Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIDDK seeks to accelerate the pace of scientific research towards prevention, more effective treatment, and cure of type 1 diabetes. To this end, NIDDK is committed to providing opportunities to utilize existing clinical resources to increase our understanding of type 1 diabetes etiology and pathogenesis in humans. This opportunity is intended to fund collaborative projects using subjects (and/or their samples) who have been phenotypically and genetically characterized for risk of developing type 1 diabetes.

To apply for funding, applicants must have documented access to subjects and/or samples from the relevant consortia, or an availability report from the NIDDK repository (https://www.niddkrepository.org/home/ ). The document from the consortium can indicate that approval for access is contingent on funding, but must state the type and number of subjects and/or samples approved, and the document must be included as part of the application (see below for instructions). Successful applicants are expected to abide by the policies and procedures for data sharing and publications described on each consortium’s website and consistent with NIH policies for data sharing.

Examples of possible projects include but are not limited to:

• Discovery and testing of biomarkers of type 1 diabetes in peripheral blood or tissues, including correlates of: disease susceptibility, environmental triggers, autoimmunity, disease progression (including measures of beta cell mass or function).
• Minimally invasive, targeted imaging of pancreatic inflammation or beta cell mass in persons at high and low risk of developing type 1 diabetes, with or without a short course of anti-inflammatory intervention.
• Evaluation of vaccine responses in persons with type 1 diabetes risk; including effects of vaccines on metabolic as well as immunological measures.
• Evaluation of changes in immune parameters in response to short term treatment with immunomodulatory drugs.
• Measuring functional correlates of type 1 diabetes risk, assays requiring special collection techniques or specimens.

To assist applicants with this and other related funding opportunity announcements, two webinars are planned. They will be held on September 17, 2015 and September 21, 2015 at 12 noon EDT. Applicants should visit the NIDDK website for more information about registering for one of these informational webinars.

For examples of projects funded under similar FOAs, use the NIH Research Portfolio Online Reporting Tool (RePORTER). Enter the FOA designations (PAR-11-349, PAR-11-350, PAR-13-013, PAR-13-028, PAR-14-064, PAR-14-065, PAR-14-257, PAR-14-258, separate queries) in the field labeled FOA in the "Project Details" section, clear the Fiscal Years field in the top right corner of the query page, and run the query to view descriptions of awarded grants.

The following provides specific guidance about projects that are allowed under this FOA. Applicants are strongly encouraged to contact NIDDK Scientific/Research staff listed below if they have any questions about the suitability of their project for funding under this FOA.

This FOA is intended to fund research aimed at understanding the etiology and pathogenic processes in type 1 diabetes.

• Studies can be cross-sectional or longitudinal, and can use samples from an archive, new samples collected from subjects specifically for this project (if justified, living biobank ), or clinical studies that involve direct interactions with subjects identified in collaboration with existing networks.
• If interactions with subjects are required, including those involving the collection of new samples, the project must be collaborative with an existing clinical study. Only consortium-approved additional work associated with sample collection and subject access is allowable. Projects cannot include funding for a new or separate clinical research infrastructure for sample collection and subject recruitment and study.
• Small exploratory pilot studies to gather information relevant to type 1 diabetes prediction and prevention are especially encouraged when samples are plentiful and for subject-access studies.
• Mechanistic studies in at-risk populations are encouraged.
• Clinical pilot studies involving safe interventions of short duration, involving a minimal number of subjects, and using mechanistic endpoints.
• Large, collaborative and coordinated projects that make use of multiple Program Directors/Principal Investigators, and that make efficient use of limited samples, are encouraged.

This FOA will NOT fund the following:

• Clinical trials to test efficacy of interventions for type 1 diabetes prevention or treatment are not allowed. Efficacy endpoints include C-peptide preservation or insulin dose, for example. Other funding mechanisms, including TrialNet (http://www.diabetestrialnet.org/researchers/index.htm), are available for the development and implementation of clinical trials with clinical efficacy endpoints.
• Projects that use samples or subjects derived from restricted clinical studies, such as those that only allow access to resources by consortium members, or those that place restrictions on publications or data access that are inconsistent with NIH policy, are not allowed. However, as long as the consortium has a process by which potential collaborators from outside the consortium can gain access to subjects and/or samples, consortium scientists may also apply for funding of projects under this FOA.
• Research using animal models or human cell lines.

Human Subjects Protections:

If applicants propose to use samples from an archive, and if the applicant can remain blinded to subject identity, the study may be exempt( see http://grants.nih.gov/grants/policy/hs/index.htm for more information). However, if new samples are being collected specifically for the proposed study, or an intervention is planned, a plan for human subjects protection including local IRB review and review by Data and Safety Monitoring Board (DSMB) or Observational Study Monitoring Board (OSMB) may be required (see NIH guidelines for clinical research http://grants.nih.gov/grants/policy/hs/index.htm). If review by an external board is required, applicants may use the established DSMB or OSMB of the parent study if the consortium allows.

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)

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

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

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

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

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

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

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

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

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

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

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

Dr. Francisco O. Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817
Telephone: 301-594-5452
Fax: 301-480-4126
Email: [email protected]

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.

