Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Clinical Centers to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium (U01)

Activity Code

U01 Research Project Cooperative Agreements

Announcement Type

Reissue of RFA-DK-10-502

Related Notices

  • September 25, 2020 - This RFA has been reissued as RFA-DK-20-504.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)

Funding Opportunity Announcement (FOA) Number


Companion Funding Opportunity

RFA-DK-16-507, U01 Research Project Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)


Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for Clinical Centers (CCs) under the NIDDK Gastroparesis Consortium, to conduct studies on Gastroparesis (GP) to unravel the cellular and molecular mechanism implicated in GP, disease expression, quality of life issues, and develop new therapeutic interventions in GP.

The Consortium to be composed of a Scientific Data Research Center (SDRC) and Clinical Centers (CCs) will form multi-disciplinary teams to undertake a comprehensive clinical, epidemiological and biological characterization of patients with GP to gain insight into the pathophysiology of GP and its sequela: chronic abdominal pain, nausea and vomiting, poor metabolic control and impaired quality of life.

To achieve the goal of a comprehensive characterization of evolving Gastroparesis both in diabetic and non-diabetic patients, the Scientific Data Research Center (SDRC), under RFA-DK-16-507, will take on the administrative and data collection/analysis functions and will be responsible for the conduct of all of the ongoing and future studies of the CCs.

In addition, a major collaborative effort within the Consortium will be the establishment of an annotated repository of bio-specimens (blood stools and when feasible gastric tissue) to allow for the identification and validation of biomarkers for risk stratification and/or early detection.

Key Dates
Posted Date

December 22, 2015

Open Date (Earliest Submission Date)

February 2, 2016

Letter of Intent Due Date(s)

February 2, 2016

Application Due Date(s)

March 2, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2016

Advisory Council Review

October 2016

Earliest Start Date

December 2016

Expiration Date

March 3, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Gastroparesis (GP) is a chronic symptomatic disorder associated with delayed gastric emptying.

Gastroparesis predominantly affects young women (females outnumber males by a ratio of 4:1, the average age is 34). The symptomatic profile of gastroparesis includes nausea (90% of patients), vomiting (>80%), bloating (75%), early satiety (60%), and abdominal pain (~50%). Symptoms in individual patients can vary in both the combination of symptoms and their severity. Because of its chronic and often intractable nature, the disorder has a tremendous impact on both patients and society. Gastroparesis remains difficult to treat, in large part, because of the lack of knowledge of the underlying pathophysiology. Several factors have impeded the progress in this field including the paucity of patients seen by any one center, the absence of uniform diagnostic criteria, and the lack of generally available and reliable methods for physiological testing. Given the complexity of the problem, and the profound degree of morbidity associated with this disorder, an important need exists to study patients in a systematic manner. Such studies can best be achieved by recruiting patients and collecting data from multiple centers as part of a network of investigators focused on this disorder. In recognition of this fact, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established the Gastroparesis Clinical Research Consortium (GpCRC) in 2006 and renewed the consortium in 2010. Since many gaps still existed despite the progress of the consortium, in April 2015, an External Scientific Committee recommended support of the Consortium activities for another 5 years.

Research Objectives

Through the acquisition of a cohort of well-characterized patients and associated biospecimens (blood, stools and when feasible gastric tissue), the clinical research consortium will provide the resources and collaborative opportunities necessary for achieving many of the research objectives identified in the strategic plan of NIDDK for Gastroparesis.

The overriding objective of this research program is to pursue clinical research on Gastroparesis (both sporadic and associated with diabetes mellitus type 1 and 2 and obesity), by identifying and characterizing a large cohort of patients with gastroparesis to encourage translational research focusing upon elucidating the pathogenesis that will provide the basis for understanding the natural history and developing means of diagnosis, treatment and clinical management of Gastroparesis and its sequela: chronic abdominal pain, nausea, vomiting, poor metabolic control and impaired quality of life.

Applicants will be expected to propose studies that will further the objectives indicated above. While each applicant from a Clinical Center will propose protocols in their individual applications, the final studies to be carried out by the consortium will be determined by NIDDK. Examples of research objectives and questions the clinical center applicant may address include:

  • Genome-wide and epigenetic studies in patients with and without GP as well as diabetic and obese patients with and without GP, may unlock future clues to pathophysiology of GP.
  • Functional studies to determine the underlying causes of gastric motor disturbances. Such studies could include isometric force measurements, intracellular recordings and electrophysiology of specific cell types including ICC and smooth muscle cells. Further information regarding the coupling between pacemaker sites is also desirable.
  • What are key differences between idiopathic and diabetic GP? What mechanisms underlie phenotypic differences in symptom expression in Type 1 diabetics?
  • Better understanding of epidemiology, to define whether Functional dyspepsia and GP represent a spectrum of the same disease and better understand whether there are differences in genotypes and phenotypes. Role of gender in pathophysiology/symptom expression and response to treatment. Role of sex hormones in pathophysiology/symptom expression and response to treatment. Role of peptides/NTs important to obesity (Peptide YY, ghrelin, GLP-1, etc.) with possible links to an inflammatory component;
  • Institute clinical trials specific to disease subtypes to determine efficacy of treatment strategies to improve symptoms and outcome. Key endpoints for studies depend largely on symptom instruments, therefore future work on the role of quantitative markers of function (breath test, capsule, etc.) may be able to provide functional tools which correlate with symptoms and can be used as endpoints in therapeutic interventions in GP.
  • Is pain related to GP a peripheral or a central mechanism? Is nausea related to GP a central or peripheral process?
  • In patients with chronic unexplained nausea and vomiting (CUNV) with normal gastric emptying, what is the mechanism and how do they differ from those with delayed gastric emptying with and without Gastroparesis?
  • What are the mechanisms to account for hypervigilance in GP? Is this a sensory phenomenon in GP?
  • Are EGGs or other diagnostic tools used in GP effective and reliable tools to correlate with symptoms and disease severity? Do these tools predict response to therapy? Does it change management? Should we still be doing this?.
  • Exploration and design of new Patient Reported Outcomes (PRO) in future clinical trials.
  • Better understanding of the role of inflammation, to determine if it represents the key insult that bridges all GP etiologies
  • Better understanding of the role of obesity in the pathophysiology of idiopathic GP or type II GP
  • Is it Interstitial Cell of Cajal (ICC) cell number that s important, or ICC cell function (transmitters, up/down regulation of proteins)? What drives the change in Macrophage 1 vs. Macrophage 2 cell number and cell function?
  • Role of the microenvironment and smooth muscle cell/ICC/PDGFRa+ cell (SIP syncytium)? Influence of gender on ICCs and SIP syncytium? Is the SIP syncytium a surrogate marker for GP, or is this the key player? Are other cells as important?
  • What is the role/impact of the human microbiome and human virome on disease expression?

Addressing many of these objectives will require a multidisciplinary team, including:

  • Immunologists. One of the over-arching themes of discovery so far is that inflammation may play an important role in gastroparesis either from diabetes, obesity, prior infection or surgery. The altered macrophage function may be a manifestation of an inflammatory hit . The addition of an immunologist would help focus this component of the work of the consortium.
  • Neurobiologist/Pain management specialists. Given the role of pain and nausea in the syndrome, what is the role of central versus peripheral causation?
  • Nutritionists. There has been no work yet focused on nutrition except for a comment about fermentable carbohydrates (FODMAPs). Given the evidence that FODMAPs may be important in IBS, this might deserve further investigation. Addition of a nutritionist would aid in investigations into the significant number of obese patients with gastroparesis.
  • Psychologists. The instruments include SF36, Beck and other measures of psychological distress. Results could be mined from existing data to develop hypotheses for future study.
Organization of the Gastroparesis Clinical Research Consortium (GpCRC)

The GpCRC will consist of the following entities: The NIH, up to seven Clinical Centers (CCs), and one Scientific Data Research Center (SDRC), an Executive Committee, a Steering Committee and its subcommittees, a Data and Safety Monitoring Board (DSMB), and other committees as needed. The responsibilities of each entity of the Network are described in the Terms and Conditions of Award.

The NIDDK will be responsible for organizing and providing support for the GpCRC and will be involved substantially with the awardees as a "partner," consistent with the Cooperative Agreement mechanism. A designated NIDDK Project Scientist will provide programmatic oversight, will monitor subject recruitment and study progress, ensure disclosure of conflicts of interest and adherence to NIDDK policies. The NIDDK will appoint Chairperson(s) of the Steering Committee and all members of the DSMB. An additional NIDDK Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The Scientific Data Research Center (SDRC) will take on the administrative and data collection/analysis functions and will be responsible for the conduct of all of the ongoing and future studies of the Consortium. In addition, the SDRC will be responsible for supporting any protocol development or modifications; providing sample size calculations, statistical advice, questionnaires, and data analysis; supporting development, implementation, and maintenance of a data base of clinical information and blood samples; developing or modifying any data safety and monitoring plans; supporting manuscript preparation; maintaining web-based data entry, digital data storage, and automated electronic medical record downloads of data to a centralized database; and, providing overall study coordination and quality assurance, including coordination of the activities and meetings (including conference calls or face to face meetings) of the Data and Safety Monitoring Boards (DSMB), the Executive and Steering Committees, and other needed committees. The SDRC will prepare or modify protocols for submission to the DSMB and the Steering Committee for their approval prior to the implementation of any study protocols or protocol change. The SDRC will be responsible for preparation of documents for the Food and Drug Administration (FDA) in support of Investigational New Drug Applications (INDs) held by the NIDDK on behalf of the Consortium. The SDRC will prepare all reports including data reports for review by the DSMBs at their meetings. The SDRC will provide DSMB meeting logistics and provide planning logistics in conjunction with the NIDDK. The SDRC will also be responsible for the logistics and planning of the meetings of the Steering Committee and the various operational committees of the GpCRC. The SDRC will be responsible for acquiring and administering subcontracts as needed (see Terms and Conditions of Award). The SDRC is also responsible for movement of biological samples, and deposition of data and samples in the NIDDK Repository. The SDRC will work with the NIDDK Repository and the CCs to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repositories and dispensed to steering committee approved ancillary study sites. In addition, the SDRC will coordinate with the NIDDK Data and Biospecimen Repository to prepare the collected data and biosamples for eventual archiving and distribution as per NIDDK policy ( ). All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time.

Study Governance

Steering Committee. The Steering Committee will be the main governing body of the SDRC (see the Terms and Conditions of Award). The Steering Committee will be composed of the Program Directors/Principal Investigators (PDs/PIs) of each CC in the Consortium, the PD/PI of the SDRC, the NIDDK Project Scientists and the NIDDK Program Official. Study Co-Chairs will be appointed by NIDDK. The Steering Committee will have primary responsibility for the general organization of the GpCRC, and approval of publications and ancillary studies. The Steering Committee will be responsible for the conduct and monitoring of studies and reporting study results. Topics for investigational and treatment protocols will be proposed and prioritized by the Steering Committee. Other subcommittees of the Steering Committee will be established and will operate as necessary, such as publications, ancillary, protocol, pathology and radiology. All face to face Steering Committee, DSMB, and other necessary face to face meetings requiring the presence of NIDDK personnel will be held in the Washington, DC/Baltimore metropolitan area or other suitable venue.

Executive Committee. An Executive Committee will be comprised of Study Co-Chairs (appointed by NIDDK), the PD/PI of the SDRC, the NIDDK, and NIDDK Program Official. The Chair of the Executive Committee will be appointed by the NIDDK. The Executive Committee will be convened to effect management decisions required between Steering Committee meetings, as required for the function of the Consortium. Other NIDDK and SDRC personnel, as deemed necessary by the Project Scientists and Program Official, may also be included.

Data and Safety Monitoring Board. An independent Data and Safety Monitoring Board (DSMB) will be established by the NIDDK and ad hoc members from other NIH institutes, as necessary, to review protocols and monitor patient safety and performance of each study. As a part of its responsibilities, the DSMB will submit recommendations to the NIDDK regarding the continuation of each study. The DSMB will be responsible for final approval of the Data and Safety Monitoring Plan developed by the SDRC. All protocols or changes to protocols will be approved by Institutional Review Boards, the Steering Committee, the Data and Safety Monitoring Board, and the NIDDK before initiation.

Other Special Performance Requirements

The GpCRC will continue to be a collaborative effort that will require frequent interactions of awardees among themselves and with the NIDDK. Applicants are expected to:

  • Participate in Steering Committee meetings (expected to occur in person 3-4 times a year in the Washington DC/Baltimore metropolitan area or other suitable venue), and as monthly (or as needed) teleconference, site visits as required by the NIDDK and regular subcommittee telephone conference calls;
  • 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 Steering Committee any applicant institutional specific clinical studies that may overlap with the clinical activities of the GpCRC;
  • 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 Steering Committee;
  • Actively seek to implement each consortium-wide protocol approved by the DSMB and the NIDDK that the site is selected for participation;
  • Comply with all study policies and quality assurance measures approved by the Steering Committee;
  • Agree to oversight of the study by a Data and Safety Monitoring Board (DSMB);
  • Transmit study data to the Coordinating and Data Management Center in a timely and accurate manner (Clinical Centers and subsites only);
  • Report all adverse events in accordance with procedures established by the Steering Committee, and NIDDK and 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 steering committee or the NIDDK; and
  • Accept the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A Award Administration Information".
See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed


The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $4.3 million to fund up to six Clinical Centers and one Scientific Data Research Center (SDRC), through this FOA and RFA-DK-16-507, respectively.

Award Budget

Application budgets for the clinical centers are limited to $250,000 in direct costs per year. Application budgets should reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)


  • 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)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession


  • 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

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. This means that the NIH will not accept:

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

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at

2. Content and Form of Application Submission

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

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

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, preferably electronically, should be sent to:

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, Maryland 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: 301-594-8897

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: The following attachments must be included in the application.

1. Clinical Protocol Synopsis

The file name "Clinical Protocol Synopsis.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

The clinical protocol synopsis must include the following information:

  • A description of the study population in aggregate for the entire study, including participant eligibility and inclusion/exclusion criteria;
  • Approaches to be used for recruitment, retention and follow-up of procedures, including a discussion of any anticipated changes in the composition of the study population over the course of the study, for example, owing to relocation and/or aging of the population under study;
  • A description of the ability of clinical centers to retain their participant population, including a table showing the past retention and the demographics of the available population at every site;
  • Descriptions of all clinical, laboratory, physiological, and/or behavioral tests to enable the research questions to be answered; and
  • A description of each clinical site and how data from the sites will be obtained, managed, and protected; A description of the data management and quality control plan
  • Applications that lack the Clinical Protocol Synopsis are incomplete and will not be peer reviewed.

2. Statistical Analysis Plan

The filename "Statistical Analysis Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

The applicant(s) should describe the statistical methods to be used, including the sample size and power calculations and plans for the primary and secondary analyses. This plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study.

3. Data and Safety Monitoring Plan (DSMP)

The filename "Data and Safety Monitoring Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

The DSMP should be commensurate with the risk level of the proposed clinical research and must be included for all clinical trials (see:

and multi-center clinical studies. Information about DSMPs is available on the NIDDK website:

All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems, as applicable) to the applicable regulatory agencies (e.g., Institutional Review Board (IRB), the Office of Human Research Protections, and the Data and Safety Monitoring Board.

The DSMP should be site-specific and must address the following areas:

  • What will be monitored and by whom;
  • Methods to assure participant safety and privacy
  • How any reportable events will be managed and reported.
SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

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. 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.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

The Research Strategy section should include:

  • A discussion of the significance of the problem being studied, the need for the study, and the potential impact of the results of the study, as well as how the study will test the hypothesis(es) proposed. A description of and rationale for the proposed study design;
  • A discussion of progress made during previous funding periods; A concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the study;
  • A description of the protocol(s) to be followed, including a discussion of potential biases or challenges in the protocol and how they will be addressed. Applications must discuss (1) exclusion and inclusion criteria for selecting samples as cases or controls; and (2) discuss procedures for acquiring samples and obtaining clearances from State and regulatory authorities, including those from an institutional review board (IRB).
  • A brief description of how the statistical methods described in Statistical Analysis Plan.pdf support the planned research strategy including the underlying assumptions (and data) used to link power calculations to the endpoints and to the hypothesis(es) being tested;
  • A brief acknowledgement of responsibilities as part of a multi-center, collaborative project.
  • In this section, there should be sufficient description of the items listed above to permit thorough evaluation of the proposed study. Technical details contained in the 'Clinical Protocol Synopsis', statistical analysis plan, and data and safety monitoring plan can be referenced from within the Research Strategy section, in order to avoid duplicating text.

Clinical Center (CC) PD/PI should describe willingness to work collaboratively with other members of the Consortium, the Scientific Data Research Center (SDRC), the Data Safety Monitoring Board and the NIDDK Central repository. CC applicants (including subcontract sites) should describe how they will be able to submit data to the SRRC and biospecimens to the NIDDK Repositories (supported by an independent contract from NIDDK) and to central laboratories and biological cores as approved by the Steering Committee. CCs must show how they will work in collaboration with the SDRC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as established by the study protocol. CCs must also provide information regarding future plans for involvement with operational committees of the Consortium (e.g. Recruitment, Publications, etc.) and the establishment of uniform procedures and policies.

In addition, the applicants for Clinical Centers must propose protocols to be carried out by the consortium.

Applicants must include descriptions of any plans for interacting with potential private sector collaborators.

Applicants must document the ability to recruit patients, procure specimens prospectively, collect epidemiological and clinical data using previously developed Common Data Elements, and to process, track, and store specimens. Applicants should describe in detail any proposed retrospective and/or prospective specimen collections that will be used for Consortium activities. The description should include information on the types of patients and control subjects to be accrued, clinical information to be collected, and types of specimens to be collected.

An organizational structure for the CC should be set forth in the application, delineating specific personnel (e.g., pathologists, radiologists, neurobiologist, nutritionists, etc.) available to carry out the approved protocols. The PD/PI should state his/her general support of collaborative research and interaction with the NIDDK, the other CCs, and the SDRC through the Network concept.

If feasible, future clinical study protocols may be overseen by a centralized IRB. Investigators are encouraged to express willingness to consider this model or comment on barriers to implementation of centralized IRB review and ongoing oversight at their individual institutions. In order to maximize the impact and efficiency of the GpCRC, investigators are requested to state willingness to present site-specific gastroparesis studies that may potentially conflict with the activities of the Consortium to the Steering Committee for comment and consideration as network-wide studies.

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

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

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

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

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to (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 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 on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Overall Impact

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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.


Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?


Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the applicant have an appropriate plan for interaction with potential private sector collaborators?

Do the key personnel provide unique expertise that is suited to the scientific mission of the GpCRC? Have the key personnel demonstrated an ongoing record of scientific accomplishments that are aligned with the GpCRC scientific objectives?


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? Future patient enrollment potential: Are the CC patient recruitment, enrollment, and retention plans sufficient to contribute to the long term follow up of patients? Is there an appropriate and feasible strategy to optimize retention and follow-up of patients enrolled in the GpCRC Registry?


Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the 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/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?


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

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.


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


Not Applicable


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


Not Applicable

Additional Review Considerations

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.

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

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 the National Institutes of Diabetes and Digestive and Kidney Diseases (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 FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). 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.
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 VI. Award Administration Information
1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

Cooperative Agreement Terms and Conditions of Award

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 (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(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). Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees 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 awardee/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 and completeness. Awardees 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, 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 awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.

7. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.

8. Reporting of the study findings. Awardees 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 awardee 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 awardees consistent with NIH and study policies.

9. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIDDK support; or special access to study results, primary data/summary information, or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party is permitted only after concurrence by NIDDK.

10. Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and steering committee policies on publications.

11. Maintaining confidentiality of information: The awardee(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 a company collaborating with the study.

12. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archiving and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The PI or his/her designee will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution. In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the study’s Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. Subsequently samples and data will be available to the wider scientific community in accordance with the NIH policy on Data Sharing ( and,, and, as well as the NIDDK policy for data sharing in multi-center and large single-center clinical studies

13. The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If trials conducted under this grant are applicable clinical trials subject to FDAAA, the sponsor or his/her designee will perform the mandatory study registration and reporting of study results to For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at In addition, grantees should be aware that clinical trials not covered by FDAAA may still require registration in an approved registry in order to be published, according to the guidelines issued by the International Committee of Medical Journal Editors (

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

An NIDDK Project Scientist with substantial involvement will:

1. Serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the awardees 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 Scientists or designee 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 awardees 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 NDDK Project Scientist or designee may coordinate activities among awardees 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 designee 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 identified in the Notice of Award will:

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 safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

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.

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.

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.

Appoint a Data and Safety Monitoring Board (DSMB) as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the DSMB.

Areas of Joint Responsibility include:

In addition to the interactions defined above, NIDDK Project Scientists and Awardees shall share responsibility for the following activities:

1. 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 awardees, 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 Scientists. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientists 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.

A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIDDK and by interacting closely with the awardees during protocol development and implementation.

2. External Study Oversight.

An independent Data and Safety Monitoring Board will be established by the NIDDK for Phase III clinical trials or other high risk studies as appropriate. An Observational Study Monitoring Board (OSMB) will be established for observational/epidemiologic studies. These Boards will review study progress, safety data and interim results, as appropriate, and provide guidance to the NIDDK.

Dispute Resolution

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CR Part 16.

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free) Customer Support (Questions regarding registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system:

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

Scientific/Research Contact(s)

Frank A. Hamilton, M.D., MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8877

Jose Serrano, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8871

Peer Review Contact(s)

Maria Davila-Bloom, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7637

Financial/Grants Management Contact(s)

Elizabeth Gutierrez
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8844

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.

Authority and Regulations

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

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