GEORGE M. O’BRIEN KIDNEY RESEARCH CENTERS

Release Date:  February 2, 2001

RFA:  RFA-DK-01-015  (This RFA has been reissued, see RFA-DK-06-010) 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  May 11, 2001
Application Receipt Date:       June 12, 2001

PURPOSE

This Request for Applications (RFA) invites investigators to submit 
research applications for the George M. O"Brien Kidney 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 kidney 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) develop 
*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 kidney 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 cell and molecular biology, biochemistry, physiology, 
genetics, epidemiology, immunology and pathology.  Coupled to the above 
expertise will likely include appropriate expertise to topical areas of 
research related to the pathogenesis of kidney diseases such as: 
diabetic nephropathy and other endocrine and metabolic disorders, 
hypertension in kidney disease, hereditary renal disease, immunologic 
renal disease, and acute renal failure and toxic cell injury.

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 little preliminary 
data and are reviewed based on the development of hypotheses and 
supporting literature.

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 Request for 
Applications (RFA), GEORGE M. O’BRIEN KIDNEY RESEARCH CENTERS, is 
related to the of priority area of Chronic Kidney Disease, Diabetes, 
Disability and Secondary Conditions and Educational and Community-Based 
Programs.  Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and nonprofit 
organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and 
eligible agencies of the Federal government.  Foreign institutions are 
not eligible for P50 grants.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as 
principal investigators.

To be considered eligible, applicant organizations must have: (1) a 
statement of institutional commitment that addresses how the 
institution will incorporate the O’Brien Kidney 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 Kidney 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.

NIDDK program staff listed under INQUIRIES should be consulted if there 
are questions regarding any of the above eligibility requirements for 
exclusion.   

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 kidney 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.  

The earliest anticipated award date is April 1, 2002.

FUNDS AVAILABLE

The NIDDK intends to provide sufficient funds in FY 2002 to fund four 
(4) new and/or competing continuation center grants in response to this 
RFA.  Four competing continuation applications are anticipated in 
response to this RFA.  New or competing renewal O’Brien Kidney Research 
Center applications may request maximum annual direct costs of $700,000 
(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 $700,000, 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 provide support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds in 
FY 2002 and the receipt of a sufficient number of applications of 
outstanding scientific and technical merit.   It is not definitively 
known at this time whether this RFA will be reissued, but it is likely 
that a re-competition for three (3) additional O’Brien Kidney Research 
Centers will be announced for FY 2003.  

RESEARCH OBJECTIVES

Background

Based on the most current data, as of the end of 1997, 304,083 patients 
were being treated for end-stage renal disease (ESRD) and 79,102 new 
patients began ESRD treatment in 1997.   The incidence of ESRD 
continues to mount, and is projected to rise to 172,667 by 2010.  
Minority populations suffer a disproportionate share of kidney disease, 
especially diabetes (most common reported cause of ESRD) and 
hypertension, and ESRD continues to be a disease that affects African 
Americans (constitutes 32 percent of treated ESRD patients) and Native 
Americans at a rate 3 to 5 times greater than the rate of Caucasian 
Americans.  The medical, social, and financial implications of this 
disease continue to make ESRD a major public health and public policy 
problem.  Another common form of kidney disease, which affects an 
estimated 5 percent of hospitalized patients, is acute renal failure 
(ARF).  When ARF requires hemodialysis, the mortality rate increases to 
more than 60 percent.  In addition to costs associated with mortality, 
ARF-associated medical expenses are estimated at $8 billion per year.

Although important advances have been made in understanding ARF in 
animals, translating that knowledge from experimental models to humans, 
which is complicated by its heterogeneity, has fallen far short of 
expectant goals of impacting on the morbidity and mortality of this 
disease.  There is no cure for chronic kidney disease, and progression 
to kidney failure for many may be slowed if the disease is diagnosed 
and managed early.  With considerable progress already being made in 
understanding the basic physiology and pathophysiology of the normal 
renal systems, further unraveling of the mechanisms of those processes 
that lead to progressive deterioration in the function of these systems 
“is a work in progress.”  Nevertheless, major advances have been made 
in the management of their clinical consequences.  For example, 
sustained and intensified research efforts have lead to the refinement 
of renal dialysis, improved vascular access techniques and increased 
allograft survival have steadily improved during the last decade.  
Also, prior racial differences between African Americans and Caucasians 
in one-year patient and graft survival have disappeared.

The National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) supports through the Division of Kidney, Urologic and 
Hematologic Diseases (DKUHD) seven George M. O’Brien Kidney Research 
Centers, two Centers of Excellence in Pediatric Nephrology and four 
Interdisciplinary Centers for Polycystic Kidney Disease Research.  
These Centers are part of an integrated program of kidney-related 
research support within the NIDDK.  Centers have provided a focus for 
increasing the efficiency and collaborative effort among groups of 
successful investigators at institutions with established comprehensive 
kidney research bases.  

