GEORGE M. O"BRIEN UROLOGY RESEARCH CENTERS
 
RELEASE DATE:  May 8, 2002

RFA:  DK-02-032 (Reissued as RFA-DK-07-004)
 
PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Diabetes and Digestive and Kidney Diseases   
 (http://www.niddk.nih.gov/)
National Cancer Institute 
 (http://www.nci.nih.gov) 

LETTER OF INTENT RECEIPT DATE:  October 17, 2002
APPLICATION RECEIPT DATE:  November 19, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA

This Request for Applications (RFA) invites investigators to submit research 
applications for the George M. O"Brien Urology Research Centers Program.  The 
emphases for this program are fourfold (1) to continue to attract new 
scientific expertise into the study of the basic mechanisms of urological 
diseases and disorders, (2) to encourage multidisciplinary research focused 
on the causes of these diseases, 3) explore new basic areas that may have 
clinical research application, and 4) generate *Developmental Research 
(DR)/Pilot and Feasibility (P&F) studies of two years duration, which are 
anticipated will lead to new and innovative approaches to study urological
disease, and the eventual submission of competitive investigator-initiated 
R01 research grant applications.
 
The mounting complexities associated with the studies of disease processes 
will likely require investigators who have training and expertise in 
disciplines such as cell and molecular biology, biochemistry, physiology, 
genomics and proteomics, developmental biology, tissue engineering, 
epidemiology, immunology and pathology.  In addition, appropriate expertise 
will likely include a focus into topical areas, such as factors influencing 
the development and progression of benign prostate growth, understanding 
bladder urothelium responses to infections, effects of diabetes on lower 
urinary tract, immunobiology and neurobiology of the lower urinary tract and 
relationship to urological disease, factors influencing the development of 
urolithiasis, genetics of urological diseases, factors influencing normal and 
abnormal bladder urothelial biology, etc.

The major emphasis of these projects should be on understanding the normal 
growth and development processes of the urinary tract and the development of 
non-malignant disorders, e.g. benign prostatic hyperplasia, prostatitis, 
urinary incontinence and dysfunctional voiding, urinary tract infections, 
interstitial cystitis, pediatric bladder and developmental urological 
disorders, erectile function, urinary tract stone disease, chronic pelvic pain 
of bladder origin, as well as the urological malignancies.   

Individual institutions with both basic and clinical research capabilities 
are eligible to apply.  Inter-institutional collaborative research 
arrangements are also appropriate and encouraged.  Coordination for such 
arrangements must be evident and clearly meaningful and appropriate for the 
research proposed.

*Generally DR/P&F proposals are expected to have limited preliminary data and 
are reviewed based on the clear development of hypotheses and supporting 
literature.

RESEARCH OBJECTIVES

Background

The application of human genomic information to improve clinical outcome is a 
major challenge facing biomedical researchers today.  Nevertheless, with the 
elucidation of the human genome, there has been an explosion of new methods 
and technologies that should allow for the routine discovery of new genes and 
the identification of their biological relevancy.  However, the understanding 
of normal cellular processes and the development and progression of urological 
diseases will require more than the delineation of an array of complex 
protein-protein interacting pathways.  These pathways are aberrantly modified 
in disease states and reflected in the subtle protein changes in the cell.  
Such changes in protein expression are likely to be translated into changes in 
cell growth, differentiation, and/or apoptosis.  In addition, because of the 
complexity and heterogeneity of many of the urological diseases there is an 
ever increasing need for the to utilize these new molecular approaches to well 
characterized experimental animal models for the study the physiology and 
neurophysiology of lower urinary tract function. 

Prospective applicants are urged to consult the research priorities web pages 
of both the NIDDK and NCI for additional urological research areas of interest 
to the institutes: www.niddk.nih.gov/fund/fund.htm and 
www.nci.nih.gov/research_programs/priorities/.

The O"Brien Research Center must be an identifiable unit within a single 
university medical center, or within a consortium of cooperating institutions 
with a university affiliation.  The original intent of the O"Brien Research 
Centers was to bring together investigators from relevant disciplines in a 
manner that would enhance and extend the effectiveness of research related to 
the urological disease and its complications.  More recently the overall goal 
of the O"Brien Urology Research Center has been expanded to bring together, in 
a cooperative, multidisciplinary and integrative manner, basic science and 
clinical investigators to enrich the effectiveness of research into causes, 
treatment and cure of the many urological diseases which fall within the 
purview of the NIDDK.
  
