Full Text DK-93-16

SERUM, URINE, AND SEMEN INDICATORS OF BENIGN PROSTATE DISEASE

NIH GUIDE, Volume 22, Number 3, January 22, 1993

RFA:  DK-93-16

P.T. 34

Keywords: 
  Urogenital System 
  Urology 
  Diagnosis, Medical 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 18, 1993
Application Receipt Date:  March 26, 1993

PURPOSE

The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) is soliciting grant applications for support of research
studies on factors in serum, urine, and semen that indicate the
presence and progression of the benign diseases of the prostate,
specifically benign prostatic hyperplasia (BPH) and chronic
abacterial prostatitis (CAP).

The purpose of this request is to solicit applications that propose
to investigate factors in the serum, urine, and semen that indicate
the presence of the benign diseases of the prostate growth, that can
quantify any changes in these benign diseases, and that can
differentiate between these benign diseases and malignant prostate
changes.

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 Request
for Applications (RFA), Serum, Urine, and Semen Indicators of Benign
Prostatic Diseases is related to the priority area of diabetes and
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).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, 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.
Minority individuals and women are encouraged to submit as Principal
Investigators.

MECHANISM OF SUPPORT

Support of this program will be through the NIH research project
grant (R01).  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.  Generally, future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The total requested project period
for applications submitted in response to this RFA may not exceed
five years.  Applicants must limit their requests to not more than
$160,000 direct costs for the initial budget period.  The earliest
possible award date will be September 30, 1993.

FUNDS AVAILABLE

For FY 1993, $1,000,000 will be committed by the NIDDK to fund
applications submitted in response to this RFA.  It is anticipated
that five to eight awards will be made by the NIDDK.  However, this
funding level is dependent upon the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NIDDK the award of grants
pursuant to this RFA is also contingent upon the availability of
funds for this purpose.

It is anticipated that the majority of applications submitted, and
ultimately funded, in response to this RFA will be for the support of
new projects.

RESEARCH OBJECTIVES

Background

The benign diseases of the prostate, i.e., benign prostatic
hyperplasia and chronic abacterial prostatitis, affect untold numbers
of men of all ages.  These diseases are generally insidious in their
onset and, when they have advanced to the symptomatic stage, either
become more difficult to treat, have a greater morbidity associated
with treatment, or have progressed to the point where symptoms cannot
be adequately resolved with treatment.  In addition, it has been
suggested by some investigators that these benign diseases are
precursors of malignant cellular change in the prostate.

Applications to solely study indicators of malignant prostate growth,
or that focus primarily on malignant growth are not within the scope
of this RFA.

Program project grant applications (P01) will not be accepted in
response to this RFA.

SPECIAL REQUIREMENTS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities 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 in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply to
males of all ages.  If 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 racial/ethnic group.  In addition, 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
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
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
policies.

LETTER OF INTENT

Potential applicants are strongly encouraged to submit a letter of
intent by February 18, 1993.  The letter of intent need only include:
(1) names of the Principal Investigator/program director and
principal collaborators, (2) descriptive title of the potential
application, (3) identification of the organization(s) involved, and
(4) 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 conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
5333 Westbard Avenue
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
to apply 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, MD 20892, telephone
(301) 496-7441.

For developing programs that deal with clinical populations,
applicants may wish to consider utilization of General Clinical
Research Center (GCRC) facilities. More information on the GCRC
program is available from Dr. Judith Vaitukaitis at the National
Center for Research Resources, telephone: (301) 496-6595.

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.

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

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
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by March 26, 1993.  If an application
is received after that date, it will be returned to the applicant.
The Division of Research Grants (DRG) will not accept any application
in response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  However, it is allowable to submit the same
project as both an R01 and as a component project of a program
project.  The DRG 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.  Such applications must not only include an introduction
addressing the previous critique but also be responsive to this RFA.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the DRG for
completeness. Incomplete 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.  If the application is not responsive
to the RFA, the staff will contact the applicant to determine whether
it should be returned to the applicant, or held until the next
regular receipt date and reviewed in competition with all other
applications.

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.
Applications may be subjected to triage by an NIDDK peer review group
to determine their scientific merit relative to other applications
received in response to this RFA.  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 staff 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 National Diabetes and Digestive and Kidney
Diseases Advisory Council unless not recommended for further
consideration by the initial review group.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

o  scientific/technical merit criteria specific to the objectives of
the RFA;

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

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly but not exclusively in the area
of the proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed means for protecting against or minimizing such effects.

AWARD CRITERIA

Funding decisions will be made based on the initial review group and
national advisory council recommendations, program relevance and
availability of funds.

The anticipated date of award is September 30, 1993.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:

Ralph L. Bain, Ph.D.
Deputy Director, Urology 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 fiscal matters should be directed to:

Ms. Trude McCain
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

Schedule

Letter of Intent Receipt Date:  February 18, 1993
Application Receipt Date:       March 26, 1993
Initial Review:                 June 1993
Second Level Review:            September 1993
Anticipated Date of Award:      September 30, 1993

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.849 (NIDDK) .  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.

.

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