UROLOGY RESEARCH CENTERS

Release Date:  July 16, 1998

RFA:  DK-98-018

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases
National Cancer Institute

Letter of Intent Receipt Date:  October 20, 1998
Application Receipt Date:  November 20, 1998

PURPOSE

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. 
An intent of this RFA is 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.  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.

The National Cancer Institute (NCI) plans to provide support for this
initiative in the area of prostate cancer.  Studies to be supported may
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.

HEALTHY PEOPLE 2000

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).

ELIGIBILITY REQUIREMENTS

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.

MECHANISM OF SUPPORT

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.

FUNDS AVAILABLE

The NIDDK and NCI expect to award one center grant (P50) for research into
urologic disorders in fiscal year 1999.  The anticipated award is for five
years and is contingent upon the availability of appropriated funds.  The
total amount of available funds to support this program is anticipated to be
no more than $725,000 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.

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 $725,000 total cost
cap.

RESEARCH OBJECTIVES

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 38,000 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.

Special Requirements

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.

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 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 28, 1994 (FR 59 14508-14513), and
in the NIH Guide for Grants and Contracts Vol. 23, No. 11, March 18, 1994.

NIH POLICY AND GUIDELINES ON THE 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 or Children as Participants in
Research Involving Human Subjects" published in the NIH Guide for Grants and
Contracts, March 6, 1998.  It is available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by October 20, 1998, 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 and NCI staff to estimate the potential review workload
and avoid conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Ann Hagan,
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

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard application deadlines as indicated
in the application kit.  Application kits are available at most institutional
offices of sponsored research, or 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. 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:

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:

Dr. Ann Hagan,
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS 37F
Bethesda, MD  20892-6600

Applications must be received by November 20, 1998.  If an application is
received after that date, it will be returned to the applicant without review.

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 Directors.
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.

REVIEW CONSIDERATIONS

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 function.

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 and the National Cancer Advisory Board 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 cope 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
investigators.

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 investigators.

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), 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.

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 strategies.

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.

AWARD CRITERIA

The anticipated date of award is September 1, 1999.  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.

Schedule

Letter of Intent Receipt Date: October 20, 1998
Application Receipt Date:      November 20, 1998
Initial Review:                March 1999
Second Level Review:           May 1999
Anticipated Date of Award:     September 1, 1999

INQUIRIES

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 to:

Charles H. Rodgers, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-19J
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  rodgersc@extra.niddk.nih.gov

Inquiries regarding cancer-related programmatic issues may be directed to:

Jorge Gomez, M.D., Ph.D.
Office of Centers, Training and Resources, ODDES
National Cancer Institute
Executive Plaza North, Suite 512
Bethesda, MD  20892
Telephone:  (301) 496-8528
Email:  jg1w@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@extra.niddk.nih.gov

AUTHORITY AND REGULATIONS

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 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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