Release Date:  January 5, 2000

RFA:  DK-00-015


National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  March 21, 2000

Application Receipt Date:  April 21, 2000 


The prostate and other organs of the genitourinary tract are highly 
heterogeneous tissues, consisting of many cell types.  Better understanding of 
the properties of the individual cell types and their interaction, 
particularly during development, is likely to lead to new approaches to 
prevent and treat diseases of these organs.  This RFA is to encourage the 
development of new research tools and methods to study development and biology 
of the prostate and genitourinary tract.  Strategies to be supported include 
systematic assessment of gene expression in specific cell types in the 
developing prostate and genitourinary tract; methods to tag individual cell 
types for purification, analysis, and characterization; tools to manipulate 
gene expression in vivo in individual cell types; and development of 
clinically relevant cell lines.


The NIH is committed to achieving the health promotion and disease prevention 
objectives of "Healthy People 2000," a national activity for setting priority 
DEVELOPMENT is related to the priority areas of "Chronic Debilitating 
Illnesses" and "Cancer." Potential applicants may obtain a copy of "Healthy 
People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.


Applications may be submitted by domestic and foreign for-profit and nonprofit 
organizations, public and 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.


This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) and exploratory research grant (R21) mechanisms.  Except as 
otherwise noted in this announcement, awards will be administered under 
policies as stated in the NIH Grants Policy Statement. 

R01 applications submitted in response to this RFA may not request a total 
project period of more than 3 years. In general, the maximum budget request 
for R01 applications should be limited to $350,000 in direct costs, excluding 
indirect costs on consortium arrangements, for each budget year. Exploratory 
research grant (R21) applications may not exceed 2 years for the total project 
period.  The maximum budget request for R21 applications may not exceed 
$100,000 in direct costs for each budget year.  The R21 grant mechanism may be 
used by new investigators or experienced investigators to develop pilot and 
feasibility studies for new and innovative approaches to prostate and 
genitourinary development.  R21 applications generally are expected to have 
little preliminary data and are reviewed based on the development of 
hypotheses and supporting literature.

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH's National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research. In such 
a case, 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 customary peer review procedures.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The anticipated award date is 
September 29, 2000.


The NIDDK and NIEHS intend to commit approximately $4 million in FY 2000 to 
fund 3-4 new research project grants (R01) and 8-10 new exploratory research 
grants (R21) in response to this RFA. Although the financial plans of the 
NIDDK and NIEHS provide support for this program, awards pursuant to this RFA 
are contingent upon the availability of funds and the receipt of a sufficient 
number of applications of outstanding scientific and technical merit. 


A.  Background 

Although our understanding of the molecular mechanisms that underlie early 
development of the vertebrate embryo has advanced dramatically, there has been 
much less progress in clarifying the processes that orchestrate the formation 
of the elaborate structures that make up many of the body's organ systems, 
including the genitourinary system.  The prostate, kidney, bladder, and other 
organs of the genitourinary tract share common embryological origins, 
developing from the metanephric blastema, Wolfian and Mullerian ducts.  A 
number of genes critical for the early differentiation of cells in the 
genitourinary tract have been identified, but the molecular processes and cell 
interactions that allow for the development of the full cellular complexity of 
the mature organs are poorly understood. 
The major goal of this initiative is to ensure that research tools are 
available so that a broad range of innovative methods can be applied to 
studying prostate development.  Elucidating early steps in genitourinary tract 
development and subsequent steps in determining and differentiating prostate 
cell lineages is expected to identify genes important in prostate diseases, 
particularly those associated with abnormal growth, such as benign prostatic 
hyperplasia, prostate cancer, and other malignancies of the genitourinary 

The cellular heterogeneity of the prostate and other organs of the 
genitourinary system creates special challenges for studying disease and 
normal physiology. The development of methods that account for the spatial and 
cellular complexity of these tissues is critical if new techniques for 
systematic study of gene expression are to be effectively applied to studying 
developmental events.  Many interesting genes are likely to be expressed at 
very low levels, either at key stages of development or in highly restricted 
cellular locations. Therefore, strategies are needed to deal with both 
anatomical complexity, such as laser capture microdissection, and cellular 
heterogeneity, such as use of cell-specific promoters for cell tagging and 
isolation methods.  Goals of these approaches would be in part to isolate 
homogeneous cell populations for library construction, EST sequencing, and 
assaying gene expression.  There is also a need to develop techniques to 
visualize RNA distribution within these tissues, bioinformatic methods to 
visualize topologic results, and new methods to acquire material from archival 

The major focus of this initiative is to develop tools for research in the 
mouse, since a wide variety of genetic and genomic approaches are possible in 
this species.  Particularly relevant for this initiative are methods to 
manipulate the mouse genome.  However, in view of the importance of studying 
gene expression in human disease, this initiative will also consider R21 pilot 
and feasibility studies of human material.  Other species may offer unique 
advantages for developing methods to study cellular heterogeneity of the 
prostate.  Studies using other species will be considered responsive to this 
RFA provided that a rationale is given for using the alternative species.

