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 - Clinical Trial Not Allowed)

Activity Code

P20 Exploratory Grants

Announcement Type

Reissue of RFA-DK-17-002

Related Notices
  • NOT-OD-18-009 - Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.
Funding Opportunity Announcement (FOA) Number

RFA-DK-17-033

Companion Funding Opportunity

None

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).  Among the goals of this Program is to further advance research in benign urology by building research teams and facilitating resources generation and sharing. The research teams should be composed of individuals with complementary expertise who propose to either develop innovative resources (Resource Development Projects) or a new research project (Scientific Research Projects) that utilize integrative approaches to address questions relevant to benign urological diseases or disorders. Patient-centered research is encouraged. Resources developed by the Resource Development Projects will be shared upon validation while resources developed within the Scientific Research Projects will be shared at the end or termination of the award, as appropriate and consistent with the program goal of further advancing research.  Each Developmental Center is centered on a single Project and must contain an Administrative Core and an Educational Enrichment Program. As part of the efforts of the Division of Kidney, Urologic and Hematologic Diseases (DKUH) to expand and enhance benign urology research, 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

October 6, 2017

Open Date (Earliest Submission Date)

January 28, 2018

Letter of Intent Due Date(s)

January 28, 2018

Application Due Date(s)

February 28, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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)

Not Applicable

Scientific Merit Review

June/July 2018

Advisory Council Review

October 2018

Earliest Start Date

December 2018

Expiration Date

March 1, 2018

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 using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3.  

    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

    The burden of benign urinary tract diseases and disorders on patients, their families, caregivers and society is enormous. Patients suffer considerable morbidity throughout their lives, leading to a decreased quality of life and overall health. 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 the development of drug therapies for some conditions has minimized the need for surgical intervention. 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, urinary stone disease, and lower urinary tract symptoms associated with benign prostatic hyperplasia, urinary incontinence, chronic prostatitis /chronic pelvic pain syndrome and interstitial cystitis/bladder pain 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 benign urological disorders; the absence of innovative resources and appropriate tools; and the paucity of objective diagnostic criteria and tests to identify these 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 benign urologic diseases and disorders also contribute to the lack of progress in improved treatments. 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, behavioral and community health 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 urologic research community to foster projects that can mature into comprehensive programs that identify underlying etiologies of benign urologic diseases and disorders within NIDDK mission. Developmental Centers should contribute to the diagnosis, treatment or prevention of urologic diseases or disorders through basic, translational or patient-oriented research. As such the Centers Program is designed to

    • Take advantage of current talent within the traditional urologic research community; and recruit new talent to the study of benign urinary tract diseases or disorders
    • Support studies that develop comprehensive resources or take an integrative approach for the study of benign urological disorders or diseases using basic, translational or patient oriented research methods appropriate to address the research question.

    The Developmental Centers Program will be made up of Centers that have either a Resource 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 or urogynecology, and all other disciplines as appropriate to the research being proposed. To build a more interactive research community investigating benign urinary tract diseases and disorders, Developmental Center participants will work with the George M. O'Brien Urology Cooperative Research Centers Program and the KURe (multidisciplinary urologic research career development) program through joint meetings and conference calls. It is expected that Developmental Centers with a Resource Project will develop resources that will substantially enhance the ability to carry out urological research and that Centers with a Scientific Project will leverage the P20 development program into well-designed, novel projects suitable for submission as R01, multi PD/PI R01, Program Project (P01), multicenter clinical research studies (U34 to U01) or George M. O'Brien Urology Cooperative 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 research community and substantially facilitate the study of the benign urologic diseases or disorders. A patient-oriented resource could include validation of an existing patient or self-reported outcome tool in a new population or development of a new tool necessary to improve the presentation, evaluation, diagnosis and treatment of a benign urologic disease or disorder. Once validated, these resources are expected to be made freely available to the larger research community, as appropriate and consistent with the program goal of further advancing research. A 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 interventional clinical trials are not allowed. Preliminary data or data from the literature is expected to support the scientific justification of the Scientific Project. Appropriate patient-oriented scientific research projects might include studies utilizing existing databases, small case-control or qualitative studies. However, applications proposing clinical trials are not responsive and will not be reviewed.

