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	George M. O Brien Urology Cooperative Research Centers Program (U54)
Activity Code	U54 Specialized Center- Cooperative Agreements
Announcement Type	New
Related Notices	November 18, 2013 - This RFA has been reissued as RFA-DK-13-020. October 2, 2012 - See Notice NOT-DK-12-024. Technical Assistance Webinar for investigators who are planning to submit an application.
Funding Opportunity Announcement (FOA) Number	RFA-DK-12-009
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 George M. O Brien Urology Cooperative Research Centers Program. This program will provide a coordinated platform for multidisciplinary interactions between basic and clinical scientists with the goal of understanding the underlying etiology and the development, treatment, diagnosis, and prevention of specific clinically-oriented urologic disorders or diseases within NIDDK mission interests. This program will also serve as a national resource for career development of junior scientists electing to pursue research in benign urology.

Posted Date	September 20, 2012
Letter of Intent Due Date	November 14, 2012
Application Due Date(s)	December 14, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	April, 2013
Advisory Council Review	May, 2013
Earliest Start Date(s)	July, 2013
Expiration Date	December, 15, 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.

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 George M. O Brien Urology Cooperative Research Centers Program is designed to:

• conduct a wide range of basic, translational, and clinical research with the ultimate goal of improving the clinical diagnosis, detection, treatment and/or prevention of urologic disorders or diseases within the research mission of the NIDDK;
• develop, share and integrate institutional and national resources to facilitate clinical, translational, and basic scientific research on benign urologic diseases or disorders;
• attract established investigators new to non-malignant urological diseases and disorders within the mission of the NIDDK; and
• serve as a national resource for career development of junior scientists electing to conduct research in the field of urology.

The Cooperative Research Centers Program will consist of Research Centers and a single Coordinating Unit that will function with the NIDDK under a cooperative agreement as a multi-center research program. Within this Cooperative Research Centers Program, Center Directors are expected to work with NIDDK staff to promote and facilitate research collaborations and interactions within and between Centers, with the NIDDK Multidisciplinary K12 Urologic Research (KURe) Career Development Program (RFA-DK-07-006), the NIDDK Planning Centers for Interdisciplinary Research in Benign Urology (RFA-DK-12-003), and the research community to develop a national network that accelerates bi-directional knowledge between the laboratory and the clinic. The ultimate goal of the Centers program is to improve the urological health of the nation through enhanced communication, innovation and research excellence. The Centers are expected to conduct research to discover and develop promising new leads to advance our understanding of the etiology, prevention, diagnosis, and treatment of benign urological disease or disorders. The Centers shall also provide the research infrastructure to support collaborative research projects, to support the career development of junior scientists, and to recruit established investigators not previously involved in non-malignant urological research. The Coordinating Unit is expected to maintain websites and databases developed by Center investigators, carry out administrative tasks, organize Centers Program meetings, and provide centralized access to Biomedical Research Cores of the Centers. The Coordinating Unit will provide financial management of the Collaborative Research Project and the Pilot & Feasibility Programs.

The O'Brien Urology Research Centers (P50) were first solicited by the NIDDK in 1987 and most recently in 2008. The transition of the O Brien Urology Centers to a Cooperative Research Centers Program (U54) reflects the need to coordinate Centers' research efforts and to integrate the Centers with the wider research community in order to make advances in the treatment of benign urological disorders and diseases. 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, or chronic urologic pelvic pain syndromes. 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 are the gaps in our knowledge of the basic physiology, cell biology, and genetics of urological disorders; a lack of objective diagnostic criteria and tests to identify urologic diseases and disorders; inadequate in-depth characterization (phenotyping); and the paucity of information on the epidemiology and natural history of many of these illnesses. The absence of basic knowledge of the detailed structure and normal function of the urinary tract and associated organ systems (e.g., nervous system) makes it difficult to establish useful experimental in vivo or in silico models that lead to testable hypotheses and can be used to guide human studies. 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. Basic research expertise in disciplines 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. Expertise in the physical sciences such as physics, bio-engineering, chemical and mechanical engineering as well as in clinical sciences such as, urology, gastroenterology, gynecology, endocrinology, anesthesiology, and radiology will be instrumental and critical to advance the field of urology.

