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

Reissue of RFA-DK-12-009

Related Notices
  • November 26, 2014 - This RFA has been reissued as RFA-DK-15-002.
  • December 19, 2013 - See Notice NOT-DK-14-009. Notice of Technical Assistance Webinar.
Funding Opportunity Announcement (FOA) Number

RFA-DK-13-020

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 overall goal of understanding the etiology and development of benign urologic diseases and disorders, and providing a collaborative venue to design better treatments, diagnostics, and prevention strategies for these disease conditions within the 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. Accordingly, applications are sought from individuals willing to cooperate with the NIDDK under a cooperative centers program. It is expected that funded programs will work with the NIDDK in facilitating research collaborations and interactions within and among centers and with the larger research community to accomplish the overall goal of improving treatment of urologic disorders through enhanced communication and research excellence.

Key Dates
Posted Date

November 18, 2013

Letter of Intent Due Date(s)

February 18, 2014

Application Due Date(s)

March 18, 2014  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2014  

Advisory Council Review

October 2014

Earliest Start Date

December 2014

Expiration Date

March 19, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

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 support a wide range of basic, translational, and clinical research efforts with the ultimate goal of improving the clinical diagnosis, detection, treatment, and prevention of urologic diseases and disorders within the research mission of the NIDDK. The Centers program will accomplish this goal by the development, sharing, and integration of institutional and national resources; by attracting established investigators from outside the realm of non-malignant urological diseases to study these conditions; and, through the support of career development of junior scientists electing to conduct research in the field of benign urology.

The Cooperative Research Centers Program will consist of Research Centers that will coordinate activities in conjunction with the NIDDK under a cooperative agreement. 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-12-013), the NIDDK Planning Centers for Interdisciplinary Research in Benign Urology (RFA-DK-12-022; RFA-DK-13-019), and the wider research community to develop a national network that accelerates bi-directional knowledge between the laboratory and the clinic. It is anticipated these coordinated activities will enhance 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.

Background

The O'Brien Urology Research Centers were established by the NIDDK in 1987 as a stand-alone centers program and were most recently renewed in 2008. The transition of the O’Brien Urology Centers to a Cooperative Research Centers Program (U54) reflects the changing overall nature of the scientific enterprise towards interdisciplinary effort and the need to better integrate research efforts within a wider research community to advance knowledge in the treatment of benign urological disorders and diseases. Despite advances in the previous two decades in the surgical management and medical treatment of urological conditions, millions of Americans remain 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 treatment cost of these illnesses is at least 11.5 billion dollars per year.

Contributing to the inability to adequately treat patients are the gaps in knowledge of the basic physiology, cell biology, and genetics of urological dysfunction; 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 a basic understanding of the molecular structure and function of the urinary tract and its associated systems (e.g., nervous and cardiovascular systems) makes it difficult to establish useful experimental in vivo or in silico models for generating and testing hypotheses necessary to guide human studies. These knowledge gaps also make it difficult to develop translational tools, such as biomarkers and imaging techniques, necessary for human investigations. 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 vital to address the gaps in basic physiology of the urinary tract and to advance urologic research. Additional expertise outside of the biological sciences, in physics, bio-engineering, chemical and mechanical engineering, as well as in clinical disciplines of urology, gastroenterology, gynecology, endocrinology, anesthesiology, and radiology will also be instrumental to advance the field.

Areas of Research Interest

The research at each Center must coalesce upon a single major urologic disease, disorder, or urological complication relevant to the NIDDK mission. This research focus will serve as a central theme for the individual research projects. The research projects of the Center must be interactive and organized to discover and develop new leads for the diagnosis, treatment, or prevention of urological dysfunction as defined by the research theme.

A Center must include research projects utilizing at least two of the following approaches: 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, the Lower Urinary Tract Dysfunction Research Network (LURN), or GenitoUrinary Development Molecular Anatomy Project (GUDMAP). Research with translational potential is strongly encouraged.

Examples of research themes appropriate for investigation are listed below, but this list is not meant to be exclusive. Applications with a focus on and including projects focused on malignant urologic diseases are not responsive to this FOA and will not be accepted.

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
Resubmissions of RFA-DK-12-009

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $3 million in total costs in FY 2014 to fund up to two applications in response to this FOA. Although the financial plans of the NIDDK provide support for this program, awards are contingent on the continued availability of funds and the receipt of a sufficient number of meritorious applications.

Award Budget

The expected award for each center is approximately $1 million direct costs per year. Application budgets are not limited but must accurately reflect the actual needs of the proposed project.

 

Award Project Period

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

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

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.

The Center Director must be an established investigator with a record of external funding, but is not required to have a record of accomplishment in urological research. Investigators may not serve concurrently as the Director of an NIDDK O’Brien Urology Center (U54) and NIDDK Developmental Center (P20).

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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 PHS 398 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, preferably electronically, should be sent to:

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

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.  

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.  In lieu of the preprinted Table of Contents outline of Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information easily. Identify each Research Project component and each Core component by title. Assign each Research Project component a number (1, 2, 3) and assign each Core component a capital letter (A, B, C) that reflects the order in which they are presented.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Composite Budget: Present the total budget for all requested support for the first year. For each category, give the amount requested for each Research Project component and each Core component, with subtotals.

If consortium arrangements involving other institutions or organizations are proposed, include total (direct and indirect) costs associated with such in the Consortium/Contractual Costs category.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed. Composite Budget: Present the total budget for all requested support for the entire proposed period of support. For each category, give the composite amount requested for each Research Project component and each Core component, with subtotals.

If consortium arrangements involving other institutions or organizations are proposed, include total (direct and indirect) costs associated with such in the Consortium/Contractual Costs category.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed. Biographical sketches are required for all senior/key scientific and key technical personnel participating in the Overall Center, the Core components, and the specific Research Component projects. Beginning with the Center Director, and following in alphabetical order, submit biographical sketches as described in the PHS 398 Application Guide.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed. Complete this section for the Overall Center, describing the existing environment and facilities available to the Center and the projects, including any fee structures, to access the facilities. A general listing of major, shared pieces of equipment to be used by Center members should be provided and the process, including fee structure, to access shared equipment.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Introduction to Application:  Resubmission applications should include an Introduction as described in the PHS398 Application Guide.

Specific Aims: State the overall goals of the Center and summarize the expected outcomes and the impact of the outcomes on the goals of the O'Brien Centers Program as outlined in Section I.  Funding Opportunity Description. List succinctly the specific objectives of the Center.

 

Research Strategy:  Describe the major theme of the Center, its goals and objectives, background information, and the overall importance of the Research Projects and the Educational Enrichment Program in the goals of the O'Brien Centers Program as outlined in Section I.  Funding Opportunity Description. Explain the overall strategy for achieving the goals defined for the Center and how the Administrative Core, Research Projects, and Biomedical Core(s) relate to that strategy. Explain how the different aspects of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the Center, and how combined resources create a Center that is worth more than the sum of its parts.

In addition, provide the following information:

Administration, Organization, and Operation of the Center: Describe the organizational framework including an organizational chart. Include information on the support and commitment of the parent institution for the Center, and the authority and qualifications of the PD(s)/PI(s). Describe the relationship and lines of authority and sanction by appropriate institutional officials. Specifically address administrative responsibilities between the collaborating institutions, organizational components, faculty, and staff. Include information on the use of advisory or user committees, and the method of determining Core access and space assignment. Do not list specific members for any external advisory committees. The list should only include the type of expertise of the proposed members and their role in advising the Center.

Provide a plan for ensuring the solvency of the proposed team once an award has been made and for resolving conflicts between the Center personnel.

Provide a brief description and rationale for any consortia or consultants. 

Letters of Support: Include all assurance letters from consortia investigators and institutions provided in support of the application.

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 PHS 398 Application Guide, with the following modification:

Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed. Do not use PHS 398 Face Page.  For the Administrative Core, please include a single cover page entitled, Core A, Administrative Core. Include the name of the Core Director, with titles and affiliations. 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed. Do not complete this form page for the Administrative Core.

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Minimum levels of effort are 2.4 person months (20%) for the Center Director to oversee scientific and administrative duties of the Center. Associate Directors may be named as well; the combined directorship efforts may not exceed 6.0 person months. The Center administration may also include an administrative assistant. Personnel with less than 10% effort are considered Other Significant Contributors. Salary for participants with less than 10% effort should not be requested.

The Administrative Core budget must include funds of $150,000 direct costs per year to fund the Opportunity Pool Program that supports collaborative projects with investigators of other supported urology programs (see below) and/or pilot projects. These funds may be used to support internal pilot studies even if no optional pilot project program is proposed in the original application. These Opportunity Pool funds will be restricted for use pending an external peer review of the proposed projects and approval by the Center Steering Committee and the NIDDK.

Additionally, the Administrative Core budget must include funds of up to $50,000 in direct costs per year to support the Educational Enrichment Program and to support travel of the Center Director and senior/key personnel to attend the Executive Steering Committee meetings as outlined in Section VI.

Budget Justification:  Describe the specific functions of all key personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as major equipement or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts. The maximum allowable annual escalation under this FOA is 2%.

Biographical Sketch (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed. Do not complete this form page for the Administrative Core.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Introduction to Application:  Resubmission applications should include an Introduction as described in the PHS398 Application Guide.

Specific Aims: Describe the specific aims of the Administrative Core.

 Research Strategy: 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 and outreach to the wider research community. The goals of this core are to develop and maintain the vision and relevant goals of the Center; coordinate, manage, and integrate the Center components and activities, which include coordinating ongoing research between the separately funded projects and the Biomedical Research Core(s) (if proposed); harmonizing with the other Research Centers in the Cooperative Research Centers Program; and serving as a resource to the wider research community.

Describe the organization of the Administrative Core, including the Educational Enrichment Program and the Opportunity Pool Program, and their importance to the research theme of the Center. Explain the strategy for achieving the specific aims of the Administrative Core and the goals of the O'Brien Centers Program as outlined above.

Describe the strategy, by which the Administrative Core will effectively lead, organize, and provide 1) fiscal and resource management to the Center; 2) manage the Biomedical Cores(s); 3) coordinate the Center's research efforts with the other Urology programs including the NIDDK K12 KURe and NIDDK P20 Planning Center programs, and with the research community; and 4) communicate with the general public an understanding of the implications of Centers Program in the support of research for urological health. Indicate who will be responsible for each of these activities.

Outline the approaches to be utilized for internal monitoring, including Center management, fiscal administration, personnel management, planning, budgeting, and other appropriate capabilities; for establishing and maintaining internal communication and cooperation among Center investigators; for reviewing productivity and effectiveness of the activities of the Center and mitigation strategies for replacing Center personnel and terminating ineffective projects or cores.

Describe the proposed activities of the Educational Enrichment Program.  This Program may consist of seminar series, guest lectures, workshops, symposia, or other instructional opportunities that further the overall goals of the Center and broaden the reach of the Center activities to the larger research community. 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.

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 as part of the Research Strategy of the Administrative Core. 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.

The Opportunity Pool Program should be described and consist of pilot studies or collaborative projects with other O'Brien Center investigators, investigators of the NIDDK P20 Planning Centers, scholars supported by the KURe K12 program or the wider research community. The application should describe how these projects would be structured and selected for support.  Applications should not include detailed projects, but titles of potential projects may be provided. Support for a particular pilot or collaborative project is limited to two years with an option to extend the project for an additional year pending review of progress. If pilot projects are to be supported through this program, Centers are strongly encouraged to utilize the funds to support new investigators or investigators not currently supported by the O'Brien Centers.  Pilot projects are not intended to support or supplement ongoing research of an established investigator.

For all pilot projects, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable.

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 PHS 398 Application Guide, with the following modification:

Research Project and Pilot Project(s)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Research Project and Pilot Project(s)))

All instructions in the PHS 398 Application Guide must be followed. Do not use PHS 398 Face Page.  For each Research Project and optional Pilot Project(s), the please include a single cover page listing the title of the Project, the name of the PD/PI, and names of any other key personnel. Identify each Project with a number (1, 2, 3…) and a descriptive title.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed.

Key Personnel: Research Project leaders must be investigators with a record of external funding as independent Principal Investigators/Program Directors, but are not required to have a record of accomplishment in urological research. Individuals receiving support from mentored career development awards (K awards) may not serve as Research Project leaders, but may be the named investigator on a proposed Pilot Project

Table of Contents (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed. Do not complete this form page for the Research Projects or Pilot Project(s).

Detailed Budget for Initial Budget Period (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed.

Pilot Projects (optional):  Up to $150,000 direct costs per year may be requested to support pilot projects relevant to the Center's goals in years -01 and -02.  Support for a pilot project is limited to two years. Funds requested for years -03 through -05 will be contingent on review and approval of additional pilot projects by NIDDK staff.  

Budget Justifications:  Describe the specific functions of all key personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as major equipement or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts. The maximum allowable annual escalation under this FOA is 2%.

Biographical Sketch (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed. Do not complete this form page for the Research Projects or the Pilot Project(s). All biosketches of senior/key personnel should be included in the Overall component.

Resources (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Research Project and Pilot Project(s))

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Introduction to Application: For Resubmission applications, an Introduction to Application should be included as descirbed in the PHS398 Application Guide.

Specific Aims: Describe the specific aims of the project.

 Research Strategy: Describe the research strategy of the Project in the same detail and format as expected for an investigator-initiated R01 grant application. In addition, include a description of the relationship of the Project to the other Projects and how the Project addresses the overall goals of the Center. Describe how the Project contributes to the goals of the Administrative Core, especially the Education Enrichment Program, and the Opportunity Pool Program.

 Letters of Support: Include support letters, if appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Research Project and Pilot Project(s))

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Project and Pilot Project(s))

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Biomedical Core(s)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed. Do not use PHS 398 Face Page.  For each proposed Biomedical Core, include a single cover page listing the title of the Core, and the name of the Core Director. Identify each Core unit by a letter, (beginning with B, C, D…) and a descriptive title.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed. Do not complete this form page for the Biomedical Core component(s).

Detailed Budget for Initial Budget Period (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed.

Minimum levels of effort are 2.4 person months (20%) for the Biomedical Core Leader. Personnel with less than 10% effort are considered Other Significant Contributors. Salary for participants with less than 10% effort should not be requested. 

Budget Justifications:  Describe the specific functions of all key personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as major equipement or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts. The maximum allowable annual escalation under this FOA is 2%.

Biographical Sketch (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed. Do not complete this form page for the Biomedical Core component(s). All biosketches of senior/key personnel should be included in the Overall component.

Resources (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Biomedical Core(s))

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Introduction to Application: For Resubmission applications, an Introduction to Application should be included as described in the PHS398 Guide.

 Specific Aims: Describe the specific aims of the Biomedical Core.

 Research Strategy: A proposed Biomedical Core must be a shared resource that provides specialized and essential services, techniques, or instrumentation to Center participants. As the Biomedical Research Core provides specialized technologies and expertise needed to accomplish the stated goals of the Center, the Biomedical Research Core must be used by two or more of the research projects of the parent Center and no one Project should utilize greater than 50% of the Core services. Describe the purpose and objectives of the Biomedical Core and the administration, organization, and operation of the Biomedical Core. Include a description of services provided and their significance on productivity and quality, as well as documentation of cost-effectiveness and plans for quality control. Describe how access to the Biomedical Core by Center Members and the larger urology research community will be prioritized, advertised, and any fee structure. If a Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.

Provide a description of how the Biomedical Core contributes to the goals of the Administrative Core, especially the Education Enrichment Program and the Opportunity Pool Program.

In addition, provide the following information:

Letters of Support: Include support letters, if appropriate

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report (Biomedical Core(s))

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Biomedical Core(s))

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application GuidePaste Other Components here

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 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 PHS 398 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-13-030.    

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.

