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

Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)

Activity Code

 DP3 Type 1 Diabetes Targeted Research Award

Announcement Type

Reissue of PAR-11-349

Related Notices

  • January 7, 2014 - This PAR has been reissued as PAR-14-064.
  • February 11, 2013 - See Notice NOT-DK-13-006. Notice of Correction Regarding Research Using Control Subjects.

Funding Opportunity Announcement (FOA) Number

PAR-13-028

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.847

Funding Opportunity Purpose

This FOA invites applications for ancillary studies that use subjects enrolled in (or screened for participation in) the Type 1 Diabetes TrialNet clinical trials network, OR for ancillary studies that use subjects enrolled in the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC).  Studies are expected to generate scientific discoveries on disease mechanisms, disease pathogenic processes, and biomarkers of disease progression or clinical responses, or complications of type 1 diabetes.  This FOA is not intended to fund clinical trials with endpoints for clinical efficacy (including but not limited to C-peptide preservation). 

Key Dates
Posted Date

November 27, 2012

Open Date (Earliest Submission Date)

March 2, 2013

Letter of Intent Due Date(s)

March 2, 2013

Application Due Date(s)

April 2, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July, 2013

Advisory Council Review

 October, 2013

Earliest Start Date

December, 2013

Expiration Date

April 3, 2013

Due Dates for E.O. 12372

Not Applicable

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.

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

The NIDDK seeks to accelerate the pace of scientific research towards more effective prevention, treatment, or cure of type 1 diabetes and its complications. To this end, NIDDK is committed to providing access to research resources which will increase our understanding of type 1 diabetes pathogenesis, and pathogenesis of its complications, in humans.  This opportunity is intended to fund projects using subjects who have been phenotypically and genetically characterized for risk of developing type 1 diabetes through the Type 1 Diabetes TrialNet Pathway To Prevention clinical research network, and projects using subjects currently enrolled and followed for diabetic complications in the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC).

Type 1 Diabetes TrialNet

The Type 1 Diabetes TrialNet is an international network of investigators, clinical centers, and core support facilities that recruits patients and conducts research to advance knowledge about type 1 diabetes and to test strategies for its prevention and early treatment. TrialNet supports the development and implementation of clinical trials of agents aimed at preventing the disease in at-risk patients and slowing the progression of type 1 diabetes in new onset patients. The network’s “Pathway To Prevention Study” enhances understanding of how the disease develops in individuals at risk and thus helps in the formulation of future trials. The Pathway To Prevention Study provides the basis for risk assessment and recruitment of at-risk subjects into clinical trials aimed at preventing the disease in susceptible individuals.

Currently there are two ongoing clinical trials for prevention in TrialNet. One is the Oral Insulin Trial which tests the ability of insulin taken orally to prevent the disease in subjects with moderate risk of disease. The other is the Anti-CD3 Prevention Trial which tests whether a course of teplizumab therapy can prevent the disease in high risk subjects.  Other trials are planned and could be in progress at the receipt date for this FOA.  See the TrialNet website for more detailed information:  http://www.diabetestrialnet.org/researchers/index.htm.

Identification of subjects at risk for type 1 diabetes requires enormous effort.  Currently TrialNet screens nearly 20,000 relatives of people with type 1 diabetes annually to identify those with evidence of autoimmunity.  The NIDDK seeks to obtain maximum value from this effort by expanding access to the population screened for mechanistic studies.  This FOA provides a means of accessing this unique at risk population as well as support for mechanistic studies in the population of subjects screened and monitored for type 1 diabetes risk in TrialNet.  Mechanistic studies can be cross-sectional or longitudinal.  Applicants may propose to perform tests on subjects and/or collect samples "on demand" from well-defined at risk populations identified through TrialNet.  The FOA would support studies that seek access to participants in the Pathway To Prevention Study or in prevention studies for sample collection or testing.  Access to Pathway To Prevention Study participants for mechanistic studies that may require some brief and safe intervention may also be proposed. 

Studies funded by this FOA must not interfere with recruitment and participation of subjects in ongoing and approved clinical trials and studies within TrialNet.  After the review of applications submitted in response to this FOA and prior to funding, the TrialNet Steering Committee will evaluate projects NIDDK is considering for funding for feasibility and potential impact on ongoing TrialNet studies as described below.   

