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 using ASSIST or an institutional system-to-system solution; paper applications will not be accepted.

It is critical that applicants follow the Multi-Project (M) 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). 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

Program Objectives

This Funding Opportunity Announcement (FOA) encourages applications for Diabetes Research Center grants to support research in diabetes mellitus and its complications, and in related areas of endocrinology and metabolism.

The prevalence of diabetes mellitus in the United States accounts for a huge national burden of morbidity, mortality, and health care expenditures. The mission of the Diabetes Research Centers is to serve as a key component of the NIDDK-supported research effort to develop new therapies and improve the health of Americans with, or at risk for, diabetes and related endocrine and metabolic disorders. The Centers promote new discoveries and enhance scientific progress through support of cutting-edge basic and clinical research related to the etiology and complications of diabetes, with the goal of rapidly translating research findings into novel strategies for the prevention, treatment and cure of diabetes and related conditions.

To accomplish this mission, the Diabetes Research Centers:

• Create an environment that supports important and innovative research;
• Attract and retain early stage investigators and investigators new to diabetes research;
• Provide core services that leverage funding and unique expertise;
• Foster interdisciplinary collaborations, especially in emerging areas of research, to catalyze new ideas and scientific approaches;
• Raise awareness and interest in fundamental and clinical diabetes research at their institutions, as well as locally, regionally, and nationally;
• Promote the translation of scientific discoveries from bench to bedside to community in order to improve public health;
• Enhance diabetes research education and training opportunities for patients, students, scientists, and clinicians.

One of the primary objectives of the Centers is to bring together investigators from a variety of scientific disciplines in a manner that will enhance and extend the effectiveness of their research. In addition to collaborations between scientists within an institution, Centers may also foster interactions and collaborations between investigators at multiple institutions to promote a multifaceted approach to a common goal. A Diabetes Research Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, Diabetes Research Center applications must be associated with an existing program of excellence in biomedical and/or behavioral research in diabetes as well as related areas of metabolism and endocrinology. Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in diabetes and related research areas. This research should be in the form of NIH-funded research projects (R01), program projects (P01), or other peer-reviewed research, such as that supported by the American Diabetes Association and the Juvenile Diabetes Research Foundation. Research programs outside the primary institution where the Center is based may utilize the core resources and participate in Center activities; Centers are encouraged to explore such opportunities.

The research base for the Center, including any affiliated hospitals and proposed partners, must consist of at least $3,000,000 in direct costs of peer-reviewed research projects. The research base for a Center is made up of investigators with individually-funded research projects who can benefit from shared resources. Center funding will provide support for core facilities (shared resources), pilot and feasibility studies (new initiatives), and program enrichment activities. Except for pilot and feasibility studies, Center funds are not intended to support individual biomedical or behavioral research projects other than through core usage. The major source of support for biomedical research projects associated with the Center should be derived from separately-funded projects of the participating investigators who comprise the research base. Similarly, professional trainee stipends are not to be supported through Center funding.

At the time of initial submission, the applicant institution, or consortium of institutions, must have an active program of excellence in basic and clinical biomedical and behavioral research in the area of diabetes and related areas of endocrinology and metabolism. The biomedical research base will be given emphasis in the peer review process. There should be a focus on diabetes; however, related endocrinology and metabolism research relevant to diabetes may also be included in the research base. Overlap in the research base among NIDDK-funded Centers should not inappropriately inflate the research base of any Center. Focus, relevance, interrelationships, quality, and to some extent quantity, are all considerations in judging the adequacy of the research base.

The organization and structure of the Diabetes Research Center should reflect the goals of the Center, encourage collaboration, develop and implement Diabetes Research Center-wide initiatives, and promote the use of shared resources and Pilot and Feasibility Program funds. The structure can change as needed based on new scientific opportunities and partnerships. This major underpinning of the Diabetes Research Center allows for modifications of programmatic and scientific activities and areas of support to fully capitalize on the most exciting research opportunities in diabetes-related research areas.

Administrative Core (with Enrichment Program)

Diabetes Research Center applications must include an Administrative Core that will be responsible for allocation and oversight of Center resources. The Administrative Core is expected to ensure the coordination and integration of Diabetes Research Center components and activities. The Administrative Core should have a process to a) assess the productivity, effectiveness, and appropriateness of Center activities; b) determine criteria and selection process for Center membership; and c) foster collaborations and scientific opportunities among its members. In addition, all Diabetes Research Centers will be required to maintain an institutional 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 Diabetes Research Center program website (http://www.diabetescenters.org/).

The Administrative Core must provide support for enrichment activities to foster multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research. While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might operate on a regional or national level and involve multiple Diabetes Research Centers.

Support for an Enrichment Program under the auspices of the Administrative Core may be requested. Support for visiting scientists, seminars, and research fora are appropriate items for inclusion in an enrichment program as well as any appropriate, innovative means to support the goals of the Center, e.g. workshops, etc. Also, limited travel support may be requested to allow Diabetes Research Center investigators to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange. In all cases, the enrichment program should further the overall aims and objectives of the Diabetes Research Center as well as its cores. Creative new programs, not precluded by NIH or NIDDK policies, are encouraged. While Diabetes Research Centers may not support stipends for graduate students or postdoctoral fellows, the environment fostered by the existence of the Center with its core facilities in conjunction with its enrichment program and educational opportunities should serve to foster the careers of students, postdoctoral fellows and junior faculty, including K-awardees.

Biomedical Resource Cores

Diabetes Research Centers are designed around Research Cores that provide shared, specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by Center-affiliated investigators. The goal of the Diabetes Research Center program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas. Moreover, cores are intended to facilitate basic, clinical and translational research in diabetes, endocrinology and metabolic diseases in order to accomplish the stated goals of the individual Center and of the NIDDK Centers program.

