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
Limited Competition for the Accelerating Medicines Partnership (AMP) in Type 2 Diabetes Knowledge Portal (UM1 Clinical Trial Not Allowed)
Activity Code
UM1 Research Project with Complex Structure Cooperative Agreement
Announcement Type

Reissue of RFA-DK-14-503

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-DK-19-505
Companion Funding Opportunity

RFA-DK-19-012, UM1 Research Project with Complex Structure

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.847

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites an application from the current awardee institution of the Accelerating Medicines Partnership in Type 2 Diabetes Knowledge Portal (AMP T2D KP). The AMP T2D program is a collaborative partnership between the NIH, pharmaceutical companies, and nonprofit organizations to develop new models for identifying and validating promising biological targets to serve as biomarkers and/or for drug discovery (www.nih.gov/research-training/accelerating-medicines-partnership-amp/type-2-diabetes). This is a one-time FOA to provide funds to the AMP T2D KP to continue the development of the web portal and underlying, curated knowledge base; as well as to become the flagship resource encompassing the myriad types of data and information that provide an understanding of the biological heterogeneity in patients with T2D and its complications. In its next five-year period, the AMP T2D KP will be expected to expand the KP’s data sets and traits, import additional data types, deploy additional analytical and visualization tools, and increase its utility to a more diverse user base. To support the conduct of these studies, the AMP T2D KP will coordinate, support, and work with companion Functional Genomic Project awardees (RFA-DK-19-012) to continue the AMP T2D Consortium. The AMP T2D KP will also oversee an opportunity pool of funds to solicit collaborative projects to accomplish the objectives of the Consortium.

Key Dates

Posted Date

September 27, 2019

Open Date (Earliest Submission Date)
November 03, 2019
Letter of Intent Due Date(s)

November 3, 2019

Application Due Date(s)

December 3, 2019

No late applications will be accepted for this Funding Opportunity Announcement.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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
February/March 2020
Advisory Council Review
May 2020
Earliest Start Date
July 2020
Expiration Date
December 04, 2019
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in 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 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.

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Background

    Type 2 diabetes (T2D) currently affects over 300 million people worldwide and its prevalence is increasing rapidly. T2D is characterized by insulin resistance, beta cell failure, dysregulated insulin secretion by pancreatic beta-cells, and additional metabolic disturbances. Dysglycemia along with other metabolic disturbances of T2D lead to significant complications due to end organ damage. Although the current rise in prevalence is driven by environmental factors such as life-style, it is now appreciated that complex genetic determinants contribute to an inherent susceptibility to T2D and its complications. Common and rare variant genome-wide studies and exome sequencing have yielded greater than 400 loci that have significant associations with T2D, related metabolic traits, and/or diabetic complications. For the purposes of this RFA, the terms “disease” and “trait” are used broadly, to encompass diseases, risk of diseases, protective effects against diseases, complications, molecular phenotypes, organismal phenotypes, clinical phenotypes or outcomes, responses to therapeutic drugs, and other outcomes relevant to human health and disease.

    Translation of many of these disease-associated risk loci to causal variants and their downstream effector transcripts (coding or non-coding) has been complicated by the fact that the risk loci often lie in non-coding regions of the genome, far from the effector transcript they regulate. Through work accomplished by the AMP T2D Consortium, an unprecedented amount of human genomic and epigenomic data around T2D have been collated and analyzed, leading to the initial identification of over 130 possible effector transcripts. While many probable effector transcripts have been identified, in many cases their causal role has not yet been validated nor their, mechanism of action determined, and their full impact on traits has not been elucidated. At the same time, there remains significant amounts of genomic information around T2D and its complications that can be added to the AMP T2D KP as well as additional ‘omics and other data types that can be incorporated or integrated into its existing foundation.

