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

Limited Competition for the Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)

Activity Code

UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-503

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) invites one Research Project Cooperative Agreement application (UC4) from the Program Director/Principal Investigator of the Data Coordinating Center (DCC) that is currently managing this large, complex and effective network to: 1) Screen relatives of persons with type 1 diabetes; 2) Follow those found to be at-risk to better understand the pathophysiology associated with progression to disease, and 3) Conduct trials aimed at diabetes prevention in at-risk individuals and β-cell preservation in those newly-diagnosed with type 1 diabetes. The DCC will: 1) Support transfer of TrialNet samples and data to the NIDDK repositories for storage and dispensation, and 2) Provide continued support for TrialNet activities upon completion of the TrialNet DCC contract. This is a one-time solicitation to support the TrialNet DCC as part of an ongoing consortium of investigators for a maximum of five years, contingent on satisfactory performance. The DCC will manage and support a complex network of Clinical Centers, Affiliate Centers, Core Laboratories, Central Pharmacy, and other TrialNet contractors. The DCC will support a wide range of research projects in varying stages of development, implementation and completion. The DCC will provide for data and sample management, including standardized acquisition, quality control, dissemination, and public accessibility.

 
Key Dates
Posted Date

January 13, 2012

Open Date (Earliest Submission Date)

February 22, 2012

Letter of Intent Due Date

February 22, 2012

Application Due Date(s)

March 22, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July/August, 2012

Advisory Council Review

October, 2012

Earliest Start Date(s)

December, 2012

Expiration Date

March 23, 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

Purpose

This Funding Opportunity Announcement (FOA) invites one application from the Program Director/Principal Investigator of the current Data Coordinating Center (DCC) for Type 1 Diabetes TrialNet, an ongoing research consortium conducting clinical studies aimed at prevention of and early intervention in type 1 diabetes. The DCC is responsible for development and implementation of observational studies, clinical trials, and associated mechanistic studies conducted by a network of Clinical Centers and associated clinical sites (Affiliates Centers), for direction of communication and coordination among the Clinical and Affiliate Centers, and for management of the collection and analysis of genetic, immunologic, pathogenic, clinical and biological samples and data from the clinical sites. The DCC is also responsible for: 1) support of study protocols and Manuals of Operation for each TrialNet study; 2) maintaining the TrialNet internal and public websites, and 3) organizing TrialNet Steering Committee meetings, Data Safety Monitoring Board (DSMB) meetings, External Evaluation Committee (EEC) meetings, and other meetings and workshops as necessary. In addition, the DCC is responsible for transferring all data and biosamples that are the property of NIDDK to the appropriate NIDDK repositories.

Background

Type 1 diabetes is a serious and burdensome chronic disease that usually affects children and young adults. Rates of type 1 diabetes are rising worldwide. TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes. TrialNet researchers are striving to prevent type 1 diabetes through better characterization of the natural history of the disease, identification of persons at risk, and clinical evaluation of exciting new therapies that balance potential risks and benefits. The goal of TrialNet is to perform intervention studies to preserve insulin-producing cells in individuals at risk for type 1 diabetes and in those with new-onset type 1 diabetes.

The TrialNet international clinical trials consortium has been ongoing since 2001. TrialNet has developed a large and effective network to: 1) screen relatives of persons with type 1 diabetes, 2) follow those found to be at-risk to better understand the pathophysiology associated with progression to disease, and 3) conduct trials aimed at diabetes prevention in at-risk individuals and β-cell preservation in those newly-diagnosed with type 1 diabetes. Since its inception, TrialNet has screened more than 98,000 at-risk relatives. In addition, TrialNet has performed studies in individuals at-risk for type 1 diabetes as well as those newly diagnosed with the disease. These studies evaluate the effect of interventions targeting a number of distinct mechanisms strongly suspected to play a role in the pathogenesis of T1D. To date, the consortium has completed two prevention studies: the DPT-1 Oral Insulin Trial and the Nutritional Intervention to Prevent Autoimmunity in Type 1 Diabetes Trial. TrialNet is currently enrolling, treating, and following subjects in two prevention trials: the Oral Insulin Study and the AntiCD3 Study. TrialNet has completed four trials in individuals with new-onset type 1 diabetes: Mycophenolate Mofetil (MMF)/Daclizumab (DZB), Rituximab, CTLA4-Ig (Abatacept) and GAD-alum Vaccine. Some subjects in the latter three studies continue to undergo long-term follow-up. TrialNet is currently treating and following individuals in two fully-enrolled new-onset studies: Anti-IL-1β (Canakinumab) and Intensive Metabolic Control. TrialNet is currently considering a number of promising prevention and new-onset trials for development and implementation. TrialNet also provides necessary infrastructure support for additional investigator-initiated studies that utilize TrialNet subject populations), data, and biosamples (such as Living Biobank and Ancillary Studies).  Thus, TrialNet is complex, unique consortium that requires extensive coordination and organization.

Scope

The DCC is responsible for executing all TrialNet study protocols according to schedules and procedures contained in the study Manuals of Operations in collaboration with NIDDK staff and with the Clinical and Affiliate Centers at which participants are screened, enrolled, treated, and followed.

