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

Discovery of Early Type 1 Diabetes Disease Biomarkers in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (U01 Clinical Trial Not Allowed)

Activity Code

 U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-17-021

Companion Funding Opportunity

None

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

 93.847

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) requests applications to explore human pancreatic tissues for the discovery of early biomarkers of T1D pathogenesis, the description of specific signaling or processing pathways that may contribute to the asymptomatic phase of T1D, the development of clinical diagnostic tools for the detection and staging of early T1D in at-risk or recently-diagnosed individuals, and/or the identification of therapeutic targets for the development of preventative or early treatment strategies. Successful applicants will join the Consortium on Beta Cell Death and Survival (CBDS), whose mission is to better define and detect the mechanisms of beta cell stress and destruction central to the development of T1D in humans, with the long-term goal of detecting beta cell destruction and protecting the residual beta cell mass in T1D patients as early as possible in the disease process, and of preventing the progression to autoimmunity. The CBDS is part of a collaborative research framework, the Human Islet Research Network (HIRN, https://hirnetwork.org), whose overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. This FOA will only support studies with a primary focus on increasing our understanding of human disease biology (as opposed to rodent or other animal models).  This FOA will not accept applications proposing a clinical trial.

Key Dates
Posted Date

February 15, 2018

Open Date (Earliest Submission Date)

April 10, 2018

Letter of Intent Due Date(s)

April 10, 2018

Application Due Date(s)

May 10, 2018 , 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.

No late applications will not be accepted for this Funding Opportunity Announcement.

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 2018

Advisory Council Review

October 2018

Earliest Start Date

December 2018

Expiration Date

May 11, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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

Background

Type 1 Diabetes (T1D) is a progressive immune-mediated disease that is preceded by an asymptomatic period of highly variable duration in humans. In addition to genetic susceptibility, it is believed that biological or environmental triggers contribute to the development of an autoimmune response targeting specifically and exclusively insulin-producing beta cells, and to the progressive disappearance of functional beta cells from the pancreatic islet, leading to the initiation and development of clinical T1D. Current immunomodulatory interventions result, at best, in the partial stabilization of beta cell function but do not lead to full recovery of endogenous insulin secretion.  It is therefore important to focus future research efforts on the identification of the cellular and molecular events that contribute to disease initiation in the human pancreas during the asymptomatic phase to facilitate the development of preventative or therapeutic interventions that could be administered at the earliest possible stage of the disease. Critical to the development of these alternative therapeutic strategies is the identification, in or around the human pancreatic islet, of cellular or molecular biomarkers that can report on (and, in many cases, contribute to) early pathogenesis. Such biomarkers could result in improved protocols for the detection of early disease (before the appearance of autoimmunity markers) in genetically at-risk populations, and the identification of new therapeutic targets for the development of beta cell preservation or immunomodulatory therapeutic strategies. Also important is the characterization of specific cellular processes that may be dysregulated in or around subsets of beta cells in individuals at risk of developing T1D, and may contribute significantly to early pathogenesis. Many pathways involved in the processing of proteins, DNAs, RNAs, lipids and metabolites have not been thoroughly investigated in the context of beta cell biology or T1D pathogenesis. For example, it is now well-established that dysregulations of posttranslational processes or deficiencies in protein checkpoint pathways can happen in beta cells and lead to the production of modified epitopes or fusion protein species that contribute to the initiation of an autoimmune response. But while a small number of these molecular events have been described (including post-translational disulfide bond rearrangement in insulin, glutamine deamidation of several islet-associated proteins, and formation of hybrid peptides by trans-peptidation), the abundance, diversity and underlying mechanisms that lead to the formation of these abnormal protein cell products in beta cells during the asymptomatic phase of the disease remain largely unexplored. Likewise, while RNA processing pathways are known in several tissues to contribute to the sensing of endogenous dsRNA as nonself, to be implicated in the activation of anti-viral signaling pathways, to contribute to the generation of autoantigens in autoimmune diseases such as systemic lupus erythematosus, the possible contribution of such RNA processing pathways to beta cell dysfunction and T1D pathogenesis is completely unknown.

