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 Data Coordinating Center of Accelerating Medicines Partnership (AMP) in Type 2 Diabetes (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of RFA-DK-09-004

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

RFA-DK-14-503

Companion Funding Opportunity

RFA-DK-14-003, U01 Research Project – Cooperative Agreements

Number of Applications

See 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 Program Director/Principal Investigator current awardee of the Accelerating Medicines Partnership (AMP) in Type 2 Diabetes Data Coordinating Center (DCC) (AMP T2D-GENES DCC). The AMP T2D-GENES consortium will consist of the DCC as well as participating sites being solicited by the companion FOA. The mission of AMP T2D-GENES is to characterize the genetic variations in human genomic regions that have been putatively associated with type 2 diabetes (T2D) and conduct follow-up functional studies of particular genetic variants.  This is a one-time FOA to provide funds to the AMP T2D-GENES DCC to continue the development of the web portal and deposit, aggregate and process the data generated, as part of an ongoing consortium of AMP T2D-GENES investigators as well as T2D-GENES community, for a maximum of five years, contingent on satisfactory performance. To support the conduct of these studies, AMP T2D-GENES DCC will coordinate manage and support the centers and provide the administrative infrastructure for the NIDDK-funded AMP T2D-GENES consortium. The AMP T2D-GENES DCC will build on and expand the previous work of the T2D GENES consortium.

Awardees under both FOAs will work collaboratively to establish the AMP T2D-GENES consortium. 

Key Dates
Posted Date
Open Date (Earliest Submission Date)

June 18, 2014

Letter of Intent Due Date(s)

June 18, 2014

Application Due Date(s)

July 18, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2014

Advisory Council Review

January 2015

Earliest Start Date

April 2015

Expiration Date

July 19, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

This Funding Opportunity Announcement (FOA) is one of two FOAs that implement the Accelerating Medicines Partnership in Type 2 Diabetes  Data Coordinating Center (DCC) (AMP T2D-GENES). This FOA will solicit the administrative structure needed to support AMP T2D-GENES activities and the complementary FOA (RFA-DK-14-003) will solicit investigator-initiated projects from research groups to complete the catalog of genes contributing to T2D and to begin evaluating their function.  The goal of the DCC is to maintain and continue to develop the webportal to aggregate and collate data on T2D genes and their functional variants that can be queried by the scientific community.  In addition, the DCC will also provide the administrative infrastructure for the AMP T2D-GENES consortium, a collaborative activity being continued by NIDDK via the companion FOA to characterize the genetic variations in human genomic regions that have been putatively associated with T2D and conduct follow-up functional studies of particular genetic variants. 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 T2D-GENES investigators will be shared in a timely way with other investigators in the consortium and with the research community at-large. The AMP T2D-GENES DCC will also oversee the AMP T2D-GENES opportunity pool, and enable the timely sharing of AMP T2D-GENES generated data between AMP T2D-GENES investigators and with the research community.

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 (http://www.nih.gov/science/amp/).

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.

The AMP T2D-GENES consortium will follow all the guidelines of the AMP.

Background

T2D-GENES was established by the NIDDK in 2009 to identify genetic variation associated with T2D with an emphasis on minority populations disproportionately affected by the disease. The T2D-GENES consortium will transition to the AMP T2D-GENES consortium. The AMP T2D-GENES will build on and expand the previous work of the T2D GENES consortium. The mission of the AMP T2D-GENES consortium is to characterize the genetic variations in human genomic regions that have been putatively associated with T2D and conduct follow-up functional studies of particular genetic variants to gain novel insights into the functions of these variants and the mechanisms by which they may contribute to disease. This knowledge will facilitate development of tools for risk prediction and early treatment of disease.