Estimated Project Funding: Enter the budget request. This number should include total costs (direct and indirect) for the entire project period. Note that a detailed budget cannot be accepted in the application; it will be requested as Just-In-Time information.

It is expected that applications will span a wide range of budgetary requirements, from small studies utilizing few subjects and/or samples to larger studies with more expensive testing. Small exploratory studies are encouraged, especially when using subjects.

For studies that require access to subjects, applicants can request, in addition to funding for their own lab, funds for selected costs incurred by the relevant Coordinating Center, specifically related to the proposed study and outside of normal screening and monitoring. For example, if a study requires an additional collection at the next scheduled monitoring visit, there will be no need to budget for costs related to the scheduled visit, but some of the cost of obtaining the additional samples should be requested (i.e., payment for a blood draw on a capitated basis, cost for a specific collection tube, and cost of shipping samples to the assay lab). Studies that require additional visits outside of those normally scheduled will need to budget for the costs associated with additional visits, including subject travel. If the proposed study will require subjects to visit to a specific location for a specific test (for example, an imaging study), subject travel should be included in the request. No costs should be requested for staff salary at the consortium's clinical sites. Costs associated with data collection (case report forms) for data types currently collected do not need to be requested, but if the data or sample collected is new, funds can be requested for this purpose. Funds budgeted for Coordinating Center activities are only estimates. Exact costs will be determined in negotiation with NIH program staff for those applications with an impact score within funding range.

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, with the following additional instructions:

Research Strategy: The Research Strategy should include the following information:

• Significance: describe the expected effect of the results on understanding disease pathogenesis, etiology, progression, or potential response to treatment.
• Background: provide a strong scientific rationale for study; include justification for access to these particular subjects and/or limited, irreplaceable and valuable samples. Applicants must explain how the proposed research will take advantage of the associated clinical and phenotypic data and why the proposed research requires these specific subjects or samples.
• Experimental approach: The question being posed by the investigator must be appropriate to the source of the biospecimens, how they were collected, prepared, analyzed, and stored, their age, and the phenotypic and other accompanying data. Applicants should clearly describe the number of subjects and/or samples required and subject and/or sample characteristics, including any controls. Providing a table listing the number of subjects and/or number and quantity of samples to be used is strongly suggested. In all cases, applicants should only request the minimum number of subjects and/or samples, and minimum volume of samples, that are needed for the study, and all requests should be statistically justified (see below).
• Assay performance and data analysis: Include preliminary data demonstrating the applicant’s experience with the assay or technique that will be used with the requested subjects/samples, including for example, variability and quality control data. The expected effect sizes and group differences, as part of a statistical plan with calculations should be provided to demonstrate that the number of subjects and samples will be sufficient to answer the question.
• Data/sample management: Describe how the accompanying phenotypic data, as well as the data from sample analysis, will be managed. For example, who will have primary responsibility for organizing, storing, and archiving the data? Who will maintain computer data files and make needed work files available to those who will analyze the data? How will the privacy of information be guarded and guaranteed? Describe how samples will be handled and potentially returned to the repository or destroyed.

Letters of Support: For studies using subjects, or data and samples that are consortium controlled, applicants must obtain a letter from the consortium granting access (can be conditional on funding). Applicants must apply to the consortium through the relevant ancillary studies application process with sufficient time for consortium review prior to the application due date for the FOA (at least 6 weeks prior to application due date). Documentation of approval for access (which may be contingent on funding approval) should consist of a letter or email from the clinical consortium's Ancillary Studies Chair or other official as designated by the consortium, and must be included as a Letter of Support. For NIDDK Repository-held samples, applicants must visit the NIDDK Repository website: https://www.niddkrepository.org/home/, register for a login and password, and make a preliminary application for access to samples. The Repository will then provide a standardized report which will indicate that samples are present in sufficient number and quantity or volume for the study. This report must be included with the grant application (in the Letters of Support section) or the application will be considered incomplete and will not be reviewed.

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

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

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

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions and responsiveness by the 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 [email protected] 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? 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?

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?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

Is the study of these specific subjects and/or samples, as compared to other available sources of similar subjects and/or samples, well-justified? Does the study take full advantage of the unique characteristics of these particular subjects and/or samples? Does the study account for any limitations of the subjects and/or samples?

Are there a table and a clear description of and justification for the number of subjects and/or samples and volume of sample being requested? Does the applicant have approval (which may be contingent on funding) for access to subjects and/or samples?

Are the assay performance characteristics adequate and likely to provide interpretable results? Is the statistical plan adequate to demonstrate that the number of subjects and samples will be sufficient to answer the question?

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?

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

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

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

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Not Applicable

Not Applicable

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

Reviewers will assess 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.

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

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

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

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

As part of the scientific peer review, all applications:

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

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

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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 http://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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Lisa M. Spain, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-9871
Email: [email protected]

Katarzyna Bourcier
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3482
Email: [email protected]

Dianne M. Camp, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7682
Email: [email protected]

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7794
Email: [email protected]

Jill A. Saletta
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5489
Email: [email protected]

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. .