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 The Type 1 Diabetes TrialNet Natural History Study (Living Biobank) (DP3)
Activity Code	DP3 Type 1 Diabetes Targeted Research Award
Announcement Type	New
Related Notices	November 27, 2012 - This PAR has been reissued as PAR-13-028. September 7, 2012 - See Notice NOT-DK-12-018. Notice of Intent to Publish NIDDK Funding Opportunity Announcement: Research Using Subjects from the Type 1 Diabetes TrialNet Pathway to Prevention Natural History Study (Living Biobank) (DP3). December 1, 2011 - See Notice NOT-DK-12-005. This Notice amends Section II. Award Information, Award Budget Section for NIDDK provides additional instructions regarding the budgeting of consortium and contractual costs and Just In Time submissions.
Funding Opportunity Announcement (FOA) Number	PAR-11-349
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 FOA invites applications for ancillary studies that use subjects enrolled in (or screened for participation in) the Type 1 Diabetes TrialNet clinical trials network. Studies are expected to generate scientific discoveries on disease mechanisms, disease pathogenic processes, and biomarkers of disease progression or clinical responses. This FOA is not intended to fund clinical trials with endpoints for clinical efficacy (including but not limited to C-peptide preservation).

Posted Date	September 27, 2011
Open Date (Earliest Submission Date)	November 7, 2011
Letter of Intent Due Date	November 7, 2011; May 7, 2012
Application Due Date(s)	December 7, 2011 and June 7, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	March 2012 and September 2012
Advisory Council Review	May 2012 and January 2013
Earliest Start Date(s)	June, 2012 and February, 2013
Expiration Date	June 8, 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.

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

Nature of the Research Opportunity

The NIDDK seeks to accelerate the pace of scientific research towards more effective prevention, treatment, or cure of type 1 diabetes. To this end, NIDDK is committed to providing access to research resources which will increase our understanding of type 1 diabetes pathogenesis 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 clinical research network.

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 Natural History Study enhances understanding of how the disease develops in individuals at risk and thus helps in the formulation of future trials. The Natural History 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. 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 solicitation 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 Natural History Study or in prevention studies for sample collection or testing. Access to Natural History 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 Natural History 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 Natural History 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. All research funded by this opportunity must use subjects enrolled in or screened for the TrialNet Natural History Study or in the prevention trials described above..

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.

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 Natural History 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.

Examples of projects include but are not limited to:

• New technology for measurement of biomarkers of type 1 diabetes in peripheral blood, including correlates of: disease susceptibility, environmental triggers, autoimmunity, disease progression (including measures of beta cell mass or function);
• Evaluation of blood glucose excursions in persons at high risk for type 1 diabetes using continuous glucose monitoring to better understand dysglycemia, especially in its earliest stages and as it progresses to overt clinical symptoms or diagnosis;
• Minimally invasive, targeted imaging of pancreatic inflammation or beta cell mass in persons at high and low risk of developing type 1 diabetes, with or without a short course of anti-inflammatory intervention;
• Evaluation of vaccine responses in persons with type 1 diabetes risk;
• Evaluation of changes in immune parameters in response to short term treatment with immunomodulatory drugs;
• Measuring functional correlates of type 1 diabetes risk, assays requiring special collection techniques or specimens not currently collected in TrialNet.

Applications should include:

• Background and rationale for study;
• Specific objectives, including how the results would be integrated with other study results, and the impact of the results on understanding disease pathogenesis, progression, or potential response to treatment;
• Study details, including the number of subjects required and subject characteristics;
• Request for funding only for studies involving subjects enrolled in or screened for the TrialNet Natural History Study;
• Amount and type of samples if appropriate, variability and quality control characteristics of any proposed assay or test, expected effect sizes and group differences, a statistical plan with calculations to demonstrate that the number of subjects and samples will be sufficient to answer the question;
• Plans for sample management, including return to the TrialNet repository of any unused specimens;
• Plans for data management, recognizing that data generated from any study funded by this FOA will be shared with the TrialNet consortium and the public through the NIDDK repository according to current NIH data sharing guidelines. In many studies utilizing samples, the applicant can remain blinded to subject identity using masking identifiers by the TrialNet 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) may be required (see NIH guidelines for clinical research) (see also below under review criteria). If review by a DSMB is required, applicants may use the established TrialNet DSMB;
• Budget request. It is expected that this FOA will attract project proposals with a wide range of budgetary requirements, from small exploratory studies requiring few samples and inexpensive collections to larger or more complicated studies with more expensive tests. Small exploratory studies with costs below the budget limits published in the FOA are encouraged. Applicants should request, in addition to funding for their own lab, funds for selected costs incurred by the TrialNet Coordinating Center, specifically related to the proposed study and outside of normal TrialNet screening and monitoring. Tables are provided at the TrialNet public website (http://www.diabetestrialnet.org/researchers/index.htm) to assist applicants in estimating these extra costs. For example, if a study requires an additional collection at the next scheduled TrialNet monitoring visit, there will be no need to budget for costs related to the scheduled visit, but some of the costs of obtaining the additional samples should be requested (i.e., payment for a blood draw on a capitated basis, cost for a specific collection tube, and cost of shipping samples to the assay lab; estimates of these costs are provided on the TrialNet website). Studies that require additional visits outside of those normally scheduled by TrialNet will need to budget for the costs associated with additional visits, including patient travel. If the proposed study will require subjects to visit to a specific location for a specific test (for example, an imaging study), patient travel should be included in the request. No costs should be requested for staff salary at the TrialNet clinical sites. Costs associated with data collection (case report forms) for data types currently collected by TrialNet do not need to be requested, but if the data or sample collected is new, some costs should be requested. Funds should be requested for analyses or reports performed by the TrialNet Data Coordinating Center. Costs budgeted for TrialNet Coordinating Center activities are only estimates. Exact costs will be determined in negotiation with NIH program staff for those applications with a priority score within funding range.