T2D currently affects over 300 million people worldwide and the prevalence is increasing rapidly. It is characterized by insulin resistance, beta cell failure and dysregulated insulin secretion by pancreatic beta-cells. Although the current rise in T2D prevalence is driven mainly by changes in life-style, complex genetic determinants are widely considered to contribute to an inherent susceptibility to this disease. Common variant genome-wide studies have yielded > 70 loci that are genome-wide significantly associated with T2D and many others with related glycemic traits. At very few of these 70 loci, have researchers yet established the causal transcript (i.e. the gene through which the T2D-risk is mediated), the direction of the effect, the mechanism of action, or the full impact on human physiology. By the end of 2013, the field of T2D genetics will have collected data on a scale not available for any other disease:  n>100,000 individuals genotyped genome-wide for common variants (GWAS), n>75,000 genotyped for low frequency coding variants using the exome chip, n=19,000 sequenced deeply in exons for rare and private variants, and n>4,000 whole genome sequenced at high coverage.  Thus the goal of the RFA is to continue the development of the web portal and deposit, aggregate and process the data generated, as part of an ongoing consortium of AMP T2D-GENES investigators as well as the broader T2D genetics community as well as provide for the expertise and infrastructure needed for data and sample management, including standardized acquisition, harmonization, annotation, quality control, dissemination, and public accessibility.

Objectives and Scope

The primary mission of the AMP T2D-GENES DCC will be to maintain and continue to develop a web portal as well as promote communication and collaboration among the consortium participants. This will be accomplished through facilitating scientific interactions using regular teleconferences of committees, sub-committees and scientific working groups; organizing annual or bi-annual face-to-face meetings of the consortium; developing web-based communication tools; and managing the award of subcontracts for a AMP T2D-GENES opportunity pool that will support collaborative projects developed by the AMP T2D-GENES Steering Committee. The AMP T2D-GENES DCC will also ensure the rapid and timely sharing of AMP T2D-GENES -generated data and resources within the consortium, and with the community at large. In that regard, it is expected that the AMP T2D-GENES DCC will be mostly responsible for developing an accessible archive of AMP T2D-GENES consortium activities as well as be responsible for building a user-friendly interface to facilitate the dissemination and sharing of these data, as well as the sharing of AMP T2D-GENES-generated data, resources and protocols through a central AMP T2D-GENES website. It will also be responsible for developing methods to track and facilitate movement of data from AMP T2D-GENES  sites into central data repositories; for ensuring rapid and timely data release to the investigators and to the community; and for facilitating coordination of AMP T2D-GENES activities and findings with other related database efforts.

Activities of the AMP T2D-GENES DCC will be undertaken with input from, and through cooperation with, the Steering Committees of AMP T2D-GENES consortium, and with feedback from the AMP T2D-GENES External Evaluation committee.

Program Organization

The award funded under this FOA will be a cooperative agreement (see Section VI.,Cooperative Agreement Terms and Conditions of the Awards). The awardee will meet as a Steering Committee, which will include the Program Director/Principal Investigator from the DCC and the Program Director/Principal Investigator from each grant of the companion RFA and the NIH Project Scientist. One awardee from this or the companion FOA will be selected by the Steering Committee to chair the Committee.  In addition, outside consultants may be appointed to serve as non-voting members to provide expert advice and assistance with respect to research priorities, specific new and transitioning research projects, technologies, standards, etc. The use of such outside consultants may be recommended by any of the voting members and their participation in scientific activities will require consensus among the voting members of the consortium.

Because this area of science is rapidly changing, most of the planning for this project will occur after the awardees are selected..  Flexible planning and face-to-face coordination will be required for multiple aspects of this project. The Steering Committee will plan follow-up studies based on the sequencing results, and coordinate the analysis, presentation and dissemination of the results in publications.  Many resources required for these studies will be supported centrally after the appropriate experiments are planned.  Awardees will analyze the resulting data and share their results with the Steering Committee and develop publications to share these results with the scientific community. All methods, protocols and data developed by AMP T2D-GENES investigators are expected to be made available to the research community.   The AMP T2D-GENES DCC will coordinate the individual U01s. The timeline and processes for sharing within AMP T2D-GENES and with the community at large will be established by the AMP T2D-GENES NIDDK Project Scientist and the AMP T2D-GENES PD(s)/PI(s). All participants will be expected to adhere to these policies as a term of the award, consistent with achieving the goals of the program. Policy documents for AMP T2D-GENES will be accessible on the AMP T2D-GENES website.  There is an expectation that data will be deposited to the web portal as discussed above and made available through dbGaP, db SNP etc. with phenotype data being made available according to NIH GWAS policies, and sequence data being made available to qualified researchers through a controlled-access repository operating at NCBI.

