Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)

Title: George M. O’Brien Urology Research Centers (P50)

Announcement Type
This is a reissue of RFA-DK-07-004.  

Request For Applications (RFA) Number: RFA-DK-08-016  

Catalog of Federal Domestic Assistance Number(s)
93.847

Key Dates
Release Date: December 31, 2008
Letters of Intent Receipt Date: February 18, 2009
Application Receipt Date: March 18, 2009
Peer Review Date(s): June – July 2009
Council Review Date(s):  August 2009
Earliest Anticipated Start Date: September 2009
Additional Information To Be Available Date (Url Activation Date): December 1, 2008
Expiration Date: March 19, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing

   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for George M. O’Brien Urology Research Centers to:

A Center will also support pilot and feasibility studies to develop and test innovative approaches to therapy, tools, or improve diagnoses; as well as develop an Educational Enrichment Program. Furthermore, Centers collaboration and interactions will be enhanced by frequent conference calls. A national, in-person meeting of all the funded Centers will be scheduled twice in year one and then annually thereafter.  

Overview:

Each Center must address a single major clinically-oriented urologic syndrome or disease (“theme”) that is within NIDDK’s mission. Each Center must include:

Close collaboration and interactions among Centers will be enhanced with regularly scheduled conference calls and in-person meetings.

Background:

The first solicitation of the O’Brien Urology Research Centers occurred in 1987. In February 2007, the NIDDK sponsored the Workshop on Advancing Urologic Science and Career Development. Summary of this meeting can be located through a link at the Website: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/OBrien_Updates.htm. From this meeting, the NIDDK now seeks to enhance this program to potentially allow for regional, national and even international collaborations. Like many surgical specialties, the field of urology has changed significantly with advancing technology in diagnostic and therapeutic options for non-malignant urologic diseases over the past two decades. Minimally invasive surgeries and procedures have changed the clinical management of these patients. However, millions of Americans are afflicted with urologic disorders and diseases including urinary tract infections, urolithiasis, lower urinary tract symptoms 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.

Despite advances, clinical, translational, and basic research is still needed to successfully reduce the burden of urologic diseases and disorders in the U.S. population.  Examples of gaps in our understanding include lack of objective diagnostic criteria/tests to identify diseases and disorders, inadequate phenotyping, and lack of information on the epidemiology and natural history for many of these illnesses.  In addition, there are few useful experimental models, either animal or computer generated phantoms, to aid in translating results to humans.  Translational tools, such as imaging techniques and biomarkers need to be developed and applied to these illnesses if significant advances are to be made in the coming years. 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 remain as the essential foundation of urologic research. Expertise in the physical sciences such as physics, bio-engineering, chemical and mechanical engineering as well as in other clinical sciences such as neurology and neurobiology, gastroenterology, gynecology, endocrinology, anesthesiology, and radiology will be extremely helpful and critical to help advance these fields of urology.

Research Goals and Scope:

The goals of the George M O’Brien Urology Research Centers are to 1) advance research and insight into clinical urologic diseases and syndromes; 2) provide an interdisciplinary and multidisciplinary foundation for communication and collaboration between translational or basic scientists and clinical researchers in the field of urologic disease that will ultimately improve the diagnosis, prevention, and treatment of urologic disorders and diseases; 3) attract new scientific expertise and/or  new investigators to study clinical urological diseases and disorders, and 4) integrate urologic research into the surrounding institution. Research with clinical or translational potential is strongly encouraged. Centers will provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of urologic disease research.  Centers should be located in a single institution but may have participation and sharing of resources by multiple institutions with complementary research bases through subcontracts. Sharing research bases in other institutions may be at the local, regional, national, or even international levels.

Research at each George M. O’Brien Urology Center must be centered on a single clinically-oriented major urologic disease or disorder relevant to NIDDK’s research mission, which will serve as a central theme for individual research projects and the biomedical core(s). The Center must provide an interdisciplinary approach utilizing clinical, translational and basic science research.

The scope of these projects should be on genitourinary urologic disorders and diseases relevant to NIDDK mission interests. For detailed listing of NIDDK mission interests, see the link at the Website at:  http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/OBrien_Updates.htm. An applicant whose focus is on malignant urologic diseases will be deemed non-responsive to this FOA. Representative areas of research appropriate for investigation include, but are not limited to:

Project Organization

Each Center will consist of the following key components, described below:

Main Multi-disciplinary Research Projects:

