Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

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 38.4 million people in the U.S. Another 97.6 million Americans aged 18 years or older are estimated to have prediabetes. The total estimated cost of diagnosed diabetes in 2022 was $413 billion total (direct and indirect) medical costs and lost work and wages in the United States.

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 research across the translational science spectrum (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.

Research Mission and Goals

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 type 2 diabetes. An emphasis on the diabetes translational science spectrum to reduce or eliminate diabetes-related health disparities, and related conditions, and improve health equity is encouraged. For the purposes of this NOFO, translational science spectrum represents the stages of research involved in bringing more treatments to all people more quickly. The stages of translational research include basic research, preclinical research, clinical research, clinical implementation, and public health. The stages do not happen in a straight line or in one direction. Each stage builds upon and informs the others. Translational science principles characterize effective translational science approaches, and an understanding of these scientific principles underlie each step of the translational process.

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 translational science spectrum 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 translational science spectrum research and health equity;
• Raise awareness of and interest in diabetes translational science spectrum 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 translational science spectrum 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.    

Center Structure and Activities

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 translational science spectrum 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 translational science spectrum 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, Clinical and Translational Science Awards, and Center for Engagement in Diabetes Equity Research, etc.). The goal of the Diabetes Center program is to make translational science spectrum 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 diabetes translational science spectrum 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 evaluation 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 translational science spectrum 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 base 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 that must be 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: 1) create an opportunity for early-stage investigator career development; 2) assess the state of the science; 2) identify research gaps in the field that CDTRs could address through consultative services; and 3) promote community of practice, publish scientific opportunities.  The symposium will be held for a minimum of three times during the  funding period with a documented summary of key findings provided to the NIDDK that is also broadly disseminated. 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/), Digestive Diseases Research Centers (http://www.digestivediseasescenters.org/) and the Center for Engagement in Diabetes Equity Research (https://med.nyu.edu/centers-programs/national-center-engagement-diabetes-equity-research/). 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 translational science spectrum 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 will be held at a different CDTR site each year. .

Applications that propose cores to significantly support basic and preclinical research (bench to bedside) or biomedical behavioral or clinical research other than research-to-practice translation and clinical implementation and public health translational research) are not responsive to this opportunity and will not be reviewed.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• 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 Organization) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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 per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

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: required
• Administrative Core: required
• Translational Research Core: 2 required
• National/Regional Resource Core: optional
• Pilot and Feasibility Program: required
• Enrichment Program: required
• National Enrichment Program: optional

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

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.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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

Budget (Overall)

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

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

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.

PHS 398 Research Plan (Overall)

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 type 2 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 type 2 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 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 science spectrum, 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 as demonstrated  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 have 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 to address emerging priority topics, 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 and 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 How to Apply - Application Guide.

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

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin Core'.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ 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/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 (Administrative Core)

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, Center for Engagement for Diabetes Equity Research) 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 Committee.

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.

PHS 398 Research Plan (Administrative Core)

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 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 P and F program 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. Applicants should describe how they will ensure continuous feedback and guidance from relevant communities/collaborators who facilitate robust diabetes translational research (e.g., advisory boards with community members and health care system representatives, etc.). 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 How to Apply- Application Guide, with the following modification:

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

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
• A Data Management and Sharing Plan is not applicable for this Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Translational Research Core

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. 

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.

The aims should describe how the core will enhance scientific progress and improve the uptake of research through support of rigorous translational science spectrum research 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.

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 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 associated with diabetes translational research 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 NOFO.

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.

National/Regional Resource Core (optional)

When preparing for your application, use Component Type 'Resource Core'.

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (National/Regional Resource 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) (National/Regional Resource 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 Personnel Profile (National/Regional Resource 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 (National/Regional Resource 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.

If applicants propose a National/Regional Resource core, applicants may request up to $100,000 in direct costs total per year beyond the direct cost cap for up to 2 cores.

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

PHS 398 Research Plan (National/Regional Resource Core)

Specific Aims: Clearly state the aims of the National/Regional Resource Core. The aims should describe how the national/regional resource cores will use an approach to advance health equity. 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 budget cap must be used to support national/regional activities outside the applicant institution(s) and its affiliated hospitals. For applicants proposing a National/Regional Resource 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 science spectrum research 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.Applicants have the opportunity to propose novel, innovative cores/activities to cover additional priority translational research areas to NIDDK where possible (e.g., disability is now a new designated NIH health disparities population).

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 translational science spectrum 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 National/Regional Resource core provides a needed service to a wider scientific community on a geographic or national level and extends the reach of the CDTR expertise and resources beyond the primary institution(s). 

Justification for Proposing a Core: The establishment and continued support of a National/Regional Resource 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 used 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 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.

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 (National/Regional Resource 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.

Pilot and Feasibility Program

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

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

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

Complete only the following fields:

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

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 each 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.  The pilot and feasibility study must be clearly associated with diabetes translational research. Examples of topics unrelated to diabetes translational research but more appropriately covered by other NIDDK- or NIH-funded consortia or centers include but not limited to a focus on chronic kidney disease, Alzheimer's disease, or other chronic diseases.

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 diabetes 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 type 2 diabetes 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 up to four 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 associated with diabetes translational research should be documented by listing the number(s) of the relevant publication(s) from Table G, 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.

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.

Enrichment Program

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 Program 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. 

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

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

PHS 398 Research Plan (Enrichment Program)

Specific Aims: Clearly state the aims of the 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)

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

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

SF424 (R&R) Cover (National 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 (National Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research and Related Other Project Information (National 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) (National 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 (National 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 (National 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 National Enrichment Program Director and any other professional and administrative personnel. The National 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 National Enrichment Program activities such as workshops, research forums, symposia, Center retreats and seminar series. Funds for National 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 National Enrichment Program.

Travel: Travel funds to support visiting scientists under the auspices of the National 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 CDTR 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 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 (National Enrichment Program)

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

Research Strategy: Describe plans for the National 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 precluded by NIH or NIDDK policies, are encouraged.

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

For renewal applications: Describe the existing National 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 National Enrichment Program.

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 innovative, cutting-edge diabetes translation research topics to advance careers of early-stage investigators; coordinate with involvement of all other CDTR directors and NIDDK staff; promote a virtual Community of Practice or learning community to engage a larger number of early-stage investigators than those who attended the symposium; include a community engagement component; focus on workforce development topics beneficial to early-stage investigators and new investigators to the field and a scientific research gap; promote opportunity for early-stage investigators and senior investigators before/after symposium to 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 (should address scientific gaps and opportunities to engage early-stage investigators and communities in all phases of small and large projects), journal article, or another outlet widely available to relevant scientific communities and stakeholders; identify research gaps in the field that CDTRs could address through consultative services; and include an evaluation component (e.g., participant survey). Symposium participants must include early-stage investigators affiliated with the CDTR program as well as early-stage investigators and faculty attendance or mentorship involvement from Historically Black Colleges and Universities, Hispanic-serving institutions, Tribal colleges, and other minority-serving institutions. The outreach strategy for engaging early-stage investigators outside the CDTR program must be included. 

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 subpopulation 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 organizations (e.g., academic institutions, healthcare systems, cross-sector entities) may also be solicited to inform symposium activities as appropriate.

The symposium must be an in-person meeting and conducted three times during the funding period (at a different CDTR site each time) with a documented summary of key findings provided to the NIDDK that is also broadly disseminated. The symposium is expected to consist of 1.5 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. 

Other Attachments:

Specific names provided for Other Attachments must be no more than 50 characters including spaces.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

Budget forms provided for each activity code are listed in the application package at https://grants.nih.gov/grants/how-to-apply-application-guide.html; Application Forms and Activity Mapping can be found at: NIH Application Forms and Activity Code Mapping.

R&R or Modular Budget ( National Enrichment Program)

All instructions in the How to Apply- Application Guide must be followed.

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to 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 Resource 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 project 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 project proposed).

As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.

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.

Significance

Does the project 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 project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO:

Evaluate how well the proposed CDTR focuses 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, improving population health, or novel, priority translational research areas? How will the proposed CDTR resources and expertise enhance and advance diabetes translational science spectrum 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 there proposed short-, mid-, and long-term plans that describe the CDTR’s approach to attracting and retaining new and junior investigators with backgrounds underrepresented in the biomedical research workforce for the purposes of CDTR membership, partnership models, and the P and F applicant pool?

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?

Investigator(s)

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 CDTR 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 CDTR?

Specific to this NOFO: How 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?  How are 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?

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?

Innovation

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

Specific to this NOFO: How successfully does the Center appear to encourage innovative ideas through their P and F Program? To what extent do the Cores provide new methods, techniques, and/or resources and demonstrate the ability to adapt when needed to support investigators in emerging areas of diabetes translational research, as appropriate to the purpose of the Core and the research supported by the Center? 

In addition, for applications involving clinical trials

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

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

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

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?

Environment

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

Specific to this NOFO: How supportive is the institutional commitment to the Center program's management and scientific impact? Is there evidence of institutional commitment to the Center program, including among institutions involved in the National/Regional Resource Core, if proposed? Is there clear potential for interaction with scientific investigators and relevant collaborators from other departments and institutions?

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria - Overall

As applicable for the project 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)?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project 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 or 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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not applicable.

Renewals

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

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

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

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

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

How 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?

Revisions

Not applicable.

 Not Applicable.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

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 policies and practices, 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 will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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).

Prior Approval of Pilot Projects

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Awardees will provide updates at least annually on implementation of the PEDP.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help  (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Shavon Artis Dickerson, DrPH, MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-3055
Email: [email protected]

Michele Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: [email protected]

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: 301-594-8853
Email: [email protected]

Section VIII. Other Information

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 2 CFR Part 200.