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	NIDDK Interconnectivity Network Coordinating Unit (U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	New
Related Notices	May 26, 2017 - This RFA has been reissued as RFA-DK-17-010.
Funding Opportunity Announcement (FOA) Number	RFA-DK-11-030
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
FOA Purpose	The purpose of this FOA is to support development of a web portal and associated bioinformatics required to facilitate information sharing between NIDDK-supported resources and the scientific community, with the ultimate goal of synergizing scientific advances in NIDDK interest areas. A pilot project, the NIDDK Consortium Interconnectivity Network (dkCOIN), established the feasibility of creating a limited network and web solution for information sharing between a subset of NIDDK basic science consortia (www.dkcoin.org). Based on the success of this pilot, NIDDK is soliciting applications for a Coordinating Unit that will provide the leadership and vision needed to create a user-friendly infrastructure linking multiple NIDDK resources and data. The Coordinating Unit will be responsible for developing a platform that will seamlessly connect the NIDDK investigator community to integrated information, resources and data held by NIDDK supported programs and projects, with the goal of providing a uniquely valuable and powerful resource for NIDDK investigators.

Posted Date	October 20, 2011
Letter of Intent Due Date	February 15, 2012
Application Due Date(s)	March 15, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/ July, 2012
Advisory Council Review	October, 2012
Earliest Start Date(s)	December, 2012
Expiration Date	March 16, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

In 2010, NIDDK began testing the feasibility of using web-based solutions to interconnect research programs, with the goal of enhancing resource sharing within the NIDDK research community. In the pilot program (dkCOIN; www.dkcoin.org), four NIDDK-supported consortia were used as prototypes to demonstrate feasibility of the concept. NIDDK programs involved in the pilot included the Nuclear Receptor Signaling Atlas (NURSA; http://www.nursa.org), the Beta Cell Biology Consortium (BCBC; http://www.betacell.org), the Mouse Metabolic Phenotyping Centers (MMPC; http://www.mmpc.org) and the Animal Models of Diabetic Complications Consortium (AMDCC; http://www.amdcc.org). The dkCOIN pilot succeeded in developing a user-friendly web portal for coordinated information browsing between the four consortia. Extensibility was proved through expansion of dkCOIN to include the Type 1 Diabetes Mellitus Database (T1Dbase; http://www.t1dbase.org). In this FOA, NIDDK is moving forward with this concept by soliciting a coordinating center that will serve the broader interests of NIDDK in its desire to interconnect research communities to build collaborations and synergies within and across scientific disciplines.

The role of the coordinating unit (CU) solicited under this FOA is to provide the vision, leadership and infrastructure needed to facilitate greater utilization of NIDDK resources, and to add value to existing resources by providing an environment that will foster new collaborations and synergies within the NIDDK research community. The CU will provide the scientific direction and administrative management to seamlessly integrate information, resources and data held by NIDDK related research groups with the goal of providing a uniquely valuable and powerful integrated resource of NIDDK-relevant information. With the addition of links to relevant world-wide repositories and virtual libraries, the Interconnectivity Network-CU will provide an expanded portal for NIDDK investigators seeking to expand and extend the impact of their research programs. The Interconnectivity Network-CU will design solutions that are easily adaptable, extensible, evolvable and portable particularly to a cloud environment. Development and/or adaptation of novel bioinformatics tools will serve to facilitate greater utility of the data drawn from the individual sources. The CU will be responsible for providing validated tools and methods as needed to enhance the utility of NIDDK data and resources for the investigator community. The collection and storage of publicly available data will be expected to persist beyond the project period covered under this announcement. Therefore, the development and management of this resource are considered a stewardship that shall be subject to transfer at the end of the project period. It is therefore imperative that the database and core functions of the data repository be independent of physical location and use publicly available software. The number of resources and data to be integrated by the CU are expected to grow as the project period progresses. Given the expected increase in demand for computing capacity over the lifetime of the project, applicants will be expected to propose strategies for the CU that are compatible with and operational on cloud computing platforms.

Scope

i. Build a web-based portal that will interconnect the NIDDK research community using state-of-the-art approaches and functionalities.

ii. Devise search and analysis strategies that will be operational on a cloud-computing or other neutral, easily accessible environment to distribute ownership and maintain resiliency of the network.

iii. Identify and make available tools to foster mining of information from the network and any constituent research programs, as well as provide links to relevant data sources from the broader research community

iv. Conduct outreach to the broader community of stakeholders and potential users to better define needs, use cases, and potential solutions to enhance value and use of the data and resources

v. Develop a vision for how the NIDDK Interconnectivity Network can contribute greater scientific value with the goal of advancing the scientific mission of NIDDK

vi. Plan workshops and other consultations to advance the build-out and utilization of dkCOIN

The successful applicant will present a strategy and efficient plan to fulfill all responsibilities, functions and activities required of the NIDDK Interconnectivity Network Coordinating Unit, including:

• Evolution or redesign of the existing website (http://www.dkcoin.org/) to enable sharing of information, reagents and databases between NIDDK supported investigators and the broader scientific community. This should include unique resources generated and/or listed by additional NIDDK consortia such as the GenitoUrinary Molecular Anatomy Project (http://www.gudmap.org/). Resources to be collected may include antibodies, adenoviruses, genetically manipulated mouse strains and mESC lines, as well as microarray, ChIP-seq/RNA, metabolomics, proteomics, and quantitative PCR datasets. The CU will be responsible for coordinating and increasing the collection of shared reagents, protocols and databases; for improving the description of and access to shared resources; and for facilitating access to informatics tools needed to enhance the utility of the resource. The CU will also be responsible for development of easily adaptable tools that will allow future consortia to seamlessly integrate with dkCOIN or its successor. These will represent a set of best practices for future use.
• Development and oversight of data and resource access to provide key resource compendia and assure access to unique shared datasets for the community. This will include providing a maximally efficient means for data collection, storage, and availability, from a variety of sources, and ensure that designs are adaptable, extensible and portable within a cloud computing environment.
• Identification of stakeholder and user needs to also include development of new and adaptation of existing bioinformatics tools to facilitate meeting these needs. Outreach may include organizing scientific retreats and workshops to facilitate information exchange and foster new collaborations. Interaction with the broader community of stakeholders and potential users should be encouraged to facilitate both greater use and value of the resources identified through the CU. The CU will be responsible for initiating and enhancing interactions with other NIDDK or NIH centers and consortia. Such interactions may include joint scientific events and/or integration of research databases.
• Strategy for development and management of this data repository as a stewardship that shall be subject to transfer at the end of the project period. Therefore, the data and core functions of the database shall be cloud compatible and use publicly available software. Any proprietary tools must be able to be decoupled from core functions of the database or be made publically available so stewardship of the repository can be transferred at the end of the project period or subsequent to a future re-competition.
• Effective management through a Steering Committee (SC) and an External Evaluation Committee (EEC). The CU will advertise network activities and provide written reports, posters and slide presentations describing the NIDDK-Interconnectivity Network research effort to stakeholders and outside constituencies and organize ad-hoc teleconferences to facilitate integration and expansion activities.

In addition, the CU should be prepared to seamlessly integrate with the NIDDK webpage to provide further integration of the resources/data offered by the CU and the needs of NIDDK (www2.niddk.nih.gov).

To help with the management of the network, NIDDK staff and the Coordinating Unit will be assisted by two administrative bodies: the NIDDK Interconnectivity Network Steering Committee (SC) and the NIDDK Interconnectivity Network External Evaluation Committee (EEC).

The Steering Committee (SC) is the principal governing body of the network. It consists of the PD(s)/PI(s) of the Coordinating Unit, NIDDK staff members (one voting), and the PD(s)/PI(s) of participating consortia/programs or their duly designated representatives.

An External Evaluation Committee (EEC) will be constituted to help NIDDK staff in its task of administering dkCOIN activities. It will be composed of 4-5 highly-regarded scientists, selected by NIDDK, who provide oversight and advice regarding ongoing activities and future directions of the NIDDK Interconnectivity Network.

The CU will organize the monthly conference calls of the network SC, as well as bi-annual in-person SC meetings. On a regular basis, the CU will gather progress reports on shared activities (cores, website development, etc) to be discussed by the SC. The CU may also be asked to write reports on the general activity and progress of the consortium to be used by NIDDK staff or the EEC.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDDK will commit $600,000 Total Costs in FY2012. It is anticipated that one award will be made.
Award Budget	This FOA is limited to a budget of $400,000 Direct Costs per year inclusive of consortium and subcontract F&A.
Award Project Period	One award will be made for fiscal year 2012 for a period of up to five years. Future year amounts will depend on annual appropriations.

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

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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

NIDDK encourages all qualified applicants regardless of prior association with the dkCOIN pilot or other large NIDDK programs to apply to this FOA. The information systems, consulting, and database archiving tasks required to design and execute dkCOIN are highly technical, and require extensive experience, expertise, and long-term commitment. It is expected that applicants will have the technical capability and management skills to independently carry out this ambitious agenda.

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

The letter of intent should be sent to:

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

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

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

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398 Application Guide.

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 (please note all format requirements) as described in the PHS398 Application Guide.

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following 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.

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? How will they identify, solicit, and interact with PD(s)/PI(s) of assimilated projects to expand the network? Do the applicants have a strong and consistent track record of NIDDK-supported research? Do the applicants have extensive experience in oversight of large, multi-component research programs and show evidence of strong administrative skills? Are the PD(s)/PI(s) well known and considered to be experts in their respective areas of expertise?

Innovation

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

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Not Applicable.