For this particular announcement, note the following: 

For O'Brien Center applications (U54), peer review of scientific and technical merit focuses on four areas:  (1) The individual Research Projects; (2) The Administrative Core (esp., Educational Enrichment Program); (3) The individual Biomedical Cores; and (4) the U54 Center as an integrated effort, creating a research enterprise that is greater than the sum of its parts.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 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 address an important problem or a critical barrier to progress in the field? If the aims of the Center 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? 

Will the goals of the Center, if successful, lead to advances in benign urological research and increase the research capability of the urology research community?

Does the Biomedical Core(s) provide an essential resource to the Center's research projects and could it benefit the larger urology research community?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Centert? 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?  Has new and important talent been recruited to the Center? 

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? 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 center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  Are the strategies for achieving the goals of the Center well-defined, feasible, and likely to lead to a multi-disciplinary effort within the Center, advances in urological research, and increase the research capability of the larger urology research community? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects?  

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? Are the structure and functions of the Administrative Core adequate to oversee the Center, significantly promote urological research beyond the traditional field of urology, and provide significant research and educational opportunities? Is there clear evidence of institutional commitment to the Center such as space, protected time, and/or additional financial support for co-funded activities such as the Enrichment Educational Program or the Opportunity Pool Program? Is there a suitable environment for Center interactions and cross-fertilization with scientists from other departments, fields of expertise, and institutions?  

Additional Review Criteria - Overall

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Center as an Integrated Effort

The overall U54 will also be evaluated as an integrated research effort focused on a central scientific theme within the urological research mission of the NIDDK. The relationship and contributions of each proposed Research Project and Biomedical Core to the overall Center goals will be evaluated and contribute to the overall impact/priority score. This assessment will be consider the following:

Will there be coordination, interrelationships, and synergy among the projects and cores as they relate to the central research theme?

What are the advantages of conducting the proposed research as a program over individual research projects?

Will the center structure enhance the value of the individual projects? Are mechanisms proposed for regular communication among the project leaders and outside collaborators?

Are the administrative structures in place for daily management of the Center, including internal evaluation of the research projects?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is  justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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.

Review Criteria for Research Projects and Pilot Project(s)


Overall Impact - Research Projects and Pilot Project(s)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Project or Pilot 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 - Research Projects and Pilot Project(s)

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 Research Project address an important problem or a critical barrier to progress in the field? If the aims of the Research Project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Research 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 Research 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 Research Project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the Research Project well-integrated into the Center as a whole?   

Additional Review Criteria - Research Projects and Pilot Projects(s)

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Research Projects and Pilot Projects(s)

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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

Review Criteria for Core Components

Overall Impact - Cores

Reviewers will assign an Impact Score based on the assessment of each Core Component in terms of the following review criteria.

Additional Review Criteria - Cores

As applicable for each Core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For the Administrative Core:  Is there an effective plan for the internal management of the Center including modifying and terminating components, such as the Research Projects and Biomedical Research Core(s), and terminating Center personnel, including the Center and Administrative Directors? Is there an effective plan to evaluate overall Center performance, including internal and external advisory groups? 

For the Educational Enrichment program:  Are the strategies for the management of the Educational Enrichment program (including the Opportunity Pool Program) well-defined, feasible, and likely to succeed? Are the strategies for engaging the NIDDK K12 KURe, the NIDDK P20 Developmental Center programs, and the research community to promote urological research and provide research and training opportunities, well-defined, feasible and likely to succeed?

Does each Biomedical Research Core have the required minimum of two documented research project users? Is there an effective plan for managing the Biomedical Research Core 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 the use of the core facility?

Are the qualifications and experience of the Core director and key personnel appropriate?

Will the quality of services provided by the Core enable all center investigators to achieve their research goals?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Cores

As applicable for the Core proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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 Core functions

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. Assignment to a Scientific Review Group 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 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 National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation. 

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 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Deborah K. Hoshizaki, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-7712
Email: deborah.hoshizaki@nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8897
Email: calvof@mail.nih.gov

Financial/Grants Management Contact(s)

Diana Ly
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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.