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

George M. O’Brien Urology Cooperative Research Centers Program (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • November 18, 2013 - This RFA has been reissued as RFA-DK-13-020.
  • October 2, 2012 - See Notice NOT-DK-12-024. Technical Assistance Webinar for investigators who are planning to submit an application.

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-009

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to seek applications for the George M. O’Brien Urology Cooperative Research Centers Program. This program will provide a coordinated platform for multidisciplinary interactions between basic and clinical scientists with the goal of understanding the underlying etiology and the development, treatment, diagnosis, and prevention of specific clinically-oriented urologic disorders or diseases within NIDDK mission interests. This program will also serve as a national resource for career development of junior scientists electing to pursue research in benign urology.

Key Dates
Posted Date

September 20, 2012

Letter of Intent Due Date

November 14, 2012

Application Due Date(s)

December 14, 2012  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April, 2013  

Advisory Council Review

May, 2013

Earliest Start Date(s)

July, 2013

Expiration Date

December, 15, 2012

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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

Purpose

The George M. O’Brien Urology Cooperative Research Centers Program is designed to: 

The Cooperative Research Centers Program will consist of Research Centers and a single Coordinating Unit that will function with the NIDDK under a cooperative agreement as a multi-center research program. Within this Cooperative Research Centers Program, Center Directors are expected to work with NIDDK staff to promote and facilitate research collaborations and interactions within and between Centers, with the NIDDK Multidisciplinary K12 Urologic Research (KURe) Career Development Program (RFA-DK-07-006), the NIDDK Planning Centers for Interdisciplinary Research in Benign Urology (RFA-DK-12-003), and the research community to develop a national network that accelerates bi-directional knowledge between the laboratory and the clinic. The ultimate goal of the Centers program is to improve the urological health of the nation through enhanced communication, innovation and research excellence. The Centers are expected to conduct research to discover and develop promising new leads to advance our understanding of the etiology, prevention, diagnosis, and treatment of benign urological disease or disorders. The Centers shall also provide the research infrastructure to support collaborative research projects, to support the career development of junior scientists, and to recruit established investigators not previously involved in non-malignant urological research. The Coordinating Unit is expected to maintain websites and databases developed by Center investigators, carry out administrative tasks, organize Centers Program meetings, and provide centralized access to Biomedical Research Cores of the Centers. The Coordinating Unit will provide financial management of the Collaborative Research Project and the Pilot & Feasibility Programs.

Background

The O'Brien Urology Research Centers (P50) were first solicited by the NIDDK in 1987 and most recently in 2008. The transition of the O’Brien Urology Centers to a Cooperative Research Centers Program (U54) reflects the need to coordinate Centers' research efforts and to integrate the Centers with the wider research community in order to make advances in the treatment of benign urological disorders and diseases. Over the past two decades, the field of urology has changed significantly with advancing technology in diagnostic and therapeutic options for patient treatment of non-malignant urologic diseases. Minimally invasive surgeries and procedures, and drug therapy have changed the clinical management of these patients. Despite these advances, millions of Americans are afflicted with urologic disorders and diseases including urinary tract infections, urolithiasis, and lower urinary tract disorders associated with benign prostatic hyperplasia, urinary incontinence, or chronic urologic pelvic pain syndromes. The annual cost of treatment of these illnesses is at least 11.5 billion dollars per year.

Contributing to our inability to adequately treat patients are the gaps in our knowledge of the basic physiology, cell biology, and genetics of urological disorders; a lack of objective diagnostic criteria and tests to identify urologic diseases and disorders; inadequate in-depth characterization (phenotyping); and the paucity of information on the epidemiology and natural history of many of these illnesses. The absence of basic knowledge of the detailed structure and normal function of the urinary tract and associated organ systems (e.g., nervous system) makes it difficult to establish useful experimental in vivo or in silico models that lead to testable hypotheses and can be used to guide human studies. Furthermore, the application of translational tools, such as imaging techniques and biomarkers, will depend upon an understanding of the structure, function, and physiology of the urinary system. Basic research expertise in disciplines such as cell and molecular biology, genomics and proteomics, biochemistry, physiology, developmental biology, tissue engineering, immunology, pathology, neurobiology, and microbiology is an essential component in the advancement of urologic research. Expertise in the physical sciences such as physics, bio-engineering, chemical and mechanical engineering as well as in clinical sciences such as, urology, gastroenterology, gynecology, endocrinology, anesthesiology, and radiology will be instrumental and critical to advance the field of urology.