The DCC is responsible for receiving, managing, and analyzing data obtained from the Clinical and Affiliate Centers. This includes developing and updating standardized study forms; performing quality control on data supplied by the Clinical and Affiliate Centers; editing and entering data into the master database; storing, retrieving, maintaining, protecting, reviewing, processing, and analyzing the data; preparing reports of the results of these assessments for presentations and publications; and transmitting data to the NIDDK repository in a standardized format. The DCC is responsible for protecting patient confidentiality at all phases of the submission and analysis of data and ensuring the technical integrity and security of the data management systems.

The DCC is responsible for assuring adherence to all research plans by conducting site visits to monitor the quality of record keeping, source documentation, and accuracy of data entry as well as overseeing data quality control, including but not limited to regular data queries and data monitoring and cleaning to ensure data completeness and quality.

The DCC is responsible for providing statistical support, expertise, and oversight throughout TrialNet studies; conducting interim and final analyses per protocols; collaborating with the clinical investigators in preparation of presentations and primary and secondary publications; and providing additional analyses at the request of the Data Safety Monitoring Board (DSMB), External Evaluation Committee (EEC), or the NIDDK.

The DCC is responsible for study-wide communications, dissemination of study materials such as protocol Manuals of Operations, forms or other study documents, and development and maintenance of the TrialNet internal and public websites.

The DCC also plays a key role in the operational oversight of TrialNet Centers and subcontractors. The DCC provides training and technical assistance to the Clinical Centers in the course of their implementation of protocols, including screening, enrollment, treatment and follow-up assessments. The DCC oversees all aspects of Clinical Center performance, including timeliness and quality of data and sample submission.

The DCC will also be responsible for procurement and administration of subcontracts for laboratory services, including: central human leukocyte antigen (HLA) laboratory; autoantibody laboratories; mRNA laboratories; infectious disease laboratories; central biochemistry laboratory; and other laboratories as needed. Through subcontracts, the DCC will also procure and administer subcontracts for a central pharmacy, a medical monitor, and other services and consultants as needed. The DCC will provide capitated reimbursements to the Clinical and Affiliate Centers for study visits and procedures performed in the course of study conduct.

The DCC will also be responsible for providing administrative and logistical support services for the TrialNet Study Group, including preparation of publications, organization of periodic meetings, workshops, and conference calls. The DCC will also be responsible for preparing reports for and organizing meetings of the TrialNet DSMB and EEC. It will work collaboratively with the NIDDK and study investigators in preparation of papers for publication in the scientific literature.

The DCC is responsible for ensuring the transfer of all biosamples and data to the NIDDK central repositories according to a timeline developed with the NIDDK. The DCC is responsible for supporting and promoting data sharing by preparing a limited personal health information or de-identified data set in a format appropriate for data sharing for submission to a secure NIDDK data repository after publication of the primary and other study results or 12 months after completion of data collection for the primary endpoint, whichever comes first.

The DCC Program Director/Principal Investigator will be a member of the TrialNet Steering Committee. The Steering Committee is the main governing body of the network, and works with the NIDDK to oversee the TrialNet network. The DCC will be working closely with the Clinical Centers in a collaborative and interactive manner.

Section II. Award Information
Funding Instrument

Cooperative Agreement

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

NIDDK intends to commit to one award utilizing a Special Type 1 Diabetes Program appropriation for a total cost of $45 million in Fiscal Year 2012.

Award Budget

The requested budget will vary across years for a maximum of $45,000,000 total costs over a five year project period.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed five 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

As this FOA is a limited competition opportunity, only the institution that is the principal employer of the Program Director(s)/Principal Investigator(s) of the TrialNet Data Coordinating Center is eligible to apply in response to this FOA.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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 4-6 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.

The individual currently serving as the Program Director(s)/Principal Investigator(s) for the Data Coordinating Center may apply for support under this FOA.

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, the prospective applicant is 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.

Budget

The Budget request is entered in the Estimated Project Funding section of the SF424 (R&R) Cover component only. Award is for up to $45,000,000 in total costs for the five-year budget/project period. Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts (includes direct and F&A costs), and other allowable costs. Only the five-year total should be entered. This FOA uses "Just-In-Time" information concepts (see SF424 (R&R) Application Guide).  Detailed budget information will be requested as part of the Just-In-Time information.

PHS 398 Research Plan Component

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

The application for the DCC should describe the operational infrastructure (committees, procedures, coordination, communication, etc.) and a description of the Clinical and Affiliate Centers. It is expected that the Program Director(s)/Principal Investigator(s) of the DCC will continue to carry out a significant leadership role in the consortium.