Research at each Center must coalesce on a single urologic disease or disorder or urological complication relevant to the NIDDK mission which will serve as a central theme for individual research projects. The Administrative Core for each Center may support research projects and Biomedical Research Core(s) at other institutions/organizations through subcontracts. These outside institutions may be at the local, regional, national, or even international levels.

Each Center will consist of:

• Research Projects minimum of 3 projects
• Administrative Core including an Educational Enrichment Program
• Biomedical Research Core(s) (optional)

The Centers will provide the infrastructure for sharing resources to enhance the efficiency of research and for fostering collaborations among the Centers, the NIDDK K12 KURe and the NIDDK P20 Planning Center. As such, Center participants are expected to work collaboratively among each other and within the Cooperative Research Centers program through sharing of resources and data. In addition, the investigator must agree to be an active participant in Cooperative Research Centers program activities as deemed necessary by appropriate oversight committees. The investigator must agree to participate in the Executive Steering Committee and be responsive to recommendations provided by an independent External Expert Panel.

The research projects of the Center must be interactively organized to conduct research to discover and develop new leads for the diagnosis, treatment, or prevention of a single major urologic disease or disorder or urological complication relevant to the NIDDK mission. A Center must propose scientific research projects from among at least two of the following types of studies: 1) clinical or patient-oriented studies (such as genetics, epidemiology, natural history of a disease), 2) translational (such as tools development, imaging, or diagnostic tools development), or 3) basic laboratory science. Research projects are encouraged to use resources and databases from NIDDK sponsored studies, such as the Urological Diseases in America Project (UDA), Boston Area Community Health Survey (BACH), NIDDK Data Repository, Medical Therapy of Prostatic Symptoms Study (MTOPS), Urinary Incontinence Treatment Network (UITN), NIDDK’s Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network, or the Lower Urinary Tract Dysfunction Research Network (LURN). Research with translational potential is strongly encouraged.

Examples of research areas appropriate for investigation are listed below, but are not comprehensive. An application focused on malignant urologic diseases or in which a research project is focused on malignant disease will be deemed non-responsive to this FOA and will not be accepted.

• Urolithiasis- including pathophysiology, natural history, epidemiology, prevention, stone formation and dissolution, therapy and treatment outcomes, stone diagnostics and therapeutic development, pediatric stone treatment and outcomes.
• Urinary Tract Infections- epidemiology, pathogenesis, adherence, bacteriology, diagnostics, and prevention in adult and pediatric populations.
• Lower Urinary Tract Symptoms (LUTS) in men and women/ Benign Prostatic Hypertrophy - natural history, prevention, treatment outcomes, therapeutic outcomes, prostatic biology and pathophysiology, genetics, diagnostic and therapeutic development.
• Urinary Incontinence, Normal Bladder Function and Dysfunction- Epidemiology , treatment outcomes, therapy, pathophysiology, basic bladder biology, neurobiology of bladder function and dysfunction.
• Erectile Dysfunction- basic biology and pathophysiology, epidemiology, natural history, therapeutic and treatment outcomes, diagnostic and interventional treatment.
• Chronic Urologic Pelvic Pain Syndromes - basic biology, natural history, pathophysiology, epidemiology, diagnostic development, potential model development, genetics, associated disorders.
• Urological Complications of Diabetes and Obesity - basic biology, natural history, pathophysiology, epidemiology, potential model development, genetics,
• Congenital Urinary Malformations of Vesicoureteral Reflux - basic biology, natural history, pathophysiology, epidemiology, potential model development, genetics

The following are examples of studies to address these disorders and do not represent a comprehensive list:

• 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
• Organ maturation and its maintenance during normal aging in the development of lower urinary tract symptoms, including the immune system and changes in function and response to injury of the lower urinary tract
• 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
• Role of different cell types in heterogeneously complex organs/tissues in initiating, maintaining, and regression of urinary tract symptoms
• 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 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 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 to relevant human populations (where possible)
• Development of tools for characterizing organ function and dysfunction, including patient reported outcomes, non-invasive imaging, biomarkers

The Center Director must be an established investigator with a demonstrated funding and publication record. The Center Director will be responsible for scientific and administrative leadership and is expected to commit 2.4 person-months (equivalent to 20% full-time professional effort) to the Center and will work closely with the Executive Steering Committee. One or more Associate Directors may be named as well. The combined directorship efforts should not exceed 6 person-months (equivalent to 50% full-time professional effort). The Center Director and Associated Directors may be from any discipline as long as the criteria for leadership are met. The Center administration may also wish to include an administrative assistant.

The Administrative Core will serve as the focus for the synergistic activities of the Center. It will be responsible for the management of resources within the Center. The Administrative Core will include an Educational Enrichment Program.

The Center administrative organization and management are determined by the individual Center (subject to NIH peer review). It is expected that the administrative organization of the Center will have a supportive structure, such as an Executive committee. The major responsibilities of the Administrative Core are to:

• Develop and maintain the vision and relevant goals of the Center;
• Coordinate, manage, and integrate the Center components and activities, which include coordinating ongoing research between the separately funded projects and the Biomedical Research Core (if proposed), harmonizing with the other Research Centers in the Cooperative Research Centers Program, and working with the Coordinating Unit;
• Create mechanisms for internal monitoring, including Center management, fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities;
• Establish and maintain internal communication and cooperation among Center investigators;
• Review productivity and effectiveness of the activities of the Center and create a mechanism for selecting and replacing Center professional or technical personnel;
• Terminate unsuccessful projects, cores, or activities; and
• Maintain oversight, review the use of, and administration of funds for the Educational Enrichment Program.

Educational Enrichment Program

The Administrative Core will be responsible for an Educational Enrichment Program that should further the overall aims and objectives of the Center. The Educational Enrichment Program may consist of seminar series, guest lectures, workshops, symposia, or other instructional opportunities. Students, fellows, and junior faculty should be encouraged to take full advantage of all Educational Enrichment Program events. It is permissible for Center Institutions to co-fund the activities of the Educational Enrichment Program. Travel support to attend meetings outside of the investigator's or trainee's discipline is encouraged.

External Advisory Committee

Although optional, the use of an External Advisory Committee for each Center is highly advisable. The members must not be named in the grant application; however, the process by which members are selected must be described in detail. This group, comprised of 3-5 members, may advise the Center Director and the Center's Executive committee in the areas of scientific direction, budget, policy, collaborations, or other areas.

The Biomedical Research Core is defined as a shared resource that provides specialized and essential services, techniques, or instrumentation to Center participants. The Biomedical Research Core enables the Center research projects to be carried out more efficiently and/or more effectively. Because the Biomedical Research Core provides specialized technologies and expertise needed to accomplish the stated goals of the Center, the Biomedical Research Core (if proposed) must be used by two or more of the research projects of the parent Center.

The Biomedical Research Core should be accessible to and should increase interactions between Centers and the NIDDK K12 KURe and the NIDDK P20 Planning Center programs through cross-project/laboratory exchange, and sharing of specialized tools, technologies, and expertise. The Biomedical Research Core may also provide services to funded research projects outside the Center.

Examples of types of Biomedical Research Core resources that would be considered include, but are not limited to:

• Collection, analysis, storage and distribution of data and samples
• Provision of specialized tools and technologies or access to specialized expertise
• Development, standardization and distribution of reagents and/or protocols
• Provision of technical assistance, training, and enrichment programs
• Recruitment of patients and coordination of patient studies
• Development, beta-testing and dissemination of specialty assays, methods, and services.