For this purpose the center director should clearly define criteria that is 
used to select an investigator as a center grant participant.  The O"Brien 
Urology Research Center must also address the scientific information base and 
provide focal points for sustaining and maintaining state-of-the-art research 
that will contribute to improved detection, diagnosis, treatment and 
prevention of the urological diseases and disorders.  These centers are 
expected to conduct a wide spectrum of research activities that will 
contribute significantly to the development of specialized research resources, 
the development of improved research model systems and the expansion of the 
research base through collaborative research with scientists and clinicians in 
other institutions locally and nationwide.  

Interrelated, basic research subprojects, each with high scientific merit and 
clear research objectives have been the hallmarks of the O"Brien Urology 
Research Centers program.  In the aggregate, the subprojects should continue 
to be directed to the development of fundamental knowledge leading to the 
understanding of urological disease processes and the design of curative or 
preventive strategies.  However, a new dimension to the centers program is 
the requirement to include Research Development/Pilot and Feasibility (P&F) 
project(s) as integral components of the centers concept (described below).  
Core facilities that will benefit the overall centers program are likely 
components of a center (described below).   

Core Facilities

Core facilities in an O"Brien Urology Research Center are shared resources 
that enhance productivity or in other ways benefit a group of investigators 
working to accomplish the stated goals of the center.  Cores should be 
designed to furnish a group of investigators with a specific technique, 
service, determination, or instrumentation in a manner that will enhance the 
research in progress, consolidate manpower effort, and contribute to cost-
effectiveness by providing a service at lower cost and possibly higher quality 
than if each investigator were to attempt the same activity individually. 
Cores may be proposed in relation to any acceptable research activity of the 
center, but usually fall into one of four categories: (l) provision of a 
technology that lends itself to automation or preparation in large batches 
(e.g., radioimmunoassay and tissue culture), (2) complex instrumentation 
(e.g., electron microscopy or mass spectrometry), (3) animal preparation and 
care, and (4) technical assistance and training (e.g., molecular biology).

Examples of possible core resources that would be considered within the scope 
of this request for applications include the following:

o Molecular biology core to supply oligonucleotides and provide automated 
DNA sequencing capability,
o Animal models core to develop, breed, and maintain animal models for 
diseases of interest, which can be used to improve understanding of the 
human forms of the disease,
o Tissue culture core for the harvest, cultivation, and handling of large 
numbers of cells,
o Other cores needed to characterize gene transfer systems.

These cores are not listed in any particular order, nor should they be 
construed to represent a comprehensive list of cores that could be fostered 
under this program. 

The establishment of and continued support for biomedical research cores 
within an O"Brien Urology Research Center must be justified on the basis of 
use by Center investigators.  The minimum requirement is significant usage by 
two or more principal investigators each with a Center project.  A director 
must be named for each core.  The organization and proposed mode of operation 
of each core should be described, with a plan for prioritizing investigator 
use of the core as well as the criteria for determining core users or 
potential users.

Each core must have in place a procedure to evaluate efficiency and to 
maintain appropriate quality control. Limited developmental research is an 
additional appropriate function of a core facility, so long as the research is 
related directly to enhancing the function or utility of the core and is not 
an undertaking that should be funded through other mechanisms.  Teaching the 
investigators and/or their staff members" new techniques and methodologies is 
also an important function of the cores.  The cores are not intended to 
supplant investigator capabilities, rather, they are intended to enhance the 
opportunities of investigators to learn and become proficient in the 
technologies available through the core.

Developmental Research (DR)/Pilot and Feasibility (P&F) Projects 

The DR/P&F program should provide modest support for innovative initiatives 
with the potential to advance progress in understanding cellular and molecular 
mechanisms that initiate or are involved in the progression of specific 
urological diseases.  This program is directed toward both 
new/young and established investigators who wish to explore the feasibility of 
a novel approach to a problem in this area.  Investigators eligible for DR/P&F 
funding fall into three general categories: (1) new investigators without 
current or past NIH support as a principal investigator, and whose current or 
previous support from other sources have been modest, (2) established 
investigators with limited previous Urology research experience who wish to 
apply their expertise to a problem in this area, and (3) established 
urological investigators who propose testing innovative ideas that represent a 
clear departure from their ongoing research directions.  It is anticipated 
that the majority of the recipients of DR/P&F funding will be from the first 
category.  

