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 coordinating center for the Integrated Islet Distribution Program (IIDP-CC) facilitates the distribution of human cadaveric islets for biomedical research. By fostering the use of human islets in fundamental research, IIDP resources support advances in human islet biology and promote the development of new therapies for the prevention and treatment of diabetes.

The National Institutes of Health support many multi-faceted programs to advance human islet research, with the goal of developing new approaches to prevent and treat diabetes. This vigorous research effort consists of both investigator initiated projects and multi-disciplinary consortia. Reproducible access to high quality human islets has become fundamental for many of these programs. NIH support for the procurement, processing, and distribution of human islets was initiated through an Islet Cell Resource Center (ICR) program established in 2001 by the National Center for Research Resources (NCRR), together with the NIDDK and the Juvenile Diabetes Foundation International (JDRFI). Since 2009, the Integrated Islet Distribution Program (IIDP) managed by NIDDK has assumed responsibility for this activity and has distributed more than 200 million islet equivalents to over 100 investigators. Many key advances in human islet biology have been made possible through research supported by IIDP resources. Importantly, recent studies have suggested that human and murine islets are significantly different, underscoring the need for continued support for human tissue research in this challenging field.

The IIDP currently supplies over 100 investigators with human islets for their research programs. The IIDP Coordinating Center serves as an organizing intermediary between investigators and the islet isolation centers that procure and prepare islets for research purposes. To receive research islets through the IIDP, investigators must have ongoing, peer reviewed grant funding or approval from an IIDP-empaneled scientific review committee. Electronic application materials and other program information are made available through online IIDP web services. When a donor pancreas is recovered and the processed islets are directed for research purposes, an electronic system matches the characteristics of islets being offered with the research requirements specified by investigators, and notifies the researcher of islet availability.

Unlike rodent islet processing, the preparation of human islets requires expertise that is available in relatively few laboratories. In addition, providing islets for research at regular predictable intervals is costly. Procurement of human pancreata for research purposes typically costs $5000, and islet isolation costs exceed $14,000 for each organ that is processed. Quality control testing of islets adds further expense. Researchers currently pay $0.12 per islet equivalent plus shipping costs, and islet production facilities are reimbursed per islet equivalent shipped. In addition, as part of its ongoing mission to serve the diabetes research community, the IIDP is currently expanding procurement and distribution of human islets from donors with a history of Type 2 diabetes. Future activities may include facilitating the procurement of organs from prediabetic donors, or providing islets from donors with other forms of diabetes mellitus. The IIDP coordinating center manages all of these transactions.

The IIDP coordinating center will continue to oversee the distribution of human islets from islet isolation centers to researchers. The coordinating center will be responsible for organizing this process to ensure it is timely and equitable, for maintaining adequate quality control across the multiple procurement and isolation centers, and for fostering and promoting information exchange among investigators engaged in human islet research. Toward these goals the IIDP coordinating center will be responsible for two interrelated functions.

IIDP Coordinating Center- Administrative Functions

Administrative activities of the IIDP Coordinating Center (IIDP-CC) will consist of initiating subcontracts with qualified islet isolation centers, and providing the needed infrastructural support to maintain efficient and cost-effective oversight of resources that are acquired and distributed via the IIDP.

IIDP-CC Administrative Functions include:

a) Receiving online islet request applications, qualifying investigator recipients, and processing these data to maintain a complete and continuously updated electronic roster of approved investigator users and their projected needs;

b) Soliciting and qualifying potential islet production centers with respect to cGMP certification, assuring quality performance standards of prepared islets, providing training for standardized shipping/distribution protocols, subcontracting to appropriate laboratories to provide islets and adjust these subcontracts as warranted;

c) Implementing, maintaining and continuously improving the electronic notification system;

d) Developing, implementing and maintaining an electronic financial database documenting payment records;

e) Maintaining accurate records of islet shipments from production sites to islet recipients including quantities and batch release test characteristics, analyzing trends in demand for islets and projecting future islet requirements; ensuring timely submission of quality control data to the IIDP website;

f) Collecting information on user satisfaction and analyzing these data for quality improvements;

