NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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 educational enrichment of 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 will 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-17-012), the NIDDK Developmental Centers for Interdisciplinary Research in Benign Urology (RFA-DK-17-033), and the wider research community to develop a national network that accelerates bi-directional knowledge between the laboratory and the clinic. It is expected that 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 educational enrichment 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 transitioned to a Cooperative Research Centers Program (U54) in 2012. This transition was effected to reflect the changing overall nature of the scientific enterprise towards interdisciplinary efforts and the need to better integrate research efforts with 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 cellular/tissue structure and function of the urinary tract and its associated systems (e.g., nervous and lymphatic systems) makes it difficult to establish useful experimental in vivo or in silico models for generating and testing hypotheses necessary to guide many 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.

Center

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. The Administrative Core for each Center may support research projects and Biomedical Research Core(s) at other institutions/organizations through subcontracts. These outside institutions may be at the local, regional, national, or even international levels.

Each Center will consist of:

• Administrative Core including an Educational Enrichment and an Opportunity Pool Program
• Research Projects minimum of 3 projects
• Biomedical Research Core(s) (optional)
• Pilot Project Program (optional)

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

Center Director

The Center Director must be an established investigator with a demonstrated funding and publication record. The Center Director is responsible for scientific and administrative leadership and is expected to work closely with the Executive Steering Committee. One or more Associate Directors may be named as well. The Center Director and Associated Directors may be from any discipline as long as the criteria for leadership are met. Center Director will be responsible for scientific and administrative leadership. This includes, but is not limited to, the following duties:

• Maintaining the Center’s vision and ensuring the relevance of the Center’s goals to the research mission of the Division of Kidney, Urologic and Hematologic Diseases;
• Establishing and overseeing internal communication and cooperation among Center investigators;
• Oversight of the Administrative Core and the Educational Enrichment Program;
• Creating mechanisms for internal monitoring, selecting, and replacing Center professional or technical personnel; and
• Communicating with NIDDK program staff, the George M. O Brien Urology Cooperative Research Centers Program, and the KURe Program.

Administrative Core

The Administrative Core will serve as the focus for the synergistic activities of the Center. It will be responsible for the management of resources within the Center. The Administrative Core will include an Educational Enrichment Program, an Opportunity Pool Program and an optional Internal Pilot Project Program.

The Center administrative organization and management are determined by the individual Center (subject to NIH peer review). It is expected that the administrative organization of the Center will have a supportive structure, such as an internal Executive committee. The major responsibilities of the Administrative 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 (if proposed), and harmonizing with the other Research Centers in the Cooperative Research Centers Program,
• Create mechanisms for internal monitoring, including Center management, fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities;
• Establish and maintain internal communication and cooperation among Center investigators;
• Review productivity and effectiveness of the activities of the Center and create a mechanism for selecting and replacing Center professional or technical personnel;
• Terminate unsuccessful projects, cores, or activities; and
• Maintain oversight, review the use of, and administration of funds for the Educational Enrichment Program.

Research Centers' meetings

The Center is required to participate in one in-person Executive Steering Committee meeting annually, and at other times as agreed to by the Committee. The purpose of this meeting is to share research experiences with other Centers, assess progress, identify new research opportunities, share materials, enhance and further the potential impact of the Centers. In addition, the Center Director, Project leaders, and supported graduate students and post-doctoral research fellows are expected to participate in the Urology Program Directors' meeting to present ongoing progress to the NIDDK supported research community. The Urology Program Directors' meeting is held approximately every 18 months.

Educational Enrichment Program

The Administrative Core will be responsible for an Educational Enrichment Program that should further the overall aims and objectives of the Center. The Educational Enrichment Program may consist of seminar series, guest lectures, symposia, and workshops that educate Center members and the research community on how to use available databases or other resources. Other instructional opportunities, including summer student experiences (at the high school, college, and graduate or medical student level) may be developed. Students, fellows, and junior faculty should be encouraged to take full advantage of all Educational Enrichment Program events. Center Institutions may co-fund the activities of the Educational Enrichment Program. Travel support to attend meetings outside of the investigator's or attendee's discipline is encouraged.

Opportunity Pool Program

The Opportunity Pool Program seeks to encourage interactions between Center investigators, the NIDDK KURe fellows, and investigators of the NIDDK Developmental Planning Centers and or the larger research community. A goal of the Opportunity Pool Program is to increase the research capacity of the urology research community by leveraging the resources within the Center. Although funds are not provided directly for training purposes, the Opportunity Pool Program should provide funds for specific educational opportunities, such as travel support of investigators to learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange.

