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 Continuation of Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) (UM1)

Activity Code
 
Announcement Type

Reissue of RFA-DK-03-022

Related Notices

  • February 23, 2011 - See Notice NOT-DK-11-008 Notice of Correction for Program Organization and Direct Cost Limits.

Funding Opportunity Announcement (FOA) Number

RFA-DK-10-503

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility Section III. 3. Additional Information on Eligibility.

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

 93.847   

FOA Purpose

This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, invites two applications, one from the principal investigator for the Clinical Centers and one from the principal investigator of the Data Coordinating Center, both currently supported by , Adolescent Bariatrics: Assessing Health Benefits & Risks, renamed Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and funded under RFA-DK-03-022.  The purpose is to continue their longitudinal assessment of adolescent subjects to assess the longer term safety and efficacy of bariatric surgery. This is a one-time solicitation to support the Teen-LABS consortium for a maximum of five years, contingent on satisfactory participant recruitment and retention.

Key Dates
Posted Date
Letter of Intent Due Date

March 9, 2011

Application Due Date(s)

April 6, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June-July, 2011

Advisory Council Review

October, 2011

Earliest Start Date(s)

December, 2011

Expiration Date
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

This FOA is inviting two applications, one from the principal investigator for the Clinical Centers and one from the Program Director of the Data Coordinating Center, both currently supported as  Adolescent Bariatrics: Assessing Health Benefits & Risks, renamed Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and funded under RFA-DK-03-022.  The purpose is to continue their longitudinal assessment of adolescent subjects to assess the longer term safety and efficacy of bariatric surgery.  This is a one-time solicitation to support the Teen-LABS consortium for a maximum of five years, contingent on satisfactory participant recruitment and retention. 

NIDDK has supported the Teen-LABS consortium since June 2006.  To date, the consortium has enrolled 200  severely obese adolescents who were scheduled for bariatric surgery at the participating clinical centers, for pre-operative and longitudinal post-operative evaluation.  

NIDDK is inviting renewal applications from the Principal Investigator of the Clinical Centers' grant and from the Program Director of the existing Data Coordinating Center in order to continue the efforts of the Teen-LABS consortium to enroll participants and collect data before and after bariatric surgery.

Program Organization and Coordination

The Teen-LABS Consortium will consist of the following components: the NIH (NIDDK), a consortium made up of multiple Clinical Centers, a Data Coordinating Center, a Steering Committee and its subcommittees, a Data and Safety Monitoring Board, and other committees as needed.  The responsibilities of each component of the Teen-LABS consortium are described in the Terms and Conditions of Award. 

The NIDDK will be responsible for organizing and providing support for the Teen-LABS Consortium and will be involved substantially with the awardees as a "partner," consistent with the Cooperative Agreement mechanism detailed in Section VI. 2. Administrative and National Policy Requirements below.   A designated NIDDK Project Scientist will have substantial involvement in the project above and beyond normal stewardship and monitoring of the award.  A designated NIDDK Program Official will provide normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. The NIDDK will appoint the Chairperson(s) of the Steering Committee and all members of the DSMB.

Clinical Centers (CCs): The CCs will continue to recruit subjects into the approved Teen-LABS studies and will conduct the longitudinal follow-up as described in the study protocols.  Site PIs for the CCs will be required to participate in a cooperative and interactive manner with one another and with the DCC in all aspects of the Teen-LABS Consortium (see Terms and Conditions of Award). Only investigators who wish to continue to carry out the protocols of the Teen-LABS consortium and agree to be governed by the policies of the Teen-LABS consortium and its steering committee should be included in the overall CC application in response to this FOA.

Data Coordinating Center (DCC): The DCC will continue to support the Teen-LABS consortium.  This includes supporting any protocol development or modifications; providing sample size calculations, statistical advice, questionnaires, and data analysis; supporting development, implementation, and maintenance of a data base of clinical information and blood samples; developing or modifying any data and safety monitoring plans; supporting manuscript preparation; and providing overall study coordination and quality assurance, including coordination of the activities and meetings (including conference calls) of the Data and Safety Monitoring Board, the Steering Committee, the Coordinators Committee, and other needed committees.  The DCC will prepare or modify protocols for approval by the Steering Committee and  DSMB prior to the implementation of any study protocols or protocol change.  The DCC will also prepare all reports, including data reports for review by the DSMB at their meetings.  The DCC will also be responsible for the logistics and planning of the meetings of the Steering Committee and the various operational committees of Teen-LABS.  The DCC will be responsible for acquiring and administering subcontracts as needed.  (See Terms and Conditions of Award).  

Study Governance

Steering Committee.  A Steering Committee will be the main governing body of the Teen-LABS consortium (see Terms and Conditions of Award).  An Executive Committee comprised of the Principal Investigator of the Clinical Center grant and Co-chair, if appropriate, the Principal Investigator of the DCC, and the NIDDK Project Scientist also will be convened to effect management decisions required between Steering Committee meetings, as needed for efficient progress of the study.  Other subcommittees of the Steering Committee will be established and will operate as necessary such as Publications, Adjudication and Ancillary Studies.