    If successful, the Resource Project will have a significant impact on the ability of members of the larger scientific community to propose and implement innovative and state-of-the art studies; whereas the Scientific Project should have the potential for teams to develop comprehensive programs 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 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 urologic research community;
    • Develop analytical tools for meta-analysis of existing databases and learning platforms for dissemination of tools to the urologic 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;
    • Develop methodology for evaluating the impact of type and quantity of food/nutrients and fluids on urine composition and micturition patterns;
    • Develop self or patient reported tools necessary for prevention, diagnosing or treating benign urologic disorders or disease in persons who do not identify with their sex assigned at birth;
    • Develop or validate patient or self-reported tools necessary for prevention, diagnosing or treating benign urologic disorders or disease in non-English speaking or otherwise diverse or disadvantaged population; or
    • Develop patient, self or other reported tools for assessing nontraditional factors that may be important to prevention, diagnosing or treating benign urologic disorders or disease

    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;
    • Studies that allow for psychosocial or cognitive phenotyping of patients undergoing treatment for benign condition associated with lower urinary tract symptoms with the goal of expanding the understanding of factors that may contribute to response or nonresponse to treatment; or
    • Studies that examine the role of nontraditional factors in persons with lower urinary tract symptoms independent of whether they have sought care.

    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 benign urologic 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
    • 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 to facilitate investigation of lower urinary tract function, structure, and development or the prevention, diagnosis of treatment of benign urologic conditions associated with lower urinary tract symptoms. 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 required to have teams with 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 or urogynecologist 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 Administrative Core is responsible for working closely with George M. O'Brien Urology Cooperative Research Centers and the KURe programs and for establishing and maintaining 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 should provide outreach to larger research community and provide a means for inclusion of new disciplines into benign urology research. The Educational Enrichment Program may include but is not limited to:

    • A lecture series of experts with scientific backgrounds that are nontraditional in benign urologic research;
    • Visits from invited experts with scientific backgrounds that are nontraditional in benign urologic research;
    • Short-term student experiences (at the high school, college, and graduate or medical student level); or
    • Workshops that educate Center members and the research community on how to use available databases or other resources.

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

    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 - Only one subsequent renewal application is allowed 
    Resubmission from RFA-DK-17-002
    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIDDK intends to commit $1,000,000 in FY 2018 to fund up to 3 awards.

    Award Budget

    Application budgets are limited to no more than $200,000 in direct costs per year.

    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

    • 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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not 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.

    • 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.

    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 should be an investigator with an established record of external funding, but is not required to have a record of accomplishment in benign urologic research. Investigators who are key personnel of an existing U54 O'Brien Urology Center or an existing P20 Center in response to RFA-DK-17-002 are not eligible to apply as Center Director. 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.

    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).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

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

    2. Content and Form of Application Submission

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

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    John Connaughton, Ph.D.
    Chief, Scientific Review Branch
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301- 594-7797
    Email: NIDDKLetterofIntent@mail.nih.gov 

    Page Limitations

    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.

    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:

    • Overall: required
    • Administrative Core: required
    • Project: 1 required, maximum of 1
    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)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    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)

    Follow standard instructions.

    Project Summary/Abstract: State whether this application includes a Research Development or Scientific Research project. Summarize the scientific theme and goal of the Center and provide a brief overview of the 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 Attachments: The following "Other Attachments" should be included with the Overall Component 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.

    Collaborations: Although pre-existing collaborations are not required, a description of any relationships between members is requested. 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 served as training mentors or long time research associates of said Center member.

    Project/Performance Site Location(s) (Overall)

    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)

    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)

    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.

    PHS 398 Research Plan (Overall)

    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 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 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 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 Resource Sharing Plan.

    As appropriate and 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.   

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

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

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

    PHS Assignment Request Form (Overall)

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

    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:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant's Project
    • Proposed Project Start/Ending Dates
    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. 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) (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)
    • 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.   
    Budget (Administrative Core)

    Budget forms appropriate for the specific component will be included in the application package. Minimum level of effort is 2.4 person months for the Director (administrative duties). Personnel with less than 1.2 person months effort are considered Other Significant Contributors. Salary request for participants with less than 1.2 person months effort should be well justified.

