• Coordination and integration of the CDTR components and activities
• Assessment of productivity, effectiveness, and appropriateness of CDTR activities, assessment of scientific opportunities, and areas for collaboration among Center members
• Develop criteria for Center membership and a process for reviewing and updating membership.
• Organization of CDTR enrichment activities, such as retreats, invitation of consultants, meetings, and seminars
• Organization of the Internal and External Advisory Committees to coordinate and review Center activities
• Recordkeeping of meeting minutes and measures of success including: use of Center facilities, publications, pilot and feasibility awards, and new grant applications resulting from preliminary data enabled by the CDTR
• Interactions with other NIH supported Research Centers, the NIDDK, and other appropriate individuals, groups, or organizations
• Maintenance of a Center website, with the administrative core taking primary responsibility for its curation and oversight.

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). New applications should not list members of the EAC but should describe what expertise is needed. Renewal applications must document the functions and effectiveness of the External and Internal Advisory Committees along with the membership of these committees.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution. However, past experience has demonstrated that the effective development of the Center programs requires close interaction between the Center Director, Core/Program Leaders, appropriate institutional administrative personnel, and the members of the community in which the Center is located. Therefore, each Center applicant should establish an administrative structure that will permit the development of such interactions. The Administrative Core of each applicant institution is responsible for managing/overseeing all of the funds for the center and all of its components.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Not Applicable

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Translational Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Translational Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (Translational Research Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Translational Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research and Related Senior/Key Person Profile (Translational Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Translational Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: A core Director must devote a minimum of 1 person month to the Core to ensure adequate oversight. A co-director or other professional or technical staff may be included. Stipends for graduate students and postdoctoral fellows are not appropriate for a Translational Research Core.

Equipment: If specialized equipment costing more than $5,000 per piece is requested, the application must provide a clear justification based on the core services being provided to CDTR investigators. Equipment may only be requested in the initial year of the project period.

Supplies: Consumable supplies directly related to the Core are an allowable expense.

Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect an equivalent percentage of the service contract based on the overall use by the Center Investigators.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Translational Research Core)

Specific Aims: Clearly state the aims of the Translational Research Core. The aims should describe how the core will enhance scientific progress and improve the uptake of research through support of rigorous translation research aimed at prevention and improved treatment of diabetes and related conditions. The aims should describe how the core will enhance the efficiency, productivity, effectiveness and multidisciplinary nature of diabetes translation research.

Research Strategy: The Core may be based solely at the applicant institution or at multiple institutions through subcontracts. If subcontracts are to be utilized the applicant must clearly demonstrate how a cohesive and integrated operation will be ensured and describe the advantages of this approach to the performance of core functions. The Center may also provide resources for funded projects at collaborating institutions without a sub-contractual arrangement with the parent institution.

Definition: A translational research core provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. The Core should be designed to furnish a group of investigators with expertise and research resources that enhance the research quality and contribute to cost effectiveness.

Justification for proposing a core: The establishment and continued support of a translational research corewithin a Center are justified on the basis of use by independently funded Center investigators. The minimum requirement for establishing a core is significant usage by two or more investigators with independently-funded, peer-reviewed projects. While investigators holding awards from the Center Pilot and Feasibility Program are appropriate users of the core facilities, their use does not contribute to justification for establishment or continued support of a core.

Recharge System: A recharge mechanism is acceptable to help defray costs to the Center. If such a cost recovery system is developed, a detailed charge justification must be presented. Participating Center members must also be informed to include such costs with their full budget justifications in their applications for individual grant support.

Program Income: Centers are encouraged, where appropriate, to develop a program income (re-charge/fee-for-service) system for use of core services. Such a program income system would constitute a method of charging core users for their usage of expertise and research resources. Program income must be re-invested into direct support of Center-related activities and/or expenses and may not generate a profit for the Center.

