Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

  • December 22, 2015 - This RFA has been reissued as RFA-DK-16-010.
  • Components of Participating Organizations
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (

    Title:  Limited Competition for the Continuation of the NIDDK Gastroparesis Consortium (U01)

    Announcement Type
    This is a reissue of RFA-DK-05-004.

    Update: The following update relating to this announcement has been issued:

    Request For Applications (RFA) Number: RFA-DK-10-502

    Catalog of Federal Domestic Assistance Number(s)

    Key Dates
    Release Date: May 17, 2010
    Letters of Intent Receipt Date: June 21,2010
    Application Receipt Date: July 19, 2010
    Peer Review Date: October 2010
    Council Review Date: February 2011
    Earliest Anticipated Start Date: April 1, 2011
    Additional Information To Be Available Date (Url Activation Date): Not Applicable
    Expiration Date: July 20,2010

    Due Dates for E.O. 12372

    Not Applicable

    Additional Overview Content

    Executive Summary

    Table of Contents

    Part I Overview Information

    Part II Full Text of Announcement

    Section I. Funding Opportunity Description
    1. Research Objectives

    Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

    Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        B. Eligible Individuals
    2.Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

    Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
        A. Receipt, Review and Anticipated Start Dates
             1. Letter of Intent
        B. Sending an Application to the NIH
        C. Application Processing
       D.  Application Assignment
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

    Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Anticipated Announcement and Award Dates

    Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
         A. Cooperative Agreement Terms and Conditions of Award
             1. Principal Investigator Rights and Responsibilities
             2. NIH Responsibilities
             3. Collaborative Responsibilities
             4. Dispute Resolution Process
    3. Reporting

    Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

    Section VIII. Other Information - Required Federal Citations

    Part II - Full Text of Announcement

    Section I. Funding Opportunity Description

    1. Research Objectives

    The purpose of this Limited Competition is to invite applications from the participating clinical sites and the Data Coordinating  Center (DCC)  that have participated in the Gastroparesis Consortium, and therefore have continued access to the cohort of patients and the data from the prospective observational study of Gastroparetic patients.  The primary objectives of this initiative are to continue follow-up of the well-characterized and highly motivated gastroparetic patients and to continue ongoing trials that have been initiated and to provide a platform for informative ancillary studies.

    The NIDDK Gastroparesis Clinical Research Consortium (GPCRC) is a cooperative network of six clinical centers and one Data Coordinating Center (DCC) . One of the missions of the GPCRC is to improve the understanding of Gastroparesis by conducting multicenter, observational studies on well characterized patients with Gastroparesis. 

    The Gastroparesis Registry was implemented as an observational study of patients with Gastroparesis. Initial recruitment for most sites began in 2006, and final patient follow-up studies are planned through March 2011. The Registry consists of 569 patients meeting specific entry criteria with symptoms of at least 12 weeks duration, gastric emptying assessed with scintigraphy, and no abnormality causing obstruction as seen by upper endoscopy.  Initial Registry data at enrollment are extensive and include detailed history and physical examinations, validated symptom questionnaires including Patient Assessment of Upper Gastrointestinal Disorders Symptoms Severity Index (PAGI-SYM), upper endoscopy results (within 1 year of enrollment), 4 hour gastric emptying scintigraphy results (within 6 months of enrollment), laboratory tests including hematology and blood chemistries. 

    The major goals of the Gastroparesis Registry were to establish a cohort of 500 well-characterized patients with Gastroparesis with various etiologies.  This goal has been met. Other goals of the GP registry were to prospectively and systematically follow a well-characterized cohort to define the natural history and clinical course of Gastroparesis. This GP registry has allowed the Consortium to establish and maintain a database of enrolled subjects which provide a reliable resource for rapid recruitment of well-characterized patients for several ongoing studies. In addition, the Registry has provided opportunities to study pathologic changes in the gastroparetic stomach. Thus, some recent data suggest a pathophysiological link between interstitial cells of Cajal (ICC) numbers and electrophysiology changes and GP symptoms.

    Also, preliminary findings from the Gastroparesis consortium suggest that idiopathic Gastroparesis is a disorder that particularly affects young women. Half of cases presented acutely, often in association with an initial infectious prodrome.  Many patients with idiopathic Gastroparesis were overweight or obese. The data suggest that idiopathic Gastroparesis is a phenotypically diverse syndrome with substantial variations in symptom severity related to gender, body mass, type of symptom onset and degree of delayed gastric emptying. These results provide the basis for ongoing studies to determine whether these variations relate to differences in pathogenesis and whether they impact on the clinical course of this disorder.