The objectives of the O’Brien Kidney Research Centers have been to 
bring together investigators from relevant disciplines in a manner that 
will enhance and extend the effectiveness of research related to kidney 
disease and its complications.  An O’Brien Kidney Research Center must 
be an identifiable unit within a single university medical center or a 
consortium of cooperating institutions, including an affiliated 
university.  The overall goal of the O’Brien Kidney Research Center is 
to bring together on a cooperative basis, clinical and basic science 
investigators in a manner that will enrich the effectiveness of kidney 
research.  For this purpose the applicant must clearly state the 
considerations for center membership.  Criteria for designating an 
investigator as a center grant participant should be defined and included 
in the guidelines for center participation.

The Specialized Center (P50) must be an identifiable unit within a 
single university medical center or within a consortium of cooperating 
institutions with a university affiliation.  The overall goal of a P50 
Center is 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 ESRD.  
The O’Brien Kidney Research Centers must 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 kidney disease.  
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 Kidney Research Centers program.  
In the aggregate, the subprojects should continue to be directed to the 
development of fundamental knowledge leading to the understanding of 
kidney 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 Kidney 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 some 
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, infection 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 Kidney 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 cause renal disease.  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 work on kidney who wish to apply their expertise to a 
problem in this area, and (3) established renal 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. 

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 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 Kidney Research Center grant may budget for and provide 
limited support for an optional enrichment program, whose description and 
budget may 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.  

SPECIAL REQUIREMENTS
Annual O’Brien Kidney Research Center Workshop
O’Brien Kidney Research Center investigators may be expected to 
participate in an annual or biennial workshop, organized and convened 
by the DKUHD-NIDDK, to share positive and negative results with other 
O’Brien Kidney 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 
ESR patients. Travel funds for the Principal Investigator and selected 
O’Brien Kidney Research Center investigators and collaborators are to 
be budgeted for this purpose.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a 
complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS.

It is the policy of NIH 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 was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.
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. Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.
LETTER OF INTENT 

Prospective applicants are asked to submit, by May 11, 2001, a letter 
of intent that includes a descriptive title of the proposed research, 
the name, address, and telephone number of the Principal Investigator, 
the identities of other key personnel and participating institutions, 
and the number and title of the RFA in response to which the 
application may be submitted.

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 NIDDK staff to estimate the potential review 
workload and plan the review.

The letter of intent is to be sent to:

Chief, Review Branch 
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 653 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone:  (301) 594-8885
FAX:  (301) 480-3505

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants.  These forms are available at most 
institutional offices of sponsored research and may be obtained from 
the Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, telephone 301-435-0714, email: GrantsInfo@nih.gov.

The RFA label available in the PHS 398 (rev. 4/98) application form 
must be affixed to the bottom of the face page of the application.  
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 sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change. Please note this is in pdf format.
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 time of submission, two additional copies of the application must be 
sent to:

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 655 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)

Applications must be received by the application receipt date listed in 
the heading of the RFA.  If an application is received after that date, 
it will be returned to the applicant without review. Supplemental 
documents containing significant revision or additions will not be 
accepted, unless applicants are notified by the Scientific Review 
Administrator.  

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 previously 
reviewed, but such applications must include an introduction addressing 
the previous critique.

REVIEW CONSIDERATIONS

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.

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.

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

a.  Individual Research Subprojects:

Within the O’Brien Kidney 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 
kidney disease 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 initial 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 
Kidney 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 Kidney 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 Kidney 
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 Kidney 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 renal disease.

c.3.  general quality of the pilot projects provided by the O’Brien 
Kidney 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 
proposals and to oversee the use of funds for the proposed DR/P&F 
program. This mechanism must include the use of appropriate consultants 
for review from the scientific community external to the center.  

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

d.  Overall Program Organization and Capability:

d.1.  scientific qualifications and involvement of the O’Brien Kidney 
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 
Kidney Research Center promote and facilitate scientific interactions 
between subprojects, pilot projects, etc., and effective use of the 
O’Brien Kidney 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 Kidney Research 
Center programs,

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

d.8. written assurance that O’Brien Kidney 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 Kidney 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 Kidney Research Centers,

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

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  Adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated

o  The reasonableness of the proposed budget and duration to the 
proposed subproject research.

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

o The adequacy of the proposed plan to share data.  

Schedule
Letter of Intent Receipt Date:    May 11, 2001
Application Receipt Date:         June 12, 2001
Peer Review Date:                 October-November, 2001
Council Review:                   February 13-14, 2002
Earliest Anticipated Start Date:  April 1, 2002

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.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to 
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

M. James Scherbenske, Ph.D., 
Renal Physiology/Cell Biology and 
 Kidney Centers and SBIR Program Director
DKUHD-NIDDK, NIH
6707 Democracy Blvd, Room 613
Bethesda, MD 20892-5458
Telephone:  (301) 594-7719
FAX:  (301)480-3510 
E-mail: js255f@nih.gov

Direct inquiries regarding fiscal matters to:

Mrs. Mary K. Rosenberg 
Grants Management Branch
DEA-NIDDK, NIH
6707 Democracy Blvd, Room 638
Bethesda, MD 20892
Telephone:  (301) 594-8891
FAX: (301) 480-3504
E-Mail: RosenbergM@extra.niddk.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.849.  Awards are under authorization of the Public Health 
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public 
Law 99-158, 42 USC 241 and 285) and administered under NIH grants 
policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-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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