Department of Health and Human Services

Part 1. Overview Information
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

Function of Type 1 Diabetes Genes (DP3)

Activity Code

DP3 Type 1 Diabetes Targeted Research Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-11-019

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847

FOA Purpose

This Funding Opportunity Announcement (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 for projects to determine the function of human leukocyte antigen (HLA) and non-HLA genes. In addition there are many human T1D regions for which there is no compelling functional candidate gene and thus additional work to identify causal genes and potential causal variants and elucidate the mechanisms whereby changes in the function or regulation of these genes are likely to provide crucial new insights into disease pathogenesis are also encouraged.

Key Dates
Posted Date

October 3, 2011

Open Date (Earliest Submission Date)

January 29, 2012

Letter of Intent Due Date

February 1, 2012

Application Due Date(s)

February 29, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2012

Advisory Council Review

October 2012

Earliest Start Date(s)

December 1, 2012

Expiration Date

March 1, 2012

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Type 1 diabetes (T1D) is characterized by autoimmune destruction of insulin-producing pancreatic beta cells.  It has a strong genetic basis that is modified by environmental factors.  T1D is a “polygenic” disease; it arises from the interaction of variations in multiple genes.   Many studies have been conducted to identify genes for T1D. Just a few years ago, only five genes involved in the disease were known. Now approximately 50 genes or gene regions have been identified. 

Genetic, functional, structural, and animal model studies all indicate that the highly polymorphic HLA class II molecules, namely the DR and DQ α-β heterodimers, are central to susceptibility to T1D. In addition to the class II genes HLA-DRB1 and HLA-DQB1, independent effects of HLA-A, HLA-B, and HLA-DPB1 were also recently observed as contributing to the overall risk for T1D. It is estimated that HLA contributes 40-50% of the risk.  Other, non-HLA, T1D loci have comparatively small effects on disease risk relative to HLA but comparable effect sizes to risk loci identified in other common disorders.  These include the INS locus, where variation is thought to impact the transcription and expression of insulin, modulating thymic selection of T cells specific for this autoantigen. Variants at the CTLA4 locus are implicated in T1D risk, potentially by altering the production of differentially spliced products from the locus which affects T cell activation.  SNPs in the IL2RA region, that encodes one chain of the heterodimeric IL-2 cytokine receptor, are associated with T1D.  Finally, a non-synonymous coding region SNP in the PTPN22 gene has been associated with T1D as well as a number of other autoimmune disorders.  This SNP, which predicts an Arg to Trp substitution at position 620, increases the activity of the PTPN22 encoded phosphatase, Lyp, resulting in hyporesponsiveness of T cells.

Recently, the application of genome-wide SNP typing technology to large sample sets by The Type 1 Diabetes Genetics Consortium (T1DGC) and its collaborators and other investigators, and comparisons with results from other immune-mediated diseases, have provided convincing support for approximately 50 genes or gene regions that significantly affect the risk T1D.  Although more than 70% of heritability has been identified, work is already underway to identify the missing heritability.  The remaining missing heritability for T1D is likely to be explained by as yet unmapped common variants, rare variants, structural polymorphisms, and gene-gene and/or gene-environmental interactions, in which we can expect epigenetic effects to play a role. Thus additional work is needed to identify causal genes and potential causal variants for further differentiation in allele-specific expression and genotype-to-phenotype studies. The examination of the T1D genes and their pathways may reveal the earliest pathogenic mechanisms that result in the engagement of the innate and adaptive immune systems to produce massive β-cell destruction and clinical disease and provide leads for new therapeutic targets.

Objectives

This Funding Opportunity Announcement (FOA) utilizing the DP3 mechanism solicits applications from integrative teams and individual investigators for projects to determine the function of HLA and non-HLA T1D risk genes. Although it is known that the HLA region plays a major role in the development of T1D and that particular polymorphic peptide-binding pockets of HLA class II molecules are involved in susceptibility and resistance to the disease process, the exact mechanism(s) by which the HLA molecules confer susceptibility to immune-mediated destruction of the pancreatic islets is still not known in its entirety. It is known that the binding of key peptides from autoantigens (preproinsulin, GAD, insulinoma-associated 2 antigen, and zinc transporter, ZnT8) so far identified to HLA class II molecules in the thymus and in the periphery is likely to play an important role. We now know that certain HLA Class I molecules  can be over-represented in people with T1D, but exactly how HLA alleles impact susceptibility and protection needs to be better studied, as CD8 T cells are thought to be very important in disease pathogenesis. It is still not known which specific peptides bind to the most predisposing or protective DQ trans-heterodimers. In addition, the T cell receptors that bind disease-promoting or protective HLA/peptide complex are poorly understood, as are the mechanisms that confer susceptibility or resistance to disease. Thus, one of the objectives of this initiative is to determine the function of HLA molecules in the disease process.