The DCC applicant must also address the following regarding responsibilities and requirements for the DCC:

1. Participation in the design of all research studies and the development or updating of Manuals of Operation, data collection forms, and questionnaires;

2. Continued implementation and upgrading of systems for communication among Steering Committee members and among study sites;

3. Data collection, editing, processing, analysis, and reporting;

4. Monitoring of adherence to the research plans and data quality;

5. Continued implementation and upgrading of procedures that ensure the safety and confidentiality of all records;

6. Continued implementation and upgrading of procedures for coordinating submission of samples and data from the participating Clinical and Affiliate Centers to the TrialNet Central Laboratories and NIDDK Repository;

7. The DCC application should include an overall sharing plan for data generated during the funding of TrialNet. The plan should specifically indicate what will be shared, with whom it will be shared (including the NIDDK Data Repository), when it will be shared, by what means it will be shared, and the conditions that will apply to recipients of shared data. This plan must be approved by the NIDDK before the award will be issued under this FOA.

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, with the following modification:

The following items should be submitted as part of the Appendix:

Foreign Institutions

Not Applicable.

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.

Since these awards will be issued with a 5-year budget and project period from the same fiscal year appropriation, he grantee will not have any authority for an automatic extension nor will one be permitted with NIH prior approval.  Funds will not be available for expenditure beyond September 30th of the 5th fiscal year after the period of availability. Thus, extensions of the budget/project period will not be allowed.

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, the applicant is 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.

The TrialNet consortium will continue to be a collaborative effort that will require frequent interactions of awardees among themselves and with the NIDDK. The applicant must explicitly indicate their willingness to:

1. Participate in Steering Committee meetings (two to three times per year), site visits required by the NIDDK, and other regular subcommittee telephone conference calls;

2. Cooperate with other TrialNet investigators in the development and design or modification of research protocols, and cooperate in carrying out approved research protocols;

3. Abide by common definitions; common methods for patient recruitment, enrollment, and retention; and common protocols, procedures, tests, and reporting forms as determined by majority vote of the Steering Committee;

4. Actively seek to implement each consortium-wide protocol approved by the Steering Committee and NIDDK after endorsement by the EEC;

5. Comply with study policies and quality assurance measures approved by the Steering Committee;

6. Agree to oversight of the study by the TrialNet DSMB and EEC;

7. Report all adverse events in accordance with procedures established by the Steering Committee, NIDDK, and the FDA;

8. Cooperate with other TrialNet investigators in the publication of study results and the eventual release to the scientific community of study procedures and other resources;

9. Accept the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.Administrative and National Policy Requirements.

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.

Reviewers should evaluate the impact of the DCC on the progress of the network toward its common goals, but should not evaluate the specific clinical network components which are separately funded by individual U01 awards.  Reviewers should also consider the future plans of the DCC to improve and upgrade systems that could help the network make more progress during the UC4 award period.

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?   

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/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

Not Applicable.

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)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:

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(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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.

2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.

3. Designating Protocol Chairs. The Principal Investigators (for studies involving multiple coordinated awards) shall designate a single Protocol Chairperson (if the Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.

4. Implementing collection of data specified by the study protocol, by the Steering Committee. For a multi-center study, each awardee/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.

5. Establishing procedures for data quality and completeness. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple awards, a plan for analysis of pooled data will be developed by the Steering Committee.

6. Submitting interim progress reports, when requested, to the NIDDK Program Director including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Director may require additional information from individual awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.

7. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.

8. Reporting of the study findings. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to the Government rights of access consistent with current HHS, PHS and NIH policies. The awardee must also be adherent to Study Publication and Presentation Policy.  The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with awardees consistent with NIH and study policies.

9. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIDDK support; or special access to study results, primary data/summary information, or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party is permitted only after concurrence by NIDDK.

10.  Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and steering committee policies on publications.

11.  Maintaining confidentiality of information:  The awardee(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of a company collaborating with the study.

12. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archival and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The PI or his/her designee will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution. In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the study’s Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. Subsequently samples and data will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and, http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

13. The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If applicable, the PI or his/her designee will perform the mandatory study registration and reporting of study results to ClinicalTrials.gov. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at http://prsinfo.clinicaltrials.gov/fdaaa.html.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

1. Serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

2. For multi-center studies, participation in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

3. Serving as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

4. Substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:

a.     Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.

b.    The NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.

c.     Reviewing procedures for assessing data quality and study performance monitoring.

d.    The NIDDK Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participate in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.  

In addition, a separate NIDDK Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions.  Additional responsibilities include. 

Interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

Reviewing and approving protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.

The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.

Making recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

Appointment of a Data and Safety Monitoring Board (DSMB) as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the DSMB.

Areas of Joint Responsibility include:

In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:

1. Steering Committee.

A Steering Committee organized by the study investigator(s) will be the main governing body of the study.

The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of  results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.

The Steering Committee will be composed of all Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.

A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIDDK (see item D2 below) and by interacting closely with the awardees during protocol development and implementation.

2. External Study Oversight.

An independent Data and Safety Monitoring Board will be established by the NIDDK for Phase III clinical trials or other high risk studies as appropriate. The Data and Safety Monitoring Board will review interim results periodically and provide guidance to the NIDDK.

Dispute Resolution:

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CR Part 16.

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)

Ellen Leschek, M.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 603
Bethesda, MD 20892-5450
Telephone: 301-402-8291
Email: LeschekE@extra.niddk.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)

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