Support of research projects within the Opportunity Pool program should be integrated into the overall research goals of a specific Center and where possible make use of the resources provided by the Biomedical Research Core. Such research projects should represent new collaborations between Center's Project Leaders and a) early stage investigators or b) established investigators not previously involved in urological research. It is expected that these projects will generate preliminary data to support larger research applications such as R01 applications. These research projects are not intended to support or supplement ongoing research of an established investigator. Research projects to investigate basic research findings in a clinical setting are encouraged. Opportunity Pool Research Projects are limited to $100,000 direct costs per year and are initially 2 years with an option to extend the project an additional year pending exceptional progress.

It is expected that each Center will be associated at any time with 2 to 4 Opportunity Pool Research projects. Funds for the Opportunity Pool program should be requested as part of the Administrative Core budget, and will be restricted for use to support Opportunity Pool Program pending an external expert panel review and approval by the Executive Steering Committee. Center Institutions may co-fund the activities of the Opportunity Pool Program.

In addition to the Opportunity Pool Program, internal pilot projects may be supported through the Center. The Internal Pilot Project Program will support early stage investigators or those investigators not currently supported by the O'Brien Center. Pilot projects are not intended to support or supplement ongoing research of an established investigator. Initial support for a proposed internal pilot project is limited to two years and is separate from the Opportunity Pool Program. Successful internal pilot projects may be extended for an additional year.

External Advisory Committee

Although optional, the use of an External Advisory Committee for each Center is highly advisable. The members must not be named in the grant application; however, the process by which members are selected must be well developed. 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

Research Projects

The research projects of the Center must be interactively organized to conduct research to discover and develop new leads for the diagnosis, treatment, or prevention of a single major urologic disease or disorder or urological complication relevant to the NIDDK mission. The Center's research projects must utilize 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, or which include a project on, malignant urologic diseases are not responsive to this FOA and will not be reviewed.

• 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.

Biomedical Core

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

The Biomedical Research Core should be accessible to and should increase interactions between the O'Brien Centers and the NIDDK Multidisciplinary K12 Urologic Research Career Development and the NIDDK Developmental Centers for Interdisciplinary Research in Benign Urology programs through cross-project/laboratory exchange, and sharing of specialized tools, technologies, and expertise. The Biomedical Core may also provide services to funded research projects outside the Center.

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

• Collection, analysis, storage and distribution of data and samples
• Provision of specialized tools and technologies or access to specialized expertise
• Development, standardization and distribution of reagents and/or protocols
• Provision of technical assistance, and educational enrichment programs
• Recruitment of patients and coordination of patient studies
• Development, beta-testing and dissemination of specialty assays, methods, and services.

See Section VIII. Other Information for award authorities and regulations.

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.

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.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.

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 SF424 (R&R) Application Guide.

The Center Director is required to have an established record of external funding, but is not required to have a record of accomplishment in urological research. Center Director may not serve concurrently as the Center Director of an NIDDK Urology O Brien Center and as a PD/PI for a Urology Developmental Center (P20). However, current P20 PDs/PIs are eligible to apply for an NIDDK Urology O'Brien Center with the expectation that support from the P20 would terminate upon receipt of a U54 award.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

John Connaughton, Ph.D.
Telephone: 301-594-7797
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core (use for Administrative Core	12
Core (use for Biomedical Cores)	6
Project (use for each Research Project)	12
Pilot Projects	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Cores: optional, maximum of three
• Projects: required, minimum of three
• Pilot projects: optional, maximum of two

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: State the overall goals of the Center and how these goals will be achieved. 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.

Research Strategy:

Describe the major theme of the Center, its goals and objectives, and background information. Explain the overall importance of the Research Projects and the Educational Enrichment Program in achieving the goals and objectives of the Center and the overall 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 (including the Educational Enrichment Program and Opportunity Pool Program) 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 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. For renewal applications, please list members of the any external advisory committee and provide a summary of their activities in the previous project period.

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 as provided in the SF424 (R&R) Application Guide, with the following modification:

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, as well as provide an overview for and describe the oversight of the resource sharing activities of the Center as a whole.

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.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Administrative Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The overall Center Director will serve as the Administrative Director.

Budget forms appropriate for the specific component will be included in the application package.

