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

Planning Centers for Interdisciplinary Research in Benign Urology (IR-BU) (P20)

Activity Code

P20

Announcement Type

Reissue of RFA-DK-10-001

Related Notices

  • November 5, 2012 - This RFA has been reissued as RFA-DK-12-022.
  • January 10, 2012 - See Notice NOT-DK-12-006. Notice to Clarify the Research Strategy Page Limitation.

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-003

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847

FOA Purpose

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Planning Centers for Interdisciplinary Research in Benign Urology (IR-BU) (P20). The intent of this solicitation is to encourage studies that take an integrative approach towards addressing problems in benign urology. Because lower urinary tract symptoms, such as frequency, urgency, dysuria, terminal dribbling etc., are descriptive, it has been difficult to attribute these symptoms to specific etiologies or to particular urinary tract organs and tissues, supporting structures, or to the peripheral or central nervous system. Furthermore, the lack of fundamental information about lower urinary tract development and physiology has hampered the ability to develop strategies to address lower urinary tract symptoms. These planning centers are to foster programs that undertake a broad approach towards research in benign urology that can integrate investigations of organ-specific development and genetics, structure and function, and physiology and pathophysiology with in vivo studies to understand the potential interplay of urologic and non-urologic organs and tissues. The research teams are expected to be built from established investigators from the basic science and urology and other disciplines. Each IR-BU Center (P20) is limited to a single Scientific Project and must contain an Administrative Core and an Educational Enrichment Program.

Key Dates
Posted Date

December 21, 2011

Letter of Intent Due Date

February 20, 2012

Application Due Date(s)

March 20, 2012

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June-July 2012  

Advisory Council Review

October 2012l

Earliest Start Date(s)

December  2012

Expiration Date

March 21, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose/Research objectives

The overall objective of the Planning Centers for Interdisciplinary Research in Benign Urology (IR-BU) (P20) is to encourage studies which take an integrative approach in addressing basic problems in benign urology in order to advance our understanding of symptomatic benign urological disorders. Urological disorders of specific interest are those that produce lower urinary tract symptoms, including lower urinary tract symptoms associated with benign prostate hyperplasia (LUTS/BPH), urinary incontinence (UI), overactive bladder (OAB), urinary tract infection, vesicoureteral reflux (VUR), and neurogenic bladder.   

The P20 exploratory planning grants are to support the development of research teams that can integrate studies of organ-specific development, structure and function, and physiology and pathophysiology with in vivo animal and human studies to understand the complex interplay of urologic and non-urologic organs involved in the development and persistence of lower urinary tract symptoms. The teams are required to draw upon expertise from non-tradiational urology fields of study. This strategic approach is partially based on the recommendations presented in the NIDDK Research Progress Report and Strategic Plan for Pediatric Urology (http://www2.niddk.nih.gov/AboutNIDDK/ReportsAndStrategicPlanning/NIDDK_Research_Progress_Report_and_Strategic_Plan_for_Pediatric_Urology_2006.htm),the 2007 NIDDK Advancing Urologic Science and Career Development Meeting (http://www3.niddk.nih.gov/fund/other/_pdfs/2007_Urologic_Science_Workshop_MeetingSummary.pdf), the 2009 Urology 2.0: Advancing Urology Research Workshop (http://conferences.thehillgroup.com/urologymeeting/), and the NIDDK Prostate Research Strategic Plan (http://www.nih.gov/news/health/jul2008/niddk-25.htm).

The impact and burden of lower urinary tract symptoms to patients are enormous. Patients suffer considerable morbidity throughout their lives, leading to a decreased quality of life for the patient and their families. Epidemiological data suggest the prevalence of lower urinary tract symptoms, LUTS/BPH, UI, and OAB is high, but measured prevalence varies substantially due to a lack of uniform definitions and the methods of collection. For example, the prevalence of UI appears to vary from 2.5% to 60%, depending on the population. Despite this variation, UI is the leading cause for admission to nursing homes. Management of UI is dependent upon surgery (which is only partially effective) or a single class of approved drugs. This class of drugs is only 13-25% more effective than placebo and 2/3 of patients discontinue use because of side effects. LUTS/BPH and OAB are treated with a wide variety of costly drug, surgical, and behavioral treatments that are only aimed at alleviating the symptoms, even though diverse causes are likely to underlie both syndromes. Neurogenic bladder is treated by surgical or other invasive procedures that ultimately do not address the underlying etiology. 

The consequences of many congenital urinary malformations may lead to lower urinary tract symptoms. Thus, advancements in our knowledge of the developmental processes underlying lower urinary tract structure and function, as well as further understanding of the physiological changes associated with urinary tract symptoms will also enhance our ability to develop improved treatment for the consequences of urinary tract malformation. Vesicoureteral reflux (VUR) is such a developmental defect and affects up to 10% of newborns (approximately 450,000 babies) every year. VUR results from the abnormal attachment of the ureter to the bladder that causes retrograde flow of urine into the ureter and kidney. Depending upon the severity, VUR will resolve spontaneously or can lead to renal failure. A severe complication of VUR is urinary tract infection that can lead to renal damage or scarring. Current treatment of VUR is moderately successful and ranges from antibiotic prophylaxis and regular radiographic evaluation to surgical procedures. Establishing effective prevention and management of lower urinary tract symptoms and congenital urinary malformation will require an understanding of the underlying causes and the normal and abnormal development of the organ systems involved.

The strategy of the IR-BU program is to foster teams capable of undertaking studies to identify the root causes and systems involved in lower urinary tract symptoms. As such, active team members are expected to represent a broad field of expertise capable of leading studies that will promote an understanding of the normal development, maturation, and physiology of organ systems likely to be involved, and the study of the pathophysiology of animal models that mimic aspects of lower urinary tract symptoms. The development of conceptual and mechanistic models and in vivo animal experimental systems that recapitulate specific lower urinary tract symptoms is crucial for understanding and testing the complex interplay of urologic and non-urologic organs. This approach and the closer examination of relevant patient populations will provide a basis for developing testable conceptual and mechanistic models. To date discipline-focused, research teams have not undertaken such approaches.

Knowledge gained from these studies will serve as the foundation to develop effective treatments and strategies for prevention.  In addition, characterization of in vivo animal models that mimic aspects of specific lower urinary tract symptoms will help direct the improved detailed phenotyping of patients and thereby support the development of more informative patient subgroups. Stratification of patient populations should provide a means to select optimal prevention and therapeutic strategies to improve the clinical outcomes for patients with lower urinary tract symptoms.

Overall structure and goals

Each IR-BU Center will consist of a team coalesced around a single scientific topic and scientific project. Because the goal of the IR-BU program is to foster new teams, applications will not require preliminary data to establish the collaborative interactions of the team members, but rather one of th goals of the Center is to generate the preliminary data necessary to establish the bona fides of the IR-BU participants as a well-integrated interdisciplinary research team. The IR-BU Centers are expected within a two-year period to develop well-designed interdisciplinary projects suitable for submission for a George M. O’Brien Urology Research Center (P50), a multi-PD(s)/PI(s) R01, or a Program Project (P01) award. However, IR-BU Centers can be considered for renewal. Each center will have an Administrative Core which is responsible for 1) the allocation and oversight of all IR-BU Center resources, 2) establishing and maintaining all collaborations and the Educational Enrichment program, and 3) 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. 

Center Director

The Center Director must be an established investigator and will be responsible for scientific and administrative leadership. This includes, but is not limited to, the following duties:

Interdisciplinary teams

A goal of the IR-BU program is to build teams that draw upon a broad range of expertise to investigate lower urinary tract function/structure/development and the underlying causes of lower urinary tract symptoms. Investigators within and outside of urology are encouraged to interact in the broad field of lower urinary tract biology to build the basic knowledge essential for establishing conceptual/mechanistic models, tools, and resources necessary for developing translational studies in lower urinary tract symptomatic disorders. Inclusion of a urological clinician or physician scientist within the research team is required to maintain awareness of the clinical relevance of the project to lower urinary tract symptoms. In addition, teams are required to have active involvement of established investigators with appropriately diverse expertise although new investigators are allowed. Investigators who are part of an existing O’Brien Urology Center may not submit an application.

Specific examples of team members might include:

Scientific Research Project

The Scientific Research Project will be a single project and will be overseen by a Program Director(s)/Principal Investigator(s) or multiple Program Director(s)/Principal Investigator(s) (see Section IV. 2 Applications with Multiple PD(s)/PI(s)). The Scientific Research Project will contribute to our understanding of the etiology of lower urinary traction symptoms through studies of the normal development, physiology, genetics and/or pathophysiology of the lower urinary tract and associated organs and tissues. Because a goal of the IR-BU Center is to build new teams, preliminary data are not required to establish the collaborative interactions of the team members. The Scientific Project may include human studies, and/or use mouse and other animal experimental systems. Animal studies are appropriate for the study of normal development, maturation, and physiology of the lower urinary tract system and associated organs, and animal models are acceptable even though they might only recapitulate aspects of urologic symptoms.

The strategy for establishing IR-BU teams is to provide the intellectual infrastructure to foster projects that can mature into comprehensive programs that take advantage of an understanding of the lower urinary tract physiology/development/genetics and which can lead to the determining the underlying etiology of lower urinary tract symptoms. Such a comprehensive approach towards the study of lower urinary tract symptoms could, for example, include the study of neural modulation, circadian rhythm, epigentics and environmental factors in understanding social stress incontinence; the study of diabetes/obesity, chronic inflammation, and cholesterol in prostatic inflammation; or the study of  inflammation, macrophages, and fibrosis in BPH. Such comprehensive programs will lead the way towards translational studies to prevent, diagnose, and manage lower urinary tract symptoms.

To accelerate the ability to plan for future translational studies, the research topics should encompass fundamental studies in lower urinary tract biology (development/physiology/genetics) and dysfunction and where appropriate include analysis of human samples from previous or ongoing clinical studies/trials or human phenotyping studies. 

Specific examples of research topics that are responsive to this solicitation are listed below. Although cell culture studies are permissible, they will need to be carefully justified. These are broad examples meant only to provide illustration of potential directions, and not to be restrictive.

Applicants must provide a compelling vision for how these studies will contribute to our understanding of urinary tract symptoms and the eventual development of translational studies. 

Applications primarily focused on kidney injury secondary to urologic disorders are not responsive to the FOA, and will be not be reviewed. 

Administrative Core

An Administrative Core will serve as a foundation for the synergistic activities of the Center, provide travel support for Center personnel, and be responsible for an Educational Enrichment Program.

The Educational Enrichment Program may comprise and include funds for 

To support the team building activities of the P20 centers the IR-BU teams will meet bi-annually in Bethesda, initially to introduce the IR-BU teams and subsequently to discuss progress on the establishment of integrative research teams.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $1 million in FY 2012.

Award Budget

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

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

The Center Director must be an established investigator, but need not have a record of accomplishment in urological research; however, the inclusion of a urologic clinician or physician scientist in the IR-BU team is required. It is expected that other IR-BU team members will have the diverse expertise appropriate for the proposed studies in the Scientific Project.  Therefore, established investigators from diverse fields not traditionally involved in urological studies are expected to be included and actively involved. New investigators are also allowed but should not be substituted for established investigators. Because not all relevant expertise may be represented at a single institution, applicants are encouraged to establish teams through collaborations with research groups outside their own institution.

The Center Director need not be the Administrative Core Director. Investigators who are part of an existing O’Brien Urology Center are not eligible to apply.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

The letter of intent should be sent to:

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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

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

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

In addition, modify the PHS 398, starting with the Table of Contents, to include the following items in the following order using the page limits below when provided:

Composite Detailed Budget for Initial Budget Period (Entire Project, 398 Form Page 4)

Composite Budget for Entire Proposed Period (398-Form Page 5)

Budgets Pertaining to Contractual Arrangements

Detailed Budgets (Initial and Entire Period) and Budget Justifications for the Research Project and Administrative Core including the Educational Enrichment Program)

Biographical Sketch – IR-BU center PD/PI

Other Biographic Sketches – Key Personnel, etc.

All Personnel Report

Checklist

Summary Description of the Proposed IR-BU Center (limited to 6 pages including the subsections below)

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.,

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants must budget for travel for at least three investigators to attend bi-annual reverse site visit/progress meetings to be held in Bethesda, Maryland.  Funds for the Educational enrichment program are limited to $25,000.

Supplemental Instructions:

Summary of the Proposed IR-BU Center (limited to 6 pages)

ResearchTeam: Describe the research team, expertise outside of the field of urology, and the role of team members in addressing the research problem.  Provide a  statement for satisfying the eligibility criteria bulleted in Section III.1.B for eligible individuals (1-2 pages recommended).  

Scientific purpose of the IR-BU Center:  Provide a brief description of the research aims of the Scientific Research Project followed by a explanation of how the Scientific Research Project integrates organ-specific development, structure and function, and/or physiology and pathophysiology studies with in vivo studies to understand the potential interplay of urologic and non-urologic organs and tissues. Describe how will this lead to an understanding of the development and persistence of lower urinary tract symptoms. 

Administrative Core

Describe the administrative structure of the center and its role in 1) the allocation and oversight of IR-BU 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.

Describe efforts to ensure the success of the team building and the steps taken to ensure that the center will remain focused throughout the course of the award. Provide a plan for ensuring the solvency of the proposed team once an award has been made and for resolving conflicts within the IR-BU Center. Specifically address administrative responsibilities between the collaborating institutions, organizational components, faculty, and staff.

The Administrative Director need not be the Center Director.

Provide an official signed letter of understanding establishing the collaboration between the institutions or organizational components and document all significant inter-institutional commitments as appropriate.

Educational Enrichment Program

Describe how the Educational Enrichment program will be organized and governed and how it will support or augment the development of an interdisciplinary approach to the proposed studies. All IR-BU Centers are expected to establish and maintain a website to advertise and highlight the activities of the Educational Enrichment program.

Other Requirements  

The Center Director must be an established investigator, but need not have a record of accomplishment in urological research; however, the inclusion of a urologic clinician or physician scientist in the IR-BU team is required. It is expected that other IR-BU teams will have diverse expertise appropriate for the proposed studies in the Scientific Project and therefore, new or established investigators from diverse fields not traditionally involved in urological studies are expected to be included. Because not all relevant expertise may be represented at a single institution, applicants are encouraged to establish interdisciplinary teams through collaborations with research groups outside their own institution.

Applicants must budget for travel for at least three investigators to attend bi-annual reverse site visit/progress meetings to be held in Bethesda, Maryland.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

Reviewers will provide an overall impact/priority 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

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

Significance

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

Does the ADMINISTRATIVE CORE enhance the collaborative effort of bringing different fields of study together to successfully carry out the proposed research? Does the Educational Enrichment Program make significant contributions to the goals/specific aims of the IR-BU Center? Does it foster integrative research approaches to understand the underlying causes of benign lower urinary tract symptoms, or developmental, functional, physiologic, or pathophysiological changes 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 New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is the composition of the investigators appropriate for building an interdisciplinary research team? 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, is a urologic clinician or physician scientist associated with the project?

Are the scientific and administrative leadership abilities of the proposed Center Director appropriate? Does the Center Director have an appropriate time commitment for the effective management of the Center? Is there evidence that the researchers and faculty of the partnering institutions have worked closely together in the preparation of the application and will continue to do so in meeting the proposed objectives?

Innovation

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

Approach

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

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

Will the Center foster new multidisciplinary interactions and will these interactions generate the preliminary data necessary to establish a well-integrated multidisciplinary research team that is capable of generating new and innovative research grant applications?

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

Are the arrangements and organizational structure for the ADMINISTRATIVE CORE adequately developed and appropriate for the aims of the Scientific Project and the Educational Enrichment program? Does the application describe how internal communication and cooperation among Center investigators will be maintained? Are the arrangements for oversight and use of funds for travel and the Educational Enrichment Program adequately described? Are the resources and responsibilities appropriately distributed and justified given the goal and objectives of the proposed IR-BU center? Does the applicant describe an effective process for resolving conflicts between investigators?      

Environment

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

Additional Review Criteria

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

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

Revisions

Not Applicable.

Additional Review Considerations

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/priority score.   

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Diabetes and Digestive and Kidney Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NDDK Advisory Councill. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Deborah K. Hoshizaki, Ph.D.
Division of Kidney, Urologic and Hematologic Disease 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Democracy Two, Room 645
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-7712
FAX: (301) 480-3510
Email: deborah.hoshizaki@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Diana Ly
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room Number 723
6707 Democracy Boulevard
Bethesda, MD 20892-5464
Telephone: (301) 594-9249
Email: dianaly@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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