g) Maintaining and enhancing the IIDP public and password protected website to foster communication and information exchange between islet investigators and islet isolation centers;

h) Tracking scientific progress directly attributable to IIDP resources as shown by publications and other tangible results;

i) Overseeing a robust and competitive opportunity pool program. The IIDP Opportunity Pool will be deployed with the primary goal of enhancing the use of human islets in fundamental research. Among other uses, pilot funds may be used to subsidize the distribution of islets to early stage investigators and/or to researchers new to the field of human islet research. The IIDP-Opportunity Pool may also be used to enhance the availability of islets from diseased or rare patient populations, including patients with a history of diabetes. Small feasibility studies designed to address key questions related to islet procurement, production or delivery may also be supported by the IIDP opportunity pool. The IIDP-CC will be responsible for providing the technical support needed to enable electronic submission, review and progress reporting, as well as financial tracking of any opportunity pool awards.

j) Coordinating and providing statistical, technical, administrative, and logistical support for the activities of the IIDP External Scientific Panel and any other committees that may be empaneled to assist with the overall scientific direction, management, and direction of the IIDP. These responsibilities include preparation of rosters, scheduling of meetings and conference calls, preparation of materials, arranging travel and meeting logistics, and preparation of meeting summaries.

IIDP Coordinating Center- Quality Control

Quality control functions to be pursued by the IIDP Coordinating Center (IIDP-CC) will foster the development, implementation and oversight of rigorous program-wide quality control procedures. The IIDP's quality control activities will develop recommendations for standardizing procedures at islet production centers (where feasible) and will perform systematic testing of samples being distributed by the program's islet production sites. Through the implementation of standardized protocols and procedures, the IIDP-CC will ensure that key features of each islet batch shipped to investigators are independently analyzed and verified. IIDP quality control data should be acquired and uploaded directly to the IIDP website, and be provided in readily accessible forms/formats that can be linked to information provided by the Organ Procurement Organizations (OPOs), including donor data obtained from medical charts.

IIDP-Quality Control (QC) Activities include:

a) Devising, standardizing and implementing a human islet QC pipeline. This IIDP-QC pipeline will perform a defined set of assays that will assess the quantity, quality, and function of each islet shipment provided by IIDP-affiliated islet isolation centers. Tests should be designed to be cost-effective, and to maximize the information obtained from the smallest number of islet equivalents. Protocols to be used should be designed to subject islet preparations to multiple tests in parallel and/or in sequence to maximize information obtained from each islet preparation. Reproducibility, sensitivity and accuracy of any proposed tests should be provided. The battery of tests to be performed by IIDP-QC should include histopathological analyses as well as assays specifically designed to mirror tests performed at islet isolation centers. Additional assays that can be justified as particularly informative and cost-effective may be incorporated into the IIDP-QC pipeline.

b) Regular monitoring to ensure the accuracy and efficiency of the IIDP-QC pipeline. The pipeline will be required to return QC data expeditiously for approximately 115 islet shipments annually, at the rate of 10-12 islet shipments/month.

c) Developing strategies to seamlessly report and upload QC and associated data to the IIDP website. The intent is to provide IIDP customers and affiliated islet isolation centers with timely, useful and standardized quality assessments as measured following receipt of islet preparations from the islet isolation centers. In addition, IIDP-QC will be responsible for extracting and uploading to the IIDP web services any appropriate data elements that need to be linked to the QC data records.

See Section VIII. Other Information for award authorities and regulations.

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.

The PD/PI should be a senior established investigator with expertise in providing oversight and financial management of complex programs that provide resources to the diabetes research community. It is further expected that the PD/PI will have a depth of expertise and track record in human islet biology research, with a strong record of providing quality control assessments of human islets. If the PD/PI is not an expert in human islet biology and islet quality control, a senior independent investigator with expertise in human islets must be included as a part of the leadership team for the IIDP-CC.

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 obtain 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 should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 7005
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-7797
Email: NIDDKletterofintent@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.