Research Goals and Objectives

This initiative will support the exploration of human pancreatic tissues for the discovery of early biomarkers of human T1D pathogenesis, and for the description of impaired signaling or processing pathways in human beta cells that may trigger inflammation within the islet and contribute to the development of a cell-specific autoimmune response. In the context of this initiative, a “biomarker” is understood as a biomolecule (secreted or not), or a cell type or cell subtype, that is present in the islet compartment or in the larger pancreatic tissue environment during the asymptomatic phase of the disease, and can shed light on the pathogenic events that lead to the demise of pancreatic beta cells in early T1D. This initiative encourages the use of such biomarkers, alone or in combination, for the development of highly-sensitive and highly-specific assays for the detection and staging of early disease, and for the identification of cellular or molecular components of the pancreatic environment that could serve as therapeutic targets for preventative or early treatment strategies. This initiative will also support the description of specific human islet signaling or processing pathways that may contribute significantly to T1D pathogenesis, for example through the production of misexpressed or misprocessed cell products, or the engagement of abnormal cellular responses (including senescence, apoptosis and pro-inflammatory cytokine production) that may alter beta cell function, state or survival, or lead to the specific recruitment and activation of immune cells. Validation of the contribution of such pathways to T1D pathogenesis using clinical tissue specimens or bio-samples is encouraged as part of the application, but is not required. Research strategies responsive to this initiative include, but are not limited to:

  • Identify modified, misprocessed, or abnormal cell products that may result from or contribute to a stressed human islet environment, such as lipid moieties or metabolites produced locally in unusual quantities, or modified protein, RNA, or DNA species;
  • Identify islet-specific products that may be secreted in response to stress, injury, or inflammation, such as microvesicle or exosome protein or RNA cargos, or cleaved extracellular matrix or cell-membrane proteins, that can be detected in the circulation and be used as biomarkers of early disease;
  • Identify immune cell subtypes present in the human pancreatic tissue (including B and T cells, dendritic cells and macrophages) that are characteristic of a stressed endocrine compartment during the asymptomatic phase of T1D but may not be easily detected in the circulation using non-targeted screening approaches; describe these rare but highly-specific immune cell subtypes by means of complex molecular signatures, such as single cell epigenomics or transcriptomics profiles, that can report on cell identity and specificity with a higher granularity than commonly used immune cell surface markers; develop means of detecting and quantifying these rarely circulating immune cell populations in the blood of pre-diabetic individuals through sequencing-based rather than antibody-based strategies;
  • Explore specific cellular signaling (including ER stress, senescence, apoptosis, DNA repair) or molecular processing pathways (RNA splicing, RNA editing, posttranslational modifications) that may be impaired or activated in subsets of beta cells during the asymptomatic phase of T1D and lead to inflammation or the generation of neoantigens; develop molecular tools to control these processes and pathways to study their contribution to disease initiation and/or as a first step towards the development of early disease therapeutics;
  • Develop reliable and sensitive multiplexed assays for the quantitation in peripheral blood or body fluids of panels of early T1D biomarkers previously identified in human pancreatic tissues (including peptides, proteins, RNAs, DNAs, lipids and metabolites); validate new biomarkers and diagnostic tools in human clinical samples, and optimize biomarker assays specifically for clinical applications and for use in small volumes of clinical samples such as blood or serum through improvement of specificity, sensitivity, throughput, reproducibility, scalability, and cost.

Given the important differences (genetic, developmental, morphological, cellular and molecular) that exist between the human and rodent islet environments, the use of human pancreatic tissues as a primary experimental system for the acquisition of new knowledge should form the basis of the applications written in response to this initiative. In situations where the efficient exploration of specific aspects of the pancreatic tissue or islet environment is greatly accelerated or facilitated by use of rodent models, limited use of rodent models is allowed if properly justified, but it is expected that results and hypotheses derived from these models will be validated in human tissues in a systematic fashion and throughout the funding period of the grant.