Minimum levels of effort are 2.4 person months (20%) for the Administrative Director (Center Director)to oversee scientific and administrative duties of the Center. Associate directors may be named as well. If multi-PD/PIs, all may serve in an administrative capacity, with one designated as the Administrative Director and others as Associate Directors or all may share the overall Administrative Director duties. In any administrative leadership structure, the combined directorship efforts may not exceed 4.0 person months. If all multi-PI/PDs are sharing overall Administrative Director duties, their combined effort must meet the 2.4 person-month minimum described above. The Center administration may also include an administrative assistant.

The Administrative Core budget must include funds of $150,000 direct costs per year to fund the Opportunity Pool Program that will support the development of pilot projects and new collaborative Center projects that engage a) early stage investigators or b) established investigators not previously involved in urological research.

Additionally, the Administrative Core budget must include funds to support travel of the Center Director and senior/key personnel to attend the Executive Steering Committee meetings and the Urology Program Directors' meetings as outlined in Section VI and up to $50,000 in direct costs per year to support the Educational Enrichment Program. The Educational Enrichment program may support the activities outlined in Section I, as well as travel support of investigators to learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange.

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 equipment or alterations and renovations. For years 2-5 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.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims of the Administrative Core including the Educational Enrichment Program and the Opportunity Pool Program.

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 Core(s); harmonizing with the other O'Brien 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 Core(s); 3) coordinate the Center's research efforts with the other urology programs including the NIDDK KURe and NIDDK Developmental 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.

Educational Enrichment Program

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 attendee's discipline is encouraged.

Opportunity Pool Program

The Opportunity Pool Program is restricted to external pilot studies or collaborative research projects with other O'Brien Center investigators, investigators of the NIDDK Developmental Centers, scholars supported by the KURe K12 program, or the wider research community. The application should describe how these studies or projects would be solicited and selected for support Applications should not include details of the work proposed, but titles of potential studies or projects may be provided. Support for a pilot project is limited to two years, with an option to extend it for an additional year pending review of progress.

For the Opportunity Pool Program, 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.

External Advisory Committee

Although optional, the use of an External Advisory Committee for each Center is highly advisable. The members must not be named in the grant application; however, the process by which members are selected must be described in detail 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. For renewal applications, please list members of the External Advisory Committee that have served in the previous project period and provide a summary of their activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The application can note that the Data Sharing Plan submitted within the Overall Component applies to the entire Center.

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.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type 'Project

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: In 1-3 sentences, describe the relevance of the project activities on urologic public health. Please label this attachment 'Project X narrative,' where 'X' denotes the project number within the Center application.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Project Leader is required to have an established record of external funding, but is not required to have a record of accomplishment in urological research. The Project Leader may serve either as the Center Director of an NIDDK Urology O'Brien Center or a Developmental Center for Interdisciplinary Research in Benign Urology (P20), but may not serve as both concurrently.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Minimum level of effort is 1.2 person months (10% effort) for the Project Leader. Personnel with less than 10% effort are considered Other Significant Contributors, and salary support for such individuals 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 equipment or alterations and renovations. For years 2-5 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.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the Specific Aims of the project.

Research Strategy: Describe the research strategy of the Research 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 Research Project to the other Projects and how the Research Project addresses the overall goals of the Center. Describe how the Research Project contributes to the goals of the Administrative Core, especially the Education Enrichment Program, and the Opportunity Pool Program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The applicant can note that the Data Sharing Plan outlined in the Overall Component 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.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Other Requested Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Core

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

SF424 (R&R) Cover (Biomedical Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biomedical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: In 1-3 sentences, describe the relevance of the Biomedical Core activities on urologic public health. Please label this attachment 'Core X narrative," where 'X' denotes the number of the Core within the Center application.

Project /Performance Site Location(s) (Biomedical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Biomedical Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Biomedical Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biomedical Core)

Budget forms appropriate for the specific component will be included in the application package.

Minimum levels of effort are 2.4 person months (20%) for the Biomedical Core Lead. Personnel with less than 10% effort are considered Other Significant Contributors. Salary for participants with less than 10% should be well justified.

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 equipment or alterations and renovations. For years 2-5 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.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Biomedical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

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 Core provides specialized technologies and expertise needed to accomplish the stated goals of the Center, the Biomedical 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. Describe the system for requesting services and tracking the services provided. 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.
• For renewal applications, provide a summary of Core usage over the previous project period, as described above.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The applicant can note that the Data Sharing Plan outlined in the Overall Component 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.