B. Objectives and Scope

This RFA encourages the development of new research tools and methods to study 
the early stages of development of the genitourinary tract and subsequent 
development and differentiation of prostate cell lineages.  Strategies to be 
supported include methods to systematically assess gene expression in specific 
cell types in the developing prostate and genitourinary tract; methods to tag 
individual cell types for purification, analysis and characterization; tools 
to manipulate gene expression in vivo in individual cell types; and 
development of clinically relevant cell lines.

Specific goals of this initiative are to develop the following research 
resources for the mouse:

1. Methods to tag and isolate specific cell types in the developing 
genitourinary tract and prostate;

2. Methods to systematically assess gene expression for the major cell types 
of the developing genitourinary tract and prostate;

3. A systematic catalog of cell-specific patterns of gene expression in the 
early stages of genitourinary tract development and in each cell type of the 
developing and adult prostate. These efforts are expected to include cDNA 
library construction and EST sequencing as appropriate;

4. Bioinformatic capacity to ensure that the research community has access to 
gene expression information; and
Sharing strategies to ensure that other research tools are available.

Research project grants (R01) will support the major objectives of this RFA.  
Funded investigators will be expected to participate in a cooperative 
initiative to achieve these goals.  The final program, developed by the group 
of grantees, will utilize the strengths of individual investigative teams, for 
example in cell isolation, library construction, EST sequencing, in vivo 
manipulation of gene expression, and bioinformatics.

Grantees are expected to develop strategies to determine the extent to which 
existing EST and cDNA resources adequately represent genes expressed in 
specific cell types.  It is anticipated that the group of grantees will 
collectively develop a plan to focus additional EST sequencing efforts for 
maximum yield.

Smaller, pilot exploratory research grants (R21) will support development of new 
strategies and innovative approaches to meet additional goals of the RFA, and to 
provide special expertise to help direct the larger centers in early prostate or 
genitourinary biology. Such pilot projects might include, for example:

1. Generation of cell-specific antibodies by phage display, and purification 
of cells by flow cytometry;

2. Development of validated, cultured cell lines with patterns of gene 
expression similar to in vivo cells;

3. Identification of cell-specific promoters, tagging of specific cells in 
vivo by GFP fusion proteins, and development of methods for inducible 
modification of gene expression in vivo;

4. Development of reagents to trace cell lineage during development, purify 
stem cells, and develop lineage-specific cell culture models;

5. Development of methods to retrieve information from archived biopsies;

6. Development of methods to visualize RNA expression and provide topological 
information about expression patterns.


A. Annual Meetings of Grantees

The NIDDK Program Director will convene a group consisting of the Principal 
Investigators of each funded grant, a NIEHS Program Director, plus invited 
expert consultants.  Annual meetings will encourage exchange of information 
among the Principal Investigators.  A major goal of these meetings is to 
facilitate progress by providing a forum that will lead to coordination, and 
sharing of skills, ideas, technology, data, biological reagents, and 
bioinformatics.  Applicants must include in their proposal travel funds for 
the Principal Investigator and up to one other key research scientist for 
three 1-day meetings the first year and two 1-day meetings in subsequent 
years, all in Bethesda, Maryland. The Principal Investigator must include a 
statement indicating willingness to participate in these meetings, follow 
common protocols, and collaborate with other grantees.

During the grant period, technologies will improve and the rate of progress 
and focus of work supported by the grant(s) may change.  The Principal 
Investigator(s), in consultation with the other grantees and the NIDDK and 
NIEHS Program Directors, will make any necessary adjustments to accommodate 
the changing research environment, to remain focused on appropriate goals, to 
maintain excellent coordination with the other projects funded under this RFA, 
and to incorporate new technological advances.

B. Sharing Data and Biological Materials in Human Genetic Research

Timely sharing of information, materials, and technology will speed scientific 
discovery by permitting researchers access to sufficiently large and 
well-characterized resources as quickly as possible.  This sharing of 
materials and data, including those not yet or never published, is essential 
to rapid progress and will help to avoid unnecessary duplication of large data 
collections.  To ensure timely sharing of information and materials, 
applications should describe in detail how, when, and in what manner data, 
materials, and technology will be made available to the scientific community. 
 In addition, applicants should outline plans to adequately safeguard the 
genetic research rights and interests of participants.

A period of time will be required to verify the accuracy of data, perform 
initial analyses, and protect intellectual property rights to ensure that 
inventions, including therapeutic agents, are pursued and developed rapidly 
for the benefit of the public.  Thus, a protected period, from the time data 
and materials are collected to the time they are made available to other 
qualified investigators, may be appropriate.  The onset and duration of this 
period will vary, depending upon the nature of the research project.  
Applicants must justify the length of the proposed protected period.

Applicants should discuss any pre-existing intellectual property rights, 
including options to for-profit research sponsors that might be associated 
with the clones, sequences, and experimental results that may be generated.

Where appropriate, grantees may work with the private sector to make unique 
resources available to the larger biomedical research community at a 
reasonable cost. Applicants may request funds to defray the costs of sharing 
materials or submitting data, with adequate justification. 


It is the policy of the NIH that women and members of minority groups and 
their subpopulations 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 policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which was published in the Federal Register of March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide For Grants and Contracts, Vol. 23, No. 
11, March 18, 1994, available on the web at: 


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.


Prospective applicants are asked to submit by March 21, 2000, a letter of 
intent.  Include a descriptive title of the proposed research; the name, 
postal and email addresses, and telephone number of the Principal 
Investigator; the names of other key personnel and participating institutions; 
and the number and title of this RFA.

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 NIH staff to estimate the potential review workload and avoid 
conflict of interest in the review.

Send the letter of intent to:

Chief, Review Branch 
Division of Extramural Activities, NIDDK
Natcher Building, Room 6AS-37F
45 Center Drive MSC 6600
Bethesda, MD 20892-6600 
Telephone:  (301) 594-8885
FAX:  (301) 480-3505


The research grant application form PHS 398 (rev. 4/98) 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 Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: GrantsInfo@nih.gov, and at 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award.  It is anticipated that these changes 
will reduce the administrative burden for the applicants, reviewers, and 
Institute staff.  The research grant application form PHS 398 (rev. 4/98) is 
to be used in applying for these grants, with the modifications noted below.


All grant applications responding to this RFA must follow the format for 
modular grants and will request direct costs in $25,000 modules, up to a total 
direct cost request of $350,000 per year ($100,000 for R21s).  The total 
direct costs must be requested in accordance with the program guidelines and 
the modifications made to the standard PHS 398 application instructions 
described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $350,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative (F&A) costs] for the initial budget 
period.  Items 8a and 8b should be completed indicating the Direct and Total 
Costs for the entire proposed period of support.

of the PHS 398. It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.)  At the top of the page, enter the total direct costs requested for 
each year.  This is not a Form page.

o Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of key personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.  Indirect costs for 
subcontracts are included in the total costs for the application.  The 
subcontract costs should not be in modular form but should be rounded to the 
nearest $1,000. 

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers to assess each individual's qualifications for a specific role in 
the proposed project, as well as to evaluate the overall qualifications of the 
research team.  A biographical sketch is required for all key personnel, 
following the instructions below.  No more than three pages may be used for 
each person.  A sample biographical sketch may be viewed at: 

- Complete the educational block at the top of the form page.
- List position(s) and any honors.
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations.

o CHECKLIST: Complete and submit this page with the application.  If the F&A 
rate agreement has been established, indicate the type of agreement and the 
date. All appropriate exclusions must be applied in the calculation of the F&A 
costs for the initial budget period and all future budget years.

o Provide the name and phone number of the individual to contact concerning 
fiscal and administrative issues  should additional information be necessary 
following the initial review.  

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Failure to use 
this label could delay processing of the application such that it may not 
reach the review committee in time for review.  In addition, type the RFA 
title and number on line 2 of the face page of the application form and mark 
the YES box. 

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)

At the time of submission, send two additional copies of the application to:

Chief, Review Branch
Division of Extramural Activities, NIDDK
Room 653, 6707 Democracy Blvd, MSC 5452
Bethesda, MD 20892-5452

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.  Supplemental documents 
containing significant revisions or additions will not be accepted, unless 
applicants are notified by the Scientific Review Administrator.  

The Center for Scientific Review (CSR) 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 
CSR 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, but such applications must 
include an introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK and NIEHS.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration. 

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 review criteria stated below.  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, generally the top half of the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the appropriate National Advisory Council.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1)Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?  Are the proposed target cells important in clinical disease or 

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Do they utilize state-of-the-art technology?  Is the necessary 
technical and analytical expertise available?  Does the applicant acknowledge 
potential problems and {offer/suggest} alternative tactics? Is the approach 
broad and diverse enough to find and characterize something new and 

(3) Innovation:  Does the project employ novel concepts, approaches, or 
methods? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?  Will the 
resultant cell-specific reagents advance understanding of developmental 
disorders and clinical diseases? It is understood that some of the projects 
might be more descriptive than hypothesis driven.  However, has the 
investigator adequately justified this approach and adequately described and 
limited the descriptive portion leading to the development of a testable 

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the proposed work appropