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.

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

The NIDDK currently supports two consortia that are designed to support research into diabetes and its complications: the Mouse Metabolic Phenotyping Centers and the Diabetic Complications Consortium. The purpose of this FOA is to invite applications for a Coordinating and Bioinformatics Unit for these joint efforts that will continue to serve the administrative and bioinformatics needs of these two programs.

The Mouse Metabolic Phenotyping Centers (MMPC; http://www.mmpc.org/) were established in 2001 (RFA-DK-00-014) and renewed in 2006 (RFA-DK-05-008) and 2010 (RFA-DK-10-006). The program has had a continuing goal of advancing biomedical research by providing standardized, high quality metabolic and physiologic phenotyping services for mouse models of diabetes, diabetic complications, obesity and related disorders. The MMPC is currently a consortium of six Centers. The MMPC program will be renewed through grants awarded under a companion FOA (RFA-DK-15-010). In addition to the cooperative research grants supporting fee-for-service phenotyping activities, the MMPC program supports an administrative infrastructure, a collaborative research database, and an opportunity pool fund that is used to support pilot and feasibility and collaborative research projects promoting the mission of the MMPC consortium. The resources created through the MMPC awards and their associated activities are intended to substantially accelerate and expand the identification, validation and utility of mouse models for diseases within the NIDDK mission.

The NIDDK Diabetic Complications Consortium (DiaComp; http://diacomp.org/) originated in 2001 as the Animal Models of Diabetic Complications Consortium (AMDCC;RFA-DK-01-009). The AMDCC was subsequently renewed in 2006 (RFA-DK-05-011) and evolved into the Diabetic Complications Consortium under a subsequent FOA (RFA-DK-10-007). The DiaComp (and former AMDCC) programs are designed to foster communication and collaboration between investigator communities involved in complications research.

In 2011, the coordinating and bioinformatics activities of both the MMPC and DiaComp programs were consolidated into a single Coordinating and Bioinformatics Unit. This FOA will support a continuation of the joint coordinating unit for the MMPC and DiaComp programs that originated under RFA-DK-10-007. The MMPC/DiaComp-CBU will continue to be responsible for organizing meetings and workshops as needed to enhance sharing of data and resources across both programs and with the research community at large. The MMPC/DiaComp CBU will also be responsible for administering opportunity pool funds for both programs.

The MMPC/DiaComp Coordinating and Bioinformatics Unit (CBU) will be a combined resource that will continue to be shared by two NIDDK programs: the Mouse Metabolic Phenotyping Centers and the Diabetic Complications Consortium. Activities to be undertaken by the CBU include: 1) providing clerical and administrative support, 2) curating, maintaining and managing central databases, 3) funding and overseeing financial management of consortium-related expenses, including opportunity pools, 4) updating and maintaining internet and intranet websites for the consortia, and 5) promoting each consortium via advertising and by facilitating collaborations with other related programs.

CBU Administrative Functions in Support of Research

• Facilitating cohesive and collaborative interactions by organizing, funding, and providing minutes/reports of regularly scheduled meetings and conference calls involving the consortia and their advisors. It is expected that the CBU will coordinate and provide meeting support including organizing and providing funds for face-to-face meetings, and will provide coordination and funds for travel and housing for annual meetings of the External Scientific Panels (ESP) for each consortium as outlined in Part II Section I and in Part II Section VI.2.
• Organizing monthly teleconferences of Executive Steering Committee meetings and as needed for other subcommittees; providing minutes and reports of Executive Steering Committee and External Scientific Panel (ESP) meetings; tracking and posting of minutes of regular meetings of committees on a members-only website.
• Curating and maintaining public websites for each consortium and providing logistical advice and support as-needed for maintaining individual consortium-related websites; development and maintenance of members-only websites, including establishment and maintenance of an Internet-based mechanism for rapid data and document transmission and electronic communication among participants in the consortia and between the consortia and the NIH; development of methods and means to document and advertise consortium activities, including development and distribution of advertising materials for the consortia and any associated opportunity pool programs; updating and posting of protocols, Guidelines and Policies, and any associated consortium-related documents as deemed necessary by oversight committees and NIH staff.
• Managing the solicitation, review and selection of projects to be funded under MMPC and DiaComp opportunity pools; awarding subcontracts and providing fiscal oversight for opportunity pool programs for each consortium.
• Coordinating consortium activities across each program, including collaborations with outside groups; assisting with preparation of consortium publications on best practices or standardized procedures; advertising training opportunities; curation of the MMPC catalog and optimization of MMPC services across Centers.
• Tracking of business activities and workflow at individual MMPCs; filing records of MTAs and other documents submitted with service requests; maintaining records of any formal collaborative agreements at the MMPCs; monitoring utilization of cores.
• Designing and implementing methods for evaluating MMPC customer service, such as a formal process for obtaining feedback from users. The CBU may also organize meetings or workshops for MMPC customers for the purpose of sharing information and data, obtaining feedback, training, exploring the need for new tests, or monitoring the value of a particular set of tests to the user community.

CBU Bioinformatics Functions

• Curation, maintenance, and expansion of the MMPC and DiaComp databases as needed to accommodate a centralized and comprehensive internet-based database of important phenotypic information acquired by each consortium;
• Tracking and facilitating movement of data from MMPC sites and DiaComp sites into respective central data repositories; providing training for personnel (including on-site visits) as needed to ensure rapid and timely data depositions; providing advice and guidance on use of the database to investigators within and outside the consortia;
• Facilitating coordination with other related database efforts as directed by consortium Steering Committees and ESPs, including but not limited to Mouse Genome Informatics (MGI); the International Mouse Phenotyping Consortium; the KOMP and MMRRC repositories.
• Additional bioinformatics functions as proposed in the application or as required by the MMPC or DiaComp Executive Steering Committees and program associated ESPs.

The CBU will provide administrative coordination and bioinformatics support for each consortium. The Mouse Metabolic Phenotyping Centers Consortium will consist of cooperating Phenotyping Centers (MMPCs) and this shared CBU; it will be guided by an MMPC Executive Steering Committee and a dedicated External Scientific Panel. The Diabetic Complications Consortium will consist of multiple complications-related projects and this shared CBU; it will be guided by DiaComp Executive Steering and External Scientific Panel Committees. The CBU will be guided by input from the MMPC and DiaComp Steering Committees and External Scientific Panels (ESPs), as well as by input from an independent CBU-dedicated ESP.

Consortium Activities and Responsibilities

The Program Director/Principal Investigator (PD/PI) of the CBU must agree to be participate in consortium-wide activities as deemed necessary by appropriate oversight committees.

Executive Steering Committee

The PD/PI of the CBU must agree to participate in the Executive Steering Committee of each consortium. These Executive Steering Committees meet monthly by teleconference and each year in person to encourage information exchange within the consortia. For the MMPC, the Executive Steering Committee will consist of the MMPC Center Directors, the PD/PI of the Coordinating and Bioinformatics Unit, NIH Project Scientists, the NIDDK Project Officer, and other Core Directors and MMPC personnel as needed. For DiaComp, the Executive Steering Committee will consist of the PD/PI of the Coordinating and Bioinformatics Unit, DiaComp awardees, NIH Project Scientists, and the NIDDK Project Officer. The Chairs will be chosen from among non-NIH members of each committee, and may rotate annually. The role of the NIDDK Project Scientist is described under Cooperative Agreement Terms and Conditions of Award, Section VI 2. The NIDDK Project Officer is the NIDDK staff person responsible for reviewing annual progress and signing off on Grant Progress Reports. The purpose of the Executive Steering Committees will be to discuss and evaluate concerns and cooperative activities of the consortia. If voting is necessary for an action item, members of the Executive Steering Committee and the NIH institutes hold one vote each. The Executive Steering Committees will discuss and evaluate Subcommittee and Core activities and provide feedback to Subcommittee leaders at least bi-annually, implement changes in subcommittee membership or direction if needed, discuss and evaluate new projects, collaborative projects, and pilot and feasibility programs.

External Scientific Panel (ESP)

The PD/PI of the CBU must indicate his/her intention to be responsive to recommendations provided by independent External Scientific Panels associated with each consortium, and to recommendations provided by an ESP solely dedicated to CBU activities. The MMPC, DiaComp and CBU ESPs will meet annually to review progress and will provide an annual report and recommendations to NIDDK and to the Executive Steering Committees of each consortium. The CBU will be responsible for organizing and providing minutes of these meetings.

Members of the ESP will be nominated by the Executive Steering Committees of each consortium and will be selected and invited by the NIH. A chairman will be chosen from among the ESP membership, who will be accomplished senior scientists from academia and industry with backgrounds in diabetes, diabetic complications, obesity, animal models, mouse genetics, and technologies associated with mouse phenotyping. If voting is necessary for an action item, members of the ESP and the ESP chair hold one vote each. The Executive Steering Committees of each consortium will discuss implementation of ESP recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to their respective ESPs.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

Applicant Organizations

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

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

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

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

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.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

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

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.

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

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

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

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

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

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

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817
Telephone: 301-594-8897
Fax: 301-480-3505
Email: calvof@mail.nih.gov

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

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.

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

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

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 CBU should have a Director, an administrator, a dedicated website and database curator, and additional personnel as needed to support its proposed activities.