    To address these gaps, the NIDDK is soliciting applications to this RFA and its companion RFA (RFA-DK-19-012) to address the overarching goals of 1) accelerating the pace of understanding of the genetic architecture of T2D and its complications, 2) identifying effector transcripts with predicted causal relationship to T2D and its complications, 3) validating the strength of predicted effector transcripts through experimental work and their placement in networks, and 4) making this information broadly available to the scientific community to foster fundamental and clinical research,  ultimately resulting in the identification of potential biomarkers for disease and the discovery of potential therapeutic targets. To accomplish these goals awardees to the AMP T2D KP (RFA-DK-19-505) and Functional Genomic Projects (FGPs; RFA-DK-19-012) will form a Consortium, working together toward the overarching goals.

    Accelerating Medicines Partnership

    The NIH, pharmaceutical companies and nonprofit organizations have together created the Accelerating Medicines Partnership (AMP) to develop new models for identifying and validating promising biological targets for new diagnostics and drug development. A major goal is to generate pre-competitive, disease-specific data that will be publicly accessible to the broad biomedical community for further research (https://www.nih.gov/research-training/accelerating-medicines-partnership-amp/type-2-diabetes).

    A critical program goal of the AMP initiative is to advance research in specific disease areas by creating a community resource of data, analyses, and other research resources which are publicly available and accessible to the broad biomedical community. In order to maximize scientific exchange and accelerate research in that field, it is expected that all information, data, protocols, resources, and methods developed by AMP investigators will be shared in a rapid and timely way with other investigators in the consortium and with the research community at-large. Given the amount and complexity of the data, success will require rapid and broad access across the biomedical community to allow for further analyses and collaborative research efforts.

    The AMP initiative envisions that all data generated (including processed/analyzed data) will be deposited in a rapid and timely way into a repository that is accessible for use by the broad biomedical community, and that these data will remain available to all qualified investigators, consistent with applicable laws, regulations, and policies and unencumbered by any intellectual property claims. While the NIH encourages patenting of technology suitable for subsequent private investment that may lead to the development of products that address public needs, the NIH discourages premature claims on pre-competitive information that may impede research. It should be recognized that the research supported under the AMP initiative is intended to be precompetitive and will neither make use of proprietary pre-existing intellectual property nor is expected itself to produce patentable findings. Similarly, other research resources developed under the AMP initiative are expected to be made available to the research community.


    Goal and Objectives of the AMP T2D Portal

    This Funding Opportunity Announcement (FOA) intends to continue the Accelerating Medicines Partnership in Type 2 Diabetes Knowledge Portal (AMP T2D KP). This FOA announces applications for the administrative structure and technical and scientific infrastructure needed to support AMP T2D KP activities and data and tools emerging from complementary Functional Genomic Projects (FGPs; RFA-DK-19-012). The overall goal for the next iteration of the AMP T2D KP is to create the flagship resource that encompasses the myriad types of data and information that provide an understanding of the biological heterogeneity in patients with T2D and its complications. This will be accomplished by maintaining and continuing to develop the web portal and supporting infrastructure to aggregate, collate, and analyze multiple data types on risk variants and causal effector transcripts for T2D and its complications.

    By providing access to these resources to the community, the AMP T2D KP will accomplish its goal of conducting and facilitating research leading to disease knowledge, therapeutic targets, and biomarkers. To maximize scientific exchange and accelerate research in that field, it is expected that all information, data, protocols, resources, and methods developed by AMP T2D KP investigators will be shared in a timely way with other investigators in the consortium and with the research community at large. It will also provide for the expertise and infrastructure needed for data and sample management, including standardized acquisition, harmonization, annotation, quality control, dissemination, and timely public accessibility. The AMP T2D KP will also oversee an opportunity pool to solicit and fund additional projects based on emerging needs and to leverage newer technologies.

    Overview

    The AMP T2D KP will accomplish its goals by using existing extensive T2D clinical genomics information as a foundation upon which to add and integrate additional ‘omics data types, phenotype data, and functional genetics studies to define the genetic architecture of T2D and identify key disease-driving molecular networks. Key nodes within these networks are expected to serve as candidate biomarkers or points for therapeutic modulation. The AMP T2D KP itself will not generate new data, but rather will serve as a curated repository, analytical platform, and portal for publicly available data. The research, results, and resources of the AMP T2D KP will accelerate the pace of diabetes research to ultimately improve the care of patients by providing the data and evidence for:

    • Identifying conditions and factors central to robust characterization of patients in disease- and treatment-relevant sub-types;
    • Understanding type 2 diabetes risk, initiation, progression, and complications development;
    • Associating efficacy and safety of existing therapies with patient sub-types;
    • Discovering biomarkers for type 2 diabetes and its complications;
    • Improving clinical decision making at the individual patient level;
    • Identifying key modulation nodes in disease-driving molecular networks to enhance novel biomarker therapeutic discovery.

    Activities of the AMP T2D KP will be undertaken with input from, and through cooperation with, a Consortium Steering Committee composed of AMP T2D KP and FGPs awardees and additional funding partners, in addition to feedback from the AMP T2D KP and FGP’s External Program Consultants.

    Data and Knowledge Base

    The Data and Knowledge Base of the AMP T2D KP will serve as the primary database, integrator, and analytical platform for publicly available type 2 diabetes and complications relevant ‘omics data, including data produced by the FGPs (RFA-DK-19-012). It may also serve this function for certain publicly available data types generated by other, highly-relevant NIDDK- or AMP T2D-funded research endeavors. It is expected that the AMP T2D Data and Knowledge Base should possess the following characteristics:

    • Provide a common, curated catalog of T2D- and complications-relevant traits for mapping of data;
    • Incorporate genomic and genetic data around T2D and its complications and use this as a foundation upon which to incorporate additional data types (e.g., ‘omics, EHR profiles);
    • Provide users with the ability to perform analyses on its data via tools in the Publicly-Accessible Knowledge Portal and via access to underlying datasets;
    • Provide download access to as many underlying data sets as possible to registered users that agree to an end user agreement.

    Publicly-accessible Knowledge Portal

    The Publicly-accessible Knowledge Portal serves as the primary publicly accessible presentation layer (front end) for display of aggregated data and knowledge. The front end should possess the following characteristics:

    • Be useable by a variety of user types (e.g., clinicians, researchers, patients);
    • Allow users to perform analyses and visualizations of the underlying data in the Data and Knowledge Base;
    • Interface with other knowledge portals to provide access to additional data types not directly supported by the AMP T2D KP.

    Coordination Component

    The Coordinating Component will provide for overall coordination of the AMP T2D KP efforts and the Consortium formed with the FGPs (RFA-DK-19-012) and will oversee use of the External Opportunity Pool funds. This will be accomplished by:

    • Facilitating scientific interactions using regular teleconferences of committees, sub-committees, and scientific working groups and organizing face-to-face meetings of the consortium;
    • Ensuring the rapid and timely sharing of consortium-generated data and resources within the consortium, and with the community at large;
    • Facilitating coordination of AMP T2D KP activities and findings with other related database efforts;
    • Managing the solicitation, evaluation, and award of subcontracts on a yearly basis from an opportunity pool that will support collaborative projects with investigators outside of the AMP T2D and FGPs; for projects such as, but not limited to:
      • Integration of new cohort data into the AMP T2D Data and Knowledge Base;
      • Development of new analytical or visualization tools for deployment in the portal;
      • Generation of new experimental tools around key causal variants, effector transcripts, and proteins identified by the T2D KP for use by the broader diabetes research community.

    Organization and Management of the AMP T2D KP

    A Steering Committee will be formed to provide direction and coordinate activities for the AMP T2D KP and FGP awardees. This group will establish procedures for the function of the Consortium. Once yearly, the Steering Committee and other key personnel are expected to convene in person at a meeting to review scientific progress, highlight key consortium activities, and communicate with NIDDK staff. External Program Consultants will be selected by the NIDDK to review the functioning and progress of the consortium and to ensure that the Consortium is organized and operating optimally and efficiently. The NIDDK, after consulting with the EPCs, may request modification to sub-projects or re-prioritization of effort among sub-projects. It is expected that the Consortium will establish strong working relationships with other related efforts, including collaborative projects, and will share scientific approaches and results pre-publication.