Management of the core and operational plan: The organization and proposed mode of operation of the core should be presented. Included should be a plan for prioritizing investigator use of the core as well as a definition of qualified users. If use by investigators outside the parent institution is proposed, the mechanism by which such investigators will apply and be evaluated and selected should be detailed. The definition of qualified users should not be too narrow. Some minor core use could serve to entice established investigators in other scientific disciplines into diabetes translational research.

Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the CDTR and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Renewal applications: Information relative to the core in renewal applications should generally cover all of the same points as initial applications. In addition, past performance and accomplishments should be described and highlighted. The effect of the service provided by a core on investigator productivity and cost effectiveness should also be addressed. In renewal applications, any major changes should be carefully documented.

Progress Report Publications List: Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented by listing the number(s) of the relevant publication(s) from Table E which was attached in the Center Overview component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the

Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the

Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Translational Research Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Translational Research Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (National/Regional Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (National/Regional Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (National/Regional Research Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (National/Regional Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research and Related Senior/Key Person Profile (National/Regional Resource Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (National/Regional Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Applicants may request up to $100,000 in direct costs per year beyond the direct cost cap.

Funds requested for this opportunity must be carefully documented and justified, and should be dedicated solely to expanding core services to investigators outside of the parent institution or an affiliated hospital.

Personnel: A core Director must devote a minimum of 1 person months to the Core to ensure adequate oversight. A co-director or other professional or technical staff may be included. Stipends for graduate students and postdoctoral fellows are not appropriate for a National/Regional Resource Core.

Equipment: If specialized equipment costing more than $5,000 per piece is requested, the application must provide a clear justification based on the core services being provided to CDTR investigators. Equipment may only be requested in the initial year of the project period.

Supplies: Consumable supplies directly related to the Core are an allowable expense.

Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect an equivalent percentage of the service contract based on the overall use by the Center Investigators.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (National/Regional Research Core)

Specific Aims: Clearly state the aims of the National/Regional Research Core. The aims should describe how the core will enhance scientific progress and improve the uptake of research through support of rigorous translation research aimed at prevention and improved treatment of diabetes and related conditions. The aims should describe how the core enhances the efficiency, productivity, effectiveness and multidisciplinary nature of diabetes translation research. These descriptions should specifically explain how the National/Regional resources Core extends the reach of the CDTR expertise and resources beyond the primary Institution(s).

Research Strategy: A coremay be based solely at the applicant institution or at multiple institutions through subcontracts. If subcontracts are to be utilized the applicant must clearly demonstrate how a cohesive and integrated operation will be ensured and describe the advantages of this approach to the performance of core functions. The Center may also provide resources for funded projects at collaborating institutions without a sub-contractual arrangement with the parent institution.

Applicants should document that there is sufficient demand by the wider scientific community for the proposed core services. The research base in diabetes at the institution(s) that would use the regional core(s) should also be documented. Plans for prioritization of research core services, as well as training to the broader research community, should be provided. Funds requested for this opportunity must be carefully documented and justified, and should be dedicated solely to expanding core services to investigators outside of the parent institution or an affiliated hospital.

Since type II translational research often requires collaborative research efforts, applicants should demonstrate that they have existing or plan to develop new partnerships that will leverage skills and resources at other institutions to enhance the CDTR’s capacity to advance and support translational science. Demonstration of collaborations might include linkages between disciplines, other institutions, community partners and health departments.

Definition: A National/Regional Research Core provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. The core should be designed to furnish a group of investigators with expertise and research resources that enhance the research quality and contribute to cost effectiveness.

Justification for proposing a core: The establishment and continued support of a National/Regional Research Core within a Center are justified on the basis of use by independently funded Center investigators. The minimum requirement for establishing a core is significant usage by two or more investigators with independently-funded, peer-reviewed projects. While investigators holding awards from the Center Pilot and Feasibility Program are appropriate users of the core facilities, their use does not contribute to justification for establishment or continued support of a core.

It should be clear how the National/Regional resources Core extends the reach of the CDTR expertise and resources beyond the primary Institution(s).

