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; 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.

Required Application Instructions

It is critical that applicants follow the 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

The burden of lower urinary tract symptoms to patients is enormous. Patients suffer considerable morbidity throughout their lives, leading to a decreased quality of life for the patient and their families. Over the past two decades, the clinical practice of urology has significantly changed as advanced technology has led the way to minimally invasive surgeries and procedures, and through the development of drug therapies. Despite these advances, millions of Americans still suffer from urologic disorders and diseases, and their symptoms are not alleviated. These disorders include recurrent urinary tract infections, urolithiasis, and lower urinary tract disorders associated with benign prostatic hyperplasia, urinary incontinence, chronic prostatitis /chronic pelvic pain syndrome and painful bladder syndrome. The annual cost of treatment of these illnesses is at least 11.5 billion dollars per year.

Contributing to our inability to adequately treat patients is the lack of a critical mass of talented and innovative researchers who can address the gaps in our fundamental knowledge of the physiology, cell biology, and genetics of urological disorders; the absence of innovative resources and tools; and the paucity of objective diagnostic criteria and tests to identify urologic diseases and disorders. Efficient in-depth characterization (phenotyping) of patients and relevant animal models and the dearth of epidemiology and natural history studies of urologic diseases and disorders also contribute to lack of progress in patient therapy. Recruitment of research expertise in areas such as cell and molecular biology, genomics and proteomics, biochemistry, physiology, developmental biology, tissue engineering, immunology, pathology, neurobiology, microbiology and epidemiology is an essential component in the advancement of urologic research. Furthermore, the application of translational tools, such as imaging techniques and biomarkers, will depend upon an understanding of the structure, function, and physiology of the urinary system and recruitment of talent beyond the traditional clinical specialty of urology.

The Developmental Centers for Interdisciplinary Research in the Benign Urology Program seeks to enhance the intellectual infrastructure of the benign urology research community in order to foster projects that can mature into comprehensive programs that identify underlying etiologies of lower urinary tract symptoms and contribute to the diagnosis, treatment or prevention of urologic disorders or diseases within NIDDK mission interest. As such the Centers Program is designed to:

• Take advantage of current talent within the urological research community; and recruit new talent to the study of benign urology;
• Support studies that develop comprehensive resources or take an integrative approach for the study of benign urological disorders or diseases.

The Developmental Centers Program will be made up of Centers that have either a Resource Development Project or a Scientific Project. All Centers will have an Administrative Core which includes an Educational Enrichment Program. Other Cores such as a Biomedical Core are not permitted. The research teams will be led by an established investigator and should consist of individuals from the basic sciences, clinical urology, and other disciplines as appropriate to the research being proposed. To build a more interactive urological research community, Developmental Centers' participants will work with the George M. O Brien Urology Cooperative Research Centers Program and the KURe program through joint meetings and conference calls. It is expected that Developmental Centers with a Resource Development Project will develop resources that will substantially alter the ability to carry out urological research and that Centers with a Scientific Project will leverage the support from this program into well-designed, novel projects suitable for submission as R01, multi PD/PI R01, Program Project (P01), or Research Center (U54) applications.

Resource Development and Scientific Research Projects

A project focused on resource development should develop a comprehensive set of tools that will be thoroughly validated, utilized by the urologic research community, and substantially facilitate the study of the lower urinary tract. Once validated, these resources are expected to be made freely available to the larger research community. The more traditional Scientific Project should focus on a single scientific topic that would contribute to our understanding of the etiology of lower urinary tract symptoms through studies of the normal development, physiology, genetics and/or pathophysiology of the lower urinary tract and associated organs and tissues. The Scientific Project may utilize appropriate animal models or propose translational investigations utilizing human tissues or data, but studies proposing clinical trials are not allowed. Preliminary data or data from the literature is expected to support the scientific justification of the Scientific Research Project.

If successful, the Resource Development Project will have a significant impact on the ability of investigators to propose and implement innovative and state-of-the art studies; while the Scientific Research Project should have the potential to develop into a comprehensive program that can illuminate the underlying etiology of lower urinary tract symptoms. To accelerate the ability to plan for future translational studies, studies within the Scientific Research Project are encouraged to include lower urinary tract dysfunction and, when appropriate, include analyses of human biological samples or data from previous or ongoing clinical studies or cohorts.

Research topics that would be considered responsive to this FOA are listed below. Although solely in vitro studies are permissible, they would need to be carefully justified. The topics below are meant to illustrate potential research directions and are not designed to be exhaustive. Applicants are encouraged to contact the appropriate Scientific/Research contact listed in Section VII. Agency Contacts prior to developing an application.