    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

    Renewal applications from RFA-DK-14-503.

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    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

    The NIDDK intends to commit $4 million in FY2020 to fund 1 award.

    Award Budget
    Application budget requests are limited to $3,000,000 direct costs per year.
    Award Project Period

    The maximum project period is 5 years.

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

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    This FOA is limited to the current AMP T2D KP awardee institution supported under RFA-DK-14-503.

    Only the current awardee under RFA DK-14-503 is eligible to apply under this announcement
    Foreign Institutions
    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply Non-domestic (non-U.S.) components of U.S. Organizations are not 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) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active 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

     

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 instructions in 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.

     

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

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

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

    The letter of intent should be sent to:

    John Connaughton, Ph.D.
    Chief, Scientific Review Branch
    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

    , with the following exceptions or additional requirements:

    The Research Strategy section is limited to 30 pages and should consist of the following subsections with the indicated page limits:

    • Sub-Section A. Overview
    • Sub-Section B. Data and Knowledge Base
    • Sub-Section C. Publicly-accessible Knowledge Portal
    • Sub-Section D. Coordination Component
    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.  

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

    The following additional budget-related information must be included:

    • Applicants must budget funds for travel for at least one PD/PI to attend an annual 2-day meeting of the AMP T2D Consortium in Washington, D.C. area.  
    R&R Subaward Budget
    All instructions in the SF424 (R&R) Application Guide must be followed.
    PHS 398 Cover Page Supplement
    All instructions in the SF424 (R&R) Application Guide must be followed.
    PHS 398 Research Plan
    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Research Strategy: The Research Strategy must consist of the following sub-sections A – D, as defined below, uploaded as a single PDF attachment.

    Sub-Section A. Overview: This subsection should consist of a vision for the AMP T2D KP and a summary of the overall scientific and administrative approaches to be undertaken in the proposed project, which will be described in more details in sub-sections B-D.

    Applicants should address, at a minimum, the following aspects:

    • The accomplishments and progress made during the previous funding period;
    • The overall vision to accomplish the goals of the next iteration of the AMP T2D KP;
    • How sub-sections B and C will work synergistically to meet the overall scientific research and resource needs of the AMP T2D KP;
    • How sub-section D will assist and oversee sub-sections B and C in accomplishing their goals;
    • Overall project deliverables, timelines, and milestones.

    Sub-Section B. Data and Knowledge Base: This sub-section should describe how the AMP T2D KP will identify, select, incorporate, harmonize, and analyze genomic and other data relevant to T2D and its complications and provide access to these data.

    Applicants should describe how their team proposes to handle, at a minimum, the following required functions:

    • Bring in, curate, and house publicly available genomic data at the individual patient and summary data levels;
    • Maintain a standardized dictionary of traits and phenotypes relevant to T2D and its complications;
    • Develop a platform to conduct integrated genomics analyses across individual patient through summary level data and seamlessly interface with federated nodes;
    • Collaborate and integrate with other groups to bring in additional cohort data (e.g., UK BioBank, Rare and Atypical DIAbetes NeTwork (RADIANT), Million Veterans Program, TopMed, All of Us);
    • Develop the capability to incorporate longitudinal data (e.g., clinical trial data);
    • Incorporate transcriptomic and epigenomic data relevant to the emerging understanding of the genomic architecture of type 2 diabetes and its complications;
    • Develop approaches to incorporate proteomic, metabolomic, and single cell mapping data relevant to the emerging understanding of the genomic architecture of type 2 diabetes and its complications;
    • Develop mathematical models based on meta-analysis of ‘omics data and patient traits including disease outcomes and response to interventions (e.g., drug treatment, lifestyle changes);
    • Support integration and analysis of multi ‘omics and physiological data where possible, recognizing it may sometimes be more effective to have separate knowledgebases accessed directly by the front end;
    • Integrate high-priority data or knowledge types from publicly available sources;
    • Provide means for end users to both download and directly perform analyses on as much raw data as possible and permissible.