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

Budgets are limited to $750,000 direct costs per year to support IIDP Coordinating Center Administrative Functions, including personnel, shipping, meeting expenses, supplies, and travel; up to $250,000 direct costs per year to support IIDP-CC quality control assays, including any subcontracting costs needed to establish relationships with quality control assay providers; and $300,000 direct costs per year should be included as a restricted opportunity pool that will be used to support pilot awards and incentive programs. All opportunity pool award 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:

Research Strategy:

• Explain how the project as designed will address the needs of the research community and how the planned activities are designed to meet future research needs. Explain how successful completion of the aims will bring about unique advantages or capabilities to the field.
• Explain how the track records of the PD(s)/PI(s) provide evidence of their ability to provide services to the diabetes research community, and to provide effective financial oversight of core activities and facilities as well as expertise in human islet biology.
• Explain any novel strategies that will be used to coordinate activities, and identify any novel concepts, strategies, instrumentation or management strategies that will be employed.
• Provide an appropriate plan for work-flow and a well-established timeline for providing services in a timely and efficient manner.
• Verify that resources are available within the scientific environment to support all aspects of the center activity, including electronic information handling.
• Describe how the center will provide the administrative support required to support steering committee meetings, subcontracting to islet distribution sites, oversight of quality control activities, curation of website and intranet sites, and continued improvements in associated databases to enhance interoperability between the IIDP and other related programs.
• Explain how the opportunity pool program will be managed, including plans for submission, review, and award.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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 NIDDKletterofintent@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 an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project address the needs of the research community that it will serve? Is the scope of activities for the center appropriate to meet those needs? Will successful completion of the aims bring about unique advantages or capabilities to the field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have demonstrated track records of success in providing services to the diabetes research community, and of providing effective financial oversight of core activities and facilities? Do the PD(s)/PI(s) have demonstrated expertise in human islet biology and track records of success in providing quality control assays for human islets?

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? Does the application propose novel management strategies in coordinating the activities to be administered by the center? Are the concepts, strategies or instrumentation novel to one type of research program or applicable in a broad sense?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Are an appropriate plan for work-flow and a well-established timeline proposed? Is the process for management of submission, review and award of opportunity pool projects clearly described and appropriate?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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? 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

Will the IIDP-Coordinating Center be able to:

a) Provide administrative support for steering committee meetings, reports, advertising, etc.?

b) Efficiently execute and support subcontracts as needed to support islet distribution sites?

c) Implement and oversee Quality Control activities to assess the quality of islets delivered to researchers?

c) House, maintain, and curate websites and intranet sites?

d) Provide maintenance, continued development, and aid to populate the database(s) and provide for interoperability between IIDP 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

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

Not Applicable

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.

Not Applicable

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

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 UC4, 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.

Awardee Rights and Responsibilities:

• 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, Islet Isolation Center staff, IIDP 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 IIDP-CC Program Officer and the IIDP-CC 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 researchers affiliated with the center and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the project as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching MTA amongst center affiliates 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 IIDP-CC 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 agreed upon by the Steering Committee and Subcommittees.
  • Awardees must agree to serve on subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings.

NIH Responsibilities:

• 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 IIDP-CC, attend and participate in all meetings between the IIDP 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 IIDP-CC, and review the project for compliance with operating policies developed by the Steering Committee, and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by 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 for access to IIDP resources to insure that they are within the scope of IIDP 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 Scientist 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 coordinating center. 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 IIDP 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.

Collaborative Responsibilities:

Through the Awardee Steering Committee, the study members will cooperatively develop and implement processes to ensure timely deposition of data 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 the Program Director/Principal Investigators for the award, or Contact Program Director/Principal Investigators in the case of a multi-PD/PI grant, and the NIH Project Scientist will be the main governing board of the project. 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 center grant 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, is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
  • The CC awardee agrees 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 UC4 and report to NIDDK staff.

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.

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at https://grants.nih.gov/grants/policy/myf.htm.

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: https://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
Email: support@grants.gov

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

Sheryl M. Sato, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8811
Email: smsato@mail.nih.gov

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

Christina Coriz
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 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 I diabetes and for Indians.