PHS Human Subjects and Clinical Trials Information (Biomedical Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Project

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

SF424 (R&R) Cover (Pilot Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: In 1-3 sentences, described the relevance of the Pilot Project on urologic public health. Label this attachment 'Pilot Project X narrative,' where 'X' denotes the number of the Pilot Project within the Center application.

Project /Performance Site Location(s) (Pilot Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Pilot Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot Project)

Budget forms appropriate for the specific component will be included in the application package.

Proposed pilot projects are limited to a two-year proposed scope of work; however, applicants proposing a pilot project may request up to $150,000 in direct costs in all project years. Funds requested in years -03 through -05 will be contingent on the successful completion of the proposed pilot project and the review and approval of a year continuation of the pilot or a new pilot project by the NIDDK.

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 equipment or alterations and renovations. For years 2-5 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.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims of the pilot project

Research Strategy: Describe the research strategy of the pilot project in the same detail and format as expected for an investigator-initiated R01. Provide preliminary data, if available, and describe how the pilot will evolve to a larger project that will compete for additional extramural research support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The applicant can note that the Data Sharing Plan outlined in the Overall Component applies to the pilot 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.

PHS Human Subjects and Clinical Trials Information (Pilot Project)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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 O'Brien Center applications (U54), peer review of scientific and technical merit focuses on four areas: (1) the individual Research Projects and Pilot 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.

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).

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.

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Will the Educational Enrichment Program make significant contributions to promote new research directions, meaningful collaborations, and outreach to the urology research community?

Is the Opportunity Pool Program designed to make significant contributions to promote new research directions, meaningful collaborations, and outreach to 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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?

Will or has new and important talent been recruited to the Center?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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, advance 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, and appropriate ethical oversight of funded projects?

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?

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 score. This assessment will 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?

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.

When the proposed Center 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

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

Not Applicable

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

Not Applicable

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

In addition, for applications proposing clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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? Is there a strong scientific premise for the project? 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?

In addition, for applications proposing clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the project leader(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those 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?

In addition, for applications proposing clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating 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?

In addition, for applications proposing clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the 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?

In addition, for applications proposing clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 Project well-integrated into the Center as a whole?

In addition, for applications proposing clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Center 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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) Genomic Data Sharing Plan .

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Cores

Reviewers will provide an overall impact score to reflect their assessment of the overall utility and quality of the proposed Core, considering the review criteria below. Individual criterion scores will not be provided.

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?

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? Has the application outlined a robust strategy to solicit and select applications for the Opportunity Pool Program, particularly from early-stage investigators and investigators na ve to urological research with unique expertise? 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, and plans for monitoring data and safety in clinical research projects?

Biomedical Cores: 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?

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.

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 Core 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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

Biomedical Core: Has the Biomedical Core adequately supported all research projects in the Center? Has it developed novel methodologies that have been utilized by the Center projects and outside community? Do the services provided by the Core support a continuing need for the Center and the outside community?

Educational Enrichment Program: Has the Opportunity Pool been used effectively to support urological research by early-stage investigators and investigators outside of urological research? Has the Center's educational enrichment activities fostered outreach and collaboration with investigators outside the Center?

Administrative Core: Has the Administrative Core been effective in Center management?

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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) Genomic Data Sharing Plan .

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Diabetes and Digestive and Kidney Diseases 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 in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.
• Compliance with resource sharing policies

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 Part 75, 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 interim progress reports, if requested, 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.
• Submit written responses to the recommendations of the External Expert Panel within two months of receiving those recommendations.
• 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:

• The NIDDK Project Scientist will participate 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.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Additional responsibilities of the Program Official 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.
• Monitoring 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.
• Appointing an independent External Expert Panel (EEP) that will annually review the overall Center Program progress and provide guidance to the NIDDK and the Executive Steering Committee.

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 jointly by the PD/PI and the NIDDK Project Scientist. 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 at least annually and at additional times if agreed upon by the Committee. 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.

If there are no areas of joint responsibility, leave above text as is. Otherwise, for areas of joint responsibility (examples include membership, duties, voting, steering committee, etc.), revise above text as appropriate.

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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Christopher Mullins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4902
Email: [email protected]

Jason Hoffert, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-9010
Email: [email protected]

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

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.

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 Part 75.