Full Text DK-97-002
NIH GUIDE, Volume 26, Number 14, May 2, 1997
RFA: DK 97-002
P.T. 04

  Biomedical Research, Multidiscipl 
  Disease Prevention+ 
  Treatment, Medical+ 

National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute
Letter of Intent Receipt Date:  August 25, 1997
Application Receipt Date:  September 24, 1997
This Request for Applications (RFA) invites investigators to submit
research grant applications for the George M. O'Brien Research
Centers Program.  The emphases for this program are to: (1) attract
new scientific expertise into the study of the basic mechanisms of
urological diseases and disorders; (2) encourage multidisciplinary
research focused on the causes of these diseases and disorders; and
(3) extend the development of innovative clinical and epidemiologic
studies of the causes, therapy and possible prevention of urological
diseases and disorders.  In approaching the study of these disease
processes, it is anticipated that extensive collaboration will be
required between individuals in the clinical and basic sciences,
including for example investigators with training and expertise in
cell biology, molecular biology, immunology, genetics, epidemiology,
biochemistry, physiology, and pathology.  It is the express intent of
this RFA to attract new investigators not currently active in this
field and to explore new basic areas that may have clinical research
applications. Individual institutions with both basic and clinical
research capabilities are eligible to apply. Interinstitutional
collaborative research arrangements are also appropriate and
encouraged.  Coordination for such arrangements must be evident and
clearly meaningful and appropriate for the research proposed.
The National Cancer Institute (NCI) plans to provide support for this
initiative in the area of prostate cancer.  Studies to be supported
include the full range from laboratory to clinical investigations
encompassing biology, etiology, detection, diagnosis, treatment,
prevention and control.  Of particular interest is multidisciplinary
research that links basic research to applied settings involving
patients and populations.
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone: 202/512-1800).
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.  Foreign institutions are not
eligible to apply.
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.
Applicants from institutions that 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.  If so, a letter of agreement from either the
GCRC program director or principal investigator should be included
with the application.
The NCI and NIDDK expect to award up to four center grants (P50) for
research into urologic disorders in fiscal year 1998.  The
anticipated awards are for five years and are contingent upon the
availability of appropriated funds.  The total amount of available
funds to support this program is anticipated to be no more than $2.75
million per year.  No applicant may request more than $750,000 in
total costs (including both direct and indirect costs) in the initial
budget period.  A standard escalation factor may be used for
subsequent budget periods.
Three competing continuation applications are anticipated in response
to this RFA.  The budget for the first year of a competing
continuation application may be increased by 10% above the direct
cost of the last issued noncompetitive (Type 5) award.  In all cases,
budgets are not to exceed the $750,000 total cost cap.
Urologic diseases and disorders place a substantial burden on
individuals and on society in the United States.  Urinary tract
infections had a direct hospital and physician cost of over $4
billion in 1990.  Benign prostatic hyperplasia (over $2 billion),
stone disease (over $1 billion), and bladder disorders (over $1
billion) are disorders whose costs exceed $1 billion annually.  These
diseases and disorders threaten the health, well-being, and longevity
of millions of Americans.  Although considerable progress has been
made in understanding the basic physiology and pathophysiology of the
normal urologic systems, there has been only limited progress in
unraveling the mechanisms of those processes that lead to progressive
deterioration in the function of these systems.  Nevertheless, major
progress has been made in the management of their clinical
consequences.  For example, the clinical management of benign
prostatic hyperplasia has improved over the past several years.
Unfortunately, these scientific and medical advances have not led to
the means to prevent or reverse the consequences of these diseases
and disorders; moreover, their incidence is steadily increasing.  The
proposed multidisciplinary research centers should help to provide an
environment for investigators to apply the necessary and appropriate
expertise to topical areas of research related to the pathogenesis of
urologic diseases such as immunologically mediated diseases, diabetes
mellitus and other endocrine and metabolic disorders, genetic
abnormalities, bladder physiology and pathophysiology, and
developmental and obstructive disorders.
Prostate cancer is the most common cancer in U.S. males and is the
second leading cause of cancer death in men. Mortality due to
prostate cancer is two-fold higher in U.S black men than U.S. white
men.  Costs attributable to this disease exceed $1 billion annually.
The disease results annually in a quarter of a million
hospitalizations as well as more than 40,000 deaths.  The report from
the  meeting "NCI Roundtable on Prostate Cancer: Future Research
Directions" (Reported in Cancer Research, 51: 2498, 1991) contains
information and recommendations defining areas of research that could
advance the understanding and management of prostate cancer.
Potential applicants requesting support for this area of research are
urged to acquaint themselves with the report.
Successful applicants are expected to attend a yearly meeting of
Center Directors convened by the NIDDK.  Funds to support travel to
this meeting may be requested in the budget proposed for the center.
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 is provided
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 "NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 20, 1994 (FR 59
14508-14513), and in the NIH Guide for Grants and Contracts  Vol. 23,
No. 11, March 18, 1994.
Prospective applicants are asked to submit, by August 25, 1997, 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 avoid conflict of interest in the
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8885
FAX:  (301) 480-3505
The research grant application form PHS 398 (5/95) is to be used in
applying for these grants.  Applications kits 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:
The RFA label available in the PHS 398 (rev. 5/95) 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.