Research Center

Research at each Center must coalesce on a single urologic disease or disorder or urological complication relevant to the NIDDK mission which will serve as a central theme for individual research projects. The Administrative Core for each Center may support research projects and Biomedical Research Core(s) at other institutions/organizations through subcontracts. These outside institutions may be at the local, regional, national, or even international levels.

Each Center will consist of:

The Centers will provide the infrastructure for sharing resources to enhance the efficiency of research and for fostering collaborations among the Centers, the NIDDK K12 KURe and the NIDDK P20 Planning Center. As such, Center participants are expected to work collaboratively among each other and within the Cooperative Research Centers program through sharing of resources and data. In addition, the investigator must agree to be an active participant in Cooperative Research Centers program activities as deemed necessary by appropriate oversight committees. The investigator must agree to participate in the Executive Steering Committee and be responsive to recommendations provided by an independent External Expert Panel.

Research Projects

The research projects of the Center must be interactively organized to conduct research to discover and develop new leads for the diagnosis, treatment, or prevention of a single major urologic disease or disorder or urological complication relevant to the NIDDK mission. A Center must propose scientific research projects from among at least two of the following types of studies: 1) clinical or patient-oriented studies (such as genetics, epidemiology, natural history of a disease), 2) translational (such as tools development, imaging, or diagnostic tools development), or 3) basic laboratory science. Research projects are encouraged to use resources and databases from NIDDK sponsored studies, such as the Urological Diseases in America Project (UDA), Boston Area Community Health Survey (BACH), NIDDK Data Repository, Medical Therapy of Prostatic Symptoms Study (MTOPS), Urinary Incontinence Treatment Network (UITN), NIDDK’s Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network, or the Lower Urinary Tract Dysfunction Research Network (LURN). Research with translational potential is strongly encouraged.

Examples of research areas appropriate for investigation are listed below, but are not comprehensive. An application focused on malignant urologic diseases or in which a research project is focused on malignant disease will be deemed non-responsive to this FOA and will not be accepted.

The following are examples of studies to address these disorders and do not represent a comprehensive list:

Center Director  

The Center Director must be an established investigator with a demonstrated funding and publication record. The Center Director will be responsible for scientific and administrative leadership and is expected to commit 2.4 person-months (equivalent to 20% full-time professional effort) to the Center and will work closely with the Executive Steering Committee. One or more Associate Directors may be named as well. The combined directorship efforts should not exceed 6 person-months (equivalent to 50% full-time professional effort). The Center Director and Associated Directors may be from any discipline as long as the criteria for leadership are met. The Center administration may also wish to include an administrative assistant.

Administrative Core

The Administrative Core will serve as the focus for the synergistic activities of the Center. It will be responsible for the management of resources within the Center. The Administrative Core will include an Educational Enrichment Program.  

The Center administrative organization and management are determined by the individual Center (subject to NIH peer review). It is expected that the administrative organization of the Center will have a supportive structure, such as an Executive committee. The major responsibilities of the Administrative Core are to: 

Educational Enrichment Program

The Administrative Core will be responsible for an Educational Enrichment Program that should further the overall aims and objectives of the Center. The Educational Enrichment Program may consist of seminar series, guest lectures, workshops, symposia, or other instructional opportunities. Students, fellows, and junior faculty should be encouraged to take full advantage of all Educational Enrichment Program events. It is permissible for Center Institutions to co-fund the activities of the Educational Enrichment Program. Travel support to attend meetings outside of the investigator's or trainee's discipline is encouraged.

External Advisory Committee

Although optional, the use of an External Advisory Committee for each Center is highly advisable. The members must not be named in the grant application; however, the process by which members are selected must be described in detail. This group, comprised of 3-5 members, may advise the Center Director and the Center's Executive committee in the areas of scientific direction, budget, policy, collaborations, or other areas.   

Biomedical Research Core

The Biomedical Research Core is defined as a shared resource that provides specialized and essential services, techniques, or instrumentation to Center participants. The Biomedical Research Core enables the Center research projects to be carried out more efficiently and/or more effectively. Because the Biomedical Research Core provides specialized technologies and expertise needed to accomplish the stated goals of the Center, the Biomedical Research Core (if proposed) must be used by two or more of the research projects of the parent Center.