The TrialNet Pathway To Prevention Study screens first and second degree relatives of persons with type 1 diabetes, and collects serum, RNA, plasma, and peripheral blood mononuclear cells (PBMC) every six months from enrolled subjects at risk for disease, and a smaller number of control subjects.  It is anticipated that additional specific “on demand” samples could be collected at these regular visits or before and after a brief and safe intervention.  A more detailed description of the schedule of assessments in the TrialNet Pathway To Prevention Study and the ongoing and approved TrialNet clinical trials is provided here: (http://www.diabetestrialnet.org).

Exploratory research related to understanding type 1 diabetes pathogenesis in humans is encouraged if the question is significant and the investigators are well qualified.  Small exploratory pilot studies to gather information relevant to type 1 diabetes prediction and prevention are encouraged. 

This FOA is NOT intended to fund clinical trials to test efficacy of interventions for type 1 diabetes prevention or treatment.  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.  Clinical pilot studies involving safe interventions of short duration, involving a minimal number of subjects, and using mechanistic endpoints, are allowed under this FOA. 

This FOA is NOT intended to fund studies using samples currently stored in the TrialNet or NIDDK or any other samples repository.  Other funding mechanisms (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html, and PAR-11-350) are available for ancillary studies using non-renewable longitudinal stored samples. 

Examples of projects include but are not limited to:

The Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study

EDIC (1994-present) is an observational follow-up study of the cohort from the Diabetes Control and Complications Trial (DCCT, 1983-93).  The DCCT, established through an Act of Congress, addressed the role of diabetes control, and in particular hyperglycemia, on long-term diabetic complications. 1441 type 1 diabetic individuals age 13-39 years were recruited from 29 clinical centers across the U.S. and Canada.  The cohort, consisting of 726 primary prevention subjects with no pre-existing microvascular complications and 715 secondary intervention subjects with mild retinopathy and <200 mg albuminuria/24 h, were randomly assigned to receive either intensive therapy aimed at near normal glycemia or conventional therapy aimed at maintenance of clinical well-being with no specific glucose targets. The objective was to determine whether intensive therapy would reduce the development or progression of retinopathy primarily, and secondarily nephropathy and neuropathy.  The randomized phase of the study was terminated in 1993 by the DSMB after a mean follow-up of 6.5 yrs, owing to the overwhelming beneficial effects of intensive diabetes therapy.   Compared with the conventional therapy which achieved a median HbA1c level of ~9%, intensive therapy with at least three insulin injections per day or insulin pump therapy, guided by self-monitored glucose levels, achieved a median HbA1c of ~7% and reduced the development and progression of early stages of long-term complications by 35-76%.  

The relatively young age (mean age of 33 years) and brief duration of diabetes (12 years) of the cohort at DCCT study-end in 1993 precluded exploration of the effects of intensive compared with conventional therapy on the more advanced sequelae of microvascular disease or on cardiovascular disease (CVD).  EDIC (1994-present) was launched as an observational follow-up study of the DCCT, using the same methods and annually following 95% of the surviving original cohort representing 1277 participants.  Participants are seen in 28 of the original 29 clinical centers (2 in Canada, 26 across the U.S.).  Mean age of the participants is currently 52 years.

Overarching goals of EDIC are to 1) determine the long-term effects of the original interventions on advanced complications, including CVD; 2) delineate the modern-day clinical course of diabetic complications including the interactions among complications and co-occurrence of complications; 3) explore the pathophysiologic mechanisms that underlie the development and progression of microvascular, neurologic, and cardiovascular complications, and 4) define the long-term economic impact of intensive therapy.

Annual evaluations include a history and physical examination, ECG, Doppler evaluation of brachial:ankle pressure, a standardized neurologic examination, measurement of A1c and serum creatinine, documentation of hypoglycemia and diabetic ketoacidosis; lipids, albumin excretion/creatinine clearance, dietary assessment, and quality of life are measured every other year.  An eye exam measuring visual acuity and including fundus photography is completed every four years.  Episodically, a carotid ultrasound is performed. 