All participants will be obligated to abide by the policies adopted by the majority vote of the AMP T2D-GENES Steering Committee.  It is anticipated that the Steering Committee will meet twice a year and monthly on conference calls.  All AMP T2D-GENES teleconferences and meetings will be organized and administered by the AMP T2D-GENES DCC to coordinate the research projects to be conducted by the research grantees.  In addition, the AMP T2D-GENES DCC PD/PI will meet at least once a year with the AMP T2D-GENES DCC Program Officer, the AMP T2D-GENES DCC Project Scientist and the AMP T2D-GENES External Evaluation Committee to review the progress of AMP T2D-GENES activities. Note that the DCC will support costs of all AMP T2D-GENES related meetings except for costs for research project investigators to travel and attend the meetings. The AMP T2D-GENES DCC is also responsible for providing and maintaining a record of minutes of all AMP T2D-GENES meetings.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

Renewal

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

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $2.5 million per year for one award in FY 2015.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets should not exceed $2.5 million in total costs and must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.  

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Only the current awardee serving as the Data Coordinating Center of Multiethnic Study of Type 2 Diabetes Genes consortium (T2D-GENES) is eligible to apply for this Funding Opportunity 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 not 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.

Program Directors/Program Director (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/Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Only the current PD/PI serving as the Data Coordinating Center of Multiethnic Study of Type 2 Diabetes Genes consortium (T2D-GENES) may apply.  

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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:

The letter of intent, preferably electronically, should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
FAX: 301-480-4126
Email: calvof@mail.nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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 or Modular Budget

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

Budget requests must include costs for the PDs/PIs and up to two other members of the AMP T2D-GENES DCC to attend both steering committee meetings and the annual External Evaluation Committee meeting.  

Budgets requests must include costs required to support travel of 4-5 EEC members to the annual External Evaluation Committee meeting.

Opportunity Pool: Budget requests should be structured to provide $1.5 million in total costs per year from the AMP T2D-GENES opportunity pool fund.

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 team proposes to handle the following required functions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. 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.

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 by the Center for Scientific Review and responsiveness by NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

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

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

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

Investigator(s)    

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information 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

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

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

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) Genome Wide Association Studies (GWAS).

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:

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 or Board. The following will be considered in making funding decisions:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

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 involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The awardee will be primarily responsible for the planning and conduct of the operations defined by the terms and conditions of the cooperative agreement award.

The Program Director/Principal Investigator will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research and administrative functions supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.

Awardees will retain custody of and have primary rights to the data and software developed under this award, 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, informatics tools, 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 (s) will be required to participate in a cooperative and interactive manner with NIH staff, AMP T2D-GENES investigators and one another.

Awardees 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, 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 AMP T2D-GENES members.

AMP T2D-GENES 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 biospecimens 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. 

Awardees agrees 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 AMP T2D-GENES steering committee.

The AMP T2D-GENES Awardee must operate in accordance with processes and goals as delineated in the Funding Opportunity Announcement.

Upon completion or termination of the AMP T2D-GENES project, the Awardee is responsible for making all study materials, tools, databases and procedures developed by the AMP T2D-GENES 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 Program Director/Principal Investigator, or contact Program Director/Principal Investigator 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 AMP T2D-GENES subcommittees as needed.  Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at Steering committee meetings.

Awardees 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 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 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 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(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 (Steering Committee) and the External Consultants.

The NIH Project Scientist(s) will be a member(s) of the Steering Committee and, as determined by that committee, 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(s) 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(s), and review the project(s) for compliance with operating policies developed by the Consortium (Steering Committee), and may recommend to the NIH to continue funding;  withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the Consortium (Steering Committee).  Review of progress may include regular communications with the Program Director/Principal Investigator 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 to 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 RFA, and/or a human subject ethical issues that may dictate a premature termination.

The NIH Program Scientist(s) and Program Officer will review and approve applications of the Special Opportunity Funds to insure that they are within the scope of Consortium research as described in the Funding Opportunity Announcement and NIH guidelines.

