Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Developmental Centers for Interdisciplinary Research in Benign Urology (P20)
Activity Code	P20 Exploratory Grants
Announcement Type	Reissue of RFA-DK-12-003
Related Notices	September 9, 2013 - This RFA has been reissued as RFA-DK-13-019.
Funding Opportunity Announcement (FOA) Number	RFA-DK-12-022
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to seek applications for the Developmental Centers for Interdisciplinary Research in Benign Urology Program (P20). The intent of this Program is to build research teams capable of developing new research projects that take an integrative approach towards addressing problems in benign urology. Each Developmental Center is limited to a single Scientific Project and must contain an Administrative Core and an Educational Enrichment Program. The Developmental Centers Program will work closely with the George M. O Brien Urology Cooperative Research Centers Program (U54) (RFA-DK-12-009).

Posted Date	November 5, 2012
Letter of Intent Due Date(s)	January 25, 2013
Application Due Date(s)	February 27, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June-July, 2013
Advisory Council Review	October, 2013
Earliest Start Date	December, 2013
Expiration Date	February 28, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

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. Over the past two decades, the field of urology has changed significantly with advancing technology in diagnostic and therapeutic options for patient treatment of non-malignant urologic diseases. Minimally invasive surgeries and procedures, and drug therapy have changed the clinical management of these patients. Despite these advances, millions of Americans are afflicted with urologic disorders and diseases including urinary tract infections, urolithiasis, and lower urinary tract disorders associated with benign prostatic hyperplasia, urinary incontinence, chronic prostatitis /chronic pelvic pain syndrome and interstitial cystitis. 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 absence of a critical mass of talented and innovative researchers to address the gaps in our knowledge of the basic physiology, cell biology, and genetics of urological disorders; to develop objective diagnostic criteria and tests to identify urologic diseases and disorders; to perform efficient in-depth characterization (phenotyping) and epidemiology and natural history studies of urologic diseases and disorders. Recruitment of research expertise such as cell and molecular biology, genomics and proteomics, biochemistry, physiology, developmental biology, tissue engineering, immunology, pathology, neurobiology, and microbiology is an essential component in the advancement of urologic research. Furthermore, the application of translational tools, such as imaging techniques and biomarkers, will depend upon an understanding of the structure, function, and physiology of the urinary system and recruitment of talent beyond the traditional clinical specialty of urology.

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

• take advantage of current talent within the urological research community;
• recruit new talent to the study of benign urology; and
• support studies that take an integrative approach in addressing benign urological disorders or diseases.

The Developmental Centers Program will encompass Developmental Centers that have a single Scientific Project, an Administrative Core and an Educational Enrichment Program. The research teams are expected to be built by an established investigator and should consist of individuals from the basic sciences, clinical urology, and other disciplines. To build a more interactive urological research community, Developmental Centers' participants are expected to be in close communication and are expected to work together with the George M. O Brien Urology Cooperative Research Centers Program through joint meetings and conference calls. It is expected that Developmental Center projects will develop into well-designed interdisciplinary projects suitable for submission as R01, multi PD/PI R01, Program Project (P01), or Research Center (U54) applications.

Scientific Research Project

The Scientific Research Project will be a single project focused on a single scientific topic. The Research Project will 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 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. Although not required, preliminary data or data from the literature would be valuable to support the scientific justification of the Scientific Research Project.

If successful, the Research Project should have the potential to mature into a comprehensive program that can lead to determining the underlying etiology of lower urinary tract symptoms. This approach for the study of the lower urinary tract symptoms could, for example, include the study of neural modulation, circadian rhythm, epigenetics 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. To accelerate the ability to plan for future translational studies, it is encouraged that fundamental studies within the Research project include lower urinary tract 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 solely in vitro studies are permissible, they would need to be carefully justified. These are broad examples meant only to provide illustration of potential directions, and not to be restrictive.

• 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 involving early organ maturation and its maintenance during normal aging in the development of lower urinary tract symptoms;
• Investigations involving age-dependent changes in function and response to injury of the lower urinary tract;
• 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 the genetics, development, and malformation of the lower urinary tract;
• Studies on the age-dependent changes in function and response to injury of the lower urinary tract;
• Studies on organ maturation and normal aging in the development of lower urinary tract symptoms;
• 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 generalized processes such as inflammation, adaptive or innate immunity, epigenetics, injury/regeneration, etc. in promoting, and amplifying the progression, or regression of urologic disorders;
• Identification and extensive phenotyping of animal models for modifiable risk factors (e.g., obesity, diabetes, acute infection) for 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 extensive 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.

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 not be reviewed.

Center Director

The Center Director should be an established investigator but need not have a record of accomplishment in urological research. The Center Director is expected to commit 2.4 person-months (equivalent to 20% full-time professional effort) and 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;
• establishing and maintaining internal communication, and cooperation among Center investigators;
• coordinating, managing, and integrating expertise and the studies under the Scientific Project;
• maintaining oversight of the Administrative Core and the Educational Enrichment Program;
• establishing and maintaining a website to advertise and highlight the activities of the Educational Enrichment Program;
• creating mechanisms for internal monitoring, for selecting, and replacing Center professional or technical personnel; and
• communicating with NIDDK program staff and the George M. O Brien Urology Cooperative Research Centers Program.

Research Team

A goal of the Developmental Centers 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. 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. 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. Because a goal of the Developmental Centers Program is to foster new research teams, applications will not be required to have preliminary data to establish the collaborative interactions of the Developmental Center members or present bona fides of the Developmental Center members as a well-integrated research team.

Specific examples of team members might include:

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

Administrative Core

The Administrative Director need not be the Center Director. The Administrative Core is expected to work closely with George M. O Brien Urology Cooperative Research Centers Program and to establish and maintain a website to advertise and highlight the activities of the Educational Enrichment Program. The Administrative Core is responsible for:

• providing clerical and administrative support, including communications with NIDDK and George M. O Brien Urology Cooperative Research Centers Program;
• the allocation and oversight of all Developmental Center resources;
• 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.

Educational Enrichment Program

The Educational Enrichment Program may comprise and include funds for

• a lecture series of experts from outside urology;
• visits from invited experts from outside urology and the institution; and
• summer student experiences (at the high school, college, and graduate or medical student level).

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 Resubmission The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIDDK intends to commit $1,000,000 in FY 2013 to support 3-4 Centers.
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	Scope of the proposed project should determine the project period. The maximum project period is 2 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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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.

Applicant organizations must complete the following registrations as described in the PHS 398 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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

All Program Directors/Principal Investigators (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 least6 weeks prior to the application due date.

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 PHS 398 Application Guide.

The Center Director should be an investigator with an established record of external funding, but need not have a record of accomplishment in urological research. However, the inclusion of a urologic clinician or physician scientist in the Developmental Center research team is required. It is expected that other Developmental Center 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 if they provide appropriate expertise. 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.

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

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

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

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

It is critical that applicants follow the instructions in the PHS 398 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.

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 research
• 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:

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: [email protected]

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: [email protected]

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For Section 2. Administrative Core, the research strategy is limited to 12 pages.
• For Section 3. Research Project, the research strategy section is limited to 12 pages.

To support the team building activities of the Developmental Centers program, the individual Centers will meet bi-annually in Bethesda, initially to introduce the Developmental Center teams and subsequently to discuss progress and to foster interactions with the George M. O Brien Urology Cooperative Research Centers Program. The first meeting will be on January 13-15, 2014. It is expected that Developmental Center Directors and personnel will freely communicate and work closely with the NIDDK staff and the George M. O Brien Urology Cooperative Research Centers Program.

Applicants must budget 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.

Applicants should 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.

Section 1: Relevant Background

• Face page
• Description (project summary and key personnel). Participants listed with less than 1.2 person-months (equivalent to 10% full-time professional effort) should not be listed as Personnel unless well justified, but should be listed as Other Significant Contributors.
• Table of contents
• Detailed budget for initial budget period (center)
• Budget for entire proposed project period (center)
• Biographical sketches for all center participants, begin with Center Director and Associate Director (if applicable) and the rest in alphabetical order
• Distribution of professional effort on this Center application
• All Personnel Report (for competitive renewal)
• Checklist

Section 2: Administrative Core

• Description (project summary and key personnel)
• Detailed budget for initial budget period (Administrative Core)
• Budget for entire proposed project period (Administrative Core), co-funding should be included in this section.
• Qualifications of the Director and Associate Director
• Resources including general overall description of facilities and institutional commitment
• Research plan should include
  • Description of the proposed Center. Include a brief description how the specific aims of 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.
  • Presentation of the administrative structure. Include the role of the Administrative Core in 1) the allocation and oversight 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.
  • Relationship and lines of authority and sanction by appropriate institutional officials. Include 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 Developmental Center. Specifically address administrative responsibilities between the collaborating institutions, organizational components, faculty, and staff.
  • Educational Enrichment Program. Include a description of 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.
  • 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 PHS 398 Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Other considerations:
• 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 PHS 398 Application Guide.

Section 3: Research Project

• Face page (if subcontract is involved)
• Description (project summary and key personnel)
• Detailed budget for initial budget period (research project)
• Budget for entire proposed project period (research project)
• Resources
• Research plan should include
  • Description of the Research team and eligibility of the team, see Section III.1.B
  • Vertebrate animal and or human subjects sections if appropriate
  • 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 PHS 398 Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Checklist (if subcontract is involved)
• 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 PHS 398 Application Guide.

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS 398 Application Guide.

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 PHS 398 Application Guide.

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be 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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Centert 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 Developmental 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/PI, 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?

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 provide the preliminary foundation 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 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?

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 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

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

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted 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 Council. 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.

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

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

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

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

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

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

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

Not Applicable.

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

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Deborah K. Hoshizaki, Ph.D.
Division of Kidney, Urologic and Hematologic Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-7712
FAX: (301) 480-3510
Email:[email protected]

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301- 594-8897
Email: [email protected]

Diana Ly
Grants Management Specialist
Grants Management Branch, Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-9249
Email: [email protected]

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

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