Expired RFA-DK-13-020: George M. O'Brien Urology Cooperative Research Centers Program (U54)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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.

Urolithiasis- including pathophysiology, natural history, epidemiology, prevention, stone formation and dissolution, therapy and treatment outcomes, stone diagnostics and therapeutic development, pediatric stone treatment and outcomes.
Urinary Tract Infections- epidemiology, pathogenesis, adherence, bacteriology, diagnostics, and prevention in adult and pediatric populations.
Lower Urinary Tract Symptoms (LUTS) in men and women/ Benign Prostatic Hypertrophy - natural history, prevention, treatment outcomes, therapeutic outcomes, prostatic biology and pathophysiology, genetics, diagnostic and therapeutic development.
Urinary Incontinence, Normal Bladder Function and Dysfunction- Epidemiology, treatment outcomes, therapy, pathophysiology, basic bladder biology, neurobiology of bladder function and dysfunction.
Erectile Dysfunction- basic biology and pathophysiology, epidemiology, natural history, therapeutic and treatment outcomes, diagnostic and interventional treatment.
Chronic Urologic Pelvic Pain Syndromes - basic biology, natural history, pathophysiology, epidemiology, diagnostic development, potential model development, genetics, associated disorders.
Urological Complications of Diabetes and Obesity - basic biology, natural history, pathophysiology, epidemiology, potential model development, genetics.
Congenital Urinary Malformations of Vesicoureteral Reflux - basic biology, natural history, pathophysiology, epidemiology, potential model development, genetics.
The following are examples of studies that could be proposed to address these disorders, but do not represent an exhaustive list:
Organ-specific development and genetics, structure and function, and physiology and pathophysiology with in vivo studies to understand the potential interplay of urologic and non-urologic organs and tissues.
Organ maturation and its maintenance during normal aging in the development of lower urinary tract symptoms, including the immune system and changes in function and response to injury of the lower urinary tract.
Role of distant organs (central and/or peripheral nervous system) in the development, maintenance, or regression of normal urinary function, and in the progression or expression of urinary tract voiding symptoms.
Role of different cell types in heterogeneously complex organs/tissues in initiating, maintaining, and regression of urinary tract symptoms.
Role of generalized processes such as inflammation, adaptive or innate immunity, epigenetics, injury/regeneration, etc. in promoting, and amplifying the progression, or regression of urologic disorders.
Identification and extensive phenotyping of animal models for modifiable risk factors (e.g., obesity, diabetes, acute infection) for changes associated with lower urinary tract symptoms, and where possible extend phenotyping of modifiable risk factors and associated lower urinary tract changes to a relevant patient population.
Identification and extensive phenotyping of animal models for altered central or peripheral nervous system function that contribute to lower urinary tract symptoms and extend the same phenotyping (where possible) to relevant patient populations.
Develop, identify, and extensively phenotype animal models that mimic aspects of human lower urinary tract symptoms and extend the same phenotyping to relevant human populations (where possible).
Development of tools for characterizing organ function and dysfunction, including patient reported outcomes, non-invasive imaging, biomarkers.

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

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

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

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations

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.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

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:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

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:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

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: [email protected]

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:

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.

Overall: 6 pages
Administrative Core: 12 pages
Research Projects: 12 pages
Pilot Projects: 6 pages
Biomedical Cores: 6 pages

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
Research Projects: Required, minimum of 3
Administrative Core: Required
Biomedical Cores: Optional, maximum of 3
Pilot Projects: Optional, maximum of 2

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:

Provide an overview for and describe the oversight of the resource sharing plan of the Center as a whole.
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. In keeping with the goals of the O'Brien Centers' Program, the applicants are expected to highlight potentially unique core resources and how they plan to share them with other Centers and the research community.

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:

The application can note that the Resource Sharing Plan in the Overall Center Overview applies to the Administrative Core.

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:

The application can note that the Resource Sharing Plan for the "Overall - Center Overview" applies to the project.

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.

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:

Brief description of scientific, technical, and support staff functions;
Description of current and projected services to other Core and Research projects; and
Provide a summary of projected usage of Core services (e.g., assays performed, animals supplied, etc.) by affiliated research projects, including PD/PI, name of grant, and funding source. Provide documentation that the Core will used by at least two of the Research Projects.

Letters of Support: Include support letters, if appropriate

The application can note that the Resource Sharing Plan for the "Overall - Center Overview" applies to the Biomedical Core.

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)

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

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

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

Protections for Human Subjects

Inclusion of Women, Minorities, and Children

Vertebrate Animals

Biohazards

Resubmissions

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Resource Sharing Plans

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

Inclusion of Women, Minorities, and Children

Vertebrate Animals

Biohazards

Resubmissions

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

Resource Sharing Plans

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:

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

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:

Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

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.

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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:

Pursuing research objectives consistent with the research scope of the FOA and research favorably recommended by peer review;
Conducting experiments and collecting the resulting data;
Analyzing, interpreting and presenting results and plans to the Executive Steering Committee for approved activities;
Submit monthly interim progress reports, to the Executive Steering Committee for distribution to members of the Centers program and NIDDK staff. Such reports are in addition to the required annual noncompeting continuation progress report.
Publishing results, conclusions, and interpretation of the studies.
The awardees will agree to: 1) accept the coordinating role of the Executive Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of projects within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Executive Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or cores.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

Participating in the overall coordination of the George M. O Brien Urology Cooperative Research Centers Program with the Executive Steering Committee. This includes efforts to improve and strengthen inter- and intra-center cooperation amongst the research projects of the Centers, and the Opportunity Pool Program, K12 KURe and the P20 Developmental Center Programs particularly as it pertains to cross-fertilization of basic and clinical research activities within and between centers. As a means of improving inter-center cooperation, the Project Scientist will directly participate in the activities of the smaller collaborative groups as established by the Executive Steering Committee. This will include activity of the Opportunity Pool Program, the access to the Biomedical Research Cores and outreach to the K12 KURe, the P20 Developmental Centers and the research community.
The Project Scientist will also assist the research efforts of the Cooperative Research Centers Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists.
The Project Scientist will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Cooperative Research Centers Program and NIDDK. In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.
Interact with each individual Center awardee evaluating objectives and research goals of that particular Center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Project Scientist will assist and facilitate this process and not direct it. The Project Scientist will also provide assistance in reviewing and commenting on all major transitional changes of an individual Center's activities prior to implementation to assure consistency with required goals of the George M. O Brien Urology Cooperative Research Centers Program.
Retain the option to recommend the withholding of support from a Center research project or core materially failing to meet the technical performance requirements established by this Centers Program. This includes identifying jointly with participants of the Executive Steering Committee the need to add additional research projects or service cores to Centers or to phase out a Center project or core when performance standards have not been met; and
Participate, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co-authorship of the publication or results of studies conducted by the Centers.

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

Interacting with the principal investigator(s) on a regular basis to monitor project progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Executive Steering Committee, data safety and monitoring board, and related meetings.
The NIDDK Program Official will monitor project progress, and may request that a project or portions of a project be closed for reasons including: (a) poor progress; (b) patient safety and regulatory concerns; (c) emergence of new information that diminishes the scientific importance of the project.
Making recommendations for continued funding based on: a) overall project progress; b) cooperation in carrying out the research (e.g., attendance at Executive Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

Areas of Joint Responsibility include:

Participating on an Executive Steering Committee consisting of the PDs/PIs from each of the participating centers and one NIDDK staff member who will be the Project Scientist. A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. Each full member of the Executive Steering Committee will have one vote. The purpose of the Executive Steering Committees will be to discuss and evaluate concerns and cooperative activities of the Cooperative Research Centers Program. The Executive Steering Committee will discuss and evaluate the activity of the Opportunity Pool Program, Biomedical Research Cores, and evaluate progress on research and pilot projects. The Executive Steering Committee will establish working subcommittees as necessary and provide feedback to subcommittee leaders at least bi-annually and implement changes in subcommittee membership or direction if needed. Awardee members of the Executive Steering Committee will be required to accept and implement policies approved by the Executive Steering Committee.
Meetings of the Executive Steering Committee will be convened twice during the first year and annually thereafter. The annual meeting will include the External Expert Panel. These meetings are separate from any regular conference calls. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaborations such as with industry, private foundations and/or NIH intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, and reallocate resources. The Executive Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.
In anticipation that some centers will have common research interests that address a specific basic and/or clinical research problem and thus, it is envisioned that subgroups will be formed to conduct coordinated research activities recommended by the Executive Steering Committee. As needed, the Executive Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Scientific/Research Contact(s)

Deborah K. Hoshizaki, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-7712
Email: [email protected]

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8897
Email: [email protected]

Financial/Grants Management Contact(s)

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-9249
Email: [email protected]

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.