The Biomedical Research Core should be accessible to and should increase interactions between Centers and the NIDDK K12 KURe and the NIDDK P20 Planning Center programs through cross-project/laboratory exchange, and sharing of specialized tools, technologies, and expertise. The Biomedical Research Core may also provide services to funded research projects outside the Center.

Examples of types of Biomedical Research Core resources that would be considered include, but are not limited to:

George M. O’Brien Urology Cooperative Research Centers Meetings

Each Center and the Coordinating Unit are expected to participate in two in-person Executive Steering Committee meetings the first year of funding and then annually thereafter. The first meeting will be held on September 9, 2013 in the Washington, DC area. The meetings will be organized and hosted by the Coordinating Unit. The purposes of these meetings are to share research experiences with other Centers, assess progress, identify new research opportunities, share materials, enhance and further the potential impact of the Centers. Travel funds for the Director and selected Research Center investigators and collaborators are to be budgeted.

Coordinating Unit

NIDDK will support a single Coordinating Unit for the Cooperative Research Centers Program. The Coordinating Unit is separate from the Research Centers and an application for the Coordinating Unit does not need to be linked to a Research Center application. The Coordinating Unit will: 1) provide clerical and administrative support, 2) maintain and manage central databases, 3) fund and oversee financial management of Cooperative Research Centers Program-related expenses, including the Opportunity Pools program, 4) update and maintain Center internet and intranet websites, 5) promote each Center, and 6) facilitate collaborations, including access to Centers' Biomedical Research Cores.

Administrative Functions

Coordinating Unit Personnel and Budget

The Coordinating Unit should have a Director, an administrator, and additional personnel as needed for its proposed activities. Because the Coordinating Unit will be responsible for hosting the annual evaluation meetings with the External Expert Panel, travel funds for members of the External Expert Panel  should be budgeted.

Opportunity Pool Programs

The Opportunity Pool Program consists of the Pilot and Feasibility (P&F) program and the Collaborative Project program. The application should describe how the Coordinating Unit will oversee the solicitation, review, and selection of the Opportunity Pool program projects. The P&F Program is to support new research direction in benign urology or provide support for new investigators in benign urology. A P&F project is to allow the development of preliminary data for an application for independent research support. P&F projects are not intended to support or supplement ongoing research of an established investigator. P&F projects to investigate basic research findings in a clinical setting are encouraged.

The Collaborative Project Program seeks to support interaction between Center investigators, the NIDDK K12 KURe fellows, and/or investigators of the NIDDK P20 Planning Centers. Although funds are not provided directly for training purposes, the Collaborative Project Program should provide funds for specific training opportunities such as travel support of investigators to learn new laboratory techniques, develop new collaborations, mini-sabbaticals or engage in scientific information exchange.

Projects in the Opportunity Pool program should be integrated into the overall research goals of a specific Center and where possible make use of the resources provided by the Biomedical Research Core. It is permissible for Center Institutions to co-fund the activities of the Opportunity Pool Program.

Opportunity Pool projects are limited to $100,000 direct costs per year and are initially 2 years with an option to extend the project an additional year pending exceptional progress. It is expected that each Center will be associated with 2 to 4 projects. Funds for the Opportunity Pool program should be requested as part of the Coordinating Unit budget, and will be restricted for use to support Opportunity Pool projects pending an external expert panel review of the project, and approval by the Executive Steering Committee and by NIDDK.

Site Visits

DKUHD-NIDDK will conduct an administrative site visit to the Coordinating Unit and each Center in the first year of the grant with the purpose to view the organizational set up and working dynamics. The Coordinating Unit and each Center should expect follow-up site visits during the course of the award.

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, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIDDK intends to commit approximately 3 million dollars in FY 2013 to fund up to two new Research Centers and a single Coordinating Unit.

Award Budget

The Research Center budget is not limited, but needs to reflect actual needs of the proposed Center. The expected award for each Center will be up to $650,000 direct cost per year.

The Coordinating Unit budget is not limited, but needs to reflect actual needs of the proposed Coordinating Unit. The expected award for the administrative component of the Coordinating Unit will be up to $300,000 direct cost per year and is separate from the funds expected to be awarded for the Opportunity Pool Program which is administered by the Coordinating Unit.