Each Research Core should provide state-of-the art services to multiple, funded research projects. A Center may support research at a single or set of cooperating institutions through an Institutional Core. In addition, Diabetes Research Center applicants may propose to share core services or functions with other Centers in the Diabetes Center program in order to expand, enhance, or increase the cost-effectiveness of research activities at the Center institution. Examples of biomedical research cores that would be considered responsive to this FOA include, but are not limited to:

• Analytical biochemistry
• Biostatistics
• Clinical research
• Computational biology or bioinformatics applications to diabetes
• CRIPSR/Cas9 technology support
• Functional/biological imaging
• Genetics/genomics (including epigenetics/epigenomics)
• Induced pluripotent stem cells
• Integrative physiology (human and/or animal)
• Islet isolation and function
• Metabolomics
• Protein chemistry and macromolecular structure
• Proteomics
• Translational research (bench to bedside; bedside to community/practice)

These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities. In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institution(s). Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Diabetes Center topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure.

Justification for proposing a core: The establishment and continued support of biomedical research cores 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. Additionally, the minimum of two independently-funded users does not in itself provide sufficient justification.

Proposed Diabetes Research Center cores may be an institutional shared research core. In such cases applicants must provide a rationale for using such institutional cores, such as:

• Support for the existing resource through the Center will provide added value and access to the resource beyond that which would be provided by paying for the use of the resource through a fee-for-service process;
• The institutional/departmental core represents a unique resource which would not otherwise be available (e.g. is too costly, too labor-intensive, or too specialized to be available to individuals)
• The institutional/departmental core provides a service done more effectively (i.e. more inexpensively or by specially trained personnel or requiring specialized facilities) than would be feasible in individual cores, e.g. histology, animal facilities, and thus using the institutional/shared core avoids duplication and lowers cost for Center members;
• The service/instrumentation/expertise in the centralized core can only exist with the participation of multiple centers and their user fees and Center members who need the service; instrumentation, and/or expertise in proportion to the buy-in from the center to which they belong.

For all proposed cores, the need for core support from the Diabetes Research Center must be well-justified with a broad user base of NIH-funded investigators pursuing research activities in Center topic areas. The relevance and utilization of the core services by the research base will be emphasized during the review process. The Center program and cores are encouraged to become synergistic with but not duplicative of other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes clinical research homes being established by the Clinical and Translational Science Awards (CTSAs) supported by the NIH (https://www.ctsacentral.org/), other related NIH Common Fund activities (http://commonfund.nih.gov/), and any related NIDDK-funded Center programs such as the Centers for Diabetes Translation Research (http://www.diabetes-translation.org), Nutrition Obesity Research Centers (http://www.norccentral.org), and the Digestive Diseases Research Centers (http://www.digestivediseasescenters.org). When proposed core services are already available through the research institution (e.g. via an institutional core), there must be compelling justification for their support through the Diabetes Research Center. In addition, cores must have well-defined policies to ensure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

Pilot and Feasibility Program

The Diabetes Research Center Pilot and Feasibility (P and F) program provides seed support (typically $50,000 or less in direct costs per year per project for 1-2 years) for new and innovative research projects directed at basic biomedical, clinical, behavioral, and translational research questions relevant to diabetes and its complications. Typically, at least 20-25% of the overall Center direct costs, exclusive of equipment and consortium Facilities and Administrative (F&A) costs, should be devoted for support of P and F projects.

The P and F program is particularly directed at new investigators and established investigators new to diabetes research. Established diabetes investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the Diabetes Research Center P and F program. P and F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships between basic scientists and clinical researchers. While the distribution of P and F funds to be used in each award category is ultimately at the discretion of the Center P and F committee, it is expected that the Center P and F program will, where possible, place particular emphasis on funding innovative clinical and translational research projects. Pilot and feasibility study support is not intended for large projects by established investigators that would otherwise be submitted as separate research grant applications. Pilot and feasibility funds are also not intended to support or supplement ongoing funded research on an investigator.

The solicitation and review of P and F applications, as well as the review of progress and management of the P and F program reside within each Center. This approach provides each Center with the needed flexibility for effective and efficient management of their P and F program.

Additional Opportunities for Resource Cores and Programs

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

1) To broaden the scope and reach of the Diabetes Research Center P and F program, a Center may propose to serve a wider scientific community by expanding the Diabetes Center P and F program to a different institution(s). Expansion of the P and F program to an affiliated institution/hospital is encouraged but is not sufficient to be considered a Regional/National program for purposes of expanding the allowable requested funds. In general, NIDDK currently expects Diabetes Research Centers to allow investigators at affiliated hospitals or institutions to participate in the Center P and F program. Applicants may request funds to expand their P and F program to researchers at non-Diabetes Research Center institutions.

2) To broaden the scope and reach of current research core services, a Center may propose to serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at a different institution. Such a Regional/National Core may not be established with an affiliated hospital of the applicant organization; such an arrangement would be considered an institutional, rather than a regional/national, core for the purposes of this FOA. If the Center is primarily located at an affiliated hospital, core(s) based at another affiliated hospital of the same academic institution will not be considered Regional/National Shared Resource Cores. With a regional or national core located at a different institution, the Center will service a specific research base that is expanded beyond investigators at the academic institution and/or affiliated hospitals where the Center is primarily located. Support for the expansion of the Center P and F program to investigators at the institution where the Regional/National Shared Resource Core is located may also be requested (see optional opportunity above).

3) A Diabetes Research Center may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at the applicant institution or an affiliated hospital. Such a Regional/National Shared Resource Core should provide a plan for expanding core services to investigators outside of the parent academic institution and its affiliated hospitals. Support for the expansion of the Center P and F program to the partnering institution(s) may also be requested (see optional opportunity above).

Subcontracts to Support Underserved or Health Disparity Populations

Diabetes Research Centers may propose partnerships that establish research cores and/or P and F programs at institutions of higher education (i.e., rural institutions, historically black colleges and universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs) and Hispanic-serving Institutions (HSIs) and Alaska Native and Native Hawaiian Serving Institutions), or other agencies that focus on underserved or health disparity populations. The primary goal of such partnerships is to foster scientific collaborations and to provide access to the Diabetes Research Center infrastructure to investigators at these institutions or organizations in order to foster health disparities research in populations disproportionately affected by diabetes. All funds exceeding the budget cap proposed for this purpose must be awarded to the institution that serves underserved or health disparity populations. Funding for activities supporting the collaboration at the Diabetes Research Center institution must be included within the Diabetes Research Center cap.

Additional Features

Cooperation, Coordination, and Integration: Applicants from institutions with an NIH Clinical and Translational Science Award (CTSA) program (https://www.ctsacentral.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the Diabetes Research Center. Diabetes Research Center directors should also be willing to collaborate with other NIDDK-funded Diabetes Research Centers.

Center Evolution: When proposed core services are already available through the research institution (e.g. via an institutional core), there must be compelling justification for their support through the Diabetes Center. In addition, cores must have well-defined policies to ensure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

Applicants are encouraged to consult with NIDDK staff concerning plans for the development of the Diabetes Research Center and the organization of the application.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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.

Because a Diabetes Research Center has a large and complex administrative structure, the PD/PI must have strong leadership abilities and demonstrated proficiency in managing large, multi-component programs. The Diabetes Research Center PD(s)/PI(s) must also be willing to participate in annual meetings of the Center Directors.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

Research Base: Successful Diabetes Research Center applications require an existing program of excellence in biomedical research in diabetes, its complications, and in related research in endocrine and metabolic diseases. To justify Center support, the Diabetes Research Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support. The research base for the Center, including any affiliated hospitals or proposed partners, must consist of at least $3,000,000 per year in direct costs of peer-reviewed research projects.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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 should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall (Use for Center Overview)	12
Admin Core (Use for Administrative Core)	12
Core (Use for each Biomedical Research Core)	12
P and F Program (Use for Pilot and Feasibility Program)	12

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:

• Overall (Center Overview): Required
• Administrative Core (with Enrichment Program): Required
• Biomedical Research Cores: Required, minimum of two
• Pilot and Feasibility 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 cell line table in Overall component.

Follow standard instructions.

Project Summary/Abstract: Describe the scientific theme(s) of the Diabetes Research Center and the need for a Center to support the investigators in the research base. Include the number of Center members and the overall direct costs present 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 biomedical research cores, and the pilot & 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; Pilot and Feasibility, 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 or change existing access, space, and usage; include space maps as needed. Scientific personnel and institutional resources capable of supporting the research base must be available.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided. Note: Specific research core facilities, equipment, and special resources should be listed in each proposed biomedical research core component.

Other Attachments: The following attachments should be included with the Center Overview in order 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 Diabetes Research 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 (summed), and Identify Other NIDDK Centers (if the grant listed is also included in its research base). The attachment should include, in order: Current Grant Support (Table A.1), Other Grant Support (Table A.2) and Pending Grant Support (Table A.3). Examples of Tables A.1, A.2 and A.3 are provided at the Diabetes Research Center Resource page for applicant assistance with this requirement. The 'Current Grant Support' table should include research project grants relevant to diabetes and related endocrinology and metabolic diseases research, which are considered to be potential or likely users of the core services. 'Other Grant Support' should include infrastructure/services grants (other Centers or CTSA awards), training (such as T- or F-awards) grants, and other such grants that support diabetes-related research, but would not be direct users of the core services.

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, including any affiliated hospitals and proposed partners. Do not include biographical sketches for Senior/Key Personnel that have already been provided under the Senior/Key Personnel profile for the Center Overview.

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; try to limit each to less than one page. 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 research in diabetes, its complications, or related endocrine and metabolic diseases 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). List all Diabetes Research Center 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. An example of Table B is provided at the Diabetes Research Center Resource page for applicant assistance with this requirement.

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 Diabetes Center). An example of Table C is provided at the Diabetes Research Center Resource page for applicant assistance with this requirement.

Optional: Please title this attachment "Relation to Overall Center". Provide Charts and Tables, such as an organizational chart(s) to illustrate the structure, interactions, and leaders of the institution and Diabetes Research 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.

Introduction to Application: For Resubmission, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the broad, long-term goals of the Diabetes Research Center and the need for a Center to support the investigators in the research base. Include the number of Center members and the overall direct costs present 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 a brief overview of the biomedical research cores, and the pilot & feasibility and enrichment programs. Include a brief description of anticipated impact on human disease and public health.

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 research on diabetes and related areas of endocrinology and metabolism. Therefore, applicants should demonstrate the existence of a strong, substantial research base in diabetes, its complications, and in related research in endocrine and metabolic diseases, and how that research base will benefit from the establishment of a new, or continuation of an existing, Diabetes Research Center.

Applicants should include an overview of current research in diabetes, its complications, and related areas being conducted at their institution in sufficient detail to allow reviewers to judge its extent and the interrelationship of ongoing research. The relevance to diabetes of all research included in the research base should be described. Applicants should indicate how the establishment or continuation 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.

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

A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful Diabetes Research Center. 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 Diabetes Research Center 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 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.

Provide a full narrative description of the diabetes and 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; and (d) willingness of Center investigators to contribute to the overall objectives of the Diabetes Research Center.

Strategic Vision:

Theme Provide the central theme(s) of the Diabetes Research Center and the likely supported research, resources, and relevance to diabetes. The theme(s) may be broad or focused, depending upon the goals of the Center. For clearer presentation, it is recommended that Center applicants subdivide the research base into areas of research emphasis or central research themes that link Center members and their research programs.

Goals and directions Describe the current and future directions for the Diabetes Research Center in the forthcoming project period. Indicate how the research supported by the Center will impact the understanding of diabetes, its complications and, ultimately, public health. Describe the short, mid- and long-term goals and measures of success. Describe the likely advances expected in the field of diabetes and how these advances can be applied to human disease and public health. Describe any basic science work that has successfully been translated to the bedside or community or plans to enhance that translation in the next project period. Describe the expected, widely-applicable research tools and scientific advances that will emerge from the Center’s emphasis. Document how the Center will organize and lead the team toward these advances. Identify levels of risk for these goals, potential roadblocks to achieving them, and how the Center might respond to these challenges. Renewal applications must also describe the accomplishments of the Center in the preceding project period and how it intends to build upon its successes. These accomplishments should be presented, as appropriate, in the areas of basic science, clinical research, public health, and prevention. The impact of Center-based science should be discussed in detail.

Biomedical Research Cores are to be discussed within the Strategic Vision. Summarize the services and resources provided by the Diabetes Research Center; describe how the biomedical research cores will address the scientific needs of the research base. Brief examples of ongoing or planned research should be discussed as appropriate with reference to the supporting Core.

Integration of investigators of multiple skills and talents Outline steps the Diabetes Research Center will take to promote interdisciplinary studies and collaborations, especially among basic scientists and clinical researchers. Describe the types of initiatives that will stimulate the teams and attract high-caliber professionals. Applicants should describe any academic and research partnerships that have been or will be pursued in order to advance the goals and mission of the Center.

Building research capacity Provide details on the special talents and resources that will be drawn to and built upon at the Diabetes Research Center. Indicate how these talents will be harnessed and used to promote new collaborations and produce multidimensional teams to address more complex questions. Include a plan for bringing investigators into the Center from within and outside the area of diabetes research. Describe the expertise that these individuals will share with the Center. Describe academic and research partnerships that will be pursued by the Diabetes Research Center to advance its goals and missions.

Provide a plan to determine the need for services and instrumentation of the Center. Address the steps that will ensure that the Diabetes Research Center proceeds at the cutting edge of technology and concepts. It is expected that biomedical research cores needs may change with time. Include information on the process of re-evaluation of needs and implementation of changes.

Within this section, describe the research capacity and clearly identifiable major scientific focus in diabetes research. The Diabetes Research Center grant mechanism fosters interdisciplinary cooperation among established investigators conducting high-quality research related to diabetes. Therefore, existence of a strong research capability in diabetes is fundamental to establishment of a new, or continuation of an existing, Diabetes Research Center.

Innovation: Address how the Diabetes Research Center will not only evolve with the science conducted by the Center Investigators, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions. Explain how the synergy of the Center with the research base will lead to novel services and resources in the cores and their application to important questions in diabetes research. Describe the potential for interdisciplinary collaborations among Center Investigators. For a Biomedical Research Core that by its nature is not innovative, describe how it is essential to advance the field.

Summarize the services and resources provided by the Center, and how they are managed and coordinated. Describe how the Center will address the scientific needs of the research base. 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. Also describe how the Center will enhance the research base through enrichment activities.

Leveraging of existing resources is strongly encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available. Furthermore, applicants should demonstrate that support for the existing resource through the Diabetes Research Center provides added value to the resource beyond that which would be provided by paying for use of the resource through a fee for service. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate. In such cases, appropriate letters of support from the CTSA program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the Diabetes Research Center and CTSA activities (See Letters of Support).

In addition, applicants should address the potential for integration, harmonization, and enhancement of Diabetes Research Center 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. Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in Center activities will be avoided unless expressly required to fulfill the mission of the Diabetes Research Center.

For renewal applications: Briefly, describe the progress in the research base during the previous project period including development of multidisciplinary, collaborative, and cooperative interrelationships, and any alterations in the original Center design in order to meet the evolving needs of the research base. These accomplishments should be presented, as appropriate, in the areas of basic science, clinical research, public health, prevention, and translation. Since one of the objectives of the Center is to extend research relevant to diabetes, new areas of research and acquisition of new funding should be highlighted in the overview

Progress Report Publication List (renewal applications only): In this attachment, list the titles and complete references to all appropriate publications and manuscripts accepted for publication, that have resulted from the project since it was last reviewed competitively. Identify the core(s) utilized in association with the publication. Applicants are able to use Table F, which is provided for applicant assistance with documenting the contribution of individual cores to peer-reviewed publications by the research base (see example at the Diabetes Research Center Resource page). Only list publications once. Within individual biomedical research core descriptions, refer to publications associated within the core by number as listed in the table of publications. Use an asterisk to indicate any publication that fails to cite Center grant support.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the Diabetes Research Center and its goals. The parent institution is expected to recognize the Diabetes Research Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the Diabetes Research Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members priority access to Institution’s and Center s facilities and services at minimal or reduced cost. Both the institution and pertinent departments must show a strong commitment to supporting the Center.

If collaborative linkages are being developed between the Diabetes Research Center and the local CTSA staff and/or research personnel, a letter of agreement from the CTSA PD(s)/PI(s) should be included. For any collaborative linkages between the CTSA and a specific Biomedical Research Core, the letter of support should be included within the specific Biomedical Research Core component of the application.

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 FOA.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, 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.

Other Attachments (renewal applications only; optional): Additional information related to the Center-supported Enrichment Program activities, such as agendas/announcements for Diabetes Research 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 file in .pdf format titled "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.

• 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. The Center Director 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 and related research.
• 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.
• In this component, also provide biographical sketches for any consultants. For renewal applications only, provide biographical sketches for the members of the External Advisory Committee. In the additional Senior/Key Profiles section, list those Senior/Key persons in the Project Role of "Other" with Category of "Consultant" or "Advisory Committee." New applications should NOT contact potential External Advisory Committee (EAC) members nor provide names or biographical sketches for EAC members; overall qualifications and areas of scientific expertise for the EAC members may be included.

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)/PI(s) must be 2.4 person months. Most Centers find that the size and complexity of a Diabetes Research Center warrant inclusion of a program administrator, so salary support for this individual should be included in the Administrative Core. The Enrichment Program Director must devote a minimum of 0.6 person months to ensure adequate oversight of the Program. The salary amount charged to the Diabetes Research Center grant must be commensurate with the time spent on Program activities and is subject to institutional and NIH salary policies. Again, where possible and applicable, Diabetes Research Centers are encouraged to leverage administrative resources in other NIH funded centers (e.g. Centers for Diabetes Translation Research, 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 Diabetes Research Center 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. Equipment may only be requested in the initial budget period.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the Diabetes Research Center. Include travel costs for the Center Director, Associate Director, and others as appropriate (i.e. Core Directors) to attend the Diabetes Research Center Directors' meetings held every 12-18 months.

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

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

Alterations and Renovations: Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested. Cosmetic renovations are not appropriate.

Other Expenses: Funds for development/maintenance of the Center's institutional Diabetes Research Center website may be requested. Include funds to support Enrichment Program activities such as workshops, research fora, 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.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the Center and outline interactions of the Administrative Core with each of the other Cores and Programs (P and F and Enrichment). Provide an overview of how the Administrative Core will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy: The Diabetes Research Center must be an identifiable organizational unit within a university medical center or a consortium of cooperating institutions including the university-affiliated Center. Such a Center will involve the interaction of broad and diverse elements; thus, lines of authority and approval by the appropriate institutional officials must be clearly specified. The Administrative Core plays a key role in the coordination and functioning of the Center.

Within the Research Strategy, the applicant should describe how the Administrative Core will take a leadership role in ensuring the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the Center. In addition, direct lines of communication between the Administrative Core, Biomedical Research Cores, the P and F Program, and the Enrichment Program should be delineated, as all of these cores/programs serve critical roles for Center integration. 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.

It is expected that the organization of the Administrative Core should encompass a supportive structure sufficient to ensure accomplishment of the following: coordinating and integrating the Center components and activities; reviewing the utilization and quality of core resources; interacting with the scientific and lay communities and the NIDDK in order to develop relevant goals for the Center; and interacting with the administrative and scientific leadership at the applicant institution(s) to enhance the visibility and effectiveness of the Center as a focus for diabetes research. The application should include a statement of willingness of the PD/PI, Associate Center Director, or other key personnel to attend this annual meeting of Diabetes Research Center Directors.

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 Diabetes Research Center components and activities.
• Assessment of productivity, effectiveness, and appropriateness of Diabetes Research Center activities and determination of Diabetes Research Center membership, assessment of scientific opportunities, and areas for collaboration among Diabetes Research Center members.
• Organization of Diabetes Research Center activities, such as retreats, invitation of consultants, meetings, and focus groups.
• Organization of the Internal and External Advisory Committees.
• Recordkeeping of meeting minutes and measures of success including: use of Diabetes Research Center facilities, publications, pilot and feasibility awards, and new grant applications resulting from preliminary data enabled by the Diabetes Research Center.
• Interactions with other Diabetes 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 and for ensuring proper and seamless integration of the Center website with the NIDDK Diabetes Research Center program website.

Center Evolution: Applicants must document policies and procedures for ensuring continuing evolution of Center activities, such as core services, in response to changing needs. Centers should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies.

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 and the process by which they will be selected should be described. Renewal applications should provide information on membership of the IAC/EAC and must document the functions and effectiveness of the External and Internal Advisory 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. Within this structure, each applicant institution must also establish a mechanism to oversee the use of funds for the proposed pilot and feasibility program. This mechanism must include the use of appropriate consultants for review from the scientific community outside the Center institution. These same consultants may be utilized, if desired, for review of other activities of the Center.

Enrichment Program: The Diabetes Research Center enrichment program should be designed to advance translational research in diabetes, endocrinology and metabolism and promote scientific exchange among investigators with research interests in these topic areas, and to 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. Applicants should describe any educational opportunities afforded by the Diabetes Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional educational environment. Specifically, Center applicants should provide information on diabetes-related NIDDK or other NIH Institute T32 or K12 programs at the Center institution(s), and describe how the Diabetes Center will help to integrate, facilitate and enhance activities of T32-supported trainees of K12/KL2-supported scholars. Applicants should indicate if they plan to participate in the medical student summer research program that is currently organized through the Diabetes Research Centers program (http://medicalstudentdiabetesresearch.org/ ). For those Centers that have participated in this program in the past, a brief report should be provided in the application.

Training postdoctoral fellows to conduct research in diabetes is an associated activity of a Center. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for educational and enrichment opportunities. Just as in the case of funding for individual research projects, funding for fellowships should be sought from NIH NRSA institutional training grants (e.g. T32, T35) and individual fellowships (e.g. F30, F32), and other sources such as private foundations, and commercial companies.

Letters of Support: A letter(s) from the PD/PI of any related NIDDK-funded T32 and/or T35 institutional training grant(s) at the Center institution should be included that acknowledges and details how the PD/PI of the T32 or T35 training grant intends to promote cohesive interactions between the two programs. Such letters should also briefly describe how any short-term (e.g. summer) medical student research programs, supported by NIDDK-funded T32 or T35 training grants, coordinate with Center activities related to the proposed Enrichment Program. Include any other letters of support for the proposed Core, as appropriate.

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 FOA.

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

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

Applicants should provide institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects.

When preparing your application, use Component Type Core.

A biomedical research core is a shared facility that provides a needed service to Center investigators enabling them to conduct their funded individual research projects more efficiently and/or more effectively. A Core should be designed to furnish a group of investigators with materials, techniques, determinations, instrumentations, and/or quality control to enhance research and contribute to cost effectiveness. A Core may be proposed to support any research activity of the Center, but usually fall into one of five categories: (1) provision of a technology that lends itself to automation or preparation in large batches; (2) complex instrumentation; (3) animal preparation, care and characterization; (4) clinical resources; and (5) service and training. Limited developmental research is also an appropriate function of a core facility. Such activities, however, must be directly related to enhancing the function or utility of the Core.

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical 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.

Facilities and Other Resources: The description of the physical arrangements and instrumentation for the cores should be given special attention. Arrangements for sufficient space for core activities or for access to appropriate established facilities must be made. Centers are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other Centers in close proximity, when the existing cores offer the services needed. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. When proposing the use of a shared facility, details about access, fee-schedules, and prioritization of Center members' use of the shared facility must be described. It may be advantageous for a Diabetes Research Center to provide support for appropriate personnel to work specifically for Center members in an existing facility/core (e.g., transgenic animal core) at the institution. In that case, the designated Diabetes Research Center Core Director must work closely with the parent facility Core Director to coordinate services, unless the same individual assumes both roles.

Other Attachments: The following attachment should be included in order to aid in the review of applications. The filename provided for the attachment will be the name used for the bookmark in the application image. The attachment should be in .pdf format.

Core Facility Use: Please title this attachment "Core Facility Use" and indicate the Core User, Funded Project that supports the Core use, Period of Core Use, services used, and estimated use and comments. An example of Table D is provided at the Diabetes Research Center Resource page for applicant assistance with this requirement.

Project /Performance Site Location(s) (Biomedical 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 & Related Senior/Key Person Profile (Biomedical 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. Core Directors may be acknowledged experts with independently-funded research programs that will use the core services.
• 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.
• Where appropriate, an established expert in the core activities may also be included as a consultant to the core.

Budget (Biomedical Research Core)

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

Personnel: This category should include salary support for key personnel, including the core director, co-director, and other professional and technical personnel. The Core Director must devote a minimum of 1 person month to the Core to ensure adequate oversight. The salary amount charged to the Diabetes Research Center grant must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. A Core Director with requisite expertise may devote a greater effort to the core, and with exceptionally strong justification could devote up to 12 person months. Salary support for technicians and other core personnel are allowable in accordance with the volume and type of work in the core. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through the Center. Such funding must be sought through other grant mechanisms.

Equipment: If specialized equipment costing more than $5,000 per piece is 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 Diabetes Research Center 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. Equipment may only be requested in the initial year of the proposed project period.

Travel: Funds for Center investigators/faculty to attend national or international scientific meetings or workshops may not be requested. If well-justified and related directly to Core activities/functions, limited travel funds for Core professional staff may be requested to support travel to national scientific meetings/workshops.

Supplies: Consumable supplies directly related to the operational aspects of the Diabetes Research Center core facilities are an allowable expense. This includes office materials as well as laboratory supplies. The supply budgets of separately funded individual research projects must be appropriately reduced to reflect such support, thus eliminating duplication.

Research Patient Care Costs: Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those supported by Clinical and Translational Science Awards (CTSAs) and individually supported beds. If the CTSA is to be used, include a letter of agreement from the PD/PI of the CTSA; such a letter (in .pdf format) may be attached as a 'Letter of support' for the appropriate Biomedical Research Core(s).

Request costs relating to the clinical research efforts of Diabetes Research Center investigators ONLY if there is no overlap with other funding. Costs already budgeted in individual projects should be appropriately reduced if such costs are to be transferred to the Center. The Diabetes Research Center is not intended to be a facility for health care delivery. Thus, only those patient costs directly related to research activities may be charged to the Center.

Other Expenses: Funds for equipment maintenance/service contracts may be requested but should reflect only an equivalent percentage of the service contract based on the overall use of the specified equipment by Center investigators versus other users. The budget justification for any maintenance/service contracts should document usage of the equipment by Center members. Only in very rare cases should full support for a maintenance/service contract be requested, and strong justification must be provided in such cases.

Alterations and Renovations: Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested. Cosmetic renovations are not appropriate.

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

Budget requests for a Regional/National Shared Resource Core that is located at the applicant institution or an affiliated hospital 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.

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 (Biomedical Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state the aims of the Biomedical Research Core.

Research Strategy: The need for core support from the Diabetes Research Center must be well justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support. Provide the rationale for establishing or continuing the core and the activities of the core. Cores may be proposed to support any research activity of the Center. The description of the Core should indicate how it will support the Center’s research effort in a cost-effective manner. Include a definition of qualified users and provide a list of research base investigators who will use the core, including the expected extent of their proposed use. The Core must be utilized by a minimum of two federally-funded investigators who are Center members. 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. Additionally, the minimum of two independently-funded users does not in itself provide sufficient justification. Emphasize the anticipated benefits that investigators will derive from using core facilities. Criteria for use and for prioritization must be included in the application. In addition, if Centers provide any discounts for core use by Center members

Each core must have an operational plan which must include methods to:

• Assure quality control
• Prioritize investigator use
• Monitor core use
• Adapt to new technology and to the needs of the Center members

Limited use of cores by investigators in other fields who are not Center members is encouraged, as is use by trainees, students, and junior faculty, but rules to regulate this use should be defined. If the core supports user training, the approach to and extent of training being performed in the Core should be detailed. Training is an appropriate and worthwhile activity of a Core and is encouraged.

Any Core with a relatively limited number of users must develop plans to broaden the number of Core users. Such plans are particularly important for any Core that, while not extensively used, is considered essential by the Center administration. Describe any plans to use the Core for limited developmental research, including the relevance of this research to Core services, effectiveness, and adaptability.

Centers are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other Centers in close proximity, when the existing cores offer the services needed. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. However, it should be clear that the Diabetes Research Center cores can function independently. It may be advantageous for a Diabetes Center to provide support for appropriate personnel to work specifically for Diabetes Center members in an existing facility/core (e.g., transgenic animal core) at the institution. In this case, the designated Diabetes Center Core Director must work closely with the parent facility Core Director to coordinate services, unless the same individual assumes both roles. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. Therefore, financial justification such as comparative costs of other sources of proposed core services as well as plans for cost recovery from users should be detailed.

Because cooperation between Diabetes Research Centers is also encouraged, but not required, any plans to work with one or more other established DRCs may be provided along with a description of the benefit(s) to the Center being proposed. Benefits might include, but are not limited to, cost savings, ability to provide additional or improved services, or enhanced productivity by Center members.

Applicants may propose an institutional shared research core. In such cases, the research core support provided by the Diabetes Center should be proportional to the use of the institutional research core by Diabetes Research Center members. Moreover, applicants should demonstrate that support for the existing institutional resource core through the Diabetes Research Center provides added value to the resource beyond that which would be provided by paying for the use of the resource through a fee for service. As with other research cores, details about access and prioritization of Center members to the shared research core(s) should be provided. If access is achieved by supporting an institutional core, applicants should document the current waiting time for diabetes versus non-diabetes researchers. The applicant should document that the Diabetes Center will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc. The applicant should also indicate those diabetes-specific services that are provided by the institutional core that would not typically be offered without support from NIDDK.

Applicants requesting a Regional/National Shared Resource Core that is located at the applicant institution or an affiliated hospital should document that there is sufficient demand by the wider scientific community for the expansion (or establishment) of 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.

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.

Renewal applications: Information relative to cores 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 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 F, which was attached in the Center Overview component. Do not duplicate publication lists for each Biomedical Research Core.

Letters of Support: For any proposed Regional/National Shared Resource Cores, include letters of support from partnering institutions. For any collaborative linkages between the CTSA and a specific Biomedical Research Core, a letter of support should be included within the specific Biomedical Research Core component of the application. Also, provide letters to address the career potential of, and institutional commitment to junior scientists who serve as core managers/technical directors. In addition, other letters of support for the proposed Core may be included, as appropriate

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.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Biomedical Research Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

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

Applicants should provide institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects.

When preparing your application, use Component Type P and F Program.

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 & 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: The following attachments should be included in order 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 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 Diabetes Research Center. Provide information on the most recent 5 or, if applicable, 10-year period. Include the years funded, awardee, dates and amount of P and F funding, pilot project title and brief description, P and F award type (i.e. new investigator; established investigator), numbers of abstracts and publications 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 research. Table E is provided as an example at the Diabetes Research Center Resource page for applicant assistance with this requirement.

Pilot Project Summary/Abstract (for all applications): Please title this attachment "Pilot Project Information" and provide a Project Summary/Abstract for each proposed pilot and feasibility project (including any proposed Core use), 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 & 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 Program Director and provide a valid eRA Commons ID in the Credential field. The Pilot and Feasibility Program must have a Director who is an established investigator in diabetes research.
• 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 key personnel, including the P and F Program Director, and other professional and administrative personnel. The P and F Program Director, who must have sufficient effort to manage and provide oversight, typically devotes 0.6 to 1 person month. The salary amount charged to the Diabetes Research Center grant must be commensurate with the time spent on P and F Program activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support individual Pilot and Feasibility projects. Typically, at least 20-25% of the overall Center direct costs, exclusive of equipment, should be for support of P and F projects. It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the majority of approved P and F projects. Efforts to increase the number of P and F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged.

Consultants: Include costs associated with consultants (e.g. consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Pilot and Feasibility Program, such as any external reviewers for P and F applications.

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)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

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

Research Strategy: Describe the overall goals and structure of the Pilot and Feasibility Program.

Requirements: Each Center must propose a minimum of 2 pilot and feasibility studies to be supported from NIDDK funds each year.

P and F award eligibility and related guidelines: Investigators eligible for pilot and feasibility funding generally fall into four categories: (1) new investigators without current or past NIH research support as a PD/PI (current or past support from other sources should have been modest); (2) established investigators with no previous work in diabetes who wish to apply their expertise to a problem in this area; (3) established investigators in diabetes who propose testing innovative ideas that represent clear departure from ongoing research interests; and (4) investigators developing new research techniques/technologies that could be used in a DRC Core facility. 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 equivalent 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. P and F awards are not intended to serve as 'bridge' funding for established diabetes researchers who may be experiencing a gap in research funding.

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

The application should clearly describe and justify the pool from which potential pilot and feasibility applications will be selected. This can be limited to investigators at the parent institution or expanded to include investigators at institutions with a well-defined affiliation with the Center. Such an affiliation can occur either through a sub-contractual 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.

Initial review and management of the pilot and feasibility program by the Center: By the very nature of this program, a significant responsibility for its management will be left to the Center administration during the project period.

Since pilot and feasibility studies can be awarded for varying periods of time, these studies may 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. There must also be a committee representing all the aspects of the Center to assist the P and F Director in the management of the program. The major responsibilities of the P and F Program Director and the committee will be to:

(1) Prepare and ensure appropriate distribution of announcements of the availability of pilot and feasibility funding;

(2) 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.

(3) Maintain oversight and review of progress for ongoing pilot and feasibility studies;

(4) Ensure adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects when human research subjects are involved in pilot and feasibility awards;

(5) Make recommendations to the Center for final funding decisions. A record of actions by this committee must be documented;

(6) Develop and maintain a mechanism for the oversight and review of ongoing P and F projects; this is especially important as a requirement for a second year of P and F support;

(7) Make recommendations regarding termination or other actions to the Center;

(8) 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.

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 and related areas of research and to the specific goals and objectives of the individual Center and of the Center program generally.

Pilot and feasibility program in new applications: Provide relevant information on proposed P and F projects. These should be the best applications received by the Center and should be reviewed in the manner proposed for all future P and F applications.

Pilot and feasibility program in renewal applications: In general, a renewal application should include: (1) an 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 of the benefits of the program to the Center, as well as the contribution of the uniqueness of the Center environment to the program. Some of 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 particular aspects of the past studies such as research advances, collaborations which resulted in lasting relationships, acquisition of new skills by the study recipient, or other significant outcomes. The relationship of the scope of the various studies to that of the Center should be emphasized.

The description of the management of the program should present in detail the current system used to manage 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.

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

Letters of Support: Include any letters of support for the Pilot and Feasibility Program by appropriate institutional officials at partnering organizations (other than the parent institution), if applicable.

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.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Pilot and Feasibility Program)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

If the Center's P and F Program will accept projects that include Human Subjects research, the Justification should include a description of the broad areas of Human Subjects research that would be eligible for P and F support in addition to other relevant information. Likewise, if the P and F Program will accept Clinical Trial projects, the Justification should include a description of the types of Clinical Trials that would be permitted as well as the areas of science that would be eligible in addition to other relevant information. Applicants should provide institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

For this particular Funding Opportunity Announcement, note the following:

Reviewers will be asked to evaluate the following individual sections. The overall impact score is not the average for these components.

• Research Base, including the focus, quality of research, collaborations among members, relevance to the Center's stated research focus, and, for renewal applications, the growth, re-focusing, or evolution of the research base.
• Each Biomedical Research Core, as well as any optional Cores, if requested (Regional/National), including: the potential of the core to empower diabetes research by promoting new research directions and creating diabetes-specific research opportunities that are not available through commercial or institutional resources; the documented need for and use of 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, Enrichment Program and lines of communication.
• Pilot and Feasibility Program, as well as the optional national/regional P and F Program, if requested, 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.
• Diabetes Research Center Director (PD/PI), including leadership and commitment to the stated goals of the Diabetes Research Center.

Center Pilot and Feasibility Programs have the option to support Clinical Trials.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed center rigorous? If the aims of the Center 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? What are the strengths of the Center's research base (its breadth and depth)? Is there a strong, scientifically excellent research base in diabetes, its complications, and related endocrinology and metabolic diseases at the Center? Do the focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity of the research base support the stated theme of the Center? Will the research base investigators benefit from the services/programs supported by the Center? What is the likelihood that the Center will increase efficiency; promote new research directions and meaningful collaborations among Center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective? If collaborations with other Diabetes Research Centers, or individuals outside of the research base are described, do they enhance the productivity or quality of the research base; enhance the services offered by the Center; strengthen the Enrichment Program; allow for a more efficient use of the Center's available resources; or otherwise benefit the research base?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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 responsible for the individual components willing to interact with each other and contribute to the overall objectives of the Diabetes Research Center? What are the scientific and administrative leadership abilities of the proposed Center Director and Associate Director(s) and their commitment and ability to devote adequate time to the effective management of the Center program? Are the Core Directors well-qualified and appropriate?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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? Do the Cores provide new methods, techniques, and/or resources that are not available through commercial or existing institutional resources? Do the Cores demonstrate the ability to adapt when needed to support investigators in emerging areas of diabetes and its complications, and related areas of endocrinology and metabolism research, as appropriate to the purpose of the Core and the research supported by the Center? Is the selection process by which the individual studies are selected for P and F projects appropriate? Does the Center appear to encourage high-risk , innovative ideas through their P and F program?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center 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 (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? How appropriate and relevant are the proposed cores and the modes of operation (such as potential utilization, prioritization of requests for services, cost-recovery, and quality control monitoring)? Will the cores provide opportunities not otherwise available to the investigators through other available federally-funded and/or institutional resources; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? If proposed, is support through an institutional biomedical research core well-justified, and would it provide added value and access to the resource that is beyond that which would be provided for the use of the institutional core through a fee-for-service process? Is there any role for the research cores in supporting either new investigators or established investigators moving into diabetes research? Are criteria for membership in the Diabetes Research Center clear and appropriate? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring;(b) establishment and maintenance of internal communication and cooperation among the Center investigators;(c) mechanism for selecting and replacing professional or technical personnel 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, property and 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 Center? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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? Is there evidence of institutional commitment to the Center program, including lines of accountability, regarding management of the Center grant and the institution's contribution to the management capabilities of the Center? Is there clear potential for interaction with scientists from other departments and institutions?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the Center 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the 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 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 Center 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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

Research Base: Does the Center show evidence of a stable or growing research base with strong and consistent record of scientific excellence and achievement reflected in an outstanding level of productivity and continuing success in securing peer-reviewed research funding? Does the Center show evidence of fostering multi-disciplinary collaborations among its Center investigators? Have such collaborations resulted in new research directions?

Biomedical Research Cores: Are the number and impact of research publications that acknowledge the Center sufficient to justify each core? Is there a significant fraction of papers that a) acknowledge the Center and b) do not have core personnel as co-authors? Are the number and listing of Center investigators who have used the core and resultant key advances consistent with the level of core investment? Do the number and listing of investigators who have used the core multiple times indicate satisfaction and continuing need for core services? Are there sufficient numbers of users who are not core personnel or their collaborators? Are the number and listing of users who are not Center personnel or members consistent with the best utilization of the core by the community? Are the numbers of services/tests completed by each core indicative of a growing need and sufficient to justify continued support? Is the capacity of each core with current resources sufficient to serve the needs of the Center community? Does the Center provide evidence of ability to evolve cores to meet changing needs of the research community? Does the Center provide evidence of Program Income and/or sufficient institutional support? If applicable, has the national/regional shared resource core been effective as well as beneficial to both the Center members and partnering institution(s)?

Administrative Core (with Enrichment Program): Has the administrative structure proven effective? Has oversight of Center activities, including the P and F and Enrichment programs, been effective? Does the Center website show evidence of continuing maintenance and a high level of quality and usability? Has the Enrichment program fostered multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research?

Pilot and Feasibility Program: Are the numbers and types of P and F awards well justified and related to the goals of the Center? Was the P and F program fully utilized during the previous project period? Were awards made to investigators who fully met the eligibility criteria (as described in the FOA) for pilot and feasibility support? Are data provided to document the outcome of all P and F projects completed in the last five years, including those that failed to lead to further funding? Has the P and F program led to publications of significant impact, subsequent independent R01 or other peer-reviewed support, and/or attracted new investigators into nutrition/obesity-related research? Are research papers generated under these awards, projects successfully funded with independent grants, and key advances linked to these awards well-documented and consistent with the level of support provided? For those Centers who provided P and F support to investigators new to diabetes research and/or to experienced diabetes researchers with innovative ideas, were the P and F awardees successful in their outcomes? If applicable, has the national/regional P and F program been effective as well as beneficial to both the Center and partnering institution(s)?

Not Applicable.

As applicable for the Center 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 .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Diseases 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

James F. Hyde, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7692
Email: [email protected]

Corinne M. Silva, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-7335
Email: [email protected]

Najma Begum, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8894
Email: [email protected]

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7794
Email: [email protected]

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.