Applicants should document that there is sufficient demand by the wider scientific community for the proposed core services. The research base in diabetes at the institution(s) that would use the regional core should also be documented. Plans for prioritization of research core services, as well as user training to the broader research community, should be provided. Support for the expansion of the Center P and F program to investigators at the institution where the Regional/National Resource Core is located may also be requested but is not sufficient to be considered a Regional/National program for purposes of expanding the allowable requested funds.

Recharge System: A recharge mechanism is acceptable to help defray costs to the Center. If such a cost recovery system is developed, a detailed charge justification must be presented. Participating Center members must also be informed to include such costs with their full budget justifications in their applications for individual grant support.

Program Income: Centers are encouraged, where appropriate, to develop a program income (re-charge/fee-for-service) system for use of core services. Such a program income system would constitute a method of charging core users for their usage of expertise and research resources. Program income must be re-invested into direct support of Center-related activities and/or expenses and may not generate a profit for the Center.

Management of the core and operational plan: The organization and proposed mode of operation of the core should be presented. Included should be a plan for prioritizing investigator use of the core as well as a definition of qualified users. If use by investigators outside the parent institution is proposed, the mechanism by which such investigators will apply and be evaluated and selected should be detailed. The definition of qualified users should not be too narrow. Some minor core use could serve to entice established investigators in other scientific disciplines into diabetes translational research.

Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the CDTR and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Renewal applications: Information relative to the core in renewal applications should generally cover all of the same points as initial applications. In addition, past performance and accomplishments should be described and highlighted. The effect of the service provided by a core on investigator productivity and cost effectiveness should also be addressed. In renewal applications, any major changes should be carefully documented.

Progress Report Publications List: Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented by listing the number(s) of the relevant publication(s) from Table E which was attached in the Center Overview component.

Letters of Support: For a Regional/National Core, include letters of support from partnering institutions.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (National/Regional Research Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (National/Regional Research Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Core to Support Underserved or Health Disparity Populations)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Core to Support Underserved or Health Disparity Populations)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (Core to Support Underserved or Health Disparity Populations)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Core to Support Underserved or Health Disparity Populations)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research and Related Senior/Key Person Profile (Core to Support Underserved or Health Disparity Populations)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Core to Support Underserved or Health Disparity Populations)

Budget forms appropriate for the specific component will be included in the application package.

The subcontracts for this core can be up to $75,000 in direct costs beyond the $250,000 cap in direct costs.

Personnel: A core Director must devote a minimum of 1person months to the Core to ensure adequate oversight. A co-director or other professional or technical staff may be included. Stipends for graduate students and postdoctoral fellows are not appropriate for Translational Research Core.

Equipment: If specialized equipment costing more than $5,000 per piece is requested, the application must provide a clear justification based on the core services being provided to CDTR investigators. Equipment may only be requested in the initial year of the project period.

Supplies: Consumable supplies directly related to the Core are an allowable expense.

Other Expenses: Funds for equipment maintenance/service contracts may be requested, but should reflect an equivalent percentage of the service contract based on the overall use by the Center Investigators.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Core to Support Underserved or Health Disparity Populations)

Specific Aims: Clearly state the aims of the Core to Support Underserved or Health Disparity Populations. The aims should describe how the core will enhance scientific progress and improve the uptake of research through support of rigorous translation research aimed at prevention and improved treatment of diabetes and related conditions. The aims should describe how the core will enhance the efficiency, productivity, effectiveness and multidisciplinary nature of diabetes translation research. These descriptions should specifically explain how this core extends the reach of the CDTR expertise and resources to support research specifically addressing underserved populations or populations with disparities in diabetes outcomes.

Research Strategy: The core may be based solely at the applicant institution or at multiple institutions through subcontracts. If subcontracts are to be utilized the applicant must clearly demonstrate how a cohesive and integrated operation will be ensured and describe the advantages of this approach to the performance of core functions. The Center may also provide resources for funded projects at collaborating institutions without a sub-contractual arrangement with the parent institution.