In choosing a source of human tissues, applicants are encouraged to use high-quality repositories, biobanks and procurement networks, whether linked to NIDDK-funded clinical studies such as the Diabetes Prevention Trial-Type 1 (DPT-1) or the Type 1 Diabetes Trialnet (https://www.niddkrepository.org/niddk/home), or supported by private research efforts such as the JDRF nPOD (http://www.jdrfnpod.org/) or the T1D Exchange (http://www.t1dexchange.org/). If available, pancreata that are either densely genotyped (such as from NIH-supported the GTEx collection: https://commonfund.nih.gov/GTEx) or originating from donors with well-documented disease history or health records, should be used. If the project involves studying signaling or processing pathways that are dysregulated in stressed beta cells during the asymptomatic phase of T1D, biobanked samples collected through clinical studies that are unrelated to T1D could also be useful, such as biosamples generated by the TODAY study that focuses on T2D in adolescents (https://www.niddkrepository.org/studies/today/?query=TODAY ), or by any other clinical studies related to metabolic dysregulations with clinical samples accessible through the NIDDK Central Repository (https://www.niddkrepository.org/home/ ).

The assembly of multidisciplinary teams under a single application to help address the scientific challenges outlined in this initiative is encouraged, particularly to help combine complementary expertise (such as beta cell biology, immunology, experience with state-of-the-art omics technologies or analytical tools, surgical experience and access to human cadaver donors). Single-investigator applications from individuals with the required expertise to make a major contribution are also welcome.

The HIRN is dedicated to fostering the next generation of diabetes and islet biology investigators; Early Stage Investigators (ESIs) are therefore strongly encouraged to contribute and lead projects in response to this initiative, and to apply as Contact Principal Investigator.

Cooperative Relationships and Data Sharing

Upon funding, successful applicants will join the NIDDK-supported HIRN, whose overall mission is to better understand how human beta cells are lost in T1D, and to find innovative strategies to protect or replace functional beta cell mass in diabetic patients. Specifically, successful applicants will join one of HIRN’s five consortia, CBDS, whose mission is to better define and detect the mechanisms of beta cell stress and destruction central to the development of T1D in humans, with the long-term goal of protecting the residual beta cell mass in T1D patients as early as possible in the disease process, and preventing the progression to autoimmunity (https://hirnetwork.org/consortium/cbds ).

Regardless of the team-structure proposed in the U01 application, all CBDS investigators will be expected to work closely and collaboratively with their CBDS and HIRN colleagues and to contribute to an environment of sharing and trust across the network. All methods, reagents, resources, biomaterials, protocols, data and models developed by CBDS investigators are expected to be made available to the research community. Because the individual U01 projects will be coordinated through CBDS, the timeline and processes for sharing within CBDS and with the community at large will be established by the CBDS NIDDK Project Scientist or the CBDS Steering Committee. All participants will be expected to adhere to these policies as a term of the award. Policy documents for CBDS will be accessible on the HIRN website.

As a consortium, CBDS is expected to work closely with the HIRN Administration Hub (HIRN-AH) that is composed of the HIRN Coordinating Center (HIRN-CC) and the Bioinformatics Center (HIRN-BC) to facilitate the organization and sharing of data and reagents generated by CBDS activities. At a minimum, data and analytical tools generated by CBDS investigators should become easily accessible through the HIRN portal. All CBDS participants will be expected to adhere to the sharing policies developed by the HIRN as a term of the award and to the Cooperative Agreement Terms and Conditions of Award. The NIDDK staff will designate a CBDS investigator to represent CBDS on the HIRN Trans-Network Committee (HIRN-TNC) who will be expected to participate to all meetings of the HIRN-TNC. CBDS Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must participate in person to the annual HIRN Investigator Scientific Meeting, as well as in CBDS Steering Committee teleconferences to be held at least bi-annually. All participants will be obligated to abide by the policies adopted by the majority vote of the CBDS Steering Committee. In the application, research project budget requests must include costs for the PD/PI and up to three other members of the individual project to attend the annual HIRN Investigator Scientific Meeting. The annual HIRN Investigator Scientific Meeting will last 2-3 days. In addition to the annual meeting of the HIRN, monthly CBDS webinars will be organized to facilitate early exchange scientific results between CBDS investigators and to update CBDS investigators on HIRN-related activities. All CBDS teleconferences will be organized and administered by the HIRN-CC. Note that the HIRN-CC will support costs of all CBDS and HIRN-related meetings except for costs for research project investigators to travel and attend the meetings. The HIRN-CC is also responsible for providing and maintaining a record of minutes of all CBDS meetings, which will be approved by the CBDS Steering Committee.

