Full Text DK-96-002

UROLOGY RESEARCH CENTERS

NIH GUIDE, Volume 24, Number 33, September 22, 1995

RFA:  DK-96-002

P.T. 04

Keywords: 
  Urogenital System 
  Urology 
  Hyperplasia 
  Infectious Diseases/Agents 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  May 23, 1996
Application Receipt Date:  July 23, 1996

PURPOSE

This Request for Applications (RFA) invites investigators to submit
research applications for the George M. O'Brien Research Centers
Program.  The scope of research encompassed by this program is
limited to those areas of research for which the Urology Program of
the NIDDK has primary responsibility.  These clinical and scientific
areas include the regulation of non-malignant prostate growth and
development and associated benign diseases of the prostate; urinary
bladder development and function and non-malignant diseases of the
bladder; basic and clinical studies on urolithiasis; male sexual
dysfunction, basic and clinical aspects of urinary tract infections;
and pediatric urological diseases and disorders.  The emphases for
this Centers program are three-fold:  (1) to attract new scientific
expertise into the study of the basic mechanisms of urologic diseases
and disorders; (2) to encourage multi disciplinary research focused
on the causes of these diseases; and (3) to promote the development
of preventive strategies for these diseases.  It is expected that
extensive collaboration will be demonstrated between investigators in
the clinical and basic sciences. It is the express intent of this RFA
to develop new collaborations between new investigators not currently
active in research related to urologic diseases and those with an
understanding of the disease processes.  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.

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.  This RFA,
Urology Research Centers, is related to the priority area of chronic
debilitating diseases.  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 or 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.

This RFA is a one-time solicitation.  The total requested project
period for an application submitted in response to this RFA may not
exceed five years.  The earliest anticipated award date is July 1,
1997.

FUNDS AVAILABLE

The NIDDK expects to award up to two center grants (P50) for research
into urologic disorders in fiscal year 1997.  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 $1.245 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.

Two 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 percent 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.

RESEARCH OBJECTIVES

Urologic diseases and disorders place a substantial burden on
individuals and on society in the United States.  Major progress has
been made in the management of their clinical consequences of these
diseases and there has been some progress made in understanding the
basic physiology and pathophysiology of the normal urologic systems.
Progress into understanding the mechanisms that lead to progressive
deterioration or the development of disease in these systems is
significantly lacking.  These clinical advances have not led to the
means to prevent or reverse the consequences of these diseases and
disorders; moreover their incidence is steadily increasing.

Examples of Areas of Interest:

Research areas that might be investigated with a multi disciplinary
approach include, but are not limited to:

o  Molecular approaches to the study of the regulation of prostate
growth in human tissue;

o  Chronic inflammation and its affect on urologic tissues and
systems;

o  Environmental effects on the developing urogenital systems;

o  The effects of diabetes and other systemic disorders on urologic
tissues and systems;

o  Infection, inflammation, and urologic disease;

o  Factors in urinary tract stone formation;

o  The molecular genetics of urologic diseases.

Research areas not responsive to this RFA include: Studies of cancer
or malignant growth; clinical therapy studies; and epidemiological
studies.

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

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 reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS  Volume 23, Number 11,
March 18, 1994.

Investigators may also obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 23, 1996, 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
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
45 Center Drive, Room 6AS.37F - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7515

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) 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 Office of Grants Information, Division of Research Grants,
National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC
7762, Bethesda, MD 20892-7762, telephone 301/435-0714, email:
girg@drgpo.drg.nih.gov.

Applications 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
operation;

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

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:

DIVISION OF RESEARCH GRANTS
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
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive - MSC 6600
Bethesda, MD  20892-6600

Applications must be received by July 23, 1996.  If an application is
received after that date, it will be returned to the applicant
without review.

REVIEW CONSIDERATIONS

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
function. Unsolicited material received after July 23, 1996 will not
be accepted.

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 NIH peer review
procedures.  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 will
be discussed, assigned a priority score, and receive a second level
review by the National Diabetes and Digestive and Kidney Advisory
Board.

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 qualifications and research experience of the proposed
personnel;

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;

o  Adequacy of plans to include both genders 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.

The review criteria for scientific cores include:

o  The appropriateness and utility of the core to the proposed
Center;

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 multi disciplinary 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
investigators;

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.

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 multi disciplinary 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, also of uniformly high scientific merit, 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 earliest anticipated date of award is July 1, 1997.  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.

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:

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

Direct inquiries regarding fiscal and administrative matters 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

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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