Data and Safety Monitoring Board (DSMB). An independent DSMB will be established by the NIDDK to evaluate protocols and to monitor patient safety, performance of each component of the study, and data quality.  As a part of its responsibilities, the DSMB will submit recommendations to the NIDDK regarding the continuation of the study.  The DSMB will be responsible for final approval of the Data and Safety Monitoring Plan developed by the DCC.  All protocols or changes to protocols will be approved by the Steering Committee, local Institutional Review Boards, and by the DSMB and the NIDDK before initiation. Any specific collaboration involving the resources of Teen-LABS will require approval by the Steering Committee.

Clinical Center site PIs will be required to attend Steering Committee meetings and subcommittee meetings, as appropriate, in which study plans, findings, and issues of common interests and concerns will be shared and discussed.  Funds for all clinical site PIs to attend meetings should be included in the overall Clinical Center application budget. Funds for the PI of the Teen-LABS Clinical Centers to attend one parent study (LABS) Steering Committee meeting during the five year project period should be included in the Clinical Center budget as well.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK will commit total cost of $2 million to fund two awards in FY2011, with the amount committed to future years depending on  annual appropriations..

Award Budget

Direct costs are limited to $750,000 per year for the Clinical Centers and $550,000 for the Data Coordinating Center for four years, with a larger proportion of the total funding for the DCC in the fifth and final year of the project period..

Award Project Period

The total project period for an application submitted in response to this funding opportunity 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

Foreign (non-U.S.) components of U.S. Organizations are not allowed.

The institutions that are the principal employers of the Principal Investigator of the Teen-LABS Clinical Centers grant and of the current Program Director of the Teen-LABS Data Coordinating Center are eligible to apply in response to this FOA.       

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Eligible Individuals (Project Director/Principal Investigator)

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

Individuals currently serving as the Principal Investigator for the Clinical Centers or the Program Director of 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.

Awards for the Clinical Centers (CCs) and a Data Coordinating Center (DCC) will not be made to the same Principal Investigator. 

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Letter of Intent

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

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

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
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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must 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

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Supplemental Instructions for the Clinical Center Application (CC)

The CC application should describe the previous research accomplishments of the Teen-LABS consortium, the protocols that have been approved by the Teen-LABS steering committee that will be continued, and its overall prospective research plan, as well as each participating CC's accomplishments related to previous collaborative projects within Teen-LABS (e.g., recruitment and retention of subjects, committee membership or chairmanship, project leadership, etc.). The CC application must provide detailed plans for future subject recruitment and retention, if applicable, and must indicate the roles which personnel will play in executing this research plan.

The CC application must show that each participating CC is able to submit data to the DCC and blood samples to the NIDDK Repository (supported by an independent contract from NIDDK) and to a Central Laboratory as approved by the Teen-LABS Steering Committee, how they have worked and will continue to work in concert with the DCC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as established by the study protocol.   Information about each CC's past contributions to and future plans for involvement with operational committees of Teen-LABS (e.g. Publications, Adjudication, and Ancillary Studies), establishment of uniform procedures and policies, and role in new studies approved by the Steering Committee should be provided.

The CC application must describe plans for retaining study subjects, so that a longitudinal assessment of adolescent bariatric surgery can be accomplished according to the approved protocols. The CCs' specific barriers to participant retention and plans to address these barriers should be described.

There should be evidence of strong institutional support for each participating CC, including adequate space in which to conduct clinical and research activities and office space for staff. Institutional resources for follow-up at each CC including personnel, space, and special laboratory facilities must be described in the CC application.  The CC application does not need to cite the overall data sharing plan included in the DCC application, but the CC investigators should indicate their willingness to participate fully in it.

An organizational structure for the CCs should be set forth in the application, delineating lines of authority and responsibility for dealing with problems in all general areas as well as stated willingness to follow commonly agreed upon protocols and willingness of cach CC site principal investigator and Institution to participate in a per participant basis for operational costs of patient specimen acquisition and processing.

Supplemental Instructions for Data Coordinating Center (DCC)

The application for the DCC should describe the operational infrastructure (committees, procedures for coordination and communication, etc). Where appropriate, it should credit the participation of specific CC site members in the previous work of the Teen-LABS consortium, and note what roles they are anticipated to play in implementing particular parts of the prospective research plan.  It is expected that the PI of the DCC will carry out a significant leadership role in the consortium.

The DCC applicant must also address the following regarding responsibilities and requirement for the DCC.

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

2. Development and implementation 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 plan and of data quality;

5. Establishment of procedures that insure the safety and confidentiality of all records.

6. Delineate a plan for coordinating submission of blood samples from the participating CCs to the NIDDK Repository and to the Central Laboratory.