Resource Development Projects

• Develop a dynamic inventory of Web-based urologic resources: data, materials, and tools that will serve as a framework for identifying, locating, relating, accessing, integrating, and analyzing information of interest to the broader urologic research enterprises and that would enhance cooperative activities within the urological research community;
• Develop analytical tools for meta-analysis of existing databases and learning platforms for dissemination of tools to the urology research community
• Develop a large scale map of neuronal connectivity between urological organs and/or the brain;
• Identification and extensive phenotyping of animal models for modifiable risk factors (e.g., obesity, diabetes, acute infection) for lower urinary tract 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 extensively phenotyping of animal models for altered central or peripheral nervous system function that might 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 (where possible) to relevant patient populations.

Scientific Research Projects

• Studies on the genetics, development, and malformation of the lower urinary tract;
• Studies involving early organ maturation and its maintenance during normal aging in the development of lower urinary tract symptoms;
• Studies on the age-dependent changes in function and response to injury of the lower urinary tract;
• Studies on the role of other pelvic organs (pelvic floor musculature, gastrointestinal and or reproductive tract, etc.) in lower urinary tract health and its contribution to lower urinary tract symptoms using in vivo and ex vivo approaches;
• Studies of the role of different cell types in heterogeneously complex organs/tissues in initiating, maintaining, and regression of urinary tract symptoms;
• Studies on the 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;
• Studies on central modulation and circadian rhythm in social stress induced urinary incontinence;
• Studies on the urologic sequelae of diabetes and obesity, including the role of chronic inflammation and hypercholesterolemia;
• Studies on the 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;
• Studies on the role of macrophages and fibrosis in the etiology of benign prostatic hyperplasia.

Applicants must provide a compelling vision for how these studies will contribute to our understanding of urinary tract symptoms and the eventual development of translational studies. Applications primarily focused on the development of a repository or on kidney injury secondary to urologic disorders are not responsive to this FOA and will not be reviewed.

Center Director

The Center Director must be an established investigator; however, a prior record of accomplishment in urological research is not required. The 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 Division of Kidney, Urologic and Hematologic Diseases;
• Establishing and maintaining internal communication and cooperation among Center investigators;
• Coordinating, managing, and integrating expertise and the studies under the Resource Development or Scientific Research Project;
• Maintaining oversight of the Administrative Core and the Educational Enrichment Program either directly or through the Administrative Core Director;
• 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.

Research Team

The goal of the Developmental Centers Program is to build teams that draw upon a broad range of expertise in order to investigate lower urinary tract function, structure, and development. Teams will serve as a platform to elucidate the underlying causes of lower urinary tract symptoms. Investigators within and outside urology are encouraged to collaborate in the overarching area of lower urinary tract biology to build the basic knowledge essential for establishing conceptual and mechanistic models, tools, and resources necessary for developing more translational studies in lower urinary tract symptomatic disorders. As not all relevant expertise may be represented at a single institution, applicants are encouraged to establish investigative teams through collaborations with research groups outside their own institution. Inclusion of an investigator with credentials in urological clinical care and a background in research relevant to the research team is strongly encouragedto maintain awareness of the clinical relevance of the project to lower urinary tract symptoms. Because a goal of the Developmental Centers Program is to foster new research teams, applications are not required to have a history of collaborative interactions of the Center members or present evidence of members working together as a well-integrated research team.

As a guide to developing an application, examples of team members might include:

• A urologist with knowledge of urologic disorders and patient populations to provide clinical relevance to the application;
• A neuroscientist, with knowledge of neurologic pathways and neuro-imaging;
• A biomedical engineer, medical imager, molecular systems, or computational biologist;
• A developmental or cell biologist;
• A physiologist, epidemiologist, bacteriologist, virologist; or
• A basic scientist with knowledge of cutting edge approaches to fibrosis, inflammation, injury and repair, epigenetics, etc.

Administrative Core

The Center Director is required to be Administrative Core Director. The Administrative Core is expected to work closely with George M. O Brien Urology Cooperative Research Centers Program and the KURe program to establish and maintain a website that advertises and highlights the activities of the Center including the Educational Enrichment Program. The Administrative Core is responsible for:

• Providing clerical and administrative support, including communications with NIDDK, the George M. O Brien Urology Cooperative Research Centers Program, and the KURe Program;
• Allocating and overseeing of all Developmental Center resources;
• Establishing and maintaining a website to advertise and highlight the activities of the Center including the Educational Enrichment Program;
• Establishing and maintaining all collaborations and the Educational Enrichment Program; and working with the local regulatory bodies to ensure that human subject or vertebrate animal research is in compliance with appropriate regulations and guidelines governing animal use and studies involving human subjects research.

The Educational Enrichment Program may include but is not limited to

• A lecture series of experts from outside urology;
• Visits from invited experts from outside urology and the institution;
• Workshops that educate Center members and the research community on how to use available databases or other resources.

