Subject: NIH GUIDE - RFA DK-92-13 - V20(43) 11/15/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 15 Nov 91 08:57 EST

Hi Paul,
   Please post this to the NIH Listserver as:
       RFADK-91-13.911115
                         Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DK9213 DK-92-13 P1O1 *****************************************
 
BASIC RESEARCH ON GROWTH REGULATION IN BENIGN PROSTATIC HYPERPLASIA
 
RFA:  DK-92-13
 
P.T. 34; K.W. 0715105, 0760020, 0765015, 1002004, 1002008
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date: November 30, 1991
Application Receipt Date: February 18, 1992
 
PURPOSE
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites new and experienced investigators to submit research
grant applications that will utilize state-of-the-art cellular,
molecular, and genetic techniques to elucidate the features of prostate
growth regulation that are unique to the development of benign
prostatic hyperplasia (BPH).  The purpose of this Request for
Applications (RFA) is to gain new insights into the factors that
initiate and regulate benign hyperplastic growth in normal prostatic
tissues.  The utilization of transgenic animal models and cell and
tissue cultures that display the features of human BPH is encouraged in
this RFA.
 
BACKGROUND
 
BPH is a major cause of morbidity in the adult male.  The diagnosis and
treatment of this disorder contributes significantly to health care
expenditures worldwide.  The spontaneous initiation of the benign
hyperplastic growth of the mature prostate gland is a clinical event
that is unique to primates and a few other animals.  Although it has
been amply demonstrated that normal and abnormal prostate growth is
dependant on the presence of androgens, the factors that initiate and
regulate the benign hyperplastic growth of the mature prostate have not
been adequately elucidated. A major obstacle to advancing research in
the basic science aspects of BPH has been that there has been no
suitable non-primate model that displays all the characteristics of
human BPH.  Although endocrine manipulation of animals can enhance and
retard prostate growth, it does not faithfully reproduce the
pathological and clinical milieu found in the human condition, e.g.,
serum hormone levels, glandular hyperplasia, and focal development.
 
RESEARCH GOALS AND SCOPE
 
The overall goal of this request is to increase the knowledge of the
initiation and regulation of the growth of the prostate gland as it
applies to the development of BPH.
 
New advances in prostate tissue and cell culture and in the development
of transgenic animal models, when combined with advances in molecular,
cellular, and genetic biology, have presented new opportunities for the
investigation of BPH.  The purpose of this RFA is to fund investigators
who use these techniques and models to go beyond the normal endocrine
regulatory mechanisms already demonstrated for prostate growth and look
at the role of such factors as peptide growth factors, interleukins,
oncogenes, collagen synthesis, calmodulin, extracellular matrix,
apoptosis, and inflammatory mediators in the initiation and regulation
of benign hyperplastic prostate growth.  Applicants are not limited to
the aforementioned factors but must develop innovative approaches using
proven findings from other spontaneous hyperplastic disorders such as
keloids, adrenal hyperplasia, tissue regeneration, and mesangial cell
hyperplasia.
 
A major goal of this initiative is to foster extensive collaboration
between the various disciplines of the basic sciences including
biochemistry, cellular biology, embryology, endocrinology, molecular
genetics, immunology, pharmacology, and physiology and research
disciplines in the clinical sciences, such as dermatology, nephrology,
and endocrinology, developing new models for investigating the basic
science aspects of this significant clinical problem.
 
It is not the intent of this initiative to fund projects that will
solely elucidate the structure of steroid hormone receptors in the
prostate cell or further characterize only the role of the sex hormones
in prostate growth.  APPLICATIONS THAT UTILIZE MALIGNANT CELL LINES OR
CANCER TUMOR MODELS TO REPRESENT NORMAL OR BENIGN HYPERPLASTIC GROWTH
WILL NOT BE FUNDED BY THIS RFA.
 
Applications are strongly encouraged that propose studies of the
interaction of the known promoters and regulators of prostate growth,
such as androgens, with other factors intrinsic and extrinsic to the
prostate gland, such as growth factors, and interleukins.
 
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,
Basic Research on Growth Regulation in Benign Prostatic Hyperplasia, is
related to the priority area of diabetes and chronic diseases.  The PHS
urges applicants to submit work plans that address specific objectives
of "Healthy People 2000."  Potential applicants may obtain a copy of
that report (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 202-783-3238)
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
 
The NIH policy, as applied to this RFA, is that applicants for clinical
research grants will be 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 should be placed on the need for inclusion of minorities in
studies of diseases that disproportionately affect them.  This policy
is intended to apply to individuals of all ages.  If minorities are
excluded or inadequately represented in clinical research, particularly
in proposed population-based studies, a clear and compelling rationale
should be provided.
 
The composition of the proposed study population must be described in
terms of gender or ethnic group, together with a rationale for its
choice.  In addition, gender and racial or ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objectives of the study.  This information should be
included on grant application form PHS 398 in Sections 2A-D of the
Research Plan AND summarized in Section 2E (Human Subjects).
 
Applicants are urged to carefully assess 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 or 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 includes human
biomedical and behavioral studies or 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 addresses by applicants.
 
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.
 
If the required information is not contained within the application,
the application will be returned.
 
Peer reviewers will specifically address 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 will be reflected in assigning a
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
that do not comply with these policies.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, and eligible agencies of the Federal
Government.  Applications from minority individuals and from women are
especially encouraged.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the traditional investigator-
initiated research grant (R01). The regulations (Code of Federal
Regulation, Title 42, Part 52 and, as applicable to the State and local
governments, Title 45, Part 74) and policies that govern the research
programs of the National Institutes of Health will prevail.  Under this
funding mechanism, the applicants will plan, direct, and conduct the
research programs.  The project periods during which the research will
be conducted must adequately reflect the time required to accomplish
the stated goals and be consistent with the policy for grant support.
Support will be provided for up to five years (renewable for subsequent
periods) subject to the availability of funds and progress achieved.
 
FUNDS AVAILABLE
 
For FY 1992, $1.25 million in total costs per year will be committed to
fund applications submitted in response to this RFA.  It is anticipated
that five to seven awards will be made.  This funding level is
dependant upon the receipt of a sufficient number of applications of
high scientific merit.  Although this program is provided for in the
financial plan of the NIDDK, the award of grants pursuant to this RFA
is contingent upon the availability of funds for this purpose.
Applicants must limit the budget requests to no more than $160,000 in
direct costs for the first year.
 
REVIEW PROCEDURES
 
Applications that are not responsive to the research goals and scope of
this RFA will be returned to the investigator.  If the number of
applications is large compared to the number of awards to be made, the
NIDDK may conduct a preliminary scientific peer review to eliminate
those applications that are clearly not competitive.  Those
applications will be withdrawn from further review and the applicant
and institutional business office will be notified. Responsive
applications received in response to this RFA will first be reviewed
for scientific and technical merit by an Initial Review Group convened
by the Review Branch, Division of Extramural Program Activities, NIDDK.
A secondary review for policy and program relevance to the NIDDK
mission will be made by the National Diabetes and Digestive and Kidney
Diseases Advisory Council.
 
Applications must be submitted using form PHS 398 (rev. 10/88),
available in the business or grants offices of most academic or
research institutions and from the Office of Grants Inquiries, Division
of Research Grants, National Institutes of Health, Room 449, 5333
Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441.
 
The RFA label (found in the 10/88 revision of application form PHS 398)
must be affixed to the bottom of the face page of the original copy of
the application.  Failure to use this label could result in delayed
processing of your application such that it will not reach the review
committee in time for review.
 
TO ENSURE PROPER IDENTIFICATION AND PROCESSING OF THE APPLICATION, LINE
2 OF THE APPLICATION FRONT PAGE MUST STATE: "DK-92-13, BASIC RESEARCH
ON BPH".
 
Applications must be received by close of business on February 18,
1992.
 
The original and four copies of the application must be sent to:
 
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD  20892
 
Two additional copies of the application must be sent under separate
cover to:
 
Dr. Robert Hammond
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 603
Bethesda, MD  20892
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by December 1, 1991, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the names
of key personnel, the participating institutions, and the number and
title of the RFA to which the applicant is responding.  Such letters
are requested for the purpose of obtaining an indication of the number
and scope of applications to be received.  The letter is not binding,
is not a requirement for submission, and does not enter into the review
of the application.  The letter of intent is to be sent to:
 
Robert Hammond, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 603
Bethesda, MD  20892
 
SUMMARY OF IMPORTANT APPLICATION DEADLINES
 
Letter of Intent receipt date:  November 30, 1991
Application receipt date:       Close of business, February 18, 1992
Initial review Group:           April 1992
Second level review:            May/June 1992
Earliest funding date:          July 1, 1992
 
INQUIRIES
 
Additional information regarding any aspect of this RFA may be obtained
from:
 
Leroy M. Nyberg, Jr., Ph.D., M.D.
Director, Urology Program, DKUHD
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7133
FAX:  (301) 496-9721
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.849.  Awards will be made under the authority of the Public
Health Service Act, Title III, Section 301 and Section 431 (b) (Public
Law 78-410, as amended:  42 USC 241 and 42 USC 285c-5) and administered
under PHS grants policies and Federal Regulations 42 CFR Part 52 and
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.