    Sub-Section C. Publicly-accessible Knowledge Portal: This sub-section should describe how the AMP T2D KP will support and expand its front-end web portal to provide access to underlying data through an array of analytical and visualization tools to a variety of user types.

    Applicants should describe how their team proposes to handle, at a minimum, the following required functions:

    • Maintain and continue to develop a web portal that researchers can use to identify relationships between sequence variation in potential targets or regulatory sequences in the genome for risk or protection from T2D by using phenotype-based queries, gene- or network-based queries, variant-based queries, and/or subset queries;
    • Ability of users to select or be designated into personas (e.g., clinicians, research scientists, patients/caregivers) that guide how data and resources will be presented;
    • Access to summary level information through individual patient/sample data (where applicable and allowable);
    • Present high-level lists of genomic signals, candidate effector transcripts, and networks derived from the genetic architecture of T2D-relevant traits (e.g., risk, initiation, progression, complications);
    • Allow user selection of configurable algorithms to generate high-level lists and provide clear provenance and links to methodology and data;
    • Deploy various user-friendly search, analytical, and visualization tools;
    • Display and rapidly access data for analysis from the T2D Data and Knowledge Base and federated nodes;
    • Summarize genomic and additional data types linked to key genes and non-genic regions associated with type 2 diabetes-relevant traits;
    • When needed, seamlessly access and display key data from publicly available databases and other knowledge portals which are not integrated into the AMP T2D Data and Knowledge Base (e.g., single-cell atlases, protein-centric databases, pathway and network knowledgebases, physiologic traits, endotypes);
    • Interface effectively with other publicly available data/knowledge portals that contain information relevant to understanding the biological heterogeneity of T2D and the role of causal genes, proteins, and networks;
    • Develop a strategy to regularly monitor and evaluate usability of the system, including sub-components, by the various AMP T2D stakeholders and implement changes based on feedback.

    Sub-Section D. Coordination Component: This sub-section should describe how the awardees will manage the overall functioning of the AMP T2D KP, support administrative efforts for the overall Consortium, and provide outreach and education on the AMP T2D KP.

    Applicants should describe how their team proposes to handle, at a minimum, the following required functions:

    • Provide administrative support for the AMP T2D KP SC;
    • Schedule regular and ad hoc steering committee and working group calls;
    • Organize outreach efforts and regular meetings;
    • Fund and support logistics for all meetings;
    • Foster, develop, and support collaboration efforts with external partners;
    • Support travel and logistics for External Program Consultants that will provide input on the direction of the consortium;
    • Develop methods to track and facilitate movement of data from FGPs into central data repositories and ensuring rapid and timely data release to the investigators and to the community;
    • Generate a centralized virtual library of available physical resources relevant to experimental validation of candidate effector transcripts.

    Applicants should also describe how their team proposes to administer opportunity pool funds, addressing, at a minimum, the following aspects:

    • How the AMP T2D KP will work with the Consortium’s Steering Committee, NIDDK staff, and potential other funding partners to identify emergent needs on a yearly basis;
    • How the AMP T2D KP will solicit, review, and select proposals from external investigators;
    • How subcontracts will be overseen and integrated into the overall Consortium.
    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.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the Consortium SC and approved by NIH staff. A primary goal of the AMP T2D program is to facilitate discoveries of the broad scientific community for the improvement of public health. Restrictive licensing and sharing practices for Consortium-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal. The NIH expects that the awardees, through the Consortium SC, will develop such policies, methods, and standards in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing.

    • Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. Where appropriate, applicants should identify such repositories and plans for deposition. For datatypes that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution that is consistent with achieving the goals of the program. Data should also be made available as appropriate via the AMP T2D Knowledge Portal that will serve as the central access point for information regarding data, critical tools, and reagents being developed by the Consortium. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to it in the data sharing plan.