At least three individual, but interrelated, research projects, each with high scientific merit and clear research objectives must be devoted to a single, specific theme which is a clinically-oriented major urologic disorder or disease within NIDDK mission interests. Each project will be evaluated on its ability to advance the clinically-oriented theme of the Center in terms of contributions to the understanding of the underlying mechanism, diagnosis, treatment, or prevention of the clinical disease or disorder theme of the Center. The combined efforts of these projects should aid the development of fundamental knowledge leading to the understanding of urologic disease processes and the design of treatment or preventative strategies which will further advancement in the field of Urology. At least one of the Multi-disciplinary Research Projects must be in clinical research such as clinical or patient-oriented studies (such as genetics, epidemiology, or the natural history of a disease). The remaining research projects can be clinical, translational, or basic science research, each of which clearly is interrelated and reflective of the clinical theme of the Center.  Regardless of clinical, translational, or basic science fields, each individual project must clearly specify the clinical impact of the research goal of the project. In addition, each project must have multidisciplinary component of at least two different fields from the key personnel. Examples are different basic science fields, different clinical specialties, an engineering science with clinical specialty, or any such combination.

Projects may be proposed which use resources from NIDDK sponsored studies and databases, such as from the Urological Diseases in America Project (UDA), Boston Area Community Health Survey (BACH), NIDDK Data Repository, Medical Therapy of Prostatic Symptoms Study (MTOPS), and other such studies.

Biomedical Research Core:

A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants, enabling them to conduct their funded individual research projects more efficiently and/or more effectively.  Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center. Minimum usage for the Biomedical Research Core is use by two or more main projects. Pilot and feasibility projects can use the biomedical core resources but its usage does not count towards the minimal usage requirements.  Cores should aim to increase multidisciplinary interactions at the institution through cross-project/laboratory exchange, and sharing of specialized tools, technologies and expertise between collaborating investigators. Each core should provide services to multiple funded research projects.  Centers may propose either Institutional Cores or Regional/National/International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. A new category of research base for cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might expect to use the core in some way. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, it will be evaluated as part of the core, in order to distinguish it from the local institutional research base. 

Examples of types of biomedical core resources that would be considered responsive to this Request for Applications include, but are not limited to:

Administrative Core:

Applicants must describe an administrative core which will provide intellectual leadership and serve as a foundation for synergistic activities for the Center, and be responsible for allocation and distribution of resources within the Center and to Center participants.  Additionally, the administrative core will include the Pilot and Feasibility Program, the Educational Enrichment Program, and will provide travel funds for core personnel.

The Center Director must be an established investigator in urologic research and will be responsible for scientific and administrative leadership. The Center Director is expected to commit 20% overall effort to the Center.  One or more Associate Directors should be named as well. Total directorship efforts combined should not exceed 50% effort.  The Center Director and Associate 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. 

While a Center’s administrative framework for management is left up to each Center (subject to NIH peer review), it is expected that the administrative organization of the Center will include a supportive structure, such as an internal executive committee.  Together, the major responsibilities of the Director, Associate Director(s), and the committee include: 

A record of actions by this committee must be documented and be available if requested by the initial review group.  In the case of renewal applications, all applicants should describe the effectiveness of the previous governess structure, and what has been changed.

External Advisory Committee—Although optional, the use of an External Advisory Committee is highly advisable. The members must not be named in the grant application; however, the process under which members are selected must be described in detail. This group, comprised of 3-5 members, may advise the Center Director(s) and internal executive committee in the areas of budget, policy, collaborations, or other areas and may provide another level of scientific review for the Pilot and Feasibility program.

Pilot and Feasibility Program.

The Administrative Core must include a cohesive Pilot and Feasibility Program that seeks to develop new research directions or provide an opportunity for new investigators or established investigators to enter the field of urologic research. This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the cores.  The application should describe how the Center will oversee the solicitation, review and selection of the pilot projects. A Pilot and Feasibility project is intended to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data as a basis for an application for independent research support.  Pilot and Feasibility projects are not intended to support or supplement ongoing research of an established investigator. Pilot and Feasibility projects could include clinical projects to investigate basic research findings in a clinical setting. Each Core Center application must include a minimum of two up to a maximum of four pilot projects. In the application, each project description (encompassing research goals, design, and method) should not exceed 8 pages. Each pilot project may request a maximum of $60,000 direct costs per year (excluding Facility and Administrative costs) (NOT-OD-04-040) for up to two years. Institutional supplementation of this program is strongly encouraged as it is permissible for Center Institutions to co-fund the activities of the Pilot and Feasibility Program.

After the initial review of Pilot and Feasibility proposals as described above, all responsibility for review and funding during the remainder of the project period will reside within the Center itself.  This approach provides each Center with the needed flexibility for effective and efficient management of the program. 

Pilot & Feasibility Program in competing renewal applications: 

The review of this program will be based on the past track record, the management of the program, and an assessment of overall potential needs and opportunities. In general, a competing renewal application will include:  (1) an historical overview; (2) a description of Center management of the program; (3) a description of the method for solicitation for pilot and feasibility projects and the number of respondents received for each solicitation; (4) a listing of all previous, ongoing and approved proposed Pilot and Feasibility studies with reports on those which were supported by the Center during the last project period; and (5) a statement relating to benefits of the program to the Center as well as the contribution of the uniqueness of the Center environment to the program.  Further details can be found at the O’Brien’s Urology Center Web site at: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/OBrien_Updates.htm.  