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

Budgets are limited to $300,000 direct costs to support CBU personnel, travel, consortium meeting expenses, and supplies; and $9,800,000 to support opportunity pool programs administered by DiaComp ($9,200,000) and MMPC ($600,000). All opportunity pool costs are inclusive of any consortium F&A.

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

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

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

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

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

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

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 NIDDK, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at 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.

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

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.

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).

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 the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring about unique advantages or capabilities to the research consortium?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing diabetes research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their organization structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Does the application propose novel management strategies in coordinating the research consortium the Center will serve? Are the concepts, strategies or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

Research Support Abilities

Will the CBU be able to

• Provide administrative support for consortium meetings, reports, advertising, etc.?
• Efficiently execute and support subcontracts administered under consortial opportunity pools?
• House, maintain, and curate websites and intranet sites?
• Provide maintenance, continued development, and aid to populate the database(s) and provide for interoperability between the CBU databases and other related databases?

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.

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.

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.

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

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.

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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:

• 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 will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
• Awardee(s) 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, study protocols, data analysis, conclusions, etc. per policies approved by the consortium as well as any confidential information received by third party collaborators.
• Awardees must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
• All staff of the Awardee will be required to participate in a cooperative and interactive manner with NIH staff, MMPC and DiaComp investigators, and one another.
• Awardees must share data, materials, models, methods, information and unique resources that are generated by the project in accordance 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 the research activities of other consortium members.
• The Awardee will submit a list of milestones and project deliverables to the CBU Program Officer and the CBU Project Scientist within six months of the initial award, and will subsequently provide updates on progress toward milestones and deliverables on an annual basis.
• Awardees agree to establish agreements 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 agree that industry collaborations should be governed by a research collaboration agreement (e.g. CTA, RCA, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies and procedures and any policies and procedures developed by each consortium.
• Awardees must be in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
• Upon completion or termination of the research project(s), the awardees are responsible for making all study materials, tools, databases and procedures developed by the CBU 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-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 agreen upon by the Steering Committee and Subcommittees.
  • Awardees must of on subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator's Retreat.
• Awardees may be asked 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 NIH will invite External Experts with relevant scientific expertise. The External Experts will meet to review the progress of the research projects and to advise NIH staff of scientific developments and opportunities that may enhance the achievement of study goals.
• An NIDDK Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIDDK Program Official as follows:
  • The NIH Project Scientist will coordinate and facilitate the activities of the CBU, attend and participate in all meetings between the CBU and individual consortia, and act as a liaison between the Awardee and the External Experts.
  • The NIH Project Scientist will be a member 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.
  • The NIH Project Scientist, and other designated NIH program staff will help the Steering Committee develop and draft operating policies.
  • The NIH Project Scientist and Program Officer will review the scientific progress and administrative accomplishments of the CBU, and review the project for compliance with operating policies developed by MMPC and DiaComp Steering Committees, 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 consortium steering committees. 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 of a study protocol or Consortium policy and procedure, (b) substantive change in a study protocol that are not in keeping with the objectives of the RFA, and/or a human subject ethical issue that may dictate a premature termination.
  • The NIH Program Scientist 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 Project Scientists will have substantial programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientists will have the same access and privileges to any data generated by the consortium. 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 NIH Project Scientists.
  • The NIH Project Scientist serves as a resource with respect to other ongoing NIH activities that may be relevant to CBU studies to facilitate compatibility and avoid unnecessary duplication of effort.
  • The NIH Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of (a) common research protocols(s) and statistical evaluations of data and in the publication of results.
  • The NIH Project Scientist may review procedures for assessing data quality and monitor study performance.
  • The NIH Project Scientist may be a co-author on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

Areas of Joint Responsibility include:

Through the Awardee, Steering Committees and NIH staff, the study members will cooperatively develop and implement processes to submit information to the coordinating center, 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.

• Steering Committee
  • The Steering Committee composed of each of the Program Director/Principal Investigators for each award, or Contact Program Director/Principal Investigators in the case of multi-PD/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 Directors/Principal Investigators or contact Program Directors/Principal Investigators 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 Experts.
  • NIDDK staff, in concert with the Steering Committee, will have the option to redirect research activities within the consortium 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 study Steering Committee when necessary;
  • There will be Steering Committee meetings annually. These meetings will incorporate participation and recommendations of the External Experts 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 consortium 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 External Consultants will be established by the NIDDK. The External Experts will review periodically interim progress of the UXXs 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.

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.

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

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact 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)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Kristin M. Abraham, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-8048
Email: abrahamk@mail.nih.gov

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

Christina Coriz
National Institute of Diabetes and digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8848
Email: corizc@niddk.nih.gov

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. This FOA is supported under the authority of P.L. 114-10, "The Medicare Access and CHIP reauthorization Act of 2015"; Section 213. "Extension of special diabetes program for type 1 diabetes and for Indians".