CENTERS OF EXCELLENCE IN PEDIATRIC NEPHROLOGY

Release Date:  February 12, 2001

RFA:  RFA-DK-01-016 (This RFA has been reissued, see RFA-DK-06-011) 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  May 11, 2001
Application Receipt Date:       June 22, 2001

PURPOSE

The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of 
the National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), NIH, invites grant applications for Specialized Centers of 
Research (P50) in pediatric nephrology.  The purpose of the research 
center is to attract a partnership of interdisciplinary research among 
investigators with scientific expertise who will use complementary and 
integrated approaches into the study of kidney diseases endemic to the 
pediatric population.  In approaching the study of these disease 
processes it is anticipated that extensive collaboration will be required 
among individuals in the clinical and basic sciences, including cell 
biology, molecular biology, immunology, virology, genetics, epidemiology, 
biochemistry, physiology and pathology.  Studies designed to foster and 
extend the development of new approaches into the causes, early 
diagnoses, improved treatment, and where possible, prevention of these 
diseases and disorders are appropriate.

The emphases for this program are several-fold (1) to continue to 
attract new scientific expertise into the study of the basic mechanisms 
of kidney diseases and disorders among infants, children, and 
adolescents, (2) to encourage multidisciplinary research focused on the 
causes of these diseases, 3) to explore new basic areas that may have 
clinical research application and 4) to design *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 amongst the pediatric population, and the eventual 
submission of competitive investigator-initiated R01 research grant 
applications.

Individual institutions with research capabilities relating to diseases 
of the kidney in the pediatric population 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.

Support of this program will be through the NIH Specialized Center 
(P50) award.  Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant.  Awards 
will be administered under PHS grants policy as stated in the PHS 
Grants Policy Statement.

This RFA is a one-time solicitation.  The total requested project 
period for an application submitted in response to this RFA must not 
exceed five years.  The earliest anticipated award date is April 1, 
2002.

*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), CENTERS OF EXCELLENCE IN PEDIATRIC NEPHROLOGY is 
related to the priority area of Maternal, Infant and Child Health, 
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 Centers of Excellence in Pediatric 
Nephrology high within its institutional priorities, (2) a qualified 
principal investigator who is a scientific leader in the field, (3) 
independent investigators who are successful in obtaining peer-reviewed 
research support (R01, P01, U01, or equivalent) who together 
collectively represent experience in both laboratory and clinical 
research, and utilize a balance and diversity of research approaches, 
4) research subprojects, representing a balance and diversity of 
research approaches, (5) developmental/pilot & feasibility programs, 
and (6) appropriate shared resources to support the proposed research 
of the Centers of Excellence in Pediatric Nephrology.  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. 

Criteria for designating an investigator as a center grant participant 
should be defined.  Subsets of participants based on degree of 
participation or other measures are acceptable.  Each center is 
encouraged to develop guidelines for center participation by 
investigators.

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) Specialized 
Center (P50) 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 subprojects, 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 anticipated award date is 
April 1, 2002.

FUNDS AVAILABLE

The NIDDK intends to fund two (2) new and/or competing continuation 
center grants in response to this RFA.  Two competing continuation 
applications are anticipated in response to this RFA.  Both new and 
renewal applicants may request a project period of up to five (5) years 
and a budget for up to $700,000 direct costs per year (not to exceed 
$3.5 million for five years).  However, the direct cost cap can be 
exceeded with the inclusion of Facilities and Administrative (F&A) 
Costs (previously referred to as  indirect costs ) for consortia 
subcontracts to other participating institutions.  The budgets of these 
consortia subcontracts may also include the regular cost-of-living 
increases (currently 3% per year).  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 at least $120,000 
annually for Developmental Research/Pilot and Feasibility (P&F) 
projects. 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.  At this 
time, it is not known if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

Kidney disease is a major cause of illness and death in infants, 
children and adolescents, who make up approximately 25 percent of the 
United States population.  Of this population, both incident and 
prevalent rates have increased moderately since 1990, with rates 
continuing to be highest in 15-19 age group, with particularly high 
rates -- three times those of Caucasian Americans -- in African 
American children of both genders.  It is estimated that 14,000 have 
kidney disease, 5,000 have kidney failure and are on dialysis or have a 
kidney transplant, of these about 60 percent are 12 years of age or 
younger.  As a consequence the financial cost to the American taxpayer 
is enormous.  