On renewal applications, funding levels for the Pilot and Feasibility program is described as follows.  The format for renewal of pilot and feasibility programs will depend on whether the applicant is requesting:  (1) a number of pilot projects less than or equal to that for the previous project period, or (2) an increase in the number of pilot projects.  If the applicant wishes to maintain the same number of pilot projects in a renewal application, the recommendation of the initial review group will be based on the overall performance of the Center's Pilot and Feasibility program as documented in the application.  This recommendation will be based on: (1) the extent to which awarded funds were fully utilized during the previous project period; (2) awards were made to investigators who fully met the eligibility criteria for pilot and feasibility support as outlined above; (3) Center-relatedness; and (4) success of previously supported pilot and feasibility studies (e.g., publications, subsequent independent R01 or other peer-reviewed support, and/or attraction of new investigator into Center related research).

Conversely, should the applicant institution feel that an increased level of funding for the pilot and feasibility program is justified, new pilot and feasibility studies, over and above the number currently awarded, must be submitted with the competing renewal application.  These proposals would be reviewed by the initial review group in a fashion similar to the review of pilot and feasibility studies during the initial review.  The initial review group would assess the new proposals, along with the overall performance of the program during the previous grant period to arrive at a recommendation for a possible increased pilot and feasibility funding level.

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, mentor-training courses, symposia, adult learning experiences, mini-sabbaticals, or other instructional opportunities. Students, fellows, and junior faculty should be encouraged to take full advantage of all Educational Enrichment Program events. Although funds are not provided directly for training purposes, the program enrichment activities should provide funding for specific training opportunities for Center members. For example, limited travel support is allowable for center investigators to travel to present scientific findings, learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. It is permissible for Center Institutions to co-fund the activities of the Educational Enrichment Program. Centers are encouraged to take advantage of other NIDDK teaching resources such as the NIDDK Multidisciplinary K12 Urologic Research (KURe) Career Development Program.

George M. O’Brien Urology Centers Meetings.

Each Center is expected to participate in two in-person national meetings the first year of funding and then annually thereafter. The meetings will be organized and convened by the DKUHD-NIDDK. The purpose 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 Principal Investigator and selected O’Brien Urology Research Center investigators and collaborators are to be budgeted for these purposes. The meetings will be held in the Washington, D.C. region.

Site Visits.

Initial Site Visit: DKUHD-NIDDK will conduct an administrative site visit to each center in the first year of the grant with the purpose to view the organizational set up and working dynamics of each center.

Follow Up Site Visits: Each center should expect site visits from DKUHD-NIDDK during the course of the grant.

Special Considerations:

While each Center will be expected to develop its own program in accordance with local expertise, interests, and resources; each must be responsive to national needs to develop therapies for urologic diseases and disorders and must be willing to work with the NIDDK and other Federal and national organizations in furthering the overall goals of the George M. O’Brien Urology Research Center Program.  In this regard, the Center Director and selected other Center participants may be invited to meet periodically with NIDDK staff and its consultants to review progress, identify emerging needs and opportunities, and plan approaches for future investigations.

Within the context of these guidelines, potential applicants for Center grants are encouraged to exercise the flexibility necessary to utilize the strengths of their particular institutions in preparing a plan which will eventually cover the spectrum of required activities.  While types of activities which should be included are indicated in the guidelines, specific approaches for their accomplishment are left to the individual applicant.

Because of resource limitations and in light of the size of the Center grants, it is unlikely that NIDDK will be in a position to provide hardship allowances in the event that an application for renewal of Center support is not funded.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the P50 award mechanism.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The estimated amount of funds available for support of 2 centers projects awarded as a result of this announcement is $2,000,000 for fiscal year 2009.  Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

To be considered eligible, applicant organizations must have: (1) a statement of institutional commitment that addresses how the institution will incorporate the O’Brien Urology Research Center high within its institutional priorities. Specific institutional support should be included in this statement. Examples of tangible institutional support for the O’Brien’s Urology Center include protected investigator time, facilities support, co-funding (e.g. sponsorship of pilot and feasibility projects, additional support of educational enrichment activities, additional cores, projects, etc.) (2) a diverse research base of three or more research projects involving at least one clinical research project and two or more additional projects in basic, translational, or clinical sciences, and (3) appropriate shared resources to support the proposed research of the O’Brien Urology Research Center.

Foreign institutions are not eligible to apply as the applicant organization; however, consortia subcontract agreements with foreign institutions are permitted.