A second objective is to understand the contribution of many genes that have been identified through the combination of high-density SNP coverage and large sample sizes. It has been observed that some of the genes that predispose to T1D are common with other autoimmune diseases (e.g. PTPN22) and these could lead to generalized autoimmunity whereas others may be specific to T1D. Unraveling of the mechanisms whereby changes in the function or regulation of these genes alter T1D risk is likely to provide crucial new insights into disease pathogenesis. In addition, there are many human T1D regions for which there is no compelling functional candidate gene (www.t1dbase.org) and thus additional work is also needed to identify causal genes and potential causal variants and elucidate the mechanisms whereby changes in the function or regulation of these genes are likely to provide crucial new insights into disease pathogenesis. The discovery of the genes would be relevant to developing a predictive strategy for individuals who may develop diabetes as well as new targets for therapy. In the future, genetic testing may lead to personalized treatment regimens by identifying the most appropriate class of drugs for particular patients.

Potential Research Areas, include but not limited to:

1) Human Studies:  Functional validation studies should preferably use human DNA samples from phenotypically well-characterized individuals to correlate a gene variant with a particular phenotype and/or endophenotype.

2) Comparison of wild type and gene variant functions:  The molecular alteration associated with a gene variant frequently does not reveal whether the function of a particular gene is increased, decreased, or leads to unexpected functional consequences.  Most genes have different levels of expression in different tissues.  It is important to evaluate genetic changes in multiple cell types relevant to T1D. Approaches that can address these issues will help to identify the most promising molecular targets for therapeutic interventions to treat T1D. 

3) Identification of causal genes/genetic variants:  Studies exploiting genetic methodologies in concert with other methods, such as functional genomics, in silico mapping data, gene expression profiling, to identify causative genes or epigenetic/genetic variants and then unravel mechanisms of these genes are appropriate for this program announcement.

4) Non-coding RNAs and regulatory elements:  Studies to identify non-coding RNAs relevant to diabetes and relate function to genes/variants in non-coding RNAs, microRNAs, gene regulatory elements, gene copy number, or other putative non-protein coding regions of the genome are appropriate.

5)  Epigenetics and Epigenomics:  Identification of cell type-specific epigenomic features associated with diabetes as well as functional validation of epigenetic mechanisms of gene regulation in the context of diabetes are relevant. 

6) Systems-level approaches:   Bioinformatic resources (i.e., interactome, gene expression, epigenomic, proteomic, metabolomic, and anatomical databases) can be mined to generate testable hypotheses concerning the function of candidate genes and groups of genes.

Section II. Award Information
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 $15 million in FY 2012 to fund 3-5 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 $1.25 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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.

Required Registrations

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.

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

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

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

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

Letter of Intent

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:

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: fc15y@nih.gov

Required and Optional Components

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

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 PD(s)/PI(s) 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 application 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)

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)

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.

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 Institutions

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.   

6. Other Submission Requirements and Information

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(s)/PI(s) 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(s)/PI(s) 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 NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the DK Referral Office by email at fc15y@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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

Significance

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

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) provide evidence of a unique capacity for creativity?  Does the track record of the PD(s)/PI(s) reflect a history of high impact research and publications?  Do the PD(s)/PI(s) bring new perspectives or expertise to the field of T1D research? 

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?  

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?   

Additional Review Criteria

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.

Additional Review Considerations

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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 Institute of Diabetes and Digestive and Kidney Diseases (NDDK) Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Dr Beena Akolkar, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 6105
Bethesda MD 20892
Tel: 301-594-8812
Fax: 301-480-3503
Email: akolkarb@mail.nih.gov

Peer Review Contact(s)

Francisco Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: 301-594-8897
Email: fc15y@nih.gov

Financial/Grants Management Contact(s)

Craig E. Bagdon
Grants Management Specialist
Grants Management Branch, NIDDK
Democracy Plaza II, Room 721
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456 (express zip: 20817)
Telephone: 301-594-2115
Fax: 301-594-9523
Email: bagdonc@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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