Developmental disorders of the kidney account for about one-third of 
all childhood cases. Investigators are beginning to perform molecular 
and genetic analyses to link specific gene products to normal kidney 
growth and development and human kidney diseases.  For example in 
congenital nephritic syndrome, a glomerular disease characterized by 
massive amounts of protein in urine and progressive renal failure in 
infants, researchers have recently identified mutations in glomerular 
protein called nephrin.  This disorder often progresses so that 
dialysis or renal transplantation is often required during infancy.  
Other disorders in the very young patient include renal dysplasia(s) 
and hypoplasia(s), cystic malformations, PKD, tubulointerstitial 
diseases and congenital structural abnormalities i.e., obstructive 
uropathy, vesicoureteral reflux and the resulting reflux nephropathy.  
Older children often develop end-stage renal failure from conditions 
such as immune complex disease, hereditary nephropathy, focal segmental 
glomerulosclerosis, IgA nephropathy, and the hemolytic uremic syndrome.  
The basic cellular and molecular mechanisms of the majority of these 
disorders are poorly understood.  Progression often occurs even when 
the primary disease process has been thought to be adequately treated 
and the disorder appears to have become inactive.  Several diseases 
that lead to chronic renal disease and end-stage renal disease (ESRD) 
in adults often have their origin in childhood, a notable example is 
diabetes and hypertension.  Up to one third of children who develop 
Type 1 (insulin-dependent) diabetes will develop ESRD in their twenties 
or thirties.  Strategies to prevent kidney disease ideally should begin 
in childhood or late adolescence, and therefore, a great need exists to 
better understand the pathogenesis of these conditions, with the 
ultimate aim of prevention of complications and/or the development of 
improved therapies.  In kidney disease, children face special growth 
and developmental challenges and strategies to address this are another 
urgent need. 

Representative, but not all-inclusive areas of research appropriate for 
investigation include:

(1) studies of renal disorders of genetic and congenital origin that 
may lead to progressive loss of renal function or cause severe 
metabolic imbalances in children, including hyperoxaluria, and which 
include the use of gene targeting and transgenic technologies in 
addressing Bartter s, Gitelman’s and Liddle’s syndromes during 
development, and congenital nephrogenic diabetes insipidus,

(2) further identification and study of genes and gene mutations and 
molecular events involved in renal and urogenital morphogenesis and 
differentiation,

(3) studies of events involved in cellular signaling in renal 
morphogenesis in health and disease, including the definition of events 
involved in cellular communication and mechanisms by which growing 
cells influence and are influenced by extracellular matrix, 

(4) immune-mediated disorders, including such diseases as post-
infectious glomerulonephritis, human immunodeficiency virus (HIV), 
immunoglobulin A (IgA) nephropathy, Goodpasture’s syndrome, and 
Wegner’s granulomatosis, 

(5) studies to understand the molecular mechanisms underlying the renal 
hypertension in infants and children,  

(6) studies addressing the short and long-term effects of 
anti-hypertensive agents in infants and children,

(7) identification of risk factors and predisposing factors 
contributing to renal disease progression in infants and children, 

(8) studies addressing the etiology, pathophysiology, and treatment 
strategies for end-stage renal disease in infants and young children, 
including determinants of abnormal growth and development, the 
development of animal models to quantitate the contribution of 
selective variables in growth retardation in chronic renal failure, the 
effects of exogenous recombinant hormones, and the role of uremia in 
protein synthesis in young growing infants,

9) cellular and molecular studies underlying the development and 
progression of  glomerulonephritis in children, including the molecular 
changes affecting the glomeruli, alterations of the basement membrane, 
mechanisms leading to proteinuria, and the biochemistry of the nephron 
during pathological states.

Other

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 kidney 
disease in infants, children and adolescents.  

Interrelated, basic research subprojects, each with high scientific merit 
and clear research objectives have provided the traditional framework of 
the Centers of Excellence in Pediatric Nephrology program.  In the 
aggregate, the subprojects should continue to be directed to the 
development of fundamental knowledge leading to the understanding of 
childhood 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).   