Award Project Period

The scope of the project should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the 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(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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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:

The letter of intent should be sent to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452 (for express/courier service: Bethesda, MD   20817)
Telephone: 301-594-8897
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:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD   20817)
Telephone:  301-594-8897
Email:  fc15y@nih.gov

Page Limitations

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

For Research Center applications, the Research Strategy section is limited to:

For Coordinating Unit applications, the Research Strategy section is limited to:

Special Program Requirements

Research Center Application-Content Order for Applications

Section 1:  Relevant Background

Section 2:  Administrative Core

Section 3: Individual Research Projects (present each project separately)

Section 4:  Biomedical Research Cores (present each core separately)

Coordinating Unit Application-Content Order for Applications

Section 1: Relevant Background

Section 2: Administrative Component

Section 3: Opportunity Pool Program

Research Plan

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

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 PHS398 Application Guide, with the following modification:

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.

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 and responsiveness by the National Institute of Diabetes and Digestive and Kidney Diseases (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 Research Center or Coordinating Unit  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 Center or Coordinating Unit 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center, research project, or Biomedical Research Core address an important problem or a critical barrier to progress in the field? If the aims of the Center or Coordinating Unit, research project or Biomedical Research Core 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?

What is the relevance of the research projects and Biomedical Research Core to the theme of the Center? Is there a clear blueprint for integrating basic, translational, and/or clinical research projects and using knowledge gleaned from one to guide research in the other?

Does the Biomedical Research Core represent a unique and essential resource to the Center research projects?

Does the Administrative Core have a significant commitment to education, training, and career development of future research scientists?

Does the Coordinating Unit allow for significant leadership, effective organization, administrative support, and novel strategies to ensure global integrity of the Centers program, and outreach to NIDDK K12 KURe and NIDDK P20 Planning Center programs and the research community? Is there a plan that will result in a better comprehension by the community of the objectives and goals of the George M. O’Brien Urology Cooperative Research Centers Program, a greater appreciation for research progress made as a result of funding and a better understanding of the implications of Centers Program in the supported of research for urological health?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center, research project, Administrative Core, Biomedical Research Core, Coordinating Unit, or administrative component ? 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 Center, Coordinating Unit, research project or Biomedical Research Core? 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?

Does the Coordinating Unit have an effective plan for coordinating the Research Centers and intergrating the efforts of the Research Centers with outside groups?

Is there an effective plan by which the various components of the Center will be coordinated into one multi-disciplinary effort within the Center?

Are there defined lines of accountability regarding the internal management of the Center, interactions within the institution, and interactions with other Research Centers? Is there a suitable succession plan for replacing the Center Director and other key personnel? 

Does each Biomedical Research Core have the required minimum of two documented research project users? Does the Biomedical Research Core have an effective plan for managing the core facility, including plans for advertising core facility services, managing user priority and establishing fee structure for cores offering services to external projects? Is there an efficient system (e.g.,web-based) for request of core services and tracking of core facility?

Does the administrative core have an effective plan to evaluate overall Center performance, including the projects and Biomedical Research Core (if proposed)?  Is there a process where feedback will be used to modify and or terminate components? Does the administrative core have an effective plan for managing the Educational Enrichment program and for outreach to the NIDDK K12 KURe and the NIDDK P20 Planning Center programs and the research community?

Does the Coordinating Unit have an effective plan for housing, maintenance, and curate websites and intranet sites, managing the Opportunity Pool programs and for outreach to the NIDDK K12 KURe and NIDDK P20 Planning Center programs and the research community? Does the Coordinating Unit have an efficient system for advertising, monitoring, and for effective use of the Biomedical Research Core services and coordinating with other Biomedical Research Core facility?   

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?

Is there clear evidence of institutional commitment to the Center or the Coordinating Unit such as space, protected time, and/or additional financial support for co-funded activities such as the Opportunity Pool program and Enrichment Educational Program?

Is there a suitable environment for Center interaction and cross-fertilization with scientists from other departments, fields of expertise, and institutions?

Additional Review Criteria - Overall

As applicable for the Center or the Coordinating Unit 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 - Overall

As applicable for the Research Center or Coordinating Unitt 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:

Appeals of initial peer review will not be accepted for applications submitted  in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center 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’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:

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

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:

Areas of Joint Responsibility include:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR 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

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)

Deborah K. Hoshizaki
Program Officer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7712
Email: hoshizakid@mail.nih.gov

Peer Review Contact(s)

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD   20817)
Telephone:  301-594-8897
Email: fc15y@nih.gov.

Financial/Grants Management Contact(s)

Diana Ly
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email:dianaly@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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