Each DR/P&F study award is intended to provide a modest amount of support, not 
to exceed $60,000 direct costs/year, for duration not to exceed two years, 
which will allow an investigator the opportunity to develop sufficient 
preliminary data to provide the basis for an application for independent 
research support.  DR/P&F study support is not intended for large projects by 
established investigators, which otherwise would be submitted as separate 
research grant applications.  DR/P&F funds also are not intended to support or 
supplement ongoing funded research of an investigator.

Each DR/P&F study proposal should state clearly the justification for 
eligibility of the investigator under one of the above three criteria.  A 
proposed DR/P&F study should present a testable hypothesis and clearly 
delineate the question being asked, detail the procedures to be followed, and 
discuss how the data will be analyzed.  The DR/P&F studies should be submitted 
for review generally in the format of NIH research project applications (R01), 
but with a 15-page limitation for the entire application. 

The Administrative Core oversees the handling and implementation of any DR/P&F 
program. Within this structure, each applicant institution must also establish 
a mechanism to oversee the ongoing use of funds for the proposed DR/P&F 
program. This mechanism must include the use of appropriate consultants 
(described below) for review from the scientific community external to the 
center.  These same consultants may, if desired, review and assess other 
activities of the center and may constitute the external advisory group to the 
center.  The external advisory committee need not be named in advance of the 
application submission, only the mechanism for use of the proposed DR/P&F 
program.  The projects selected to receive these funds are to be described by 
the Director in the DR/P&F section of the application.
  
Enrichment and Educational Program

The O"Brien Urology Research Center grant may budget for and provide limited 
support for an optional enrichment program, whose description and budget may 
also be included within the administrative core of the centers application.  
It may provide support for visiting scientists, seminars, and research forums.  
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.  In all cases, 
the enrichment program should further the overall aims and objectives of the 
center as well as of the scientific cores.  
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) P50 Specialized 
Center award mechanism.  This mechanism supports the full range of research 
and development from basic to clinical and intervention studies.  The 
spectrum of activities comprises a multidisciplinary approach on a specific 
urological disease process or biomedical problem. These grants differ from 
traditional program project (P01) grants in that they are more complex and 
flexible in terms of the activities that can be supported.  In addition to 
support for multidisciplinary research projects, support is also provided for 
pilot research projects, specialized resources, and shared core facilities.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for 
an application submitted in response to this RFA may not exceed five (5) 
years.  Awards will be administered under NIH grants policy as stated in the 
NIH Grants Policy Statement.

Applicants from institutions which have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research. In 
such a case, a letter of agreement from either the GCRC program director or 
principal investigator should be included with the application.  

This RFA is a one-time solicitation.  The earliest anticipated award date is 
July 1, 2003.

FUNDS AVAILABLE

The NIDDK and NCI intend to provide sufficient funds in FY 2003 to fund 
five(5) new and/or competing continuation center grants in response to this 
RFA.  New or competing renewal O"Brien Urology Research Center applications 
may request maximum annual direct costs of $750,000 (not to exceed $3.5 
million for five years).  For renewal applications, budgets requested for 
research subprojects and core facilities are limited to 20% budget growth 
over the most recent non-competing budget.  Both new and renewal applications 
must include budgets of $120,000 annually for Developmental Research/Pilot 
and Feasibility (P&F) projects.  

The direct cost cap of $750,000, however, can be exceeded by the Facilities 
and Administrative (F&A) Costs (previously referred to as "indirect costs") 
on consortia subcontracts to other participating institutions.  The budgets 
of these consortia subcontracts may include the regular cost-of-living 
increases (currently 3% per year).  Because the nature and scope of the 
research proposed may vary, it is anticipated that the size of each award 
will also vary.  Although the financial plans of the NIDDK and NCI provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds in FY 2003 and the receipt of a sufficient number of 
applications of outstanding scientific and technical merit. 
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic

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, (2) research subprojects, representing a balance and diversity of 
research approaches, (3) a qualified principal investigator who is a 
scientific leader in the field, (4) developmental/Pilot & Feasibility 
programs and (5) appropriate shared resources to support the proposed 
research of the O"Brien Urology Research Center.  Although an application must 
be submitted by a single applicant institution, subcontracted collaborative 
scientific arrangements with scientists from other institutions may be 
included if these arrangements are clearly delineated, and formally and 
officially confirmed by signed statements from the responsible officials of 
each institution.  However, a full institutional commitment must come from 
the applicant institution. 