SPECIAL REQUIREMENTS 

Other then the customary requests for support of research subprojects 
and cores (e.g., administrative, animal, etc.), the following new 
program should be included in the submissions for this RFA for Centers 
of Excellence in Pediatric Nephrology. 
 
Developmental Research (DR)/Pilot & Feasibility (P&F) Projects 

A DR/P&F program may be included which will provide modest support for 
innovative initiatives with the potential to advance progress in 
understanding cellular and molecular mechanisms that cause kidney 
diseases of the pediatric population.  This program is directed toward 
both new 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 
has been modest, (2) established investigators with limited previous work 
on the 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 per year direct costs, 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, it is imperative for each applicant institution 
to 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 center proposal may budget for and provide limited support for an 
enrichment program, whose description and budget may be included within 
the administrative core.  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.  

Annual Kidney Center Workshop

Centers of Excellence in Pediatric Nephrology investigators may be 
expected to participate in an annual workshop organized by the DKUHD-
NIDDK to share positive and negative results with other kidney research 
centers (O Brien Kidney and PKD), share materials, assess progress, 
identify new research opportunities, and establish interactions and 
research priorities and collaborations that will maximize the impact of 
the research on reducing incidence and mortality, and improving 
survival.  Travel funds for the Principal Investigator and selected 
center investigators and collaborators may 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 or 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. 655 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 301-710-0267, 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 the Scientific Review Administrator notifies 
applicants.  

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.

(1) Significance:  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?

(2) Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project 
challenge existing paradigms or develop new methodologies or 
technologies? 

(4) Investigator:  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)?

(5) Environment:  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?

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 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 
project 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 22, 2001
Peer Review Date:                 October-November 2001
Council Review:                   February 13-14, 2002
Earliest Anticipated Start Date:  April 1, 2002

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 Centers of Excellence in Pediatric Nephrology 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 
pediatric kidney disease and its likelihood of completion within the 
subproject 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 project?  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. Does the project employ novel 
concepts, approaches or methods? Are the aims original and innovative?  
Does the subproject challenge existing paradigms or develop new 
methodologies or technologies?

a.4.  Investigators:  The qualifications of the investigators to 
conduct the proposed subproject 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 
investigations 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 subproject research 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 to maintain appropriate cores and 
potential for the distribution of reagents, tissues, transgenic animals 
within and outside the Centers of Excellence in Pediatric Nephrology,

b.2. degree to which plans indicate that shared resources effectively 
and efficiently support (or will support) the subproject and P&F 
research of the Centers of Excellence in Pediatric Nephrology 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 Centers of Excellence 
in Pediatric Nephrology subproject research or pilot projects,

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 Projects

c.1.  adequacy of the process and/or track record for attracting new 
ideas for pilot studies within and outside of the Centers of Excellence 
in Pediatric Nephrology institution.

c.2. adequacy of the proposed process and/or track 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 Centers of 
Excellence in Pediatric Nephrology to demonstrate the effectiveness of 
the process of including 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 Centers of Excellence in Pediatric 
Nephrology.

d.  Overall Program Organization and Capability:

d.1.  scientific qualifications and involvement of the Centers of 
Excellence in Pediatric Nephrology 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 Centers of 
Excellence in Pediatric Nephrology promote and facilitate scientific 
interactions between subprojects, pilot projects, etc., and effective 
use of the Centers of Excellence in Pediatric Nephrology infrastructure 
(e.g., shared resources) in the conduct of research,

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

d.6.  adequacy of tangible institutional commitments that will enable 
and facilitate the research objectives of the Centers of Excellence in 
Pediatric Nephrology (e.g., special facilities, recruitments, 
discretionary resources such as dollars and space),

d.7. Interactions with Other Centers of Excellence in Pediatric 
Nephrology 

e. Interactions with other Centers of Excellence in Pediatric 
Nephrology

e.1.  adequacy of plans (new application) or progress (competing 
renewal applications) to promote and maintain communication and 
integration of scientific projects of mutual interest with other 
Centers of Excellence in Pediatric Nephrology,

e.2.  willingness to interact with other Centers of Excellence in 
Pediatric Nephrology 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 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 proposed research in the application.

o The adequacy of the proposed plan to share data.  

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
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.

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