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. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit up to $3.5 million to fund 4-6 awards in FY 2018. The number of awards is contingent upon availability of funds and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $500,000 Direct Costs per year . Budgets are expected to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 4 years.  

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are  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.
  • o   NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number 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 Grants.gov 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.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide,  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 should be sent electronically to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov

Page Limitations

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

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.  

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

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: Applicants should describe how their project could benefit from interactions and collaborations with their CBDS and HIRN colleagues, and how their proposed research will contribute to the overall scientific mission of CBDS and HIRN.

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:

It is the goal of NIDDK to further advance research by making resources, data, and reagents generated in whole or in part using funds from these U01 awards widely available to the research community with minimal restrictions.

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information

 When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.

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 Grants.gov

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 Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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, NIDDK. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

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.

Significance

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?

Specific to this FOA: Will the project contribute significantly to the overall mission of the CBDS and the HIRN?

Investigator(s)

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

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? 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? 

Specific to this FOA: is the project clearly focused on increasing our understanding of human disease biology (as opposed to mouse or other animal models), or at developing knowledge, tools and approaches that could lead to significant translational outcomes in the future? Are planned interactions with the applicant’s CBDS and HIRN colleagues adequately described? Is the plan for data sharing with HIRN and the scientific community satisfactory?

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?  

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?   

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.

Biohazards

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

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

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

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 U01, 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 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:

  • Awardee(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
  • The Principal Investigator/Program Director will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
  • The Awardee will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current HHS, PHS, and NIH policies.
  • All staff of the Awardee will maintain the confidentiality of the information developed by the investigations, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the consortium as well as any confidential information received by third party collaborators.
  • Awardees must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
  • All staff of the Awardee will be required to participate in a cooperative and interactive manner with NIH staff, one another and with the HIRN-AH in all aspects of CBDS.
  • Awardees are expected to share data, materials, models, methods, information and unique research resources that are generated by the projects in accordance with CBDS policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, awardees will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other CBDS members.
  • Awardees will submit a list of milestones and project deliverables to the HIRN CC prior to the initial HIRN meeting, and will update this list annually.
  • CBDS Awardees agree to establish agreements amongst themselves that address the following issues: (1) Procedures for data sharing among consortium members and data sharing with industry partners, as appropriate and consistent with achieving the goals of the program; (2) Procedures for safeguarding confidential information, including without limitation, any data generated by the consortium as well as information and/or data received from external collaborators; (3) Procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) Procedures for sharing biospecimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner; and (5) Procedures for reviewing publications, determining authorship, and industry access to publications.
  • Awardees agree that industry collaborations should be governed by a research collaboration agreement (e.g. CTA, RCA, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies and procedures and any policies and procedures developed by the CBDS.
  • Awardees must operate in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
  • Upon completion or termination of the research project(s), the awardees are responsible for making all study materials and procedures broadly available (e.g., putting into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a plan to accomplish this at the end of the study.
  • Awardee(s) agree to the governance of the study through a Steering Committee: The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee. Each full member will have one vote. The awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and Subcommittees.
  • Awardees must serve on CBDS subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
  • Awardees may be asked by NIH staff to scientifically review applications for special opportunity pool funds, as deemed appropriate.