Definition: A Core to Support Underserved or Health Disparity Populations provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. The Core should be designed to furnish a group of investigators with expertise and research resources that enhance the research quality and contribute to cost effectiveness.

Justification for proposing a core: The establishment and continued support of Core to Support Underserved or Health Disparity Populations within a Center is justified on the basis of use by independently funded Center investigators. The minimum requirement for establishing a core is significant usage by two or more investigators with independently-funded, peer-reviewed projects. While investigators holding awards from the Center Pilot and Feasibility Program are appropriate users of the core facilities, their use does not contribute to justification for establishment or continued support of a core.

It should be clear how the Core to Support Underserved or Health Disparity Populations extends the reach of the CDTR expertise and resources to support research specifically addressing underserved populations or populations with disparities in diabetes outcomes.

Recharge System: A recharge mechanism is acceptable to help defray costs to the Center. If such a cost recovery system is developed, a detailed charge justification must be presented. Participating Center members must also be informed to include such costs with their full budget justifications in their applications for individual grant support.

Program Income: Centers are encouraged, where appropriate, to develop a program income (re-charge/fee-for-service) system for use of core services. Such a program income system would constitute a method of charging core users for their usage of expertise and research resources. Program income must be re-invested into direct support of Center-related activities and/or expenses and may not generate a profit for the Center.

Management of the core and operational plan: The organization and proposed mode of operation of the core should be presented. Included should be a plan for prioritizing investigator use of the core as well as a definition of qualified users. If use by investigators outside the parent institution is proposed, the mechanism by which such investigators will apply and be evaluated and selected should be detailed. The definition of qualified users should not be too narrow. Some minor core use could serve to entice established investigators in other scientific disciplines into diabetes translational research.

Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the CDTR and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Renewal applications: Information relative to the core in renewal applications should generally cover all of the same points as initial applications. In addition, past performance and accomplishments should be described and highlighted. The effect of the service provided by a core on investigator productivity and cost effectiveness should also be addressed. In renewal applications, any major changes should be carefully documented.

Progress Report Publications List: Core productivity and accomplishments as demonstrated by peer-reviewed research publications supported by the core should be documented by listing the number(s) of the relevant publication(s) from Table E which was attached in the Center Overview component.

Letters of Support: For a Core to Support Underserved or Health Disparity Populations, include letters of support from partnering institutions..

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Core to Support Underserved or Health Disparity Populations)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Core to Support Underserved or Health Disparity Populations)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type P and F

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Pilot and Feasibility Program)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot and Feasibility Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (Pilot and Feasibility Program)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments: Include the following "Other Attachments". The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments should be in .pdf format.

Pilot Project Outcomes (renewal applications only): Please title this attachment "Pilot Project Outcomes" and list all Pilot Projects supported in full, or in part, by the CDTR. Provide information on the most recent 5-year period. Include the years funded, awardee, dates and amount of P and F funding, pilot project title, P and F award type (i.e. new investigator; established investigator), abstracts derived from pilot support, resulting grants funded or pending applications (including grant number/funding agency and project period), and whether the P and F awardee is still involved in Diabetes translational research. Table D is provided at this link for applicant assistance with this requirement.

Pilot Project Summary/Abstract: Please title this attachment "Pilot Project Information" and provide a Project Summary/Abstract for each proposed pilot and feasibility project for the next year (renewal applications) or first year (new applications), as well as the biographical sketch of the investigator for each of the proposed pilot and feasibility projects.

Project /Performance Site Location(s) (Pilot and Feasibility Program)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research and Related Senior/Key Person Profile (Pilot and Feasibility Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of P and F Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot and Feasibility Program)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: This category should include salary support for the P and F Program Director who must devote a minimum of 0.6 person months to ensure adequate oversight.

