Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Type 1 Diabetes Impact Award (DP3)
Activity Code	DP3 Type 1 Diabetes Targeted Research Award
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-DK-10-012
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.847
FOA Purpose	This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, encourages Research Project Grant (DP3) applications from institutions/organizations proposing groundbreaking original research addressing fundamental questions or major obstacles in Type 1 Diabetes Research, including studies that challenge current dogma. Projects must clearly address a compelling unanswered question in Type 1 Diabetes research.

Posted Date	September 16, 2010
Open Date (Earliest Submission Date)	February 11, 2011
Letter of Intent Due Date	February 11, 2011
Application Due Date(s)	March 11, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	June/July, 2011
Advisory Council Review	October, 2011
Earliest Start Date(s)	September 30, 2011
Expiration Date	March 12, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

Background

Type 1 diabetes (T1D) occurs when cells of the immune system attack and destroy insulin-producing beta cells in the pancreas. Autoimmune destruction and loss of insulin results in an increase in blood glucose levels that over time damage a wide variety of organ systems. In order to survive, patients must compensate for the loss of insulin production through daily insulin administration. Even with close attention to maintenance of normal blood glucose levels, many patients will experience significant diabetes-associated complications in major organ systems. These diabetic complications include cardiovascular disease, end-stage kidney disease, blindness, sensory and autonomic nerve damage, and amputations. While our understanding of the role played by genetics in promoting disease risk has advanced significantly over recent years, many key questions remain regarding the root causes of autoimmune destruction in Type 1 diabetes and its downstream pathologic consequences. A more thorough mechanistic understanding of the T1D disease process in at risk individuals, as well as the development of new approaches to ensure maintenance of normoglycemia in affected patients, will ultimately lead to new avenues to explore for disease prevention and therapy.

The goal of this initiative is to support bold and creative research projects that confront major challenges in Type 1 diabetes research. Collaborative investigative teams or individual scientists with novel perspectives, new ideas and innovative approaches are encouraged to apply. Studies should address major unmet needs and/or compelling opportunities and have the potential to dramatically advance the field. Successful projects will be expected to have a significant impact on Type 1 diabetes research and/or therapy.

Research Topics

This initiative seeks to foster innovation and creativity in investigators focused on major unanswered questions in Type 1 diabetes research. Pioneering investigations across the translational spectrum are encouraged and will be considered responsive to this FOA. Multidisciplinary or interdisciplinary teams attacking fundamental issues or large intractable problems are particularly encouraged to apply.

This FOA solicits applications focused on areas of opportunity relevant to Type 1 diabetes identified in the draft diabetes research plan, Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the DMICC, available at http://www2.niddk.nih.gov/AboutNIDDK/ReportsAndStrategicPlanning/DiabetesPlan. Specifically the FOA solicits applications in four areas of T1D research highlighted in the draft Strategic Planning Report: Autoimmunity, Imaging and Biomarker Development, Diabetic Complications, and Engineering the Artificial Pancreas. In addressing major issues or barriers in T1D research, responsive studies should employ interdisciplinary approaches that capitalize on clinical resources, as well as emerging technologies, tools, and model systems. Examples of advanced tools and technologies to be employed might include:

• Innovations in high throughput screening, discovery and analysis;
• Progress in nanotechnology, bioinformatics and systems biology tools;
• Advances in genetic, epigenomic, and gene x environment (GEI) approaches;
• Development and use of patient sample repositories;
• Therapeutic applications of adult stem cells;
• Novel imaging agents and technologies.

Questions to be explored in this initiative include:

Autoimmunity: What properties of immune cells and their pancreatic targets are responsible for the selective destruction of beta cells in T1D patients?