Support will not be provided for applications with research activities 
focused exclusively on basic research, or clinical research or trials, or 
epidemiological research, or malignant diseases of the urinary tract.

NIDDK program staff listed under INQUIRIES should be consulted if there are 
questions regarding any of the above eligibility requirements for exclusion.   
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution 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 programs
 
SPECIAL REQUIREMENTS

Annual O"Brien Urology Research Center Workshop 

O"Brien Urology Research Center investigators will likely be expected to 
participate in an annual or biennial workshop, organized and convened by the 
DKUHD-NIDDK, to share research experiences with other O"Brien Urology Research 
Centers, assess progress, identify new research opportunities, share 
materials, establish interactions and research priorities and collaborations 
that will maximize the impact of the research on reducing incidence and 
mortality, and improving survival of ESRD patients. Travel funds for the 
Principal Investigator and selected O"Brien Urology Research Center 
investigators and collaborators are to be budgeted for this purpose.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

o Direct your questions about scientific/research issues to:

Leroy M. Nyberg, Jr., Ph.D.,M.D.
Director, Urology Programs
Division of Kidney, Urology, and Hematology
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 627
Bethesda, MD  20892-5458
Telephone:  (301) 594-7717
FAX:  (301)480-3510 
E-mail:  ln10f@nih.gov

o Direct your questions about peer review issues to:

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

o Direct your questions about financial or grants management matters to:

Ms. Helen Ling
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 732
Bethesda, MD  20892-5456
Telephone:  (301) 594-8857
FAX:  (301) 480-4237
E-mail:  hl12d@nih.gov

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 at the beginning of 
this document.  The letter of intent should be sent to:

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Division of Extramural Activities
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Division of Extramural Activities
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
 
APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA. If an application is received 
after that date, it will be returned to the applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration. 
 
Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIDDK in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to 
have the highest scientific merit, generally the top half of the applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Diabetes and Digestive and Kidney 
Diseases Advisory Council.
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the IC.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the (IC) in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Diabetes and Digestive and 
Kidney Diseases Advisory Council.
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application 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 the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high 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.

Support will not be provided for applications with research activities 
focused exclusively on basic research, or clinical research or trials, or 
epidemiological research, or malignant diseases of the urinary tract.

Specific criteria to be used in the evaluation of grant applications are 
listed below.  

a.  Individual Research Subprojects:

Within the O"Brien Urology Research Center concept of research to be 
performed, reviewers will evaluate each research subproject using the five 
criteria listed below.  Each criterion will be addressed and considered by 
the reviewers in assigning the overall score project merit:

a.1.  Significance:  The importance of the research objective to human 
urological diseases and its likelihood of completion within the project 
period.  Do these studies address an important problem?  If the aims of the 
application are achieved, how will scientific knowledge be advanced?  What 
will be the effect of these studies on the concepts or methods that drive this 
field?

a.2.  Approach:  The adequacy of the experimental design and methods to 
achieve the research objectives.  Are the conceptual framework, design, 
methods, and analyses adequately developed, well integrated, and appropriate 
to the aims of the subproject?  Does the applicant acknowledge potential 
problem areas and consider alternative tactics?

a.3.  Innovation:  Originality and novelty of the experimental design as it 
relates to the proposed research subproject.  Does the project employ novel 
concepts, approaches or methods? Are the aims original and innovative?  Does 
the research subproject challenge existing paradigms or develop new 
methodologies or technologies?

a.4.  Investigators:  The qualifications of the investigators to conduct the 
proposed research and the appropriateness of the time commitments of each 
investigator to the conduct of the subproject.  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 (if any)?

a.5.  Environment:  The scientific environment in which the research work 
will be done, and the unique features, if any, of the environment to support 
the proposed work.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

