Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Developmental Centers for Interdisciplinary Research in Benign Urology (P20)

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of RFA-DK-12-022

Related Notices

  • November 26, 2014 - This RFA has been reissued as RFA-DK-15-001.
  • September 23, 2013 - See Notice NOT-DK-13-020. Notice of Correction to Administrative Core Budget Instructions.

Funding Opportunity Announcement (FOA) Number

RFA-DK-13-019

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to seek applications for the Developmental Centers for Interdisciplinary Research in Benign Urology Program (P20). The intent of this Program is to build research teams composed of individuals with complementary expertise who propose to develop innovative resources or new research projects that utilize integrative approaches addressing research questions relevant to benign urological diseases. Each Developmental Center is centered on a single Project and must contain an Administrative Core and an Educational Enrichment Program. As part of the larger efforts in the Division of Kidney, Urologic and Hematologic Diseases (DKUH) to expand and enhance the urology research community,  the Developmental Centers Program will work in partnership with the George M. O’Brien Urology Cooperative Research Centers Program (U54) and the Multidisciplinary K12 Urologic Research (KURe) Career Development Program.

Key Dates
Posted Date

September 9, 2013

Open Date (Earliest Submission Date)

October 18, 2013

Letter of Intent Due Date(s)

October 18, 2013

Application Due Date(s)

November 18, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

November 18, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

February/March, 2014

Advisory Council Review

May, 2014

Earliest Start Date

July, 2014

Expiration Date

November 19, 2013

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

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 (Litwin MS, Saigal CS, editors. Urologic Diseases in America. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office, 2012; NIH Publication No. 12-7865, pp. xii-xii.).

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.

Developmental Centers Program

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:

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 built 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 will 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

Scientific Research Projects

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 is required to commit 2.4 person-months (equivalent to 20% full-time professional effort) to the oversight of the Center and will be responsible for scientific and administrative leadership. This includes, but is not limited to, the following duties:

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 required to 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 be 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:

Administrative Core

The Administrative Core Director is not required to be the Center 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:

Educational Enrichment Program

The Educational Enrichment Program may comprise and include funds for

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit $1,000,000 in FY 2014 to fund 3-4 awards.

Award Budget

Applicants may request no more than $200,000 in direct costs per year. The maximum budget for the Education Enrichment Program is $25,000.

Award Project Period

The maximum project period is 2 years. The scope of the proposed project should determine the project period.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The Center Director will be an investigator with an established record of external funding, but is not required to have a record of accomplishment in urological research. The Center Director is not required to be the Administrative Core Director. Investigators who are part of an existing U54 O’Brien Urology Center or a P20 Center are not eligible to apply. An investigator, including Center Director, may only be listed as key personnel, on a single P20 application.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent, preferably electronically, should be sent to:

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

Page Limitations


Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall (use for Center Overview)

6

Admin Core

6

Project

12


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

Instructions for the Submission of Multi-Component Applications

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:

http://nih-extramural-intranet.od.nih.gov/ElectronicSubmission/files/multi-project_app_pkgs.pdf

Overall Component

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.

SF424 (R&R) Cover (Overall - Center Overview)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall - Center Overview)

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

Research & Related Other Project Information (Overall - Center Overview)

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. Also, include letters of institutional commitment.

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 Attachments: The following "Other Attachments" should be included with the Overall Component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.  All attachments need to be in pdf format.

Project/Performance Site Location(s) (Overall - Center Overview)

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.

Research & Related Senior/Key Person Profile (Overall - Center Overview)

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.

Budget (Overall - Center Overview)

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.

PHS 398 Research Plan       (Overall - Center Overview)

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:

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

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

Administrative Core

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.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative 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:  Do not complete.

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

Budget (Administrative 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 Director (administrative duties) and 1.2 person months (10% effort) for the project leader. Personnel with less than 10% effort are considered Other Significant Contributors. Salary request for participants with 10% effort should not be requested.

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          (Administrative Core)

Specific Aims: Describe the specific aims of the Administrative Core including the Educational Enrichment Program

Research Strategy: this section should contain the following:

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

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

Planned Enrollment Report  (Administrative Core)

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 (Administrative Core)

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

Project

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:

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.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Project)

Budget (Project)

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

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)

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. For both the Resource Development and Scientific Research Project, 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.

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be 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.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Scored Review Criteria Overall

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

Significance

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

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?

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

Are the time commitments of the Center Director and Associate Director(s) adequate for the effective management of the Center program? Is the time commitment of the Project Leader adequate to effectively and successfully complete the Project? Are the time commitments of Other Personnel justified and appropriate, especially individuals with less than 1 month effort?

If the Center 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?

What is the likelihood for meaningful and long-term collaboration among the Center investigators? Does the team include established investigators from non-urological fields and are they making a substantial contribution to the project? Does the team have relevant urology expertise?

Innovation

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

Approach

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

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is the Center's overall strategy to foster new interactions appropriate and likely to succeed? Will it provide the foundation necessary to establish a well-integrated research team that is capable of generating new and innovative research grant applications?

Are the arrangements and organizational structure for the Administrative Core adequately developed and appropriate for the aims of the Project and the Educational Enrichment Program? Does the application describe how internal communication and cooperation among Center investigators will be maintained and are they appropriate? Are the arrangements for oversight and use of travel funds and the Educational Enrichment Program appropriate? Are the resources and responsibilities appropriately distributed and justified given the goal and objectives of the proposed Center? Does the applicant describe an effective and appropriate process for resolving conflicts between investigators and the Center Director?

If a Research Project is proposed, and involves basic research using animal models, is there a clear vision for how the studies will contribute to the development of future translational studies?

If a Resource Project is proposed are the scope and magnitude appropriate?

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?   

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted 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. Following initial peer review, recommended applications will receive a second level of review by the National Institute of Diabetes and Digestive and Kidney Disease Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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: support@grants.gov

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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8897
Email: fc15y@nih.gov

Financial/Grants Management Contact(s)

Diana Ly
Grants Management Specialist
Grants Management Branch, Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-9249
Email: dianaly@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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