Examples of how this question may be explored include:

• Applying comprehensive high-throughput technologies to profile immune cell populations and networks in Type 1 diabetic patients and to correlate disease status with cell phenotypes, activation status, receptor structures, HLA variants, and HLA associated peptides;
• Using molecular approaches to better understand the relationship between HLA alleles and T1D risk or protection, including studies to determine how specificity of the autoimmune attack is determined;
• Developing epigenomic fingerprints of purified immune cell populations in T1D patients that correlate with immune cell function and disease status;
• Defining molecular signatures of human pancreatic cells and their progenitors in the context of active or resolving immune attack, including studies to determine how target cells may resist autoimmune attack but retain the ability to be cleared by the immune system if infected or cancerous;
• Identifying and optimizing lead compounds for new therapeutics for Type 1 diabetes and its complications.

Imaging and Biomarker Development: Can we develop imaging assays and/or biomarkers capable of measuring early events in the development and progression of T1D?

Examples of how this question may be examined include:

• Developing and validating novel approaches for noninvasive imaging of islet mass and function in humans;
• Advancing techniques for imaging of pathologic processes in T1D patients, including noninvasive assays to measure immune cell function and islet inflammation and methods to link findings to disease status and intervention outcomes;
• Applying novel molecular profiling methodologies, including mass spectrometry coupled to laser capture microdissection or MALDI imaging, to the analysis of pathological slides or tissue biopsies recovered from patients with T1D and its complications.

Diabetic Complications: What are the precise molecular pathways and sequence of events that lead to organ damage and dysfunction in T1D (including diabetes-induced damage to renal, nervous, cardiovascular, visual, urinary, gastrointestinal, as well as other systems)?

Examples of how this area may be explored include:

• Examining the effect of T1D on the capacity of adult stem cells to repair or reverse diabetic complications;
• Applying epigenomics to define the long-term and long-range modifications that explain the presence and/or extent of organ damage, including studies to define molecular mechanisms responsible for "metabolic memory";
• Using high throughput technologies and network approaches to correlate disease status with molecular profiles of individual cell types in multiple affected end organs;
• Defining mechanisms of diabetes-induced damage to the neurovasculature that lead to diabetic neuropathy, neuro-retinal abnormalities and cerebral dysfunction.

Engineering the Artificial Pancreas: Can a closed loop artificial pancreas system be designed that will maintain euglycemia and avoid hypoglycemia?

Examples of how this question may be addressed include:

• Combining principles of engineering, nanotechnology, universal design, computer science and informatics to develop novel closed loop systems or components;
• Optimizing formulations of insulin and/or glucagon as well as improving accuracy, reliability and accessibility of delivery systems;
• Developing new glucose detection principles, more accurate and robust continuous glucose sensing devices, and/or real-time detection platforms capable of measuring multiple factors with high sensitivity and precision;
• Developing reliable and integrated algorithms that translate glucose measurements into changes in the delivery of insulin, and/or observation and control modules to create individually tailored algorithms.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	This FOA is supported under a Special Statutory Program for Type 1 Diabetes Research. Total funding available for this five year program is $30 million in FY 2011 to fund 4-12 applications, contingent on the availability of funds and the submission of a sufficient number of meritorious applications.
Award Budget	Maximum direct costs are $5 million to be used over a project period of up to 5 years. NIDDK expects that the requested direct costs will range from $2 to $5 million based on the scope of the research, plus applicable Facilities and Administrative costs to be determined at the time of the award.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

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

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must be renewed at least annually
• Grants.gov
• eRA Commons

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (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.

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

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

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

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

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

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service use Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]

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

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

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

Introduction (Item 1): Omit: Not applicable. Resubmissions and Revisions are not allowable.

Specific Aims (Item 2): limited to 1 page.

Research Strategy (Item 3): including tables, graphs, figures, diagrams, and charts, is limited to 12 pages. See Table of Page Limits. Attach the 12-page Research Strategy encompassing all required elements as a single PDF document. Figures and illustrations may be included but must fit within the 12 page limit. Do not include links to web sites for further information. Do not include animations.