Other ancillary study procedures and assessments that have been conducted include coronary calcium CT scans, cardiac MRIs, nerve conductions studies, cognitive impairment testing, urologic and sexual function assessment, genetics studies through family/association studies and GWAS, epigenetic studies, measurement of haptoglobin, measurement of skin advanced glycation end-products by fluorescene spectroscopy, cheiroarthropathy assessment, and a survey to study reasons for the long-term high participation rate. 

This FOA provides a means of accessing this unique population being followed in DCCT/EDIC.  Proposed studies can be cross-sectional or longitudinal (within the time frame of the award).

Applicants may propose to perform tests on subjects and/or collect samples "on demand"  at regularly scheduled EDIC study visits. 

Studies funded by this FOA must not interfere with recruitment and participation of subjects in ongoing core and ongoing ancillary studies being conducted in the DCCT/EDIC.  After the review of applications submitted in response to this FOA and prior to funding, the DCCT/EDIC study group will evaluate projects NIDDK is considering for funding for feasibility and potential impact on the participants and staff of these ongoing studies.

This FOA is NOT intended to fund studies using DCCT/EDIC samples currently stored in the NIDDK or any other samples repository.  Other funding mechanisms (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html, and PAR-11-350) are available for ancillary studies using non-renewable longitudinal stored samples. 

Examples of projects include but are not limited to:

In many studies proposing to simply collect samples at centers and utilize the samples in the applicant's lab, the applicant can remain blinded to subject identity using masking identifiers by the relevant study's Coordinating Center.  However, if subject identity cannot be blinded, 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)  (see also below under review criteria).  If review by an external board is required, applicants may use the established TrialNet DSMB or DCCT/EDIC OSMB.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH intends to fund up to an estimate of up to 3-5 awards and  $7,000,000 contingent on NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, are expected to vary widely, and should be justified by the actual needs of the proposed project.

Award Project Period

The award project period shall not exceed 3 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 SF424 (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 Directors/Principal Investigators (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 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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.   

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  1. To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  2. Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  3. Of an application with a changed grant activity code.
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
6707 Democracy Boulevard, Room 752 
Bethesda, MD 20892-5452
(for express/courier service: 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:

Research Strategy

Applicants must explain how the proposed research will take advantage of the associated clinical and phenotypic data and why the proposed research specifically requires subjects from the TrialNet Pathway To Prevention Study.  Applicants must describe the TrialNet data that will be needed to select subjects and/or to analyze results obtained by their project.  All investigators may apply to this FOA, whether outside or within the TrialNet consortium.   All investigators are strongly advised to visit the TrialNet website http://www.diabetestrialnet.org/researchers/index.htm and to contact NIDDK staff (listed below) for assistance in applying to this FOA.

Applications to either study should include:

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, with the following modification:

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-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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before 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 before the deadline 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.

The network committees, as appropriate depending on the complexity, risk, and scope of the proposed research, will review all applications receiving a score in a fundable range to ensure that the proposed research is safe, feasible, will not interfere with ongoing or approved trials or ancillary studies, and will not impose too great a burden on subjects or network operations.  Institutional Review Board approvals from the relevant clinical sites will be required for any interventional study.  These reviews will be accomplished before any awards are issued.  Additional information from applicants may be requested after review.

If a proposed study requires FDA approval under an IND, NIDDK will hold the IND and lead the negotiations for approval.  Awards will be held until FDA approval (if required) is obtained.   

6. Other Submission Requirements and Information

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.

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.

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 Award Management (SAM). 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, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at fc15y@mail.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 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

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

Approach

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

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

Environment

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

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 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 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(s), 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:

Applications will be assigned on the basis of established PHS referral guidelines 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 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/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.

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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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)

For TrialNet:

Lisa M. Spain, Ph. D.,
Program Director for Immunobiology of Autoimmune Endocrine Diseases
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes Digestive & Kidney Diseases (NIDDK)
Telephone: 301-451-9871
Email:spainl@niddk.nih.gov

For DCCT/EDIC:

Catherine C. Cowie, PhD, MPH 
Senior Advisor & Director for Diabetes Epidemiology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  (301) 594-8804
FAX:  301 480-3503
Email:  cowie@nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

Financial/Grants Management Contact(s)

Diana O'Donovan
Senior Grants Management Specialist
Grants Management Branch, NIDDK
Telephone: 301-594-8868
Fax: 301-594-9523
Email: odonovand@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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NIH Funding Opportunities and Notices



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