7. The DCC application should include an overall sharing plan for data generated during the funding of Teen-LABS. The plan should indicate specifically 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 what conditions will apply to recipients of shared data. This plan must be approved by the NIDDK before awards will be issued under this FOA.

Other Special Performance Requirements

The Teen LABS Consortium will continue to be a collaborative effort that will require frequent interactions of awardees among themselves and with the NIDDK. Applicants must explicitly indicate their willingness to:

1. Participate in Steering Committee meetings (expected to occur in person at least annually and as teleconferences monthly or more frequently, as needed), site visits required by the NIDDK, and other regular telephone conference calls related to subcommittees,

2. Cooperate with other Teen-LABS 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 chosen by majority vote of the Steering Committee,

4. Actively seek to implement each consortium-wide protocol approved by the Steering Committee and endorsed by the DSMB and the NIDDK,

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

6. Agree to oversight of the study by a Data and Safety Monitoring Board (DSMB),

7. Accept awards for the support of research based on per-patient (capitated) rates and the actual numbers of subjects enrolled, followed, and completing the study if requested by the CC grant PI and executive committee (Clinical Centers only),

8. Transmit study data to the Data Coordinating Center in a timely and accurate manner (Clinical Centers only),

9. Report all adverse events in accordance with procedures established by the Steering Committee and NIDDK policies,

10. Cooperate with other Teen-LABS investigators in the publication of study results and the eventual release to the scientific community of study procedures and other resources,

11. Accept the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.Administrative and National Policy Requirements.

Resource Sharing Plan

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Organizations

 Not Applicable

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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 - Overall

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 projectt address an important problem or a critical barrier to progress in the field? If the aims of the projectt 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/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?  Is it likely that the goals of the research plan described in the CC application will be achieved? What is the scientific and technical merit of the proposed approach to meeting the requirements of the approved studies provided in the CC application?

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? Do the collaborative arrangements within the Teen-LABS consortium enhance the productivity of these CCs/DCC?     

Additional Review Criteria - Overall

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.

COMMITMENT: Is there evidence of commitment to continue conduct of Teen-LABS for the full project period in accordance with policies and procedures established by the Teen-LABS steering committee?

Review of CC applicants also will be based on the following specific criteria:

Recruitment and Retention: Is there evidence that the CCs will be able to meet their recruitment goals for and retention of research subjects in the Teen-LABS studies to which they have committed their participation?

Data and Sample Management: Is there an adequate plan to ensure accurate collection and timely transmission of study data to the DCC and patient samples as required by the approved Teen-LABS protocols?

Knowledge of Problems: Does the CC application demonstrate knowledge of the potential problems associated with the conduct of the Teen-LABS studies and feasible solutions to these problems?

Cooperative Experience: Is there evidence of willingness to work cooperatively in this study?

Review of the DCC application also will be based on the following specific criteria:

Understanding of the scientific, statistical, logistical, and technical issues underlying the Teen-LABS multi-center studies and knowledge necessary to lead in the areas of study design, statistics, logistics, data acquisition and management, identification of and coordination with central laboratories and serum/tissue/data repositories, handling of laboratory specimens, quality control, data analysis, and consortium coordination.

Adequacy of the proposed plans for acquisition, transfer, management, and analysis of data, quality control of data collection and monitoring, and overall coordination of the Teen-LABS activities.

The expertise, training, and experience of the investigators and staff, including the administrative abilities of the Principal Investigator and co-investigators, and the time they plan to devote to the effective coordination of Teen-LABS.

The administrative, supervisory, and collaborative arrangements for achieving the goals of the program, including willingness to cooperate with the CC site PIs and the NIDDK.

Facilities, equipment, and organizational structure to coordinate the Teen-LABS activities effectively in implementing the protocols, providing for specialized laboratory testing, and data collection.

Ability to develop or modify Data and Safety and Monitoring Plans for the Teen-LABS multisite clinical studies.  

Expertise in setting up and managing databases.

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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations - Overall

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 NIDDK.  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the  NDDK Advisory Council . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

4. 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.

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

6. 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.

7. 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.

8. 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.

9.  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.

10.  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.

11. 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).

12. 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:

An NIDDK Project Scientist with substantial involvement will:

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 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 and 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

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)

Mary Horlick, MD
 Director, Pediatric Clinical Obesity Program
National Institute of Diabetes and Digestive and Kidney Diseases Institute or Center full name (NIDDK)
6707 Democracy Boulevard, Room 679, MSC 5450 
Bethesda, MD 20892-5452
 (For UPS, FedEx: use 20817)
Telephone: 301-594-4726
Fax: 301-480-8300
Email:horlickm@niddk.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Elizabeth Gutierrez
Grants Management Specialist
Grants Management Branch, NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 743
Bethesda, Maryland 20892-5452
(for express/courier service:  Bethesda, MD  20817)
Telephone: 301-594-8844
Email:gutierrezel@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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