    • Specific Plan for Protocol, Tool, and Reagent Sharing: In accomplishing the goals of the AMP T2D program, it is likely that investigators will develop protocols, tools, and reagents that would be of broad use in the research community. The NIH intends that protocols, tools, and reagents generated by the AMP T2D be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations of T2D-relevant risk variants and effector transcripts by the larger scientific community. For all applications where applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, biomaterials, and reagents.

    • Specific Plan for Sharing Software: A software dissemination plan, is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. A dissemination plan guided by the following principles is thought to promote the largest impact:

      • The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

      • The terms should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

      • The software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

      • The terms of software availability should include the ability of researchers outside of AMP T2D and its collaborating projects to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

    • Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).

    • Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.

    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 human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form
    All instructions in the SF424 (R&R) Application Guide must be followed.

    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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

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

    Overall Impact
    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
    Scored Review Criteria
    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

     

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

    Specific to this FOA: Will the proposed project, if completed, result in significant advances in the understanding of the genetic architecture of type 2 diabetes and its complications? Will the approached approaches lead to a portal that serves as a foundation upon which to add and integrate additional ‘omics data types, phenotype data, and functional genetics studies? Will the successful completion of the aims result in a Knowledge Portal that is broadly accessible to users with a variety of backgrounds?

     

    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?

     

    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?

     

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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: Are the administrative approaches to manage the overall functioning of the AMP T2D KP, support administrative efforts for the overall Consortium  and manage the opportunity pool adequate? Are the plans to identify, select, incorporate, harmonize, and analyze genomic and other data well developed? Have the investigators provided an appropriate plan to support and expand the front-end web portal to provide access to underlying data through an array of analytical and visualization tools to a variety of user types as well as to assess user experience and make improvements based on this feedback? Is the plan to conduct outreach and training on the AMP T2D KP adequate? Have the investigators provided a robust plan to incorporate genetic and other data types on both type 2 diabetes and its complications?

    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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

     

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

    Additional Review Criteria
    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

     

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

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

     

    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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

     

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

     

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

     

    Not Applicable

     

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

     

    Not Applicable

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

    Applications from Foreign Organizations  

    Not Applicable

    Select Agent Research

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

     

    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).

     

    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.

     

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

    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.

    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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

    The Consortium will be made up of awardees to RFA-DK-19-012 and to RFA-DK-19-505 (Knowledge Portal), NIH staff that are primarily responsible for the stewardship of these awards, other scientists and groups the Steering Committee (see below) agrees to include within the Consortium, and, possibly, additional AMP T2D funding partners and awardees. The Consortium structure is meant to enable the overall goals of the AMP T2D program.