Each Center and the Coordinating Unit are expected to participate in two in-person Executive Steering Committee meetings the first year of funding and then annually thereafter. The first meeting will be held on September 9, 2013 in the Washington, DC area. The meetings will be organized and hosted by the Coordinating Unit. The purposes of these meetings are to share research experiences with other Centers, assess progress, identify new research opportunities, share materials, enhance and further the potential impact of the Centers. Travel funds for the Director and selected Research Center investigators and collaborators are to be budgeted.

NIDDK will support a single Coordinating Unit for the Cooperative Research Centers Program. The Coordinating Unit is separate from the Research Centers and an application for the Coordinating Unit does not need to be linked to a Research Center application. The Coordinating Unit will: 1) provide clerical and administrative support, 2) maintain and manage central databases, 3) fund and oversee financial management of Cooperative Research Centers Program-related expenses, including the Opportunity Pools program, 4) update and maintain Center internet and intranet websites, 5) promote each Center, and 6) facilitate collaborations, including access to Centers' Biomedical Research Cores.

Administrative Functions

• Facilitating cohesive and collaborative interactions by organizing, funding, and providing minutes/reports of regularly scheduled meetings and conference calls involving the Research Centers and their advisors. It is expected that the Coordinating Unit will coordinate and provide meeting support including organizing Executive Steering committee meetings and providing travel funds for annual External Expert Panel meetings.
  
  
• Organizing the monthly updates of Center activities, including progress reports, and teleconferences of Executive Steering Committee meetings and as needed for other subcommittees; providing minutes and reports of the Executive Steering Committee and External Expert Panel meetings; tracking and posting of minutes of regular meetings of Advisory Committees on a members-only website;
  
  
• Coordinating and maintaining public websites for each Center and providing logistical advice and support as-needed for maintaining individual Centers-related websites; develop and maintaining members-only websites, including establishment and maintenance of an Internet-based mechanism for rapid data and document transmission and electronic communication among participants in the Centers and between the Centers, the NIDDK K12 KURe and NIDDK P20 Planning Centers programs and the NIH; develop methods and means to document and disseminate Centers activities, including development and distribution of advertising materials for the Centers and Biomedical Research Cores, and any associated Opportunity Pool programs; updating and posting of protocols, Guidelines and Policies, and any associated Centers-related documents as deemed necessary by oversight committees and NIH staff.
  
  
• Managing the solicitation, review and selection of projects to be funded under the Opportunity Pools program; awarding subcontracts and providing fiscal oversight for each Center.
  
  
• Coordinating consortium activities across each Center, including collaborations with outside groups; preparation of consortium publications on best practices or standardized procedures; advertising training programs; optimizing Biomedical Research Cores services across Centers.
  
  
• Tracking of business activities and workflow at individual Centers; monitoring utilization of Biomedical Research Cores.
  
  
• Coordinating Unit will also organize meetings or workshops for the purpose of sharing information and data, obtaining feedback, training, exploring the need for new tests, or monitoring the value of a particular set of tests to the research community.

Coordinating Unit Personnel and Budget

The Coordinating Unit should have a Director, an administrator, and additional personnel as needed for its proposed activities. Because the Coordinating Unit will be responsible for hosting the annual evaluation meetings with the External Expert Panel, travel funds for members of the External Expert Panel should be budgeted.

Opportunity Pool Programs

The Opportunity Pool Program consists of the Pilot and Feasibility (P&F) program and the Collaborative Project program. The application should describe how the Coordinating Unit will oversee the solicitation, review, and selection of the Opportunity Pool program projects. The P&F Program is to support new research direction in benign urology or provide support for new investigators in benign urology. A P&F project is to allow the development of preliminary data for an application for independent research support. P&F projects are not intended to support or supplement ongoing research of an established investigator. P&F projects to investigate basic research findings in a clinical setting are encouraged.

The Collaborative Project Program seeks to support interaction between Center investigators, the NIDDK K12 KURe fellows, and/or investigators of the NIDDK P20 Planning Centers. Although funds are not provided directly for training purposes, the Collaborative Project Program should provide funds for specific training opportunities such as travel support of investigators to learn new laboratory techniques, develop new collaborations, mini-sabbaticals or engage in scientific information exchange.