Revisions

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/priority score.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications. 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(s)/PI(s) 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

• Carrying out the activities essential to maintenance and further development of dkCOIN, as well as the web portal http://www.dkcoin.org.
• Scheduling of regular Steering Committee meetings including agendas and logistics for such meetings.
• Data and Reagent Sharing: the NIDDK Interconnectivity Coordinating Unit must include technology
• transfer and sharing plans for both data and unique research resources that are
• generated by the projects in concordance with NIH policies on the sharing of data and resources. It is expected that resources developed by the CU constituent consortia will be made available to the broader scientific community, after a propriety period, at no charge other than the cost of reproduction and distribution. The grant application must also include a statement indicating the applicant’s willingness to abide by the Cooperative Agreement Terms and Conditions of the Award.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NIDDK Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study.

The Steering Committee (SC) is the principal governing body for this consortium. It consists of the PI of the Coordinating Unit, NIDDK staff members (one voting), and the PD(s)/PI(s) of participating consortia/programs or their duly designated representatives. The latter will expand as the network assimilates additional NIDDK funded projects. The head of the CU is a permanent member of the SC and chairs the Committee. The head of the CU is a permanent member of the SC and chairs the Committee. In the event that the PD(s)/PI(s) of the CU is also a PD(s)/PI(s) on one of the participating consortia they shall have only one vote on the committee. They will need to represent both the CU and any additional consortia that they lead. Key personnel other than the PD(s)/PI(s) of the CU may not be voting members of the steering committee unless performing a role as the CU's designated representative. Any compensation for consortia members performing work on behalf of the CU shall be through short term subcontract subject to the guidance of the steering committee and approval of NIDDK staff. The purpose of the SC is to discuss and evaluate concerns of network members, as well as the community at-large, help with the planning of major events (scientific retreats, etc), evaluate Unit activities and provide feedback to NIDDK Program Staff. Major decisions regarding consortium activities or its evolution (changes in sharing policies, assimilation of new consortia, movement toward a cloud computing environment, etc) will be made by the SC. The SC will also discuss implementation of recommendations or suggestions from NIDDK, or the External Evaluation Committee and then plan a strategy and timeline for implementing these changes in a timely fashion.

For multi-center studies, the NIDDK Project Scientist will participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

The NIDDK Project Scientist(s) will serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

The NIDDK Project Scientist(s) will have substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:

The NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results and in reviewing procedures for assessing data quality and study performance monitoring.

The NIDDK Project Scientist(s) or designee may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participate in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

In addition, a separate NIDDK Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study. The NIDDK Program Official will review and approve protocols prior to implementation to insure they are within the scope of peer review. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK. The NIDDK Program Official will make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

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

In addition, the NIH will:

• Request a series of milestones to be developed along with timelines for their completion. A chair of the Steering Committee will be identified by NIH Staff in consultation with the awardees.
• Constitute an External Evaluation Committee which will meet periodically with the Awardees and NIH Staff to help evaluate progress against agreed upon milestones. The Principal Investigator/Director of dkCOIN must indicate a commitment to be responsive to recommendations provided by an independent External Evaluation Committee (EEC). The NIDDK Interconnectivity Coordinating Unit EEC will meet annually to review interim progress and will provide an annual report and recommendations to NIDDK and to the Steering Committee on consortium activities. The dkCOIN Steering Committee will be responsible for organizing and providing minutes of these meetings. Members of the EEC will be nominated by the NIDDK Interconnectivity Coordinating Unit Steering Committee, selected and invited by the NIH. A chairman will be chosen from among the EEC membership, who will be accomplished senior scientists from academia and industry with backgrounds in the mission of NIDDK and technologies associated with web portal development and function, software use and development, and concepts of large scale data handling and analysis. If voting is necessary for an action item, members of the EEC and the EEC chair hold one vote each. The Steering Committee will discuss implementation of EEC recommendations, and provide a timeline and action plan for making changes in a timely fashion. The action plan will be reported to the EEC.
• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• At least two Steering Committee meetings shall be in person meetings, jointly organized by the Awardees and the NIH. The EEC will be in attendance at one such meeting.
• The awardees in conjunction with the NIH will periodically hold investigator's retreats as well as pertinent workshops designed to further the outreach and relevance of dkCOIN.
• All other responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and 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.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Arthur L. Castle, Ph.D.
Program Director, Metabolomics and Informatics
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
National Institutes of Health
6707 Democracy Boulevard, Room 791, MSC 5460
Bethesda, Maryland 20892-5460
(fed ex 20817)
Telephone: (301) 594-7719
Email:castle@mail.nih.gov

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

Christina Coriz
Grants Management Specialist
Grants Management Branch
Division of Extramural Affairs
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK )
6707 Democracy Blvd, Rm 709B, MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8848
Email:corizc@mail.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 Parts 74 and 92.