The scientific review group will also examine: the appropriateness of 
proposed project budget and duration, the adequacy of plans to include both 
genders and minorities and their subgroups, and children as appropriate for 
the scientific goals of the research and plans for the recruitment and 
retention of subjects, the provisions for the protection of human and animal 
subjects, and the safety of the research environment.

b.  Shared Resources (Cores)

b.1.  adequacy of the proposed plan and/or track record to develop and 
maintain appropriate cores and potential for the distribution of reagents, 
tissues, transgenic animals within and outside the O"Brien Urology Research 
Centers,

b.2. degree to which plans and/or track record indicate that shared resources 
effectively and efficiently support (or will support) the research of the 
O"Brien Urology Research Center in a manner that cannot be supported through 
available national resources,

b.3.  adequacy of the justification for each specialized resource relative to 
its essential need for the conduct of O"Brien Urology Research Centers 
subproject research or pilot projects and O"Brien collaborative subprojects,

b.4.  adequacy of qualifications and performance (if applicable) of managers 
of resources,

b.5.  appropriateness of the requested budgets to conduct each resource 
operation.

c.  Developmental Research Program/Pilot & Feasibility (P&F) Projects

c.1.  adequacy of the process for attracting new ideas for pilot studies 
within and outside of the O"Brien Urology Research Center institution.

c.2. adequacy of the proposed process record for continuously reviewing and 
funding a spectrum of pilot projects (e.g., research, technology development, 
resources) for their quality and importance to research that will have an 
impact on human urological diseases.

c.3.  general quality of the pilot projects provided by the O"Brien Urology 
Research Center to demonstrate the effectiveness of the process of funding 
pilot projects,

c.4.   established mechanism within the institution to solicit DR/P&F 
applications and to oversee the use of funds for the proposed DR/P&F program. 

c.5.  appropriateness of the budget relative to the needs and demonstrated 
capabilities of the O"Brien Urology Research Center.

d.  Overall Program Organization and Capability:

d.1.  scientific qualifications and involvement of the O"Brien Urology 
Research Centers Principal Investigator, as well as his/her demonstrated 
scientific and administrative leadership capabilities, adequacy of the time 
commitment of the Principal Investigator,

d.2.  adequacy of the planning and evaluation process to include: determining 
research productivity of existing projects and resources, discontinuing 
activities of low productivity, initiating new activities in response to 
important research opportunities, establishing collaborations, and the use of 
external advisors,

d.3.  adequacy of access to patients and populations for conducting current 
and projected therapeutic, prevention, detection and control research,

d.4. degree to which the organization and leadership of the O"Brien Urology 
Research Center promote and facilitate scientific interactions between 
subprojects, pilot projects, etc., and effective use of the O"Brien Urology 
Research Center infrastructure (e.g., shared resources) in the conduct of 
research,

d.5.  effectiveness of and/or plans for promoting interdisciplinary 
scientific interaction,

d.6.  effectiveness of and/or plans for integrating O"Brien Center subproject 
research and resources with existing O"Brien Urology Research Center programs,

d.7.  adequacy of tangible institutional commitments that will enable and 
facilitate the research objectives of the O"Brien Urology Research Center 
(e.g., special facilities, recruitments, discretionary resources such as 
dollars and space),

d.8. written assurance that O"Brien Urology Research Center interactions with 
commercial entities will uphold the principles of academic freedom, including 
the ability of the participating investigators to collaborate freely, and to 
send and receive biomedical research materials without restriction to other 
scientific researchers.

e.  Interactions with other O"Brien Urology Research Centers

e.1.  adequacy of plans (new application) or progress (competing renewal 
applications) to promote and maintain communication and integration of 
scientific subprojects of mutual interest with other O"Brien Urology Research 
Centers,

e.2.  willingness to interact with other O"Brien Urology Research Centers and 
with the NIDDK in sharing information, in assessing scientific progress, in 
identifying new research opportunities and in establishing  scientific 
priorities.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
subproject and P&F research proposed in the application.

o INCLUSION:  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.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    October 17, 2002
Application Receipt Date:         November 19, 2002
Peer Review Date:                 March 2003
Council Review:                   May 2003
Earliest Anticipated Start Date:  July 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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 that is available at 
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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC 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 public 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 PA 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to 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 RFA 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 No. 93.849 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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