    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 Program Director/Principal Investigator (PD/PI) 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 (FOA) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
    • Awardee(s) 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 DHHS, PHS, and NIH policies.
    • Awardee(s) are responsible for their staff in maintaining confidentiality of the information as developed by the consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
    • Awardee(s) 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 achieving the goals of the FOA.
    • Awardee(s) will be required to participate in a cooperative and interactive manner with members of the consortium including designated NIH staff (e.g., Program Official, Project Scientist).
    • Awardee(s) are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis and (2) for clinical studies, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense.
    • Awardee(s) must share data, materials, models, methods, information and unique research resources that are generated by the projects in concordance with Consortium policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, awardee(s) 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 Consortium members.
    • Awardee(s) 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; (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 bio-specimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
    • Awardee(s) agree that each industry collaboration 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.
    • Awardee(s) must agree to comply with the processes and goals as delineated within the FOA.
    • Upon completion or termination of the research project(s), the awardee(s) 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, r contact PD/PI in the case f 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 ne 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.
      • Awardee(s) must serve n Consortium subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
    • Awardee(s) may be asked to scientifically review applications for special opportunity pool funds, as it is 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 Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.
    • The NIDDK will invite External Consultants with relevant scientific expertise. The External Consultants 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 NIH IC Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:
    • The NIH Project Scientist(s) will coordinate and facilitate the research projects, attend and participate in all meetings of the Consortium Steering Committee, and act as (a) liaisons between the Awardee(s) and the External Consultants.
    • 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 ne 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(s) and Program Official will review the scientific progress, cooperation in carrying out research, and maintenance of high quality research in each of the individual research projects, and review the projects for compliance with operating policies developed by the Consortium Steering Committee, and may recommend to the NIH to continue funding; withheld support or restrict an award for lack of scientific progress or failure to adhere to policies established by the Consortium Steering Committee. Review f progress may include regular communications with the PD/PI and NIH staff, periodic site visits for discussions with awardee research teams, fiscal review, and other relevant matters. The NIH retains the option of periodic external review of progress.
      • The NIDDK reserves the right t terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or Consortium policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or a human subject ethical issues that may dictate a premature termination.
    • The NIH Project Scientist(s) and Program Official will review and approve applications of the Special Opportunity Funds to ensure that they are within the scope of Consortium research as described in the FOA and NIH guidelines.
    • The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist(s) and the Steering Committee in carrying out the goals and aims of the approved studies. The NIH will have ne vote for any key committees, regardless of the number of NIH personnel involved.
      • The Project Scientist(s) will have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientist(s) will have the same access and privileges to any data generated by the grantee. The dominant role and primary responsibility for these activities resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardee(s) and the NIDDK Project Scientist(s).
    • The NIH Project Scientist(s) serve as a resource with respect to other ongoing NIH activities that may be relevant to the Consortium’s studies to facilitate compatibility and avoid unnecessary duplication of effort.
    • The NIH Project Scientist(s) or designee may coordinate activities among awardee(s) by assisting in the design, development, and coordination of (a) common research protocol(s) and statistical evaluations of data and in the publication of results.
    • The NIH Project Scientist(s) may review procedures for assessing data quality and monitor study performance.
    • The NIH Project Scientist(s) may be (a) co-author(s) on study publications. In general, t 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 Steering Committee, the awardee(s) and NIH staff will cooperatively develop and implement processes to submit information and data to the Knowledge Portal (KP) 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 FOA.

    Steering Committee (SC)

    • The Steering Committee (SC) composed of each of the PD/PI(s) for each UM1, or Contact PD/PI(s) in the case f multi-PD/PI grants, of the study (including research projects and Knowledge Portals) and the NIH Project Scientist(s) will be the main governing board of the study Consortium. Each full SC member will have one vote. All major scientific and policy decisions will be determined by (voting policies as established by the SC 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. The SC activities and decisions will consider the advice of the External Consultants.
    • NIDDK staff, in concert with the SC, will have the option to redirect research activities within the UM1 grant(s) if it is considered beneficial to the overall program.
    • The SC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right t augment the expertise of the Steering Committee when necessary.
    • There will be (an initial) meeting and Consortium Steering Committee meetings annually. These meetings will incorporate participation and recommendations of the External Consultants when determined by NIH staff (or as stipulated in the FOA).
    • An SC Chairperson will be chosen by the NIH. In collaboration with the Knowledge Portal and the NIH Project Scientists, the Chairperson is responsible for coordinating the SC activities, for preparing meeting agendas and for chairing meetings.
    • The SC, including the Project Scientist(s), is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
    • Each research project awardee and the Knowledge Portal awardee agree to the governance of the UM1s through the SC.
    • The NIH Project Scientist(s) may work with awardee(s) on issues coming before the Steering Committee and, as appropriate, other committees.

    External Consultants

    • Independent External Consultants will be identified by the NIDDK. The External Consultants will review periodically interim progress of the UM1s and report to NIDDK staff. External Consultants may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special “opportunity pool” funds.

    Dispute Resolution:

    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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Norann Zaghloul, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone:301-435-6677
    Email: norann.zaghloul@nih.gov

    Peer Review Contact(s)

    Dianne Camp, Ph.D.
    National Institute of Diabetes And Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-7682
    Email: campdm@mail.nih.gov

    Financial/Grants Management Contact(s)

    Craig E. Bagdon
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-2115
    Email: bagdonc@mail.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.


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