Other Expenses: Include funds to support individual Pilot and Feasibility projects. Each center must support a minimum of 2 P and F projects which can be up to $50,000 direct funds per year each. The applicant should provide details on how F & A costs for P and F projects with partnering institutions will be handled.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot and Feasibility Program)

Specific Aims: Clearly state the aims of the Pilot and Feasibility Program.

Research Strategy: A Pilot and Feasibility study provides modest research support for a limited time (one to two years) to enable eligible investigators to explore the feasibility of a concept related to the mission of the Center and generate sufficient data to pursue the project through other funding mechanisms. The pilot and feasibility studies are intended to: (1) provide initial support for new investigators; (2) allow exploration of possible innovative new leads or new directions for established investigators; and (3) stimulate investigators from other areas to lend their expertise to research in this area. Pilot and feasibility study support is not intended for large projects by established investigators which would otherwise be submitted as separate research grant applications. Pilot and feasibility funds are also not intended to support or supplement ongoing funded research of an established investigator.

Requirements: Each Center must contain a pilot and feasibility program with a minimum of 2 projects.

Eligibility and related guidelines: Investigators eligible for pilot and feasibility funding generally fall into three categories: (1) new investigators without current or past NIH research support (R01, P01) as a PD/PI (current or past support from other sources should have been modest); (2) established investigators with no previous work in diabetes type II translational research who wish to apply their expertise to a problem in this area; and (3) established investigators who propose testing innovative ideas that represent clear departure from ongoing research interests. It is expected that the majority of the investigators will fall into the first category. All eligible investigators, however, must have faculty appointments and be independent investigators. Postdoctoral fellows or their equivalents are not eligible. Each pilot and feasibility study proposal should state clearly the justification for eligibility of the investigator under one of the above three criteria.

A proposed pilot and feasibility study should present a testable hypothesis and clearly delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. It must be on a topic related to the objectives and mission of the CDTR. Projects should be focused, since funding for these studies is modest and is limited to two years or less. Any one investigator is eligible only once for this support, unless the additional proposed pilot and feasibility study constitutes a real departure from his/her ongoing research.

Initial review and management of the pilot and feasibility program: By the very nature of this program, a significant responsibility for its management will be left to the P and F Program Director during the project periods. The application should clearly describe and justify the pool from which potential pilot and feasibility applications will be solicited. This can be limited to investigators at the parent institution or expanded to include investigators at institutions with well-defined affiliation with the Center. Such an affiliation can occur either through a subcontractual relationship for support of core resources or through inclusion of funded projects at a collaborating institution in the research base utilizing the shared resources of the Center. The mechanisms by which information on the availability of pilot and feasibility awards will be disseminated and by which applicants will apply and be selected for these awards must be described and will be an important element in the review of the pilot and feasibility component of the Center.

Since pilot and feasibility studies can be awarded for any period of time up to two years, studies end at various times. In addition, the studies may also be terminated by the Center administration before their approved time limit for various reasons: e.g., (1) the investigator may receive outside funding for the project; (2) the project was found not to be feasible; (3) the investigator may leave the Center institution; etc. When this occurs, the Center may make new awards for pilot and feasibility studies with the remaining funds.

While a Center's administrative framework for management of the pilot and feasibility program is basically left up to each Center (subject to NIH peer review), certain minimal requirements must be met. The program must have a director who is an established investigator in diabetes translation research. There must also be a committee representing all the aspects of the Center which will assist the P and F director in the management of the program. The major responsibilities of the director and the committee will be to:

• Maintain oversight and review of ongoing pilot and feasibility studies;
• Make recommendations regarding termination or other actions to the Center PI);
• Prepare and ensure appropriate distribution of announcements of the availability of pilot and feasibility funding;
• Arrange and preside over the scientific merit review of proposals. At least one reviewer from outside the parent institution must be used for each proposal. All reviewers should assign impact scores in accordance with the NIH system. Copies of all of the proposals with written documentation of their reviews, impact scores, and final action must be retained by the Center;
• Maintain, insofar as is possible, a record of subsequent career events of each pilot and feasibility study recipient. This record must also be made available to reviewers at the time of the renewal application;
• Make recommendations for final decisions. A record of actions by this committee must be documented.

