Full Text DK-93-21


NIH GUIDE, Volume 21, Number 45, December 18, 1992

RFA:  DK-93-21

P.T. 04

  Biology, Cellular 
  Biology, Molecular 
  Biomedical Research, Multidiscipl 

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

Letter of Intent Receipt Date:  March 8, 1993
Application Receipt Date:  April 9, 1993


This Request for Applications (RFA) invites investigators to submit
research applications for the George M. O'Brien Research Centers
Program.  The emphases for this program are threefold:  (1) to
attract new scientific expertise into the study of the basic
mechanisms of urological diseases and disorders; (2) to encourage
multidisciplinary research focused on the causes of these diseases
and disorders; and (3) to 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 the announcement 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 invited 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
program 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.  This RFA,
Urology Research Centers, is related to the area of diabetes and
other chronic disabling conditions.  Potential applicants may obtain
a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).


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.  Foreign institutions
are not eligible to apply.  Minority individuals and women are
encouraged to submit as principal investigators.


Support of this program will be through the National Institutes of
Health (NIH) specialized center (P50) award.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  Except as otherwise stated in this
announcement, awards will be administered under PHS grants policy as
stated in the PHS Grants Policy Statement.


The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the NCI expect to jointly award up to two center grants
(P50) in fiscal year 1993 for research into urologic disorders.  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 $1.5
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.  The award date for these grants will be
September 30, 1993.


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 physican 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 each 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 in U.S.
white men.  Costs attributable to this disease exceed $1 billion
annually.  The disease results in a quarter of a million
hospitalizations annually as well as more than 30,000 deaths
annually.  The report from the recent 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.

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 may be included with
the application.


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 NIH policy that women and minorities must be included in
clinical study populations unless there is a good reason to exclude
them.  The study design must seek to identify any pertinent gender or
minority population differences.


NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
in study populations so that research findings can be of benefit to
all persons at risk of the disease, disorder or condition under
study; special emphasis must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Item 4 (Research Design and Methods) of the Research
Plan AND summarized in Item 5, Human Subjects.  Applicants are urged
to assess carefully the feasibility of including the broadest
possible representation of minority groups.  However, NIH recognizes
that it may not be feasible or appropriate in all research projects
to include representation of the full array of United States
racial/ethnic minority populations; i.e., Native Americans [including
American Indians or Alaskan Natives], Asian/Pacific Islanders,
Blacks, Hispanics.

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention [and preventive strategies], diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned without review.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and reflected
in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these


Prospective applicants are asked to submit, by March 8, 1993, 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 subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDDK staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

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
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 496-7083
FAX:  (301) 402-1277


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892,
telephone (301) 496-7441.

The RFA label available in the application form must be affixed to
the bottom of the face page.  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 2a of the face page of the
application form and check the YES box.

Application must include the following items:

o  A Table of Contents;

o  A Rationale for the proposed Center and a Statement of Objectives;

o  Institutional Environment and Resources;

o  Organization and Administrative Structure of the Center;

o  Specific Managerial Responsibilities for the Center;

o  Travel funds in the proposed budget for an annual meeting of
Center Directors;

o  A description of the method for the replacement of the Center
Director (should the need arise);

o  A description of the proposed research projects;

o  A description of the proposed cores;

o  A description of the procedure to be used for the
addition/deletion of cores and projects during the proposed period of

o  A description of the administrative relationship of the Center to
the applicant institution.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by April 9, 1993.  If an application is
received after that date, it will be returned to the applicant.


Upon receipt, applications will be initially reviewed for
completeness and responsiveness.  Incomplete applications 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 staff

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.  If
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.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened
for this RFA.  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:

o  The scientific, technical or medical significance and originality
of the proposed research;

o  The feasibility and adequacy of the experimental design;

o  The degree to which projects link basic and clinical research;

o  The qualifications and research experience of the proposed

o  The availability of resources necessary for the research;

o  The appropriateness of the budget and timetable in relation to the
scope of the proposed research;

The review criteria for scientific cores include:

o  The appropriateness and utility of the core to the proposed

o  Each core unit must provide facilities or services to at least two
research projects recommended for approval;

o  The quality of the proposed facilities or services including
administrative arrangements for utilizing the core;

o  The qualifications, experience, and commitment of the personnel
involved in the core;

o  The appropriateness of the budget.

The review criteria for the overall Center program include:

o  The scientific merit of the program as a whole;

o  The significance of the overall goals of the Center;

o  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;

o  The leadership, scientific expertise, and commitment of the
proposed Center Director.

Administrative Considerations:

o  The institutional environment for and resources available to
Center investigators;

o  The institutional commitment to the proposed Center;

o  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

o  The appropriateness of the budget in relation to the proposed
activities of the Center;

o  The adequacy of addressing the protection of human subjects,
animal welfare, and biohazard issues.


The anticipated date of award is September 30, 1993. 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:     March 8, 1993
Application Receipt:  April 9, 1993
Initial Review:       July 1993
Second Level Review:  September 13-14, 1993
Anticipated Award:    September 30, 1993


Written and telephone inquiries concerning this RFA are encouraged.

Inquiries regarding non-cancer programmatic issues may be directed

Ralph L. Bain, Ph.D.
Director, Centers Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7574

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

Andrew Chiarodo, Ph.D.
Chief, Organ Systems Coordinating Branch
Centers, Training, and Resources Program
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Suite 316
Bethesda, MD  20892
Telephone:  (301) 496-8528

Inquiries regarding fiscal matters may be directed to:

Ms. Helen Ling
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467


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


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