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

  • The NIDDK will designate program staff, including a Program Officer and a Grants Management Specialist to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer and Grants Management Specialist will be named in the Notice of Grant Award.
  • The NIH will invite experts with relevant scientific expertise to provide feedback to the NIH on CBDS activities. The External Experts will meet to review the progress of the research projects and to advise NIH staff of scientific developments and opportunities that may enhance the achievement of the study goals.
  • An NIDDK Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIDDK Program Official as follows:
  • The NIH Project Scientist will coordinate and facilitate the research projects, attend and participate in all meetings of the CBDS, and act as a liaison between the Awardee and the External Experts.
  • The NIH Project Scientist(s) will be a member(s) of the Steering Committee and, as determined by that committee, and its Subcommittees as needed. Only one NIH Project Scientist will vote on the Steering Committee. Other designated NIH program staff attending the steering committee meetings will be an ex officio (non-voting) member(s).
  • The NIH Project Scientist, and other designated NIH program staff will help the Steering Committee develop and draft operating policies.
  • The NIH Project Scientist and Program Officer will review the scientific progress, cooperation in carrying out research, and maintenance of high quality research in each of the individual research project, and review the project for compliance with operating policies developed by the CBDS. Based on this review, the Project Scientist in conjunction with the Program Officer may recommend to the NIH to continue funding, or to withhold or restrict support for lack of scientific progress or failure to adhere to policies established by the CBDS. Review of progress may include regular communications between the Principal Investigator/Program Director and NIH staff, periodic site visits for discussions with awardee research teams, fiscal review, and other relevant matters. The NIH retains the option of organizing periodic external review of progress.
  • The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of (1) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or CBDS policy and procedure, (2) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or (3) concerns related to human subject safety that prompt the need for premature termination.
  • The NIH Program Scientist and Program Officer will review applications for Special Opportunity Funds for responsiveness to program goals to insure that they are within the scope of CBDS's research as described in the Funding Opportunity Announcement and NIH guidelines. The NIH will enlist additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist in carrying out the goals and aims of the approved studies. The NIH will have one vote for any key committees, regardless of the number of NIH consultants involved in the project.
  • The NIH Project Scientist will have substantial scientific programmatic involvement in research coordination and performance monitoring. The dominant role and primary responsibility for these activities resides with the awardee, however, specific tasks and activities in carrying out the studies will be shared among the awardees and the NIH Project Scientist.
  • The NIH Project Scientist serves as a resource with respect to other ongoing NIH activities that may be relevant to CBDS studies to facilitate compatibility and avoid unnecessary duplication of effort.
  • The NIH Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research protocol and statistical evaluations of data and in the publication of results.
  • The NIH Project Scientist may review procedures for assessing data quality and monitor study performance.
  • The NIH Project Scientist may be a co-author on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of 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.

Areas of Joint Responsibility include:

  • Through the Awardee(s) and NIH staff, CBDS will cooperatively develop and implement processes to submit information and data to the HIRN-AH, determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the Funding Opportunity Announcement.
  • There will be an initial face-to-face meeting of HIRN and a minimum of 2 CBDS meetings (teleconferences or face-to face meetings) annually. CBDS awardees, the CBDS Project Scientist, and the CBDS Program Official are expected to attend these meetings. One of these bi-annual meetings could be combined with the annual HIRN Investigator Scientific Retreat.

Steering Committee

CBDS awardees agree to the governance of the CBDS through a Steering Committee.