The TrialNet 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 clinical trials for type 1 diabetes prevention, 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.

See Section 6. Other Submission Requirements below for detailed application instructions specific to this FOA.

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	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIDDK Division of Diabetes, Endocrinology & Metabolism intends to fund an estimate of 5 awards, corresponding to a total of up to $5m, for fiscal year 2012. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are limited to $300,000 direct costs per year. The total direct costs over a three year period should not exceed $900,000 direct costs, and all costs must be well justified.
Award Project Period	Award periods are up to 3 years, awarded in the first year (DP3). Time requested should be justified based on the needs of the project. Projects less than 3 years in duration are allowed.

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 Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations 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 maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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.

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.

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.

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

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

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

• Descriptive title of proposed 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
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
Telephone: 301-594-8897
Fax: 301-480-4126
Email: FC15Y@NIH.GOV

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.

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.

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 modifications:

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

Appendix

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

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.

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.

Budget pages should not be submitted with applications. Follow all instructions for the DP3 submission. Detailed budget information will be requested after review.

Research Strategy Section (12 pages):

1. Subjects: Include justification for requesting access to specific subjects as well as the advantage of these subjects compared to other sources of similar subjects. Include detailed information about access to which subjects are requested. If you will be combining the results from the proposed study with those obtained from other studies, be sure to explain how the requested subjects will fit in with your overall study design.

2. Numbers/Volume: Include a clear justification for the number of subjects and amount of sample being requested. In all cases, applicants should only request the minimum number of subjects and volume of sample needed for the study.

3. Methodology: Include relevant preliminary data demonstrating the applicant’s experience with the assay or technique that will be used with the requested subjects/samples, including QA/QC data, if available.

4. Power and effect size: Describe the variability of the assay or measurement, the anticipated size of a detectable effect, and include a calculation of power demonstrating that the number of subjects/ samples requested is sufficient to answer the question.

5. Data analysis: Provide a detailed plan for data analysis. Include a brief summary of the team’s expertise and experience and evidence that they can handle the analysis proposed, or a request for assistance in data analysis from the TrialNet Biostatistics Coordinating Center.

6. Data management: Describe how the accompanying phenotypic data, as well as the data from sample analysis, will be managed. For example, who will have primary responsibility for organizing, storing, and archiving the data? Who will maintain computer data files and make needed work files available to those who will analyze the data? How will the privacy of information of beneficiaries in the files be guarded and guaranteed? Applicants are expected to return data derived from analysis of samples to the TrialNet Coordinating Center for the relevant NIDDK consortium, or the NIDDK Data Repository, along with appropriate quality measures. The plan should acknowledge the expectation to follow NIDDK instructions to return the phenotypic data and unused samples to the relevant NIDDK consortium or repository by one year after the period of award of this project.

7. Sample management: Explicitly address how the samples will be held, managed, and processed. For example, who will have primary responsibility for storing and testing samples?

8. Plans for the next phase: Describe plans for follow up studies and, if relevant, further biomarker or assay development.

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 NIDDK. 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@NIH.GOV when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/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?

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?

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?

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 NIDDK, 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:

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

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 NIDDK National Advisory Council. 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(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.

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.

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.

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.

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: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

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

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

Mary Kay Rosenberg
Grants Management Section Chief
Grants Management Branch, NIDDK
Democracy Plaza II, Room 745
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456 (express zip: 20817)
Telephone: 301-435-2816
Fax: 301-594-9523
Email: rosenbergm@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.