    Gastroparesis has been shown to complicate both type 1 and type 2 diabetes.  Preliminary findings from this consortium show that clinical features are significantly different in patients with Gastroparesis secondary to type 1 versus type 2 diabetes.  Type 2 patients are older, exhibit greater body mass, and report increased prevalence of early satiety and constipation prompting physician evaluation.  Patient-rated overall Gastroparesis severity and severity of individual symptoms are similar in the two subtypes.  Increases in the prevalence of severe retention on gastric scintigraphy and poor glycemic control in type 1 diabetes poses significant challenges for the clinicians. 

    One objective of this Limited Competition is to provide support to continue following the well-characterized cohort of gastroparetic patients and begin to utilize the NIDDK Repository of stored samples to answer important questions, but not limited to those listed below, such as:

    In addition, another objective would be the continued support of the currently approved feasibility study on Potential Efficacy of Continuous Glucose Monitoring(CGMS) and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) at all clinical sites. The objective of this multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS in guiding insulin pump therapy for 24 weeks, and to determine the feasibility of achieving improved glycemic control with CGMS guided insulin pump therapy in patients with diabetes and Gastroparesis.

    Furthermore, the limited competition also affords the ongoing clinical centers to actively recruit patients for two innovative treatment trials.  One ongoing trial assesses the effectiveness of   Neurokinin 1(NK1) receptor antagonist  to improve nausea as compared with placebo in patients with symptoms of Gastroparesis. In another ongoing multicenter, randomized, placebo-controlled trial, the clinical centers are determining whether treatment with a low dose tricyclic antidepressant will improve Gastroparesis symptoms compared with placebo. In addition, this trial will determine the effects of this drug and placebo on gastric emptying, breath testing, satiety testing, and electrogastrography in patients with idiopathic Gastroparesis.

    It is anticipated that this initiative will provide data that will enhance our understanding of the natural history of Gastroparesis and also  greatly enhance the evaluation and treatment of patients with Gastroparesis.

    In addition, the Gastroparesis Registry can serve as a platform for informative ancillary studies that could utilize the well-characterized patient cohort. 

    It is anticipated that interested collaborative groups would follow established ancillary studies policies and procedures approved by the Gastroparesis Steering Committee.  It is also anticipated that collaborating investigators would provide the additional requisite resources for conducting approved clinical studies.  

    See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

    Section II. Award Information

    1. Mechanism of Support

    This funding opportunity will use the NIH Cooperative Agreement (U01) award mechanism.
    The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

    This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see 

    This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

    2. Funds Available

    The NIDDK intends to commit approximately $4.0 million dollars in 2011 to fund six participating clinical centers and one Data Coordinating Center (DCC) in response to this Limited Competition.  An applicant may request up to $300,000 direct costs per year. An applicant with a subcontract for a patient recruitment site may request over $300,000 in direct costs, however, for costs that are commensurate with the number of Gastroparetic patients recruited at the subcontracted site.  Applicants may request up to five years of funding.  Although the financial plans of the NIDDK provide support for this program, awards pursuant to this Limited Competition are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

    Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

    Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

    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

    1.A. Eligible Institutions

    The following organizations/institutions are eligible to apply:

    1.B. Eligible Individuals

    Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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 program support.

    More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see for instructions).

    The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see

    You may submit an application if your institution received an award under the Gastroparesis Consortium.

    2. Cost Sharing or Matching

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

    3. Other-Special Eligibility Criteria

    Number of Applications. Applicants may submit only one application.

    Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

    Renewals. Renewal applications are permitted in response to this FOA.

    Section IV. Application and Submission Information

    1. Address to Request Application Information

    The current PHS 398 application instructions are available at in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

    Telecommunications for the hearing impaired: TTY 301-451-5936.

    2. Content and Form of Application Submission
    Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (

    Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form.

    The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

    Applications with Multiple PDs/PIs

    When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

    All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

    Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, ” Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

    If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

    Additional information is available in the PHS 398 grant application instructions.

    3. Submission Dates and Times

    Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

    3.A. Receipt, Review and Anticipated Start Dates
    Letter of Intent Receipt Date:  June 21,2010
    Application Receipt Date:  July 19,2010
    Peer Review Date:  October 2011
    Council Review Date:  February 2011
    Earliest Anticipated Start Date:  April 1, 2011

    3.A.1. Letter of Intent

    Prospective applicants are asked to submit a letter of intent that includes the following information:

    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.

    The letter of intent is to be sent by the date listed in Section IV.3.A.

    The letter of intent should be sent to:

    Francisco O. Calvo, Ph.D.
    Chief, Review Branch
    Division of Extramural Activities
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 752, MSC 5452
    Bethesda, Maryland 20892-5452
    Bethesda, Maryland 20817 (for courier service)
    Telephone: (301) 594-8897
    Fax:   (301) 480-3505

    3.B. Sending an Application to the NIH

    Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

    Center for Scientific Review
    National Institutes of Health
    6701 Rockledge Drive, Room 1040, MSC 7710
    Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
    Bethesda, MD 20817 (for express/courier service; non-USPS service)

    Personal deliveries of applications are no longer permitted (see

    At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:  

    Francisco O. Calvo, Ph.D.
    Chief, Review Branch
    Division of Extramural Activities
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 752, MSC 5452
    Bethesda, Maryland 20892-5452
    Bethesda, Maryland 20817 (for courier service)
    Telephone: (301) 594-8897
    Fax:   (301) 480-3505

    3.C. Application Processing

    Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

    The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

    Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at:

    4. Intergovernmental Review

    This initiative is not subject to intergovernmental review.

    5. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

    Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

    The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement

    6. Other Submission Requirements

    Applications for the Clinical Centers (CCs) who plan subcontracts must include a designated principal investigator (PI) for the subcontract.  There must be a detailed plan for communication and cooperation between the Clinical Center Director and the PI of a subcontract to the clinical center.

    Applications for the CCs should demonstrate their accomplishments related to their participation in previous collaborative projects within the GPCRC (e.g., recruitment of subjects, committee membership or chairmanship, protocol development, publications, etc.).  The PI of a subcontract in the GPCRC should demonstrate their experience and expertise in conducting collaborative clinical research studies.  The CC application must provide detailed plans for future subject recruitment and retention related to the ongoing research studies of the GPCRC.

     Each CC submitting an application in response to this FOA must provide evidence of their ability to carry out the protocols already approved by the GPCRC.

    Each CC must show how they will be able to submit data in a timely manner to the DCC and biospecimens to the NIDDK Repositories (supported by an independent contract from NIDDK).

    CCs must show how they will work in collaboration with the DCC 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 past contributions to and future plans for involvement with operational committees of the GPCRC (e.g. Recruitment, Publications, etc.) and the establishment of uniform procedures and policies.

    Each CC application must describe their plans for retaining study subjects, so that a longitudinal assessment of GPCRC can be accomplished according to the approved protocols. Plans for follow up and retention of subjects enrolled in the clinical trials must also be included in the application. Each application should describe specific barriers to the retention of the patient population at their clinical sites and discuss how they plan to address these barriers.

    There should be evidence of strong institutional support for the CC, including adequate space in which to conduct clinical and research activities and office space for staff. Institutional resources for patient care and follow-up including personnel, space, and special laboratory facilities must be described in the CC application.

    An organizational structure for the CC should be set forth in the application, delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow commonly agreed upon protocols. The principal investigator of a subcontract and the Institution(s) should indicate his/her willingness to participate in a per patient basis for operational costs of patient recruitment and retention, and follow up.

    Supplemental Instructions for Data Coordinating Center (DCC)

    The application for the DCC should describe the previous research accomplishments of the GPCRC, as well as its overall prospective research plan, including its operational infrastructure (committees, procedures for coordination and communication, etc). It is expected that the PI of the DCC will carry out a significant leadership role in the consortium. The DCC must describe all the protocols that have been approved by the GPCRC that will be continued and include the structure of the database of information being collected on all subjects.

    The DCC applicant must also address the following regarding responsibilities and requirement for the DCC:

    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 must explicitly indicate their willingness to:

    1. Participate in Steering Committee meetings (expected to occur in person 3-4 times a year in or near the Baltimore, MD area and as monthly teleconferences, or as needed), site visits required by the NIDDK, and regular telephone conference calls;

    2. 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;

    3. 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;

    4. Actively seek to implement each consortium-wide protocol approved by the DSMB and the NIDDK that the site is selected for participation;

    5. Comply with all study policies and quality assurance measures approved by the Steering Committee;

    6.  Agree to oversight of the study by a Data and Safety Monitoring Board (DSMB);

    7. Accept awards for the support of research based on per-patient (capitated) rates and the actual numbers of subjects enrolled, followed, and completing the study (Clinical Centers only);

    8. Transmit study data to the Data and Coordinating Center in a timely and accurate manner (Clinical Centers only);

    9. Report all adverse events in accordance with procedures established by the Steering Committee and NIDDK policies;

    10. Cooperate with other awardees in the publication of study results and the eventual release to the scientific community of study procedures and other resources;

    11.  Serve on and chair subcommittees and protocol committees as assigned by the steering committee or the NIDDK;

    12. Accept the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A “Award Administration Information”.

    PHS398 Research Plan Sections

    All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:


    This FOA uses non-modular budget formats described in the PHS 398 application instructions (see 

    Appendix Materials

    All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See

    Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

    Resource Sharing Plan(s)

    NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See

    (a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or

    (b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

    (c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and

    The DCC application should include an overall sharing plan for data generated during the funding of the GPCRC.  CC applications need not cite this plan in detail, but applicants should indicate their willingness to participate fully in it.  The plan should indicate specifically what will be shared, with whom it will be shared (including the NIDDK Data Repository), when it will be shared, by what means it will be shared, and what conditions will apply to recipients of shared data.  This plan must be approved by the NIDDK before awards will be issued under this FOA.

    Section V. Application Review Information

    1. Criteria

    Only the review criteria described below will be considered in the review process.

    2. Review and Selection Process

    Review Process

    Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by  the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  and in accordance with NIH peer review procedures (, using the review criteria stated below.

    As part of the scientific peer review, all applications will:

    The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support 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/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed). 

    Scored Review Criteria

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

    Significance.  Does the project address an important problem or a critical barrier to progress in the field?  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?

    Investigator(s).  Are the PD/PIs, 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? Additionally, do the specific competence and previous experience of the professional, technical and administrative staff of the CC or the DCC increase the likelihood the goals of the research plans will be achieved? Is there evidence that the adult and pediatric components will work together to achieve the goals of the GPCRC?  Are the expertise, training, and experience of the investigators and staff, including the administrative abilities of the Principal Investigator and co-investigators at the DCC, and the time they plan to devote to the effective coordination of the GPCRC adequate?

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

    Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  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?
    If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

    Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Do the collaborative arrangements within the proposed Network enhance the productivity of the CC or DCC? Are the facilities, equipment, environment and organizational structure of the DCC adequate to effectively coordinate the GPCRC activities in implementing the protocols, data collection and providing for specialized methodologies and plans for collecting and distribution of biospecimens to the NIDDK repositories, biological cores, ancillary study investigators adequate.

    Additional Review Criteria

    As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

    COMMITMENT:   Is there evidence of commitment to continue to conduct the approved studies of the GPCRC? Is there evidence of a strong willingness to work cooperatively and to participate in all aspects of a cooperative network including service on subcommittees and authoring publications and proposals?

    Review of the CC applicants will also be based on the following specific criteria:

    Recruitment and Retention:  Is there evidence that the CC will be able to meet recruitment goals and retention of research subjects in GPCRC approved studies?  Have they demonstrated their willingness and ability to recruit and retain these patients in clinical trials and epidemiological studies?

    Data and Sample Management:  Is there an adequate plan to ensure the timely and accurate transmission of study data to the DCC and patient samples to the NIDDK repositories?

    Review of the DCC application also will be based on the following specific criteria:

    Is there understanding of the scientific, statistical, logistical, and technical issues underlying the GPCRC multi-center studies and knowledge necessary to lead in the areas of biostatistical study design, statistics, logistics, data acquisition and management, identification of and coordination with drug distribution centers and serum/tissue/data repositories, handling of laboratory specimens, quality control, data analysis, and consortium coordination?

    Are the proposed plans for acquisition, transfer, management, and analysis of data, quality control of data collection and monitoring, and overall coordination of the GPCRC adequate?

    Is there ability to develop or modify the Data Safety and Monitoring Plan, Manuals of Operations and Case Report Forms for the Networks multiple sites and studies?

    Is there ability to support the NIDDK in filing the necessary paperwork for INDs to the Food and Drug Administration?

    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.

    Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

    Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see

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

    Resubmission Applications.  Resubmissions are not allowed for this FOA.

    Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

    Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    Additional Review Considerations

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

    Applications from Foreign Organizations.  Foreign Organizations are not allowed.

    Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (; and 3) Genome Wide Association Studies (GWAS) (

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

    Selection Process

    The following will be considered in making funding decisions:

    3. Anticipated Announcement and Award Dates

    Not Applicable.

    Section VI. Award Administration Information

    1. Award Notices

    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.

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

    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. See Also Section IV.5. Funding Restrictions.

    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 (

    The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

    2.A. Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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.

    2. A.1. Principal Investigator Rights and Responsibilities  

     The Principal Investigator will have the primary responsibility for the conduct of the study.  This will include any changes in study protocol that need to be made, coordination of IRB clearances, oversight of all sub-contracts, quality control, recruitment of study subjects, analysis of study results and close-out activities related to the GPCRC.

    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 HHS, PHS, and NIH policies.

    2. A.2. NIH Responsibilities

    An NIH Project will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

    The NIDDK Project Scientist will assist the Principal Investigators through the Steering Committee in carrying out the study.  The Project Scientist will have substantial scientific-programmatic involvement in assisting in protocol refinement, quality control, interim data analysis, final data analysis and interpretation, preparation of publications, and will provide assistance in coordination and performance monitoring.  The NIDDK Project Scientist will also serve as a member of the Steering Committee.

    Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

    2.A.3. Collaborative Responsibilities

    The Steering Committee, composed of the Principal Investigators of the Clinical Centers, and the principal investigator of the DCC, the Chairperson of the Steering Committee, and the NIDDK Project Scientist, will be the main governing board of the study.  This committee will have the primary responsibility for making any necessary changes to the study protocol, facilitating the conduct of participant follow-up and testing, monitoring completeness of data collection adherence to the protocol, timely transmission of the data to the DCC, and reporting the study results. It will also be responsible for establishing study policies in such areas as access to patient data and specimens, ancillary studies, publications and presentations, and performance standards.

    Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

    2.A.4. Dispute Resolution Process

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

    3. Reporting

    Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

    A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

    Section VII. Agency Contacts

    We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

    1. Scientific/Research Contacts:

    Frank A. Hamilton, M.D., MPH
    Division of Digestive Diseases and Nutrition
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 669, MSC 5450
    Bethesda, Maryland 20892-54508
    (for Express or Courier service use Zip code 20817)
    Telephone:  (301) 594-8877
    Fax:  (301) 480-8300

    2. Peer Review Contacts:

    Francisco O. Calvo, Ph.D.
    Chief, Review Branch
    Division of Extramural Activities
    National Institute of Diabetes, Digestive, and Kidney Diseases
    6707 Democracy Boulevard, Room 752, MSC 5452
    Bethesda, Maryland 20892-5452
    Bethesda, Maryland 20817 (for courier service)
    Telephone: (301) 594-8897
    Fax:   (301) 480-3505

    3. Financial or Grants Management Contacts:

    Mrs. Diana Ly
    Grants Management Specialist
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 725
    Bethesda, Maryland 20892-5456
    Telephone: (301) 594-3197
    Fax: (301) 594-9523

    Section VIII. Other Information

    Required Federal Citations

    Use of Animals in Research:
    Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

    Human Subjects Protection:
    Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (

    Data and Safety Monitoring Plan:
    Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

    Sharing Research Data:
    Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (

    Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

    Policy for Genome-Wide Association Studies (GWAS):

    NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see

    Access to Research Data through the Freedom of Information Act:
    The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

    Sharing of Model Organisms:
    NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

    Inclusion of Women And Minorities in Clinical Research:
    It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

    Inclusion of Children as Participants in Clinical Research:
    The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

    All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

    Required Education on the Protection of Human Subject Participants:
    NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at

    Human Embryonic Stem Cells (hESC):
    Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

    NIH Public Access Policy Requirement:
    In accordance with the NIH Public Access Policy ( investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (, to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at

    Standards for Privacy of Individually Identifiable Health Information:
    The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

    Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

    URLs in NIH Grant Applications or Appendices:
    All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

    Healthy People 2010:
    The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at

    Authority and Regulations:
    This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at

    The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

    Loan Repayment Programs:
    NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

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