The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientists and the Steering Committee 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 personnel involved.

The NIDDK Project Scientist will have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring.  The Project Scientist will have the same access and privileges to any data generated by the AMP T2D-GENES.  The dominant role and primary responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist.

The NIH Project Scientist serves as a resource with respect to other ongoing NIH activities that may be relevant to AMP T2D-GENES operations to facilitate compatibility and avoid unnecessary duplication of effort.

The NIH Project Scientist(s) or designee may coordinate activities among awardees 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, 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:

The AMP T2D-GENES consortium Steering committee will include the Program Director/Principal Investigator from the AMP T2D-GENES DCC and the Program Director/Principal Investigator(s) from each grant of the companion FOA and the NIH Project Scientist. Through the Awardee, AMP T2D-GENES Steering committee and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the DCC, 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.

Executive Committee (EC)

The EC will consist of: The Chair of the AMP T2D-GENES steering committee, the NIDDK Project Scientist, and representative PDs/PIs chosen among the Awardees; the EC is not a governing body and does not cast votes.

The EC will review the progress of all NIH-funded special funding opportunity program and make recommendations for improvement.  Annual reports will be prepared for each special funding opportunity to coincide with one of the annual SC meetings

The EC will be responsible for organizing the yearly External Evaluation Committee meeting

 The EC will have meetings that will be organized by the Chair of the AMP T2D-GENES consortium.  Any EC member may place items on the agenda.  These should be communicated in advance of the meeting to the Project Scientist(s) who will distribute these to all members.  The designated NIDDK Program Director(s) of U01 may be asked to participate in order to provide additional information and to summarize actions that are taken.

Steering Committee

 The Steering Committee composed of each of the Program Director/Principal Investigator for each U01, or Contact Program Director/Principal Investigators in the case of multi-PI grants, of the study (including research projects and CC) and the NIH Project Scientist(s) will be the main governing board of the study (Consortium).  Only the Program Director/Principal Investigators or contact Program Director/Principal Investigator and the NIH Project Scientist or designee will be voting members of the Steering Committee and 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 Consultants.

NIDDK staff, in concert with the Steering Committee, will have the option to redirect research activities within the U01 grant(s) if it is considered beneficial to the overall program.

The Steering Committee 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 to augment the expertise of the AMP T2D-GENES Steering Committee when necessary;

There will be two 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 Funding Opportunity Announcement).

A Steering committee Chairperson will be chosen by the NIH.  In collaboration with the CC and the NIH Project Scientists, 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(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 CC awardee agree to the governance of the U01 through the Steering Committee.

The NIH Project Scientist(s) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees.

External Consultants

An independent panel of 4-5 External Consultants will be established by the NIDDK.  The External Experts will review periodically interim progress of the U01s and report to NIDDK staff.  Members of the panel of External Experts 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.

Data Sharing:

The data sharing plan will be referenced as a term and condition of award. Applicant organization must comply with the Public Health Service (PHS) policies relating to distribution of unique research resources produced with PHS funding and sharing of research data and other research resources, as well as the grantee’s data sharing plan subject to decisions of the Network Leadership Committee.  For further information, see the NIH Data Sharing Policy at http://grants.nih.gov/grants/policy/data_sharing/.

The effectiveness of the data sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report.

The NIH intends for the resource sharing plans for the data generated under the AMP initiative to follow the policy and goals stated in the FOA.  Specifically, consistent with achieving the goals of the AMP program, all data generated (including processed/analyzed data) are expected to be deposited in a rapid and timely way into an accessible repository for use by the broad biomedical community, and for these data to remain available to all qualified investigators, consistent with applicable laws, regulations, and policies and unencumbered by any intellectual property claims.  The NIH, in consultation with the Network Leadership Committee for this project, will make all final decisions concerning data deposition and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.

Applicant organization will comply with and implement the recommendations and decisions of the Network Leadership Committee with respect to the sharing of information, data, protocols, resources, and methods developed by AMP investigators under the AMP initiative

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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Beena Akolkar
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8812
Email: akolkarb@mail.nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: calvof@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 Parts 74 and 92.


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