    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.

    PHS 398 Research Plan (Administrative Core

    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 benign urologic research community;
    • A presentation of the administrative structure. Include the role of the Administrative Core in 1) 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 ensure that the Center will remain focused throughout the course of the award; development and maintenance of Centers website;
    • Plans to assess progress in building a functional multidisciplinary team and conflict resolution; and
    • A description of the goals of the Educational Enrichment Program and how these goals will be achieved. In addition, describe the plan for the organization and governance of the Educational Enrichment Program.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: The application should note that the Resource Sharing Plan for the whole Program Project 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.

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed. The application should note that the Study Record for the whole Program Project applies to the Administrative Core.

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

    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:

    • 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.

    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 (Project)

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

    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 for the project leader. Personnel with less than 1.2 person months are considered Other Significant Contributors. Salary request for participants with less than 1.2 person months should be well justified.

    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 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, provide the previous P20 grant number, title, and the project description (including the specific aims). 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 should note that the Resource 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.   

    PHS Human Subjects and Clinical Trials Information (Project)

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

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

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

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

    3. Unique Entity Identifier and System for Award Management (SAM)

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Post Submission Materials

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

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

    Specific to this FOA: 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 of meaningful and long-term collaboration among the Center investigators that will facilitate investigation of lower urinary tract function, structure, and development or the prevention, diagnosis of treatment of benign urologic conditions associated with lower urinary tract symptoms?

    Investigator(s)

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

    Specific to this FOA: Are the time commitments of the Center Director and support staff 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?

    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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

    Specific to this FOA: 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?

    Does the application describe how internal communication and cooperation among Center investigators will be maintained and are they appropriate? Does the application reflect an understanding that it takes time and there is a process to building a collaborative team? 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?

    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? 

    Specific to this FOA: What are the strengths of the Center's research base (its breadth and depth)? 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

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

    Renewals

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

    Revisions

    Not applicable

    Additional Review Considerations - Overall

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

    Applications from Foreign Organizations

    Not applicable.

    Select Agent Research

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

    Resource Sharing Plans

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


    Authentication of Key Biological and/or Chemical Resources

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

    Budget and Period of Support

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

    Scored Review Criteria - Administrative Core

    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, an Administrative Core that by its nature is not innovative may be essential to advance a field.

    Significance - Administrative Core

    Does the proposed Center address the needs of the research developmental center that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program]?   

     
    Investigator(s) - Administrative Core

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing developmental research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

    Innovation - Administrative Core

    Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? 

    Specific to this FOA: Are there innovative aspects to the Educational Enrichment Program that will facilitate addition of new disciplines to benign urology research?

    Approach - Administrative Core

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the [projects], as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the [project] is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the project? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

    Specific to this FOA: What is the likelihood that the Educational Enrichment Program will have an impact on the larger urology research community and facilitate addition of new disciplines to benign urology research?

    Environment - Administrative Core

    Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research project it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?

    Specific to this FOA: Will institution actively promote Educational Enrichment Program to facilitate addition of new disciplines to benign urology research?

    Additional Review Criteria - Administrative Core

    As applicable for the project 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 subject's involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

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

    Renewals

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

    Revisions

    Not Applicable.

    Additional Review Considerations - Administrative Core

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

    Applications from Foreign Organizations

    "Not Applicable"

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

Scored Review Criteria - Project

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 - Project

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

Specific to this FOA: If a Research Project is proposed will the project substantially change the field of study? If successful, will it illuminate underlying etiology of lower urinary tract symptoms and will it serve as the foundation for the development of a comprehensive research program? If the proposed study 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 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? Is proposed project appropriate in scope and magnitude?

Investigator(s) - Project

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

Innovation - 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?   

Approach - Project

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Specific to this FOA: 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 - Project

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 - Project

As applicable for the project 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 subject's involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Project

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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


Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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 NIH Institute or Center 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
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 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.

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.

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Tamara Bavendam, MD, MS i
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4733
Email: tamara.bavendam@nih.gov

Peer Review Contact(s)

Ryan Morris, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-480-1296
Email: ryan.morris@nih.gov

Financial/Grants Management Contact(s)

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email:dianaly@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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