The following items are excluded from the 12-page limit for the Research Strategy Section:

• Inclusion Enrollment Report
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• MPI Leadership Plan
• Consortium/ Contractual Arrangements
• Letters of Support
• Resource Sharing Plans

Note: the 12-page limit also excludes the Project Summary/Abstract; Project Narrative; Bibliography and Literature cited; and Biographical Sketches (upload as separate PDFs).

Organize the 12-page Research Strategy as a single document in the specified order using the instructions provided below. Start each section with the appropriate heading (ie, Significance and Impact; Project Description; Investigator Qualifications; Suitability for T1D-Impact Award Program).

• Significance and Impact Statement (up to 200 words): What is the major problem or obstacle being addressed? If successful, how will the outcomes significantly advance our understanding or alter the current course of T1D research? What features of the proposal reflect an exceptional, unique or particularly creative strategy that has not been applied to the problem before (e.g, an innovative investigative team, original approach, novel technologies or tools, unique resources)? The writing should be at a level that conveys the significance and impact of the application to a broadly knowledgeable scientist who may not be an expert in the specific topic area of the application.
• Project Description: What is the major problem or obstacle being addressed? What new ideas and/or innovative combinations of approaches will be used to tackle the problem? What novel experimental designs will be employed? How will your rationale and/or approach overcome existing challenges or barriers in the field? What objective measures can be used to determine progress and success in the aims, and what is the timeline for accomplishing major goals?
• Investigator(s) Qualifications (limit, one-half page): What prior work by the PI and/or investigative team was considered to be particularly creative? What are examples of prior scientific contribution(s) that have had a major impact on your field of expertise? For projects involving multiple key personnel, how will the scientific team combine the expertise of individual investigators to build novel synergies?
• Suitability for T1D-Impact award program (limit, one-half page): Why are the planned research objectives and approaches uniquely suited to the goals of the T1D-Impact award program, rather than a more traditional grant mechanism? What aspects of the proposal might be considered high risk, exceptionally original, or against prevailing dogma? How does the proposed research diverge from your currently funded research program?

Special Instructions for Other Project Information (Section 4.4 of SF424 (R&R) Application)

Project Summary/Abstract (SF424 R&R Item 4.4.7): Follow instructions in the SF424 (R&R) Application Guide.

Project Narrative (SF424 R&R Item 4.4.8): Follow instructions in the SF424 (R&R) Application Guide.

Bibliography and Literature Cited (SF424 R&R Item 4.4.9): Limited to one page.

Continue with the instructions in the SF424 (R&R) Application Guide.

Special Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of SF424 (R&R) Application)

Biographical Sketches: Each biographical sketch should conform to standard NIH page limits and format including information relevant to Personal Statement (A), Positions and Honors (B), Selected peer-reviewed publications (C) and Research Support (D).

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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [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-10-115.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project address a major unsolved problem or barrier that is unique to Type 1 Diabetes research? If successful, will the project dramatically advance or alter the course of Type 1 Diabetes research?

Investigator(s)

Are the PD/PIs, 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 PIs provide evidence of a unique capacity for creativity? Does the track record of the PIs reflect a history of high impact research and publications? Do the PIs bring new perspectives or expertise to the field of T1D research? Does the project dramatically diverge from ongoing work in the PIs' laboratories?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application reflect an exceptional, unique or particularly creative strategy that has not been applied to the problem before?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are any high risk elements directed toward high reward outcomes? If extensive preliminary data is not provided for new, novel or high risk studies, is appropriate justification provided in the form of literature citations and data from other sources to support the proposed experimental aims?

Environment

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Diabetes and Digestive and Kidney Diseases (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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

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 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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.

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Kristin Abraham, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 795
Bethesda, MD 20892-5460
Telephone: 301-451-8048
Email:[email protected]

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, MD 20817 (for courier service)
Telephone: 301-594-8897
FAX: 301-480-3505
Email: [email protected]

Diana O'Donovan
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 709A
Bethesda, MD 20892-5456 (MSC 5456)
Telephone: 301-594-8868
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 Parts 74 and 92.