  • On an annual basis, and following input from the CBDS Steering Committee members, NIDDK staff will appoint a Steering Committee Chair who will be in charge of facilitating the CBDS Steering Committee meetings and teleconferences. In collaboration with the HIRN-CC and the NIH Project Scientist, the Chairperson is responsible for coordinating the Steering Committee activities, for preparing meeting agendas and for chairing meetings.
  • The Steering Committee, including the Project Scientist, is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
  • The NIH Project Scientist may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees.
  • The Steering Committee will be composed of the Principal Investigators/Program Directors for each U01, or by U01 representatives (one per U01 grant) chosen by the Principal Investigators/Program Directors in the cases of multi-PI grants, and the NIH Project Scientist. Only the U01 PI/PD or multi-PI U01 representatives and the NIH Project Scientist will be voting members of the Steering Committee and will attend all meetings of the Steering Committee. Each full member will have one vote. Other designated NIH program staff attending the steering committee meetings will be ex officio (non-voting) members. The CBDS Steering Committee will meet at least twice a year.
  • All major scientific and policy decisions will be determined by voting policies as established by the Steering Committee at the initial meeting. This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project. Steering Committee activities and decisions will consider the advice of the External Experts.
  • The NIH Project Scientist will help the Steering Committee develop and draft operating policies.
  • NIDDK staff, in concert with the Steering Committee, will have the option to redirect research activities being pursued within the U01 grants if it is considered beneficial to the overall program.
  • The Awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and Subcommittees. Awardees must serve on CBDS subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.

HIRN Trans-Network Committee (HIRN-TNC)

The HIRN-TNC will consist of: the PD/PI of the HIRN-CC, the PD/PI of the HIRN-BC, and the Steering Committee Chairs and Project Scientists of the HIRN scientific topic consortia (CHIB, CTAR, CMAI, CBDS and HPAC); the TNC is not a governing body and does not cast votes.

The TNC will facilitate communication and foster collaboration across the different consortia.

The TNC will be responsible for organizing the yearly HIRN Scientific Investigator’s Retreat.

The TNC will meet by teleconference at least twice a year and will be organized by the HIRN-CC. Meetings will be used to discuss and prioritize, and review the progress of applications that will use "opportunity pool" funds. Subcommittees of HIRN, as well as working groups for scientific planning may be established and require participation by the CBDS members through in-person, electronic, or teleconference meetings, as appropriate. The HIRN-CC is responsible for providing and maintaining a record of minutes of all EC meetings, which will be approved by the EC.

Expert Scientific Panel (ESP)

An independent panel of 2-5 External Experts will be appointed by the NIDDK and meet by teleconference with the CBDS Project Scientist and the CBDS Project Officer at least once a year. The CBDS-ESP will be updated on progress and give feedback to NIH on adjustments and future directions for the CBDS research projects. On an annual basis, and following input from the ESP members, NIDDK staff will appoint an ESP Chair who will be required to attend the annual HIRN Investigator Scientific Retreat, to participate to the CBDS Steering Committee meetings as ex-officio, and to serve as the CBDS-ESP representative to the larger HIRN-ESP that will also meet once a year. The CBDS ESP Chair will be tasked with relaying the CBDS Steering Committee recommendations for new Opportunity Funds Initiatives to the HIRN-ESP. All CBDS-ESP members will also be invited to listen as ex-officio to CBDS Steering Committee meetings. Members of the CBDS-ESP may be asked, on an ad hoc basis, in the peer review of applications for new research applications that request “opportunity pool” funds. The HIRN-CC will support costs for teleconferences between the ESP and the CBDS Steering Committee, will arrange the CBDS-ESP and HIRN-ESP teleconferences, maintain a record of minutes, and support costs for the CBDS-ESP chair to participate in the annual HIRN Investigator Scientific Retreat.

Dispute Resolution

Disagreements that may arise in scientific/technical matter or programmatic matters (within the scope of the award) between award recipients and the NIDDK may be brought to arbitration after first attempting to resolve the issue through the Steering Committee or its subcommittees, as appropriate. An Arbitration 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 procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR 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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Xujing Wang, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-7334 
Email: Xujing.Wang@nih.gov

Peer Review Contact(s)

Najma Begum, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8894
Email: najma.begum@nih.gov

Financial/Grants Management Contact(s)

Craig Bagdon
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-0166 
Email: bagdonc@niddk.nih.gov

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. This FOA is supported under the authority of P.L. 115-123, Bipartisan Budget Act of 2018; Section 50902. Extension for special diabetes programs.

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