Projects in the Opportunity Pool program should be integrated into the overall research goals of a specific Center and where possible make use of the resources provided by the Biomedical Research Core. It is permissible for Center Institutions to co-fund the activities of the Opportunity Pool Program.

Opportunity Pool projects are limited to $100,000 direct costs per year and are initially 2 years with an option to extend the project an additional year pending exceptional progress. It is expected that each Center will be associated with 2 to 4 projects. Funds for the Opportunity Pool program should be requested as part of the Coordinating Unit budget, and will be restricted for use to support Opportunity Pool projects pending an external expert panel review of the project, and approval by the Executive Steering Committee and by NIDDK.

DKUHD-NIDDK will conduct an administrative site visit to the Coordinating Unit and each Center in the first year of the grant with the purpose to view the organizational set up and working dynamics. The Coordinating Unit and each Center should expect follow-up site visits during the course of the award.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New 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 approximately 3 million dollars in FY 2013 to fund up to two new Research Centers and a single Coordinating Unit.
Award Budget	The Research Center budget is not limited, but needs to reflect actual needs of the proposed Center. The expected award for each Center will be up to $650,000 direct cost per year. The Coordinating Unit budget is not limited, but needs to reflect actual needs of the proposed Coordinating Unit. The expected award for the administrative component of the Coordinating Unit will be up to $300,000 direct cost per year and is separate from the funds expected to be awarded for the Opportunity Pool Program which is administered by the Coordinating Unit.
Award Project Period	The scope of the project should determine the project period. The maximum period is 5 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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually
• 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 least4-6 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/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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 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.

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, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• 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: fc15y@nih.gov

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

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For Research Center applications, the Research Strategy section is limited to:

• 12 pages for each research project;
• 12 pages for the Administrative Core; and
• 6 pages for each of the Biomedical Research Cores.

For Coordinating Unit applications, the Research Strategy section is limited to:

• 12 pages for the administrative component; and
• 12 pages for the Opportunity Pool Program.

Research Center Application-Content Order for Applications

Section 1: Relevant Background

• Face page
• Description (project summary and key personnel)
• 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
• 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 Strategy should include
  • Description of the proposed Center
  • Presentation of the administrative structure
  • Relationship and lines of authority and sanction by appropriate institutional officials
  • Educational Enrichment Program
  • Other considerations

Section 3: Individual Research Projects (present each project separately)

• Face page (if subcontract)
• 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
• Vertebrate animal and or human subjects sections if appropriate
• Checklist (if subcontract)

Section 4: Biomedical Research Cores (present each core separately)

• Descriptive abstract
• Detailed budget for initial budget period (Biomedical Research Core)
• Budget for entire proposed project period (Biomedical Research Core), co-funding should be included in this section.
• Resources
• Research Strategy should include
  • Objectives of the Biomedical Research Core
  • Core function, including quality control
  • Benefits from Core
  • Proposed developmental research or training
  • Investigators who will use the Core and proposed extent of use

Coordinating Unit Application-Content Order for Applications

Section 1: Relevant Background

• Face page
• Description (project summary and key personnel)
• Table of contents
• Detailed budget for initial budget period (Coordinating Unit)
• Budget for entire proposed project period (Coordinating Unit)
• Biographical sketches for all coordinating unit participants, begin with Coordinating Unit Director and Associate Director and the rest in alphabetical order
• Distribution of professional effort on this Coordinating Unit application
• Checklist

Section 2: Administrative Component

• Description (project summary and key personnel)
• Detailed Budget for Initial Budget Period (administrative component)
• Budget for Entire Proposed Project Period with comprehensive budgetary justifications (administrative component)
• Qualifications of the Director and Associate Director
• Resources should include general overall description of facilities and institutional commitment
• Research Strategy
  • Description of the proposed Coordinating Unit
  • Presentation of the administrative structure
  • Relationship and lines of authority and sanction by appropriate institutional officials
  • Other Considerations

Section 3: Opportunity Pool Program

• Description (project summary and key personnel)
• Detailed budget for initial budget period (Opportunity Pool Program)
• Budget for entire proposed project period with comprehensive budgetary justifications (Opportunity Pool Progr)
• Qualifications of the director, if different from the Coordinating Unit Director
• Resources should include general overall description of facilities and institutional commitment
• Research Strategy
  • Description of the Opportunity Pool Program
  • Management of the Opportunity Pool Program
  • Other considerations

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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.

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 the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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/priority score to reflect their assessment of the likelihood for the Research Center or Coordinating Unit 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 or Coordinating Unit proposed).

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

Significance

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

What is the relevance of the research projects and Biomedical Research Core to the theme of the Center? Is there a clear blueprint for integrating basic, translational, and/or clinical research projects and using knowledge gleaned from one to guide research in the other?

Does the Biomedical Research Core represent a unique and essential resource to the Center research projects?

Does the Administrative Core have a significant commitment to education, training, and career development of future research scientists?

Does the Coordinating Unit allow for significant leadership, effective organization, administrative support, and novel strategies to ensure global integrity of the Centers program, and outreach to NIDDK K12 KURe and NIDDK P20 Planning Center programs and the research community? Is there a plan that will result in a better comprehension by the community of the objectives and goals of the George M. O Brien Urology Cooperative Research Centers Program, a greater appreciation for research progress made as a result of funding and a better understanding of the implications of Centers Program in the supported of research for urological health?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center, research project, Administrative Core, Biomedical Research Core, Coordinating Unit, or administrative component ? 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?

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

If the project involves 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?

Does the Coordinating Unit have an effective plan for coordinating the Research Centers and intergrating the efforts of the Research Centers with outside groups?

Is there an effective plan by which the various components of the Center will be coordinated into one multi-disciplinary effort within the Center?

Are there defined lines of accountability regarding the internal management of the Center, interactions within the institution, and interactions with other Research Centers? Is there a suitable succession plan for replacing the Center Director and other key personnel?

Does each Biomedical Research Core have the required minimum of two documented research project users? Does the Biomedical Research Core have an effective plan for managing the core facility, including plans for advertising core facility services, managing user priority and establishing fee structure for cores offering services to external projects? Is there an efficient system (e.g.,web-based) for request of core services and tracking of core facility?

Does the administrative core have an effective plan to evaluate overall Center performance, including the projects and Biomedical Research Core (if proposed)? Is there a process where feedback will be used to modify and or terminate components? Does the administrative core have an effective plan for managing the Educational Enrichment program and for outreach to the NIDDK K12 KURe and the NIDDK P20 Planning Center programs and the research community?

Does the Coordinating Unit have an effective plan for housing, maintenance, and curate websites and intranet sites, managing the Opportunity Pool programs and for outreach to the NIDDK K12 KURe and NIDDK P20 Planning Center programs and the research community? Does the Coordinating Unit have an efficient system for advertising, monitoring, and for effective use of the Biomedical Research Core services and coordinating with other Biomedical Research Core facility?

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?

Is there clear evidence of institutional commitment to the Center or the Coordinating Unit such as space, protected time, and/or additional financial support for co-funded activities such as the Opportunity Pool program and Enrichment Educational Program?

Is there a suitable environment for Center interaction and cross-fertilization with scientists from other departments, fields of expertise, and institutions?

As applicable for the Center or the Coordinating Unit 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 project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the 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

Not Applicable

Revisions

Not Applicable

As applicable for the Research Center or Coordinating Unitt 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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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. Review assignments 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/priority score.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center 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.
• Compliance with resource sharing policies

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Pursuing research objectives consistent with the research scope of the FOA and research favorably recommended by peer review;
  
  
• Conducting experiments and collecting the resulting data;
  
  
• Analyzing, interpreting and presenting results and plans to the Executive Steering Committee for approved activities;
  
  
• Submit monthly interim progress reports, to the Coordinating Unit for distribution to the Executive Steering Committee. Such reports are in addition to the required annual noncompeting continuation progress report.
  
  
• Publishing results, conclusions, and interpretation of the studies.
  
  
• The awardees will agree to: 1) accept the coordinating role of the Executive Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of projects within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Executive Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or cores.
  
  
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Participating in the overall coordination of the George M. O Brien Urology Cooperative Research Centers Program with the Executive Steering Committee. This includes efforts to improve and strengthen inter- and intra-center cooperation amongst the research projects of the Centers, and the Opportunity Pool Program, K12 KURe and the P20 Planning Center programs particularly as it pertains to cross-fertilization of basic and clinical research activities within and between centers. As a means of improving inter-center cooperation, the Project Scientist will directly participate in the activities of the smaller collaborative groups as established by the Executive Steering Committee. This will include activity of the Opportunity Pool Program, the access to the Biomedical Research Core’s and outreach to the K12 KURe, the P20 Planning Centers and the research community.
  
  
• The Project Scientist will also assist the research efforts of the Cooperative Research Centers Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists.
  
  
• The Project Scientist will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Cooperative Research Centers Program and NIDDK. In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.
  
  
• Interact with each individual Center awardee evaluating objectives and research goals of that particular Center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Project Scientist will assist and facilitate this process and not direct it. The Project Scientist will also provide assistance in reviewing and commenting on all major transitional changes of an individual Center's activities prior to implementation to assure consistency with required goals of the George M. O Brien Urology Cooperative Research Centers Program.
  
  
• Retain the option to recommend the withholding of support from a Center research project or core materially failing to meet the technical performance requirements established by this Centers Program. This includes identifying jointly with participants of the Executive Steering Committee the need to add additional research projects or service cores to Centers or to phase out a Center project or core when performance standards have not been met; and
  
  
• Participate, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co-authorship of the publication or results of studies conducted by the Centers.

In addition, a separate NIDDK Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include:

• Interacting with the principal investigator(s) on a regular basis to monitor project progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Executive Steering Committee, data safety and monitoring board, and related meetings.
  
  
• The NIDDK Program Official will monitor project progress, and may request that a project or portions of a project be closed for reasons including: (a) poor progress; (b) patient safety and regulatory concerns; (c) emergence of new information that diminishes the scientific importance of the project.
  
  
• Making recommendations for continued funding based on: a) overall project progress; b) cooperation in carrying out the research (e.g., attendance at Executive Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

Areas of Joint Responsibility include:

• Participating on an Executive Steering Committee consisting of the Directors from each of the participating centers and one NIDDK staff member who will be the Project Scientist. A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. Each full member of the Executive Steering Committee will have one vote. The purpose of the Executive Steering Committees will be to discuss and evaluate concerns and cooperative activities of the Cooperative Research Centers Program. The Executive Steering Committee will discuss and evaluate the activity of the Opportunity Pool Program, Biomedical Research Cores, and evaluate progress on research projects. The Executive Steering Committees will provide feedback to Subcommittee leaders at least bi-annually, implement changes in subcommittee membership or direction if needed. Awardee members of the Executive Steering Committee will be required to accept and implement policies approved by the Executive Steering Committee.
  
  
• Meetings of the Executive Steering Committee will be convened twice during the first year and annually thereafter. The annual meeting will include the External Expert Panel. These meetings are separate from the monthly conference calls. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaborations such as with industry, private foundations and/or NIH intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, and reallocate resources. The Executive Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.
  
  
• In anticipation that some centers will have common research interests that address a specific basic and/or clinical research problem and thus, it is envisioned that research for Coordinating Units groups will be formed to conduct coordinated research activities recommended by the Executive Steering Committee. As needed, the Executive Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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: 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

Deborah K. Hoshizaki
Program Officer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7712
Email: hoshizakid@mail.nih.gov

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.

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

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.