All applicants should describe how these requirements will be met and have been met in the case of renewal applications. Also included should be an assessment of the relevancy of the proposed individual pilot and feasibility studies and of the program as a whole to research on diabetes type II translational research (bedside to practice) and to the specific goals and objectives of the individual Center and of the Center program generally.

After the initial review of pilot and feasibility proposals, all responsibility for review and funding during the remainder of the project period will reside within the P and F Program itself. This approach provides each Center with the needed flexibility for effective and efficient management of the program.

In general, a renewal application will include: (1) a historical overview; (2) a description of the management of the program; (3) a description of the method for solicitation for pilot and feasibility projects and the number of respondents received for each solicitation; and (4) a statement relating to benefits of the program to the Center as well as the contribution of the uniqueness of the Center environment to the program. These points are detailed in the following paragraphs.

The historical overview will cover the pilot and feasibility program since the inception of the Center. The pilot and feasibility program director may wish to highlight certain studies or certain aspects of the past studies. Collaborations which resulted in lasting relationships, acquisition of new skills by the study recipient, or other significant outcomes should be identified. The relationship of the scope of the various studies to that of the Center should be emphasized. Include the description of the management of the pilot and feasibility program, including its integration with and relationship to the rest of the administrative structure. The use of outside consultants for review should be included in the discussion. Important features of the solicitation process should be provided including the distribution and the number of respondents.

Letters of Support: Include any letters of support for the Pilot and Feasibility Program by the appropriate institutional official at partnering organizations if applicable. A letter from the PD/PI of any related NIH-funded T32 at the Center institution should be included that acknowledges and details how the PD/PI of the T32 intends to promote cohesive interactions between the two programs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot and Feasibility Program)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Pilot and Feasibility Program)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Enrichment Program.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Enrichment Program)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (Enrichment Program)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments (renewal applications only; optional): Information related to the Center-supported Enrichment Program activities, such as Center retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among Center members and other investigators, as well as other educational opportunities may be included in the application. This should be loaded as a single, combined file in .pdf format titled "Enrichment Program".

Project /Performance Site Location(s) (Enrichment Program)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research and Related Senior/Key Person Profile (Enrichment Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Enrichment Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Enrichment Program)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Personnel: This category should include salary support for key personnel, including the Enrichment Program Director and any other professional and administrative personnel. The Enrichment Program Director must devote a minimum of 0.6 calendar months to ensure adequate oversight of the Program. The salary amount charged to the CDTR grant must be commensurate with the time spent on Program activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support Enrichment Program activities such as workshops, research forums, symposia, Center retreats and seminar series. Funds for Enrichment Program- associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested.

Consultants: Include costs associated with consultants (e.g. consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Enrichment Program.

Travel: Travel funds to support visiting scientists under the auspices of the Enrichment Program may be requested as well as funds to support Center member travel for special programs.

PHS 398 Research Plan (Enrichment Program)

Specific Aims: Clearly state the aims of the Pilot and Feasibility Program.

Research Strategy: Describe plans for the enrichment program, including anticipated benefits to Center members and how the program will assist investigators, trainees, and junior faculty to accomplish the goals of the CDTR. Where applicable, coordination with enrichment programs supported by other institutional Centers should be detailed.

The Enrichment program will typically support seminars, workshops, research and career development forums, etc., but any appropriate, innovative means to support the goals of the CDTR may be proposed. Creative new programs, not precluded by NIH or NIDDK policies, are encouraged.

While CDTRs cannot support stipends for postdoctoral fellows, the environment fostered by the existence of the Center with its core facilities in conjunction with the Enrichment Program educational opportunities should serve to foster the careers of postdoctoral fellows and junior faculty, including K-awardees.