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 be an investigator with an established record of external funding, but is not required to have a record of accomplishment in urological research. Investigators who are key personnel of an existing Urology O Brien Center are not eligible to apply as the Center Director..

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).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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 instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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:

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

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core (use for Administrative Core	6
Project	12

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
• Project: required

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.

Project Summary/Abstract: Describe the scientific theme and goal of the Center and provide a brief overview of the Resource Development or Scientific Research Project, and the Enrichment Program as it relates to the theme and goal of the Center.

Project Narrative: In 1-3 sentences describe the relevance of the Center activities on public health.

Facilities and Other Resources: Describe the existing environment and facilities available to the Center and the process including fee structure to access facilities.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided and the process including fee structure (if any) to access shared equipment.

Other Attachment: The following "Other Attachment" should be included with the Overall Component in order to aid in the review of applications. The attachment needs to be in pdf format.

• Center Collaborations: Title this attachment "Center Collaborations" and organize alphabetically by Center Member (last name, first name). List all Center Members. Provide primary Department Affiliation, including location of research space, key words for research interests, and names of any Center members who are have served as training mentors or long time research associates of said Center member.

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 whether the Project is a Resource Development Project or Scientific Research Project. Describe the theme and goals of the Center and how they will advance urological research and impact the urological research community. Describe how the specific aims of the Center will achieve these goals.

Research Strategy:

• Describe the strategy by which the goals of the Center will be met with particular emphasis on the role of the Educational Enrichment Program and the Resource Development Project or Scientific Research Project.
• 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.
• Provide a plan for ensuring the solvency of the proposed team once an award has been made and for resolving conflicts between the Center Director and other Center members

Letters of Support: Include letters of institutional commitment.

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.
• Consistent with achieving the goals of this program, Resource Development Projects are expected to share reagents or protocols as they are validated and Scientific Research Projects are expected to share all reagents or protocols at the end or termination of the award.

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.

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 Center Director is required to be Administrative Core Director.

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

Minimum level of effort is 2.4 person months (20%) for the Director (administrative duties). Personnel with less than 10% effort are considered Other Significant Contributors..

The minimum budget for the Education Enrichment Program is $15,000 per year.

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

Research Strategy: This section should contain the following:

• A description of the strategy by which the administrative core and the Educational Enrichment Program will enhance and expand the larger urology research community;
• A presentation of the administrative structure. Include the role of the Administrative Core in 1) the allocating and overseeing the Developmental Center resources, 2) establishing and maintaining all collaborations and the Educational Enrichment program, and 3) working with the institution and local regulatory bodies to ensure that human subject or vertebrate animal research is in compliance with appropriate regulations and guidelines governing animal use and studies involving human subjects research.
• Describe the responsibilities of all key personnel within the Administrative Core.
• Plans to ensure the success of team building and to track participants of the Center; to ensure that the Center will remain focused throughout the course of the award; development and maintenance of Centers website.
• Include a description of how the Educational Enrichment Program will be organized and governed.

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 application can note that the Data Sharing Plan for the whole Program applies to the Administrative Core. Other resource sharing plans are not relevant to the Administrative 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.

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

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

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 (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 (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (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: 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.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (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.

Budget (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..

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 (Project)

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

Specific Aims: Identify whether this is a Resource Development or Scientific Research Project. Describe specific aims of the Project.

Research Strategy: Describe the research strategy of the Project in the same detail and format as required for an investigator-initiated R01 grant application. Include a description of how the results of the project would lead to an understanding of the development, persistence or treatment of lower urinary tract symptoms.

For renewal applications, state the previous specific aims and discuss progress in the Project during the prior funding period. Briefly describe how published key findings fit within the aims of the previously awarded P20 grant.

Progress Report Publication List: For renewal applications, include a list of publications that directly resulted from the Project during the prior funding period.

Letters of Support: Attach letters of support relevant to the Project.

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 application can note that the Data Sharing Plan for 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.

Planned Enrollment Report (Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Project)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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 NOT-OD-13-030.

GROUP 1 Related Section V.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

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? 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?

What is the likelihood the Center will enhance collaborative efforts and bring appropriate fields of study together to enlarge the urology research community? What is the likelihood for meaningful and long-term collaboration among the Center investigators? What are the strengths of the Center's research base (its breadth and depth)? Does the Educational Enrichment Program make significant contributions to promote new research directions, meaningful collaborations, and outreach to the urology research community?

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

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? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

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 .

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 consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

If a Resource Project is proposed will the resource substantially change the field of study? If successful, will it benefit the larger urology research community? Will new approaches be introduced to urological research?

Investigator(s)

Are the Project Leader(s), collaborators, or other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or has multiple Project Leaders, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted 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, as appropriate

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

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

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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

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

Francisco O. Calvo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
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.