Submit a signed, typewritten original of the application, including
the Checklist, plus three signed photocopies, in one package to:
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
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS 37-E - MSC 6600
Bethesda, MD  20892-6600
Applications must be received by September 24, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.
Applicants must follow the NIDDK Program Project Grants Guidelines
(July 1996) for Preparation of the Grant Application, Chapter 3.
Copies of the Guidelines are available from the Program Director
listed under INQUIRIES.
Each Research Project proposed (Section F -  NIDDK Guidelines) is
limited to 25 pages of text.
Applications should include the following:
A Table of Contents.
A Rationale for the Proposed Center and a Statement of Objectives.
Institutional Environment and Resources.
Organization and Administrative Structure of the Center.
Specific Managerial Responsibilities for the Center.
Travel funds in the proposed budget for an annual meeting of Center
A description of the method for the replacement of the Center
Director (should the need arise).
A description of the proposed research projects.
A description of the proposed cores.
A description of the procedure to be used for the addition/deletion
of cores and projects during the proposed period of operation.
A description of the administrative relationship of the Center to the
applicant institution.
Upon receipt, applications will be initially reviewed for
completeness and responsiveness.  Incomplete or non-responsive
applications will be returned to the applicant without further
consideration.  Evaluation for responsiveness to the program
requirements and criteria stated in the RFA is an NIDDK and NCI staff
Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific and
technical merit by an appropriate peer review group convened by the
NIDDK.  In cases where the number of applications is large compared
to the number of awards to be made, a preliminary scientific peer
review may be conducted and applications withdrawn from further
competition when they are not competitive for the award. The NIDDK
will notify the applicant and institutional official of this action.
Following this review, the applications will be given a secondary
review by the NIDDK Advisory Council unless not recommended for
further consideration by the initial review group.
The review criteria for individual research projects include:
The scientific, technical or medical significance and originality of
the proposed research.
The feasibility and adequacy of the experimental design.
The degree to which projects link basic and clinical research.
The qualifications and research experience of the proposed personnel.
The availability of resources necessary for the research.
The appropriateness of the budget and timetable in relation to the
scope of the proposed research.
The review criteria for scientific cores include:
The appropriateness and utility of the core to the proposed Center.
The quality of the proposed facilities or services including
administrative arrangements for utilizing the core.
The qualifications, experience, and commitment of the personnel
involved in the core.
The appropriateness of the budget.
Note: Each core unit must provide facilities or services to at least
two research projects recommended for approval.
The review criteria for the overall Center program include:
The scientific merit of the program as a whole.
The significance of the overall goals of the Center.
The cohesiveness and multidisciplinary scope of the Center and the
coordination and interrelationship of the projects and cores to the
common theme of the Center.
The leadership, scientific expertise, and commitment of the proposed
Center Director.
Administrative Considerations include:
The institutional environment for and resources available to Center
The institutional commitment to the proposed Center.
The administrative leadership necessary to provide for the quality
control of supported projects in the Center, the allocation of funds,
and the ability to foster communication and cooperation among Center
The appropriateness of the budget in relation to the proposed
activities of the Center.
The adequacy of addressing the protection of human subjects, animal
welfare, and biohazard issues.
Adequacy of plans to include both genders(if applicable) and
minorities and their subgroups as appropriate for the scientific
goals of the research.  Plans for the recruitment and retention of
subjects will also be evaluated.
Competing Continuation Applications:
Applicants must follow the NIDDK Program Project Grants Guidelines
(July 1996) for preparation of the Grant Application, Chapter 4, Part
B and Part C.  Copies of the Guidelines are available from the
Program Director listed under INQUIRIES.
For the purposes of this RFA a distinction between a P50 grant and a
P01 grant is made as follows:
Research projects supported by the P50 center award are of uniformly
high scientific merit, and are generally related to central issues in
urologic diseases and disorders.  Each project should be directed to
the development of fundamental knowledge leading to understanding
disease processes and the design of curative or preventative
The P50 grant mechanism provides an opportunity to approach
multidisciplinary basic research in a synergistic fashion. Close
cooperation, communication, and collaboration among all center
personnel of many professional disciplines are characteristics of a
successful P50 center.
In comparison, each research project of the P01 Program Project Grant
must contribute to or be directly related to a clearly defined
central unifying theme of the total research effort.  The projects
should demonstrate essential elements of unity and interdependence.
The anticipated date of award is September 1, 1998. Factors that will
be taken into consideration in making awards include the scientific
merit of the proposed Center as determined by peer review and the
availability of funds.
Letter of Intent Receipt Date:  August 25, 1997
Application Receipt Date:       September 24, 1997
Initial Review:                 February - April 1998
Second Level Review:            May 1998
Anticipated Date of Award:      September 1, 1998
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
Inquiries regarding non-cancer programmatic issues may be directed
Ralph L. Bain, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-19 - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  bainr@ep.niddk.nih.gov
Inquiries regarding cancer-related programmatic issues may be
directed to:
Andrew Chiarodo, Ph.D.
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Suite 512
Bethesda, MD  20892
Telephone:  (301) 496-8528
Email:  chiaroda@dcbdep1.nci.nih.gov
Inquiries regarding fiscal matters may be directed to:
Ms. Helen Ling
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8857
FAX:  (301) 480-3504
Email:  lingh@ep.niddk.nih.gov
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849.  Awards are made 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 PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
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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