For renewal applications: Describe the existing Enrichment Program, including its value to the CDTR members and how the program has been adapted to the needs of the members. Describe future plans for the Enrichment Program.

Letters of Support: Supporting letters may be provided, as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Enrichment Program)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Enrichment Program)

Not Applicable

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at calvof@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Reviewers will be asked to evaluate the following individual sections

• Research base, including the focus, quality of research, collaborations among members, relevance to the Center's stated research focus, and, for renewal applications, the maintenance, growth, re-focusing, or evolution of the research base.
• Each Translational Research Core, as well as the optional Cores, if requested (Regional/National Resource Core and Core to Support Underserved or Health Disparity Populations), including the documented need for the proposed services; number of users; qualifications of personnel; management, including prioritization and responsiveness to the needs of the users; quality control management; and any appropriate developmental work.
• Administrative Core, including committee structure, Center membership criteria, and lines of communication.
• Pilot and Feasibility Program, including the organization of the overall process of solicitation, review, and monitoring of P and F Projects, and, for renewal applications the quality, appropriateness and outcomes of supported P and F Projects.
• Enrichment Program, including the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.
• Center Director (PD/PI), including leadership and commitment to the stated goals of the CDTR.

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

Reviewers will consider each of the review criteria below in the determination of scientific 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 CDTR that by its nature is not innovative may be essential to advance a field.

Does the CDTR address an important problem or a critical barrier to progress in the field? If the aims of the CDTR 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? Will the proposed CDTR resources and expertise enhance and advance diabetes type II translational research? What is the likelihood that the CDTR will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CDTR? 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? Are the Center investigators willing to interact with each other and contribute to the overall objectives of the CDTR? What are the scientific and administrative leadership abilities of the proposed center leadership? Do they demonstrate commitment and ability to devote adequate time to the effective management of the program?

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? Does the selection process by which the individual studies were selected for P and F support appear appropriate? Does the Center appear to encourage studies consistent with the mission of the CDTR through their P and F Program?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CDTR? 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 CDTR involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? How appropriate and relevant are the proposed Cores and their modes of operation (such as prioritization of requests for services)? Will at least two funded investigators who are Center members use each Core? Will the Cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new research? Are the criteria for membership in the CDTR clear and appropriate? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the CDTR, including mechanisms for internal monitoring;(b) establishment and maintenance of internal communication and cooperation among the Center investigators;(c) mechanism for selecting and replacing staff within the Cores;(d) mechanism for reviewing the use of, and administering funds for, the P and F Program;(e) management capabilities, including fiscal administration, procurement, personnel management, planning, budgeting, and other appropriate capabilities? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the CDTR?

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?

As applicable for the CDTR proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed CDTR involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period; including:

Does the Center show evidence of a stable or growing research base with a strong and consistent record of scientific excellence and achievement?

Does the Center show evidence of continued success in securing peer-reviewed research funding related to the focus of the Center?

Does the Center show evidence of fostering multi-disciplinary collaborations among Center members?

If included in the previous award, did the Regional/National Shared Resource Core and Subcontracts to Support Underserved or Health Disparity Populations extend the reach, quality and productivity of research?

Has oversight of Center activities including the Enrichment Program been effective?

Does the Center website provide appropriate information on Center activities and Core services?

Are the number and impact of research publications that acknowledge the Center sufficient to justify continuation of each Core?

Does the Center demonstrate the ability to evolve Cores to meet changing needs of the research community?

Are the number and types of P and F awards well justified?

Does the data provided document the publications of all P and F projects completed in the last 5 years?

Did the pilot and feasibility projects lead to independent grant funding and/or new Center members?

Not Applicable

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

Not Applicable

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).

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; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Disease Advisory Council. The following will be considered in making funding decisions:

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

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Christine Hunter, Ph.D
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email: hunterchristine@niddk.nih.gov

Michele Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: barnardm@extra.niddk.nih.gov

Natasha Loveless, M.B.A.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8853
Email: natasha.loveless@nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Part 75.