Full Text DK-96-005
NIH GUIDE, Volume 25, Number 10, March 29, 1996
RFA:  DK-96-005
P.T. 34

  Urogenital System 
  Growth Factors 

National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Aging
Letter of Intent Receipt Date:  July 15, 1996
Application Receipt Date:  August 8, 1996
The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the National Institute on Aging solicit research project
grant (R01), First Independent Research Support and Transition
(FIRST) (R29) award, and Interactive Research Project Grant (IRPG)
applications for the support of basic research studies that use human
tissue and cells to focus on the molecular mechanisms of the
regulation of normal prostate growth, the factors involved in the re-
initiation of normal growth in adult men, and abnormal, non-malignant
prostate growth and disorders.  The intent of this solicitation is to
increase the diversity of approaches to the study of prostate growth
regulation and related abnormalities by encouraging investigators
from diverse research areas to apply their expertise in this area.
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, The
Regulation of Prostate Growth, is related to the priority area of
disease and aging.  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).
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.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.  Racial/ethnic minority
individuals, women and persons with disabilities are encouraged to
apply as principal investigators.  Competing renewal applications are
not eligible for this solicitation.
Support of this program will be through the NIH research project
grant (R01), Investigator-Initiated Interactive Research Project
Grant (IRPG) and FIRST (R29) 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.
This RFA is a one-time solicitation.  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.  FIRST Awards must be for five years and the total direct
cost award for the five year period may not exceed $350,000.  A
maximum of three years can be requested for foreign awards.  The
maximum dollar request is limited to $160,000 in direct costs for the
initial budget period for R01s and the individual IRPGs.  However,
the lead IRPG may include a request for up to an additional $50,000
Direct Costs for shared resources.  (Special instructions for
preparing applications for IRPGs must be requested from the program
officials listed under INQUIRIES).  The anticipated award date will
be April 1, 1997.
For FY 1997, $2,500,000 will be committed by the NIDDK to fund
applications submitted in response to this RFA.  It is anticipated
that 12 to 14 awards will be made by the NIDDK.  In addition, the NIA
will fund up to two high quality applications related to molecular
and cellular mechanisms of prostate growth in middle aged and older
men.  However, these funding level are dependent upon the receipt of
a sufficient number of applications of high scientific merit.  In
order to help meet NIDDK and NIA goals or managing the costs of
biomedical research, applicants must limit their requests to not more
than $160,000 direct costs for the initial budget period.  Although
this program is provided for in the financial plans of the NIDDK and
NIA, the award of grants pursuant to this RFA is also contingent upon
the availability of funds for this purpose.
Background:  Normal and abnormal prostate growth contribute to two
major prostate diseases: benign prostatic hyperplasia (BPH) and
prostate cancer (PCa).  Other prostate abnormalities result in the
development of chronic prostatitis.  The factors involved in the
initiation and regulation of prostate growth have been inadequately
characterized and many new factors remain to be described.  There are
also many other areas of prostate abnormality which are poorly
investigated.  Of particular importance are the immunologic
mechanisms of the prostate and the interrelationship between benign
prostate enlargement and urinary bladder abnormalities.  A large
amount of the current knowledge about these diseases has been
extrapolated from research studies on animals and animal cell lines.
The number of studies which focus on well characterized human tissue
are very limited.  If progress is to be made in effectively treating
and preventing prostate disease, the basic molecular mechanisms which
regulate prostate growth must be characterized in normal prostate
tissue and in well characterized abnormal prostate tissue.
Innovative molecular approaches to the study of cellular growth and
immunology are being utilized effectively by investigators in fields
as diverse as oncology, wound healing, morphogenesis, and
pharmacogenetics.  All too often these investigators focus on one
specific organ system or disease problem and are not encouraged to
apply their knowledge to a related phenomenon in a different tissue.
Areas for investigation: The major emphasis of  this RFA is the
solicitation of new and innovative approaches to study of prostate
growth and chronic prostate inflammation using well characterized
human tissue. (Well characterized tissue is tissue for which both a
pathological diagnosis, e.g. normal, prostatitis, hyperplasia,
chronic prostatitis, and, if possible, the concurrent clinical
parameters, are identified.)  If animal tissue is used in the study
design, it cannot be the major focus of the study but used as a
mechanism to develop or amplify studies on human tissue.
Topics that are be within the scope of this RFA include, but are not
limited to:
o  research studies on prostate stem cells,
o  common regulatory factors found in various prostate diseases such
as prostatitis, BPH and PCa,
o  the role of cytokines, interleukins, etc. in prostate growth
o  the regulation of prostate apoptosis,
o  cell/cell interactions and prostate growth
o  enzymatic factors involved in the regulation of prostate growth,
o  molecular genetics of prostate growth regulation,
o  the role of neuroendocrine cells and neuroendocrine factors in
prostate growth regulation,
o  fetal imprinting and adult prostate growth regulation.
o  the effect of diabetes mellitus on prostate growth regulation.
o  comparison of growth regulation in tissues from persons of diverse
ethnic/racial origins,
o  the molecular effects of prostate enlargement and/or outflow
obstruction in gene expression in bladder and prostate,
o  the immune defense mechanisms of the human prostate and urethra,
o  effects of bacterial agents on the molecular immunology of the
o  exocrine, paracrine and other regulator mechanisms of prostate
o  genetic differences in growth initiation in prostate tissue from
persons of diverse ethnic origins.
o  age-related changes in prostate growth  bioregulatory factors, and
prostate cell sensitivity to these factors,
o  molecular, cellular, and genetic mechanisms that lead to
initiation and sustenance of prostate growth in middle aged men.
Applications solely to study malignant prostate growth and its
regulation are not within the scope of this RFA.  However,
applications that use malignant tissue for comparative study with
benign hyperplasia, chronic prostatitis, normal cells, or models are
acceptable for application.
Program project grant applications (P01) will not be accepted in
response to this RFA.
Special Requirements: NIDDK BPH Clinical Trial Investigators:
Investigators funded by either the Pilot or Full-Scale NIDDK BPH
Clinical Trial may utilize the tissue collected by the study and
stored at the diagnostic center.  Applicants must include with their
application a letter from the NIDDK Project Officer stating that they
are eligible to use this tissue bank.  Applicants should include in
their budget any special shipping or preparation costs which will be
incurred by the diagnostic center and additional travel funds to the
NIH for two research planning meetings during the first grant period.
FIRST Award Applicants:  Must adhere to the R29 Administrative
Guidelines (revised February 1994) for eligibility, budget and period
of award.  FIRST Award applications (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award applications submitted without the required
reference letters will be considered incomplete.  Foreign
Institutions are not eligible for FIRST Awards.
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.
Because this solicitation is limited to prostate tissue, a statement
regarding the inclusion of women in the study is not necessary.
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 20, 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
Prospective applicants are asked to submit, by July 15, 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
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 37-E - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8885
FAX:  (301) 480-3505
The research grant application form PHS-398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  ASKNIH@odrockm1.od.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 checked.
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
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
also be sent to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS 37-E - MSC 6600
Bethesda, MD  20892-6600
Applications must be received by August 8, 1996.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  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.
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 Diseases
Advisory Council.
Review criteria
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;
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
o  availability of special opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions in other countries which are not readily
available in the United States or which provide augmentation of
existing U.S. resources.
o  in addition, the reviewers will be asked to address the new and
innovative character of the application; applicants should ensure
that those factors are delineated in the application.
The anticipated date of award is April 1, 1997.
Funding decisions will be made based on the scientific and technical
merit as reflected in the priority score, availability of funds, and
programmatic priorities.  Compliance with the intent and purpose of
the RFA will also be considered in funding decisions.
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is
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, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301)-480-3510
Email:  Ralph_Bain@nih.gov
Leroy M. Nyberg, Jr., Ph.D., M.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301)-480-3510
Email:  Leroy_Nyberg@nih.gov
Frank Bellino, Ph.D.
Biology of Aging Program
National Institute on Aging
Gateway Building, Suite 2C231
Bethesda, MD  20892-9205
Telephone:  (301) 496-6402
FAX:  (301) 402-0010
Email:  bellinof@gw.nia.nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Ms. Trude Hilliard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8859
FAX:  (301) 480-3504
Email:  MccainT@ep.niddk.nih.gov
Robert Pike
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
Bethesda, Md  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  pikeb@gw.nia.nih.gov
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849 (NIDDK) and 93.866 (NIA).  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 case, 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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