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 instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) requests a single source cooperative agreement application from the Pennsylvania State University Hershey Medical Center for the continuation of the Data Coordinating Center (DCC) for the currently funded T1DAPC. The DCC has been instrumental in providing all the administrative, regulatory, managerial, logistic, analytic and financial functions to establish and continue the research objectives of the T1DAPC.

Background
The spectrum of pancreatic diseases, including acute, recurrent, and chronic pancreatitis and the diabetes associated with these pancreatic diseases, represent some of the most challenging medical disorders of our time. Based on input from patient advocacy groups, diabetes, and gastroenterological professional societies and from the National Diabetes and Digestive and Kidney Diseases Advisory Council, in fiscal year 2022 the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC), a multidisciplinary research program composed of pancreatologists, endocrinologists, immunologists and radiologists to undertake a prospective longitudinal observational clinical study to investigate the incidence, etiology and pathophysiology of diabetes following acute pancreatitis (AP) with a particular emphasis on the autoimmune processes that result in T1D (the Diabetes Related to Acute Pancreatitis and its Mechanisms (DREAM) Study).

New onset diabetes that occurs within several years following AP can be diagnosed as type 1 diabetes (T1D), type 2 diabetes (T2D) or a form tied to exocrine pancreatic dysfunction and pancreas destruction, type 3c diabetes (T3cD). AP is an inflammatory disease of the exocrine pancreas that accounts for more than 300,000 hospitalizations, with health care costs exceeding $2 billion annually in the United States. AP may be due to gallstones, duct obstruction, trauma, a genetic predisposition to inappropriate activation of intra-pancreatic proteases, or the toxic effects of alcohol, drugs, infectious agents, or metabolites.

Pancreatogenic diabetes is likely the most common complication after AP, with a cumulative incidence reported to be between 23% and 40%. The temporal relationship between endocrine dysfunction and AP is highly variable and poorly described. For example, while the development of dysregulated glucose metabolism is common in patients with AP, it may have a reversible component such that hyperglycemia experienced during or shortly after AP may sometimes be resolved over time.

While prior studies have provided key observations regarding diabetes secondary to AP, conclusions have been limited by the sources of the data (clinical diagnosis or diagnostic coding for diabetes case ascertainment via chart reviews or administrative databases) and heterogeneity in study design. Definitive studies on the incidence rate and risk factors for diabetes secondary to AP require prospective, longitudinal follow-up with serial assessments of glycemic status and evaluation of potential patient- and disease-related factors. The DREAM Study undertaken by the T1DAPC was designed to directly investigate the incidence, etiology and pathophysiology of diabetes following AP with a particular emphasis on the autoimmune processes that result in T1D. This includes monitoring parameters such as the temporal relationship between AP and diabetes, relationship to pancreatitis severity, the roles of pancreatitis etiology, immunologic, genetic and genomic risk factors, environmental and biological factors, and potential discovery of biomarkers for the development of T1D and other forms of diabetes.

The T1DAPC investigators started recruiting patients in early 2022 and are poised to reach their enrollment target during the currently funded grant segment or early in the second cycle, and therefore the continuation of the T1DAPC will be largely focused on retention and longitudinal observation in the DREAM study, and on the collection of several associated biospecimens. Thereby, DREAM will provide substantial insight into the pathogenesis of diabetes that occurs after AP.

Research Objectives

The overriding objective of this research program is the continued assembly and longitudinal observation of the DREAM cohort. The DREAM study expects to enroll 1000 adult participants (age 18-75) at 0-90 days following an episode of AP. Those who did not have diabetes prior to AP (N=800) are monitored for diabetes status at 3, 6, 12, 24, and 36 months, and annually thereafter for the duration of the study using the oral glucose tolerance test (OGTT), and for autoantibodies and pancreatic function. Blood and stool are collected at all visits. Subsets of participants also undergo a mixed-meal tolerance test (MMTT), a frequently sampled intravenous glucose tolerance test (FSIGTT), or an abdominal magnetic resonance imaging (MRI) exam to monitor pancreas size, shape, architecture, fat content and function. In addition, MMTT and MRI will be conducted in participants who are diagnosed with new onset diabetes following AP during the course of the study. Diabetes will be characterized using biomarkers of T1D (anti-islet and anti-insulin antibodies), T2D (insulin sensitivity) and T3cD (basal and post-test meal levels of pancreatic polypeptide) to determine the prevalence of T1D and other forms of diabetes which occur after or as a consequence of AP.

Role of the Data Coordinating Center

The DCC will continue (1) to provide overall logistical support for the activities of the T1DAPC Steering Committee (SC) and its subcommittees and working groups; (2) to support all the administrative, regulatory, managerial, logistic, analytic and financial functions for accrual and longitudinal observation of T1DAPC patients as outlined in the DREAM study protocol, and approved ancillary studies. The DCC should execute all T1DAPC study protocols according to schedules and procedures contained in the study Manuals of Operations in collaboration with NIDDK staff and with the Clinical Centers (CC) and their affiliate sites at which participants are screened, enrolled, and assessed. Oversight of CC performance includes enforcing timeliness, and data and biospecimen quality; (3) to provide training and technical assistance to the CC in the course of their implementation of protocols, including screening, enrollment, treatment and follow-up assessments; (4) to collect, curate, manage and store all study data and provide it as needed to consortium members to support publications; (5) to manage subawards for patient costs, biospecimen analysis and other tasks as needed; (6) to develop, support and manage the T1DAPC biobank to process, safeguard and distribute the study biospecimens; (7) to design and support new studies for the conduct of studies approved by the T1DAPC SC; (8) to prepare reports and presentations for the T1DAPC’s DSMB and to collate replies to their questions; and (9) to prepare and transfer all study data and biospecimens to the NIDDK Central Repository at the close of the study. The applicant should review the NIDDK Policies for Clinical Researchers - https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers as it covers potential responsibilities delegated to a DCC.

Organization of the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)

The T1DAPC consists of NIDDK staff, up to ten CCs, and a DCC, and is governed by an Executive Committee, an SC and its subcommittees. It is overseen by an established Data and Safety Monitoring Board (DSMB). T1DAPC governance is set out in the Cooperative Agreement Terms and Conditions, section VI.2, and all applicants must agree to abide by them, and to cooperate with other consortium members.

Clinical Centers. Each CC is comprised of a multidisciplinary team of investigators (pancreatologists, endocrinology/diabetology, immunology, radiology), study coordinators and other staff needed for conducting assessments, assembling and transmitting data, and collecting, processing and shipping biospecimens. CCs are responsible for conducting the study and disseminating findings. The role of the CCs is described in RFA-DK-25-017.

Steering Committee. The SC is the main governing body of the T1DAPC and is composed of the PDs/PIs of each CC in the Network, the PDs/PIs of the DCC, the NIDDK Project Scientist(s) and the NIDDK Program Official. Each CC, the DCC, and the NIDDK Project Scientist(s) has one vote. The SC has the primary responsibility for the general organization of the consortium. The SC is responsible for the design, conduct and monitoring of studies and reporting study results. Topics for investigational and treatment ancillary protocols, and manuscripts are proposed and prioritized by the SC. Subcommittees of the SC will operate as necessary, such as those focused on diabetes, pancreatitis, immunology, publications, ancillary, protocol, pathology, and radiology.

Executive Committee. An Executive Committee will be composed of SC Co-Chairs, the PD/PI of the DCC, the NIDDK Project Scientist(s), and NIDDK Program Official. The Chair of the Executive Committee will be appointed by the NIDDK. The Executive Committee will be convened to prepare the agenda for the SC meetings and to effect management decisions needed between SC meetings, as required for the function of the Consortium. Other NIDDK and DCC personnel, as deemed necessary by the Project Scientists and Program Official, may also be included in this committee.

DSMB. An independent DSMB has been established by the NIDDK to review protocols and monitor subject safety and performance of the DREAM study. As a part of its responsibilities, the DSMB submits recommendations to the NIDDK regarding the continuation of the study. The DSMB is responsible for final approval of the Data and Safety Monitoring Plan developed by the DCC. All protocols or changes to protocols must be approved by the SC, the DSMB, and the NIDDK as well as a single Institutional Review Board that maintains reliance agreements at all participating Center institutions.

Other Special Performance Requirements

The T1DAPC will be a collaborative effort that requires frequent interactions of awardees among themselves and with the NIDDK Program Directors. Performance requirements are described in section VI.2.  The applicant is expected to:

• Provide logistics for and participate in meetings of the SC and its subcommittees. These occur monthly (or as needed) as teleconferences, with extended SC meetings twice each year. At least one of these should be in person in the Washington DC/Baltimore metropolitan area or other suitable venue);
• Participate in site visits as required by the NIDDK;
• Cooperate with other awardees in the development and design or modification of research protocols, and cooperate with other awardees in carrying out approved research protocols and disclose to the SC any applicant institutional specific clinical studies that may overlap with the clinical activities of the T1DAPC;
• Abide by common definitions; common methods for patient selection and enrollment; and common protocols, procedures, tests, and reporting forms as chosen by majority vote of the SC;
• Comply with all study policies and quality assurance measures approved by the SC;
• Manage all interaction with the single Investigational Review Board for the overall consortium:
• Agree to oversight of the study by a DSMB;
• Transmit study data to the NIDDK Central Repository as per the NIDDK policy for data sharing in multi-center and large single-center clinical studies;
• Transmit biospecimens to the T1DAPC biobank, as well as to the NIDDK central repositories;
• Report all adverse events in accordance with procedures established by the SC, and NIDDK and Food and Drug Administration (FDA) policies;
• Cooperate with other awardees in the publication of study results and the eventual release to the scientific community of study procedures and other resources;
• Serve on and chair subcommittees and protocol committees as assigned by the SC or the NIDDK;
• Accept the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2 “Award Administration Information”;
• Manage subawards to the CC for patient-facing activities;
• Manage all contracts for biospecimen storage and analysis, peripheral blood mononuclear cell analysis, autoantibodies, etc.;
• Manage electronic tools for data entry and storage, ensure data quality and completeness, and lead efforts for data analysis;
• Conduct site visits, data audits, manage missing data, keep track of biospecimens;
• Support as needed and manage subawards for MRI studies;
• Provide data to study personnel for analysis and manuscripts, etc.

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

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

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

• Only the following applicant is eligible to apply for this single source funding: Pennsylvania State University Hershey Medical Center. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed. 

Only the following applicant is eligible to apply for this single source funding: Pennsylvania State University Hershey Medical Center. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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 their 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.

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 NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Only a single award will be issued to Pennsylvania State University Hershey Medical Center. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. 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.

For this specific NOFO, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Investigators must submit a complete, justified, individual budget for each year of support requested. All costs requested and all changes in budgets after the first year should be clearly identified and justified. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating site if multiple sites or cores are proposed. (see Letters of Support in the PHS 398 Research Plan below).

In addition to the budget in support of the DCC (limited to $800,000 direct cost in year 1) in support of the functions outlined in Part 2. Section 1. Research Objectives, the DCC budget can include funds to support central laboratory services (up to $300,000/year, Total Cost); Research imaging services (up to $200,000/year, Total Cost); and T1DAPC Central repository services (up to $100,000/year, Total Cost). Requests for years 2-5 can be similar to year 1, and budget adjustments for those years may occur based on the availability of funds.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research strategy: The applicant for a DCC should describe their willingness to work collaboratively with other members of the Consortium, the Clinical Centers (CC), the Data and Safety Monitoring Board and the NIDDK Central Repository and to abide by SC governance.

The functions of the DCC can be divided into three categories: managerial/logistic, biostatistical scientific leadership, and analytic. The applicant should provide a complete description of their strategy to: (1) support all the operational aspects of the T1DAPC; (2) continue the accrual and follow up of patients in all Consortium approved clinical studies; and (3) design and support new studies (as selected by the T1DAPC Steering Committee).

The applicant should document their ability to execute all T1DAPC study protocols according to schedules and procedures contained in the study Manuals of Operations in collaboration with NIDDK staff and with the Clinical Centers at which participants are enrolled, treated, and followed. The applicant should document their scientific leadership to design and implement longitudinal studies with complete follow-up augmented by telehealth and electronic medical record / National Death Index linkage, ability to analyze longitudinal data obtained from the Clinical Centers and Affiliate Sites.

For the newly proposed studies, the applicant will be responsible of developing and updating standardized study forms; performing quality control on data supplied by the Clinical Centers and Affiliate Sites; editing and entering data into the master database; storing, retrieving, maintaining, protecting, reviewing, processing, and analyzing the data; preparing reports of the results of these assessments for presentations and publications; and transmitting data to the NIDDK Central Repository in a standardized format. The applicant must document their ability to protect patient confidentiality at all phases of the submission and analysis of data and ensuring the technical integrity and security of the data management systems.

The applicant must document their ability to assure adherence to all research plans by conducting site visits to monitor the quality of record keeping, source documentation, and accuracy of data entry as well as overseeing data quality control, including but not limited to regular data queries and data monitoring and cleaning to ensure data completeness and quality.

The applicant must document their ability to provide statistical support, expertise, and oversight throughout T1DAPC studies; by conducting interim and final analysis per protocols; collaborating with the clinical investigators in preparation of presentations and primary and secondary publications; and providing additional analysis at the request of the Data and Safety Monitoring Board (DSMB) and the NIDDK. The applicant must document their ability to implement study-wide communications, disseminate study materials such as protocol Manuals of Operations, forms, or other study documents, and develop and maintain the T1DAPC internal and public websites.

The applicant must describe their key role in the operational oversight of T1DAPC Clinical Centers and subcontractors. The DCC provides training and technical assistance to the Clinical Centers during their implementation of protocols, including screening, enrollment, and follow-up assessments. The DCC oversees all aspects of Clinical Center performance, including timeliness and quality of data and sample submission.

The DCC must demonstrate their ability to procure and administrate subcontracts for central laboratory and biobanking services.

The DCC will document their ability to provide administrative and logistical support services for the T1DAPC Working Groups, including preparation of publications and organization of periodic meetings, workshops, and conference calls. The DCC will also be responsible for preparing reports for the T1DAPC DSMB and bi-annual T1DAPC’s in person meetings. It will work collaboratively with the NIDDK and study investigators in preparation of papers for publication in the scientific literature.

Letters of Support: If parts of the costs of the application are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

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.

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 Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.

PHS Assignment Request Form

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

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). 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 the 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.

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.

Use of Common Data Elements in NIH-funded Research

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

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

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).

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.

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.

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

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

Applications will be assigned to the appropriate 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 National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKDAC).

. The following will be considered in making funding decisions:

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

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 his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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. 

NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

TERMS AND CONDITIONS OF COOPERATIVE AGREEMENT AWARDS

RESEARCH PROJECT APPLICATIONS FOR CLINICAL TRIALS, CLINICAL STUDIES, PREVENTION AND CONTROL INTERVENTIONS, AND EPIDEMIOLOGICAL STUDIES

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for:

1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.

2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Recipient(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Recipients will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.

3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.

4. Implementing collection of data specified by the study protocol. For a multi-center study, each recipient/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.

5. Establishing procedures for data quality, completeness, and security. Recipients are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee.

6. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual clinical sites. Such reports are in addition to the required annual noncompeting continuation progress report.

7. Reporting of the study findings. Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The recipient must also be adherent to Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with recipients consistent with NIH policies and network/consortium policies.

8. Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and network/consortium policies, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network/consortium studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network/consortium policies. Further, at the request of the NIDDK Program staff, any other network/consortium-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions)”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.”

9. Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network/consortium activities that includes access to any network/consortium generated resources (i.e., data and bio-samples), or study results that are not publicly available, or using the name of the network/consortium or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.

10. Maintaining confidentiality of information: The recipient(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study or network/consortium. Any exception requires written approval from NIDDK Program staff.

11. Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to exclusively use or share study generated resources until those resources are available to the public via a NIDDK approved repository per the NIDDK approved plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, bio-samples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. These resources will be available to the wider scientific community in accordance with the NIH Data Management and Sharing policy (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), per the NIDDK approved data management and sharing plan. 12. Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols, Steering Committee policies on publications, and the NIDDK approved Data Management and Sharing Plan.

13. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the recipient is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIDDK Project Scientist/Project Coordinator with substantial involvement will:

1. Serve as the contact point for all facets of the scientific interaction with the recipient (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Project Coordinator, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or Project Coordinator will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

4. Have substantial involvement assisting in the design and coordination of research activities for recipients as elaborated below:

a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.

b. The NIDDK Project Scientist or Project Coordinator may coordinate activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.

c. Reviewing procedures for assessing data quality and study performance monitoring.

d. The NIDDK Project Scientist or Project Coordinator may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

The NIDDK Program Official will be responsible for the normal scientific and programmatic stewardship of the award and identified in the Notice of Award.  The Program Official will:

1. Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, Data and Safety Monitoring Board (DSMB), and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

2. Review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by federal regulations.

3. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.

4. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

5. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Scientist or Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.

Areas of Joint Responsibility include:

In addition to the interactions defined above, NIDDK Project Scientist or Project Coordinator and Recipients shall share responsibility for the following activities:

Steering Committee

A Steering Committee organized by the study investigator(s) will be the main governing body of the study.

The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires, and other data recording forms, establish and maintain quality control among recipients, review progress, monitor patient accrual, coordinate, and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.

The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist or Project Coordinator. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist or Project Coordinator will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee. The NIDDK Program Official may serve as a non-voting member on the Steering Committee.

A Chairperson of the Steering Committee will be selected and voted on by the Steering Committee members. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and by interacting closely with the recipients during protocol development and implementation. The NIDDK Project Scientist or Project Coordinator may not serve as Chairperson. The NIDDK Program Official will review the Committee’s selection for potential bias, conflicts of interest, or lack of required expertise. If the Program Official has concerns regarding selection of the Chairperson which are not satisfactorily resolved, the Program Official may withhold concurrence if approved by the Director, Division of Extramural Activities, NIDDK based on written justification. In cases where Program Official concurrence is withheld, the Steering Committee will be required to make another selection.

External Consultants

An independent panel of External Consultants may be established by the Steering Committee. The External Consultants may periodically review interim progress of the project(s) and provide reports to the Steering Committee. Members of the panel of External Consultants may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special “opportunity pool” funds. The NIDDK Program Official will review the Committee’s selections for potential bias, conflicts of interest, or lack of required expertise. If the NIDDK Program Official has concerns regarding selection of one or more External Consultants which are not satisfactorily resolved, the NIDDK Program Official may withhold concurrence if approved by the Director of NIDDK Division of Extramural Activities based on written justification. In cases where NIDDK Program Official concurrence is withheld, the Steering Committee will be required to make another selection.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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.

4. Reporting

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.

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]

Aynur Unalp-Arida, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8879
Email: [email protected]

Paul A. Rushing, Ph.D. 
National Institute of Diabetes and Digestive and Kidney Diseases 
Telephone: 301-594-8895 
Email:  [email protected]

Karin Johnson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-443-3603
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.

This NOFO is supported under the authority of P.L. 116-59, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019; Section 1102. Diabetes Programs.