Number of Applications. Applicant organizations may not submit more than one application.

Resubmissions. Applicants may submit a resubmission application; however, such application must include an Introduction addressing issues raised in the previous critiques (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals. Renewal applications will be permitted for this FOA.

Applicant organizations may not submit more than one application.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5939.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Special Program Requirements:

Content Order for Applications

Section 1:  Relevant Background

Face Page: The RFA label must be affixed to the bottom of the face page and the title, “George M. O’Brien Urology Research Centers,” the RFA number must be typed on line 2, and the YES box must be marked.

Description         

Table of Contents

Budgets

Biographical Sketches for all Center participants beginning with Center Director and Associate Director and the rest in alphabetical order

Distribution of Professional Effort on this Center application

General description of the proposed or established Center

For Renewals: Changes from the original Center design should be highlighted

Section 2:  Administrative Component

Section 3: Overview of ongoing research and impact of Center on this research.

Section 4: Individual Multi-disciplinary Research Projects (present each project separately)

Section 5:  Biomedical Research Cores (present each core separately)

Section 6: Pilot and Feasibility Program

Section 7: Educational Enrichment Program

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date: February 18, 2009
Application Receipt Date: March 18, 2009
Peer Review Date(s): June-July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: September 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452 (courier Zip Code 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email:fc15y@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452 (courier Zip Code 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Research Plan Page Limitations

Each individual project research plan is limited to 25 pages.

Each pilot and feasibility research plan is limited to 8 pages.

Appendix Materials

All paper PHS 398 must provide appendix material on CDs only. Include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)p

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Diabetes and Digestive and Kidney Diseases and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the relevance of the separate multi-disciplinary research projects and cores to the Center objectives? Specifically for the projects, how does each Multi-disciplinary Research Project advance the clinically-oriented theme of the Center in terms of contributions to the understanding of the underlying mechanism, diagnosis, treatment, or prevention of the clinical disease or disorder theme of the Center? What is the potential of the Biomedical Research Cores for contribution to ongoing research, including their appropriateness, impact, relevance, uniqueness, modes of operation, and suitability of facilities? Do renewal applications document the use, impact, quality control, and cost effectiveness of each core, and demonstrate progress of the Pilot and Feasibility research projects? In the Educational Enrichment Program, is there a significant commitment to education, training, and career development of future research scientists?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there synergy among the Multi-disciplinary Research Projects and the Biomedical and administrative cores? Is there a minimum of three main Multi-disciplinary Research Projects with at least one clinical project? Does each individual research project promote multidisciplinary interactions and research to solve a common research question reflective of the clinically-oriented theme? Does each Multi-disciplinary Research Project have a minimum of investigators from two different fields working together? Does each Biomedical Research Core have at a minimum two documented main project users? Is there efficient and effective use of the limited pilot and feasibility funds and educational enrichment funds, including the contribution of these activities in enhancing the objectives of the Center?  

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Are two to four Pilot & Feasibility (P&F) studies submitted for evaluation as part of the review of the P&F program?  Are the P&F applicants eligible and is there an adequate selection process by which the individual studies were selected? For competing continuation applications, are data supplied on the success of previously funded P&F projects in obtaining outside support?  

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? What is the likelihood for meaningful collaboration among Center investigators? Are the Center investigators willing to interact and synergize with each other and contribute to the overall objectives of the O’Brien Center, and with other O’Brien Urology Centers? What are the scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program? Does the Center Director have a minimum 20% time commitment to the Center? Is appropriate administrative organization proposed for the following: (a) Coordination of ongoing research between the Multi-disciplinary Research Projects and Biomedical Research Core(s) and the Center, including mechanisms for internal monitoring; (b) Establishment and maintenance of internal communication and cooperation among the Center investigators; (c) Mechanism for selecting and replacing Center professional or technical personnel; (d) Mechanism for reviewing the use of and administering funds for the Pilot and Feasibility program and the Educational Enrichment program; (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities?   

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there an institutional commitment to the Center, including clear evidence of institutional support (space, protected time, and/or additional financial support for co-funded activities such as P& F and Enrichment Educational Program)? Are there defined lines of accountability regarding the internal management of the Center, interactions within the institution, and interactions with other O’Brien Urology Centers? Is there a suitable environment for interaction and cross fertilization with scientists from other departments, fields of expertise, and institutions?

NIH considers the following in evaluating Center grant applications:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Debuene Chang, M.D.
Division of Kidney, Urology and Hematology
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy 2, Room 613
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: dc475y@nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases 
6707 Democracy Boulevard, Room 752 
Bethesda , MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3. Financial or Grants Management Contacts:

William Etti, M.B.A.
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 722
Bethesda, MD 20892-5456
Telephone: (301) 594-7451
FAX: (301) 594-9523
Email: we20o@nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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