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

Diabetes is a common chronic disease that imposes considerable demands on affected individuals, communities, and healthcare system resources. People with diabetes have a higher rate of cardiovascular disease than those without diabetes and are at increased risk for microvascular complications that may lead to kidney failure, lower limb amputation, and blindness. Obesity is a significant risk factor for type 2 diabetes and the prevalence of obesity in adults and children in the U.S. has dramatically increased in the past four decades. Overweight, obesity, and/or excessive weight gain during pregnancy are also contributing to the rising rates of gestational diabetes mellitus (GDM) which in turn increases risk of future type 2 diabetes in the mother and child. Both type 1 and type 2 diabetes in youth are on the rise. Aging is also a risk factor for type 2 diabetes, and one in four nursing home patients have diabetes.

Diabetes currently affects an estimated 34.2 million people in the U.S. Another 88 million Americans aged 20 years or older are estimated to have prediabetes. The CDC estimates that one in three American children born in 2000 will develop diabetes at some point in their lives. The total estimated cost of diagnosed diabetes in 2017 was $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity.

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

Despite these advances, there remains a gap between the evidence and real-world diabetes prevention and treatment. The gap is particularly evident in many racial and ethnic minority populations and for individuals living in poverty or low resourced environments. Although diabetes occurs in all populations in the U.S., obesity, type 2 diabetes, and diabetes complications disproportionately impact U.S. racial and ethnic minority communities and low-income populations across the lifespan. High-burden populations with low socioeconomic status (SES), living in rural areas and low-resourced communities bear a disproportionate burden of illness related to these conditions compared with non-Hispanic Whites and those with high SES. Research indicates that fundamental causes of health inequities are rooted in adverse social determinants of health (SDH), which are defined by the World Health Organization as "conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life" https://www.who.int/social_determinants/sdh_definition/en/. These influences result in avoidable differences in health among populations requiring interventions at the person, healthcare system, community, population, and policy levels. A central challenge in improving population health is translating efficacious interventions conducted in well-resourced research conditions into real-world settings. Tailored approaches to address health inequities are expected to vary according to the different contextual levels and interventions involved. For example, challenges in effectively scaling-up successful interventions and reaching at-risk populations may require novel partnerships that extend beyond traditional clinical services to community contexts and non-healthcare sector organizations with missions that directly involve addressing SDH or assisting individuals overcome the negative impacts of SDH. The research opportunities include, but are not limited to, understanding the best strategies to address socioecological, economic ,and other environmental conditions that perpetuate disparities in the burden of diabetes and related conditions; designing effective prevention and treatment strategies that are accessible, feasible, culturally relevant, and acceptable to diverse populations and communities; and achieving sustainable health improvement approaches in communities with the greatest burden of diabetes and associated risk factors.

Closing the gap in holistic diabetes care and improving health equity will require diabetes T2-T4 translational research (i.e., bedside to clinical practice and community settings, dissemination and implementation) for testing innovation adaptations of evidence-based approaches to prevent and treat diabetes. Additionally, such interventions should be designed to be disseminated and sustained both behaviorally and economically in routine clinical healthcare practice, community settings, and nontraditional healthcare contexts. Multidisciplinary and diverse organizational collaborations are deemed important to foster the dynamic capacity and research framework necessary for improving health equity and population health.

The mission of the CDTRs is to serve as a key component of the NIDDK-supported research program to translate efficacious research findings within practice and the community to improve the health of Americans with or at risk for diabetes. An emphasis on the spectrum of diabetes Type 2 - Type 4 (T2-T4) translational research to reduce or eliminate diabetes-related health disparities, and related conditions, and improve health equity is encouraged. For the purposes of this FOA, T2 - T4 translational research is defined as research focused on translating interventions and approaches that have demonstrated efficacy into real-world healthcare settings, communities, and diverse populations with an emphasis on reach, sustainability, and potential for widespread implementation. T2- T4 translational research is distinct from type 1 translational research. Type 1 translational research (bench to bedside) builds on basic science findings and focuses on early phase research to "translate" these findings into potential interventions or therapeutics that might ultimately be tested in clinical trials. While type 1 translational research is a critically important piece of the research continuum, it is not the focus of this Funding Opportunity Announcement for the Centers for Diabetes Translation Research and, therefore, is not allowed.

The goal of the NIDDK CDTRs (https://www.diabetes-translation.org/) is to improve health equity approaches in the prevention and treatment of diabetes by promoting research that supports rapid dissemination, implementation, and sustained use of effective interventions and approaches. While this Center program emphasizes research to address health equity and needs of high burden populations, novel research cores designed to improve other aspects of person-centered, community, and population health are also encouraged especially when such strategies may be adapted to meaningfully inform disparity-reduction approaches.

To accomplish the mission and goals, the Centers for Diabetes Translation Research will:

• Create an environment that supports important and innovative T2-T4 translational research in diabetes;
• Attract and retain early stage investigators in addition to senior investigators new to the field when appropriate;
• Foster multidisciplinary and novel collaborations, including with non-traditional health research organizations (e.g., other university departments, community organizations, health departments, human services) where appropriate for advancing emerging scientific areas of T2-T4 translational research and health equity;
• Raise awareness of and interest in T2-T4 translational diabetes research at Center institutions as well as locally, regionally, and nationally;
• Enhance translational diabetes research education and training opportunities for patients, students, scientists, clinicians, and communities;
• Provide core services based on skills, knowledge, and expertise that are unique to T2-T4 translational research and health equity; and
• Promote the translation of scientific discoveries from bedside to practice and the community to improve diabetes prevention and treatment, and population health.

The organization and structure of the Centers for Diabetes Translation Research should reflect the strategic goals of the Center. CDTRs provide shared access to specialized technical resources and expertise and a framework for fostering synergy between disciplines, organizations, and sectors relevant to translating evidence-based approaches to real-world adoption and practice; and provide core research resources and consultation locally, regionally, and nationally in areas relevant to diabetes translation research gaps. The overall goal of this Centers program is to improve the efficiency, productivity, effectiveness, multidisciplinary, and collaborative nature of T2-T4 translational research with an emphasis on addressing health equity and novel methods/measurement activities. CDTRs also encourage collaboration, develop and implement Center for Diabetes Translation Research-wide initiatives, and promote the use of shared resources, enrichment activities, and Pilot and Feasibility Program funds. The structure should evolve as needed based on new scientific opportunities and partnerships, and a systematic process to review and modify core services and activities based on user needs for new research resources. The major underpinning of the Centers for Diabetes Translation Research allows for modifications of programmatic and scientific activities and areas of support to fully capitalize on the most exciting research opportunities in diabetes translation-related research areas.

Institution and Research Base

A CDTR must be an identifiable unit within a single institution such as a university medical center or a consortium of cooperating institutions. CDTR applications must demonstrate an existing strong base of successful external research funding (NIH or non-NIH) that is related to T2-T4 translational research in diabetes and addressing health equity or disparities. Program excellence includes a consistent and outstanding record of publications and peer-reviewed research funding in related areas. CDTRs are expected to leverage relevant skills and collaborations with other institutions, agencies, and sectors (e.g., different academic departments, health departments, healthcare systems, human service organizations, community-based organizations) to demonstrate a diverse scientific base that includes well-established and funded academic diabetes translation researchers and multidisciplinary and cross-sector expertise, where appropriate, for addressing core service themes proposed.

The research base for the CDTR, including any affiliated hospitals and proposed partners, must consist of at least $3,000,000 in direct costs of peer-reviewed research projects. CDTR expertise that would be relevant to conducting diabetes translation research might include design and analysis issues in translational research (e.g., quasi-experimental designs, evaluation of natural experiments, adaptive or practical/pragmatic clinical trials, modeling, analyses for complex designs and data systems, health economic analysis), methodologies such as community engagement or community-based participatory research, measurement at various levels (e.g., individual, family, system, community, healthcare practitioner), multi-level methodologies; and dissemination and implementation science. Domain expertise might include, but is not limited to, heath equity and health disparities, the science of integrating social and medical care interventions, the science of engagement and adherence, use of technology, (eHealth, mHealth, health information technology, and diabetes management technologies), health access and health literacy and/or numeracy, diabetes self-management, prevention, psychosocial care, lifestyle change, and health communication. These examples are not intended to represent a comprehensive list of focus areas for a CDTR.

Where possible and applicable, CDTRs are encouraged to leverage skills and collaborations with NIH-funded centers at their institution/consortium (e.g., Diabetes Research Centers, Nutrition Obesity Research Centers, and Clinical and Translational Science Awards, etc.). The goal of the Diabetes Center program is to make T2-T4 translational science resources readily accessible to a broad spectrum of investigators who are pursuing research in relevant topic areas of this Centers mission.

Administrative Core

Center for Diabetes Translation Research applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative Core should have a process to a) assess the productivity, effectiveness, and relevance of Center activities; b) determine criteria and selection process for Center membership; c) foster collaborations and scientific opportunities among its members through the planning of an enrichment program; and d) activities designed to promote broader inclusion and diversity in the Center and diabetes translation field.

The required CDTR Enrichment Program should advance T2-T4 translational diabetes research, promote scientific exchanges among investigators with related research interests, and enhance interactions between diabetes researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Activities that improve research knowledge and skills in novel areas and advance the careers of new investigators are encouraged. Additionally, limited travel support may be requested to allow CDTR core members and affiliated investigators to learn new analytical techniques, develop new collaborations, or engage in scientific information exchange.

All CDTRs will be required to create and maintain 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 national NIDDK Center program website (http://www.diabetes-translation.org/).

Translational Research Cores

Applicants must address central themes or focus areas that link Center members and their research programs. Applications must include a minimum of two research Cores and no more than five. A Core service should support research focused on enhancing translation of evidence into broader or high burden populations and communities, and into routine clinical and/or community settings or the integration of multiple sectors (e.g., addressing health related social needs/care in healthcare delivery contexts or to inform/improve care) to promote improvements in population health. Core services can also support research to identify and test approaches to overcome barriers to widespread dissemination and implementation of evidence-based approaches.

The CDTR must address a minimum of two core services. It is strongly encouraged that applicants focus on interrelated clinical research or interventional activities that address health equity (e.g., health equity or health disparity reduction approaches) in addition to novel methods/measurement activities as these are high priority areas for NIDDK. Applicants may also propose additional core services to support novel prevention and intervention diabetes research that raise the health potential of all Americans, particularly those that may be adapted to reduce disparities; and for renewal applications, to ensure continuation and momentum and progress gained in relevant or complimentary research areas that may inform health disparities research. An example of activities that may enhance the health potential of all populations may include primary care decision support tools/algorithms to increase preventive services for various patient populations. Clinical and interventional research examples have been discussed above in addition to engagement and behavior change strategies (e.g., community outreach, peer support and community health worker approaches, health information technology, remotely delivered interventions). Complex eval uation methods and techniques may include topics related to biostatistics, economic evaluation, agent-based modeling and simulation, dissemination and implementation science, life course methods, policy and systems science analysis.

Each research core should provide state-of the-art expertise to multiple funded research projects. Cores should be designed to provide specialized technical resources and multidisciplinary nature of T2-T4 translational research performed by Center-affiliated investigators. A Center may support research at a single or a set of cooperative institutions through an Institutional Core or may serve a wide scientific community on a geographic or national basis through the establishment of a National/Regional Shared Resource Core (see details below).

Justification for proposing a core: The establishment and continued support of a diabetes translation research core within a CDTR 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 CDTR 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, a minimum of two independently funded users does not in itself provide sufficient justification.

For all proposed cores, the need for core support from the Center for Diabetes Translation Research must be well-justified with a broad user based of NIH-funded investigators pursuing research activities in CDTR topic areas. The relevance and utilization of the core services by the research base will be emphasized during the review process.

Pilot and Feasibility Program

The Centers for Diabetes Translation Research CDTR Pilot and Feasibility (P and F) program provides seed funding of typically $25,000-$50,000 for new and innovative research relevant to translational diabetes research. P and F Programs are intended to provide support for early stage investigators to collect preliminary data sufficient to support a grant application for independent research support and/or to test a novel hypothesis. The P and F program is particularly directed at new investigators (https://grants.nih.gov/policy/early-investigators/index.htm) and established investigators new to the field of diabetes translational research. Established diabetes investigators pursuing timely or highly significant projects are also eligible for support under the CDTR P and F program, but such awards should be a rare exception, well-justified, and not represent the primary focus of the P and F program. Pilot and feasibility support is not intended for large projects by established investigators that are more appropriate for as grant submissions to funding agencies, nor is it intended to provide bridging support. P and F funds are also not intended to support or supplement ongoing funded research of an investigator.

The Center is expected to support a minimum of two pilot projects per grant year and convene an annual P and F awardee meeting as part of a program evaluation and to promote scientific exchanges among early stage investigators.

Additional Opportunities for Resource Cores and Programs

The goal of the optional opportunities listed below is to provide NIDDK CDTR research core service opportunities to diabetes researchers at institutions that are not currently served by the NIDDK CDTR; and to provide a national enrichment program that manages a scientific symposium to promote scientific exchanges among investigators of various stages on seminal translational works and potential CDTR opportunities.

• National/Regional Resource Core: A CDTR may serve a wider scientific community on a geographic or national level through the establishment of a National/Regional Resource Core. This core can be located at the applicant institution or an affiliated institution, but any funds requested above the cap must be used to support national /regional activities outside the applicant institution(s) and its affiliated hospitals.
• Support for the expansion of outreach for the Center's Pilot and Feasibility (P and F) program to investigators at the institution where the National/Regional Resource Core is located may also be requested but is not sufficient to be considered a National/Regional program for the purposes of expanding the allowable requested funds. See Section IV (Application and Submission Information) for more details.
• National Enrichment Program: The Center for Diabetes Translation Research may request support for a National Enrichment Program to attract graduate students and early stage career investigators to improve their understanding of cutting-edge scientific topics and pursuit of careers in diabetes translation research. Senior level researchers transitioning to the field may also be engaged. The primary goal of this national enrichment program is to manage a scientific symposium on an innovative diabetes translation research topic and seminal works to accomplish the following objectives (a) assess the state of the science of a novel topic/theme, (b) identify research gaps and needs CDTRs may be well suited to address through research resources, and (c) promote career development. The symposium will be held for a minimum of three years of the funding period. To further enhance activities in a coordinated fashion across all the NIDDK CDTRs, the national enrichment program should address or be complementary to health equity research topics. See Section IV (Application and Submission Information) for more details.

It is anticipated that only one CDTR award will include a National Enrichment Program that will be managed in collaboration with an executive steering committee with representation from all funded CDTRs.

Additional Features

Cooperation, Coordination, and Integration: 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 Award (CTSA) program (https://ncats.nih.gov/ctsa, https://clic-ctsa.org/), other related NIH Common Fund activities (https://commonfund.nih.gov/), and any related NIDDK-funded Center programs such as the Diabetes Research Centers (https://diabetescenters.org/), Nutritional Obesity Research Centers (https://norccentral.org/), and the Digestive Diseases Research Centers (http://www.digestivediseasescenters.org/). When proposed cores services are already available through the research institution (e.g., via an institutional core), there must be compelling justification for their support through the CDTR. In addition, core must have well-defined policies to ensure that intellectual property is identified and appropriately protected, but the intellectual property issues do not impede sharing of resources.

Research Base: Successful CDTR applications require an existing program of excellence in T2-T4 translational research either in diabetes or in areas directly related to diabetes. To justify Center support, the CDTR must serve a large research base of NIH-funded investigators AND pursuing research activities in Center topic areas. The research base of the CDTR must also include investigators with an established track record of productivity and funding support in prevention and control research that is directed toward translating current diabetes research findings into clinical practice, community, and/or population levels. 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.

CDTR Directors' Meeting: Annually, all CDTR Directors and other key personnel are expected to attend a meeting in the Bethesda, Maryland area to foster shared scientific projects, communicate with NIH NIDDK staff, and highlight key Center activities, lessons, and mitigation strategies (i.e., to address P and F outreach and recruitment challenges).

National Enrichment Program- Optional: If funded, all CDTR Directors and other key personnel are expected to fund investigators (primarily early stage) to attend a national enrichment program scientific symposium that will take place during 3 years of the project period (grant year 2-4). The location of these meetings may vary based on the CDTR grantee managing the program and guidance from the program's Executive Steering Committee.

Applications that propose cores to significantly support type 1 translation research (bench to bedside), or biomedical behavioral or clinical research other than research to practice translation and late stage implementation (T2-T4 translational research), are not responsive to this opportunity and will not be reviewed.

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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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

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

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

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

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.

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

NIDDKLetterofIntent@mail.nih.gov

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 Translational Research Core: the required Translational Cores and optional National/Regional Resource Core)	12
P and F (Use for Pilot and Feasibility Program)	12
Enrichment Program (Use for each Enrichment Program: the required Enrichment program, and optional National Enrichment Program)	6

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

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

The application should consist of the following components:

• Overall: 1 Required (Minimum: 1; Maximum: 1)
• Administrative Core: 1 Required (Minimum: 1; Maximum: 1)
• Translational Research Core: 2 Required (Minimum 2, Maximum 5); National/Regional Resource Core: optional (0 Minimum, 2 Maximum)
  
• Pilot and Feasibility Program: 1 Required (Minimum: 1; Maximum: 1)
• Enrichment Program: 1 Required (Minimum: 1, Maximum: 1); National Enrichment Program: Optional (0 Minimum, 1 Maximum)

Note: Applicants must use separate components for each required and optional core or program proposed.

When preparing your application, 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 CDTR and the need for a Center to support investigators in the research base. Provide a brief overview of the research base as it relates to the theme(s) of the Center, as well as an overview of the translational research cores, and the pilot and feasibility and enrichment programs.

Project Narrative: In 1-3 sentences, describe the relevance of the research to be supported and facilitated by Center activities (Core services; Pilot and Feasibility and Enrichment programs) on health equity and population health; or informing diabetes-related health disparities reduction approaches.

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 list of major, shared pieces of equipment to be used by CDTDR members should be provided. Note: Specific research core facilities, equipment, and special resources should be listed in each proposed translational research core component.

Other Attachments: The following attachments unless identified as "optional" must be included with the Overall Component to aid in the review of the applications. The filename provided for each pdf 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 pdf attachment "Grant Support" and include all Federal and non-federal grant support for Center for Diabetes Translation Research members, but do not include grant funding in non-relevant areas. 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 pdf attachment should include, in order: Current Diabetes Translation Research Grant Support (Table A.1), Other Diabetes Translation Research Grant Support (Table A.2) and Pending Diabetes Translation Research Grant Support (Table A.3). See: CDTR Application Resources for assistance with this requirement. The 'Current Grant Support' table should include research project grants relevant to diabetes translation research that 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 translational-related research, but would not be direct users of the core services.

Biographical Sketches of Center Research Base Investigators: Please title this pdf 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 or other proposed collaborators (e.g., health departments, community organizations). Do not include duplicate biographical sketches for Senior/Key Personnel that have already been provided under the Senior/Key Personnel profile of the Center Overview.

Description of Center Research Base Investigators: Please title this pdf 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: 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 the cited grant to diabetes translation research, and to the theme of the CDTR, when this is not readily apparent from the project title of the grant.

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

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

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

Optional: Please title this pdf 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 the CDTR.

Enter primary site only.

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

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

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

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

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

Specific Aims: Describe the broad, long-term objectives of the proposed CDTR to support the investigators in the research base. A strategic vision, theme, and goals must be described as well as a brief overview of the translational research cores, and the pilot and feasibility and enrichment program(s). The plan should summarize the existing expertise and resources available in the research base as well as other resources at the institution(s). Include the number of Center members and the overall direct costs present in the research base. Include a brief description of anticipated impact on human disease and population health, particularly the potential to enhance health equity and reduce disparities in diabetes and related conditions.

This plan should delineate how the CDTR will enhance ongoing projects, assist in the development of new projects, respond to future opportunities, and promote collaborations toward developing new and/or improved prevention and treatment approaches for diabetes.

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

Research Base: The Center Core grant provides a mechanism for fostering multidisciplinary collaborations and cross-agency or sectoral cooperation, where appropriate, within a group of established investigators conducting high quality T2-T4 translational research in diabetes. Therefore, applicants should demonstrate the existence of a diverse, strong, and substantial research base in this area as a fundamental requirement for, and the most important aspect of, the establishment of a Center.

Applicants should include an overview of the current research in diabetes translation and related areas being conducted at their institution in sufficient detail to allow reviewers to judge its extent and the interrelationship of ongoing research. Applicants should indicate how the establishment 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.

A high level of meaningful integration and collaboration among Center personnel from diverse scientific disciplines and organizations, where appropriate, are important features of a successful CDTR. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential members to form interactive, collaborative, and synergistic relationships. Criteria for becoming a CDTR 'member' should be clearly defined. Each Center, however, is expected to formulate these definitions based on its own situation. Center membership and affiliation are often open to those individuals who would like to promote the mission of the Center. Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined in order to better organize and facilitate the focus of the Center's mission. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Applicants should provide clear guidelines for a) how Center membership(s) is (are) defined; b) the application and selection processes for Center membership; and c) the obligations of Center membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in diabetes-related translational research (T2-T4), and the need for the use of core facilities. All research base investigators should be Center members. Designation as a Center member without the need for the use of core facilities must be well-justified.

Presentation of the research base in the application should be done in two ways: (1) by completing a Table like the one shown in "Grant Support" in "Other Attachments" (Tables A1-A3; and (2) by providing a full narrative description of the diabetes related research activities at the applicant institution and any collaborating institutions. This presentation should be organized into several areas of emphasis that demonstrate the research focus of the Center. The research of each Center participant should be discussed, and interrelationships of research being conducted by Center participants should be highlighted. Since most, if not all, of the research base will be undergone separate peer review, the quality of the individual funded projects is already established. The more important aspects include: (a) interactions and interrelationships of the research effort; (b) uses and benefits of core services; and (c) plans to develop productive collaborations among Center investigators.

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

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

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

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

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

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

Progress Report Publication List (renewal applications only): List publications related to or derived from CDTR support or assistance. Include PMCIDs. Table E is provided at CDTR Application Resources for assistance with this list. Group publications by Core used, so that the number of publications (not the list of publications) that resulted from the use of each Core can be cited in each Core narrative write-up. Portions of this table should NOT be duplicated in each Core, but the absolute number of publications from this main list should be cited.

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

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

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

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

Appendix:

Only 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 human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Center Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each applicant institution must specify one or more Center Director(s) (PD(s)/PI(s)) to be responsible for the scientific and administrative leadership of the Center. If multiple Center Directors are proposed, the application must document their complementary expertise and a Multiple PD/PI Leadership Plan that should address the following administrative aspects: roles/areas of responsibility of the PD/PIs, fiscal and management coordination, process for making decisions on scientific direction and allocation of resources, data sharing and communication among investigators, publication and intellectual property (if needed) policies, and procedures for resolving conflicts.
• The Director(s) should be an experienced and respected scientist with a proven track record for obtaining NIH funding. She/he must be able to coordinate, integrate, and provide guidance in the establishment of new programs in diabetes related translational research. Because a Center for Diabetes Translation Research has a large and complex administrative structure, the PD/PI must have strong leadership abilities and demonstrated proficiency in managing large, multi-component programs.
• One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and will serve as Acting Center Director in the absence of the Director.
• 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 additional Senior Senior/Key Profiles section, list those Senior/Key persons in the Project Role of "Other" with Category as "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)/PIs must be at least 2.4 person months. If there is a need for a full or part-time program administrator, the salary support for this individual should be included in the Administrative Core. Center directors should indicate willingness to collaborate with other NIDDK funded CDTRs. One or more Associate Directors should be named who will serve as Acting Center Director in the absence of the Director. A process must be in place and should be described in the application that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed. Again, where possible and applicable, CDTRs are encouraged to leverage administrative resources in other NIH funded centers (e.g., Diabetes Research Centers, Nutrition Obesity Research Centers, and Clinical and Translational Science Awards) to maximize efficiency of resources.

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

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

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

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

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the CDTR. Include travel costs for the CDTR Director and others as appropriate (i.e., co-Director, core Directors) to attend an annual grantee-related meeting each year in Bethesda Maryland area or at a location to be determined to attend the National Enrichment Program meeting. These meetings are expected to be co-located when possible. Note that CDTR PD(s)/PI(s) must participate in annual meetings of the Center Directors and, if funded, the National Enrichment Program's symposium activity (if one is awarded).

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

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

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

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

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

Applicants should describe an approach to attract and retain new and senior investigators with diverse backgrounds underrepresented in the NIH-funded biomedical research workforce. Approaches may include outreach to foster membership and participation in Enrichment Program activities, Enrichment Program activities itself (e.g., seminars, workshops, educational opportunities), novel partnership models, and outreach strategies to broaden the Pilot and Feasibility eligible candidate pool. This list represents examples of activities and is not intended to be exhaustive. Approaches used may reflect near- and long-term vision, goals, and activities. Demonstrating feasibility to initiate activities and improve diversity and inclusion beyond the current Center's or Institution's status is key.

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

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

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

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

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

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

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

Appendix:

Only 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 human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 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 for your application, use Component Type 'Core'.

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

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Translational Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (Translational Research Core)

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

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

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

Facilities and Other Resources: The description of physical arrangements 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 agreements 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.

Other attachments: The following attachment must be included in order to aid in the review of application. 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 pdf 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 CDTR Application Resources for applicant assistance with this requirement.

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

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role '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 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 (Translational 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 the 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 CDTR 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 appropriate for a Translational Research Core.

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

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

National/Regional Translation Core (optional): If applicants propose a National/Regional Translation core, applicants may request up to $100,000 in direct costs per year beyond the direct cost cap.

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

PHS 398 Research Plan (Translational Research Core)

Specific Aims: Clearly state the aims of the Translational Research Cores (2 minimum). The aims should describe how the core will enhance scientific progress and improve the uptake of research through support of rigorous translation research aimed at prevention and improved treatment of diabetes and related conditions. The aims should have relevance for addressing population health, health equity, and/or diabetes-related disparities. The aims should also describe how the core will enhance the efficiency, productivity, effectiveness, and multidisciplinary nature of diabetes translation research.

Research Strategy: The need for the core support from the CDTR must be well justified with clear documentation of broad use base of NIDDK-funded investigators pursuing research activities in CDTR topic areas, as well as diabetes investigators with other sources of peer-reviewed support. Cores may be proposed to support any research activity of the CDTR that addresses rigorous diabetes translation research and resource needs aligned with the CDTR thematic areas concerning improving population health, enhancing health equity, and/or reducing diabetes-related disparities. The description of the Core should indicate how it will support the Center's research effort in a cost-effective manner. The Core must be utilized by a minimum of two federally funded investigators who are Center members. While investigators holding an award from the Center's pilot and feasibility program are appropriate users of core facilities, their use does not contribute to justification for establishment or continued support of a core. Additionally, a minimum of two independently funded users does not in itself provide sufficient justification.

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

National/Regional Research Core (optional): For applicants proposing a National Regional Research Core, clearly state the aims and how this resource core clearly extends the reach of the CDTR expertise and resources beyond the primary institution(s). The aims should describe how the core will enhance scientific progress and improve the uptake of research through support of rigorous translational research (T2-T4) aimed at prevention and improved treatment of diabetes and related conditions, particularly for high-risk populations. In addition, the aims should describe how the core enhances the efficiency, productivity, effectiveness, and multidisciplinary nature of diabetes translation research.

In the research strategy, applicants should document that there is sufficient demand by the wider scientific community for the proposed core services. The research base in diabetes at the institution(s) that would use the regional core(s) should also be documented. Plans for prioritization of research core services, as well as training to the broader research community, should be provided. Funds requested for this opportunity must be carefully documented and justified and should be dedicated solely to expanding core services to investigators outside of the parent institution or an affiliated hospital. Because T2-T4 translational research often requires collaborative and novel partnership research efforts, applicants should demonstrate that they have existing or plan to develop new partnerships that will leverage skills and resources at other institutions to enhance the CDTR's capacity to provide appropriate scientific base and research infrastructure to advance and support translational science. Demonstration of collaborations might include linkages between disciplines, other institutions, community partners, health departments, and human service organizations.

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

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

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

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

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

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

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

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

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

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When involving human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

Complete only the following fields:

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

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

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

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Pilot and Feasibility Program)

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

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

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

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

PHS 398 Research Plan (Pilot and Feasibility Program)

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

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

Requirements: Each Center must contain a pilot and feasibility program with a minimum of 2 projects to be supported from CDTR funds per year. Each Center must also convene a small annual P and F awardee meeting that may be done remotely or in-person as part of an interim program evaluation and to promote scientific exchanges among early stage investigators.

Eligibility and related guidelines: Investigators eligible for pilot and feasibility funding generally fall into three categories: (1) new investigators without current or past NIH research support (R01, P01) as a PD/PI (current or past support from other sources should have been modest); (2) established investigators with no previous work in diabetes type 2 translational research who seek to apply their expertise to a problem in this area; and (3) established investigators developing new research approaches or proposing to test innovative ideas that could be used in a CDTR Core that propose testing innovative ideas that represent a clear departure from ongoing research interests. It is expected that the majority of the investigators will fall into the first category. All eligible investigators, however, must have faculty appointments and be independent investigators. Postdoctoral fellow or their equivalents are not eligible.

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

Initial review and management of the pilot and feasibility program: By the very nature of this program, a significant responsibility for its management will be left to the P and F Program Director during the project periods. The application should clearly describe and justify the pool from which potential pilot and feasibility applications will be solicited. This can be limited to investigators at the parent institution or expanded to include investigators at institutions with well-defined affiliation with the Center. Such an affiliation can occur either through a 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.

Since pilot and feasibility studies can be awarded for any period of time up to two years, studies end at various times. Additionally, the studies may also be terminated by the Center administration before the approved time limit for various reasons: e.g., (1) the investigators 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 minimum requirements must be met. The program must have a director who is an established investigator in diabetes translation research. There must also be a committee representing all aspects of the Center which will assist the P and F director in the management of the program. The major responsibilities of the director and the committee will be to:

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

All applicants should describe how these requirements will be met and have been met in the case of renewal applications. Also included should be an assessment of the relevancy of the proposed individual pilot and feasibility studies and the program as a whole to research on diabetes type 2 translational research (bedside to practice) and to the specific goals and objectives of the individual Center and of the Center program generally.

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

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

The historical overview will cover the pilot and feasibility program since the inception of the Center. The pilot and feasibility program director may wish to highlight certain studies or certain aspects of the past P and F studies. Collaborations which resulted in lasting relationships, acquisition of new skills by the study recipient, or other significant outcomes should be identified. The relationship of the scope of the various studies to that of the Center should be emphasized. Include the description of the management of the pilot and feasibility program, including its integration with and relationships 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.

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

Overview Plan for CDTR P and F Programs involving Human Subjects Research (required):

Although P and F projects should be monitored for productivity, CDTRs that fund P and F project involving Human Subjects Research must develop a formal plan for assuring compliance with all relevant NIH regulations. Details for implementation of this oversight plan must be included in the application as appropriate for either clinical studies or clinical trials. Do not duplicate information already provided in the PHS Human Subjects Clinical Trial Information form.

The following information is required as part of the oversight plan:

• Development and implementation of appropriate data and safety monitoring plans;
• Documentation of IRB approval;
• Registration of clinical trials in clinicaltrials.gov;
• Development and monitoring of appropriate study milestones;
• Oversight of participant recruitment and retention;
• Results reporting in www.clinicaltrials.gov, as appropriate; and
• Planning for dissemination of research results.

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

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 Overall component. Do not replicate publication lists in the Pilot and Feasibility Program section.

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

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

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When involving human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

SF424 (R&R) Cover (Enrichment Program)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (Enrichment Program)

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

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

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

Other Attachments (renewal applications only; optional): Additional information related to the Center-supported Enrichment Program activities, such as agendas/announcements for Center for Diabetes Translation Research retreats, symposia, workshops, meetings, specialized courses, seminar series, etc., illustrating the interactions among CDTR 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 form and titled "Enrichment Program".

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Enrichment Program)

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

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

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

Other Expenses: Include funds to support Enrichment Program activities such as workshops, research forums, symposia, Center retreats and seminar series. Funds for Enrichment Program - associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested. Each applicant should also include travel funds for CDTR directors and up to 5 investigators, primarily early stage investigators, to attend the National Enrichment Program activities in at least three grant years.

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

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

National Enrichment Program (optional): Applicants proposing a National Enrichment Program component (which is different from the enrichment program required in all applications) may only request funds for up to three years starting in grant year two; and may request funds for the following additional types of activities under the auspices of the Center Enrichment Program (a separate component must be used):

• Planning, coordination, and management, with the assistance of an executive committee involving Center for Diabetes Translation Research members, of a research symposium for graduate students, early stage investigators, and senior researchers transitioning to the field of diabetes translation research.
• Establishing an advertising strategy that includes funded CDTR programs and institutions with diabetes translation research programs.
• Coordination of and assistance with the selection of early stage investigators in the program with all of the NIDDK funded Centers for Diabetes Translation Research across the U.S.
• Expenses affiliated with the research symposium such as printed symposium materials, poster board rentals, audio-visual equipment rentals, etc. Assistance with tracking investigators who participated in the program in order to determine utility and the effectiveness of the research and educational experiences in stimulating research collaborations and products (grants, publications, etc.) among participants; and diabetes translation research as a career choice for early stage investigators in this national program. The grantee may also track collaborative research between senior investigators that result in high-impact diabetes translation activities.
• Personnel to assist with the outreach, coordination, and management of the national enrichment program.
• Funds requested for this opportunity must be carefully documented and justified and should be dedicated solely to implementing a research symposium with participants from all funded CDTRs.

It is anticipated that only one CDTR award will include a National Enrichment Program that will be managed in collaboration with an executive steering committee with representation from all funded CDTRs.

Personnel: A core Director must devote a minimum of .6 person months to the Core to ensure adequate oversight of the National Enrichment Program. A co-director or other professional or technical staff with appropriate expertise for the role described may be included. Stipends (and tuition) for research trainees (e.g., graduate students, postdoctoral fellows) are not appropriate for the National Enrichment Program.

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 (Enrichment Program)

Specific Aims: Clearly state the aims of the Enrichment Program.

Research Strategy: Describe plans for the Enrichment Program, including anticipated benefits to Center members and how the program will assist investigators, trainees, junior faculty to accomplish the goals of CDTR. Where applicable, coordination with enrichment programs supported by other institutional Centers should be detailed. The Enrichment Program will typically support seminars, workshops, research and career development forums, etc., but any appropriate, innovative means to support goals of the CDTR may be proposed. Creative new programs, not preluded by NIH or NIDDK policies, are encouraged.

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

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

National Enrichment Program (optional): Applicants proposing a National Enrichment Program component (which is different from the enrichment program required in all applications) must describe plans for managing a national symposium, including selection processes of an innovative, cutting-edge diabetes translation research topics; coordinate with involvement of all other CDTR directors and NIDDK staff; promote meaningful scientific exchanges among early stage and senior investigators; feature research products and needs of early stage investigators (e.g., poster presentations, forums to discuss early works (publications, presentations, proposal concepts); disseminate symposium proceedings for broader dissemination and knowledge building in the field through a website, white paper, journal article, or another outlet widely available to relevant scientific communities and stakeholders.

Scientific symposium topics must focus on salient research gaps and opportunities with potential for informing health equity research, which can include such topics as novel methodologies, intervention approaches, and/or specific sub-population topics. These examples for symposium topics are not intended to be exhaustive. Symposium agendas, activities, and formats should be developed using expert guidance. The national research symposium must be organized in collaboration with a national Executive Steering Committee with representation from each funded CDTR. Representation from organizational (e.g., academic institutions, healthcare systems, cross-sector entities) may also be solicited to inform symposium activities as appropriate.

The symposium must be conducted a minimum of 3 years starting in grant year 2. The symposium is expected to consist of 2 days minimum using a format that integrates scientific sessions with nationally recognized speakers, poster presentations by early stage investigators, and time to interact with attending faculty as well as with each other as noted. Meeting time should also be allocated for building early consensus on major research gaps and opportunities revealed in the meeting and which are appropriate for CDTRs to address through research cores immediately or longer term (i.e., in potential future funding opportunities).

It is anticipated that a single CDTR award will be given to operate this program in collaboration with an executive steering committee with representation from each funded CDTR.

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

When involving human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Reviewers will be asked to evaluate the following individual sections:

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

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CDTR to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the CDTR 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 project that by its nature is not innovative may be essential to advance a field.

Does the CDTR address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the CDTR are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?

Specific to this FOA:

Does the proposed CDTR focus on high priority areas for the program (i.e., relevant to health
equity, health disparities, population health, novel methods/measurement activities)? If additional core services are proposed, do the cores have potential for informing health-disparity reduction

approaches or improving population health? Will the proposed CDTR resources and expertise enhance and advance diabetes T2-T4 translational research? What is the likelihood that the CDTR will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interaction and collaborations among investigators; and prove cost-effective?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CDTR? If Early Stage Investigators or 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?

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?

Specific to this FOA: Are the PD/PIs willing to collaborate with other CDTR programs and travel to the required annual grantee meetings and the National Enrichment Program research symposium (if a National Enrichment Program is awarded)? Does the scientific base represent appropriate collaborations (e.g., strong academic partners, relevant healthcare systems, community organizations, health departments, human services) to achieve the CDTR goals related to addressing health equity or reducing diabetes-related disparities? Are the Center investigators willing to interact with each other and contribute to the overall objectives of the CDTR? Is the scientific and administrative abilities of the proposed center leadership appropriate? Do they demonstrate commitment and ability to devote adequate time to effectively manage the program?

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

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?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CDTR? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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 CDTR involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

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?

Specific to this FOA: How appropriate and relevant are the proposed cores for the research base? Will the cores provide opportunities not otherwise available to the investigators through other federally-funded and/or institutional resources; represent appropriate cost-savings/cost sharing advantage; and stimulate the development of new approaches? Will the Center appropriately support and stimulate diabetes translational research with an emphasis on addressing health equity or reducing disparities? Are criteria for membership in the Center clear and appropriate? Will the Cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new research? Is appropriate administrative organization proposed for the following (a) coordination of ongoing research between the separately funded projects and the CDTR, including mechanisms for internal monitoring; (b) establishment and maintenance of internal communication and cooperation among the Center investigators; (c) mechanisms for selecting and replacing staff within the Cores; (d) mechanism for reviewing the use of, and administering of funds for, the P and F Program; ( e) management capabilities, including fiscal administration, procurement, personnel management, planning, budgeting, and other appropriate capabilities? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the CDTR? Is an appropriate approach to enhancing diversity and inclusion discussed?

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?

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 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?

Specific to this FOA: Is there evidence of institutional commitment to the Center program, including among institutions involved in the National/Regional Translation Core, if proposed? Is there clear potential for interaction with scientific investigators and relevant collaborators from other departments and institutions?

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

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 CDTR involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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.

Not Applicable

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

Does the Center show evidence of unique expertise that is appropriate to address health equity research and stated CDTR theme/s?

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

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

Does the Center show evidence of fostering multi-disciplinary collaborations among Center members? Does it foster collaborations with other departments/institutions or NIDDK funded programs, including other previously funded CDTRs?

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

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

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

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

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

Are the number and type of P and F awards well justified? Did the pilot and feasibility projects lead to independent grant funding and/or new Center members?

Not applicable

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

Not Applicable.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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 Disease Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities that include providing core resources that address health equity and novel methods.

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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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).

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."

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

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• 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.

In accordance with NIH policy https://grants.nih.gov/grants/policy/hs/index.htm and the NIH Guide

Announcement NOT-OD-15-129, the awardee institution is responsible for ensuring that any awarded P&F projects follow all relevant regulations and policies for Human Subjects Research. The following elements or procedures must be included in the awardee institution’s P&F program oversight plan, as appropriate for all HS research inclusive of both clinical studies and clinical trials:

• Development and implementation of appropriate data and safety monitoring plans
• Documentation of IRB approval
• Registration of all clinical trials in clinicaltrials.gov
• Development and monitoring of appropriate milestones
• Oversight of participant recruitment and retention
• Results reporting in clincaltrials.gov, as appropriate
• Planning for dissemination of research results

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 submission by the due date, 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 instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Pamela L. Thornton, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-6476
Email: pamela.thornton@nih.gov

Michele Barnard
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: mb316j@nih.gov

Natasha Loveless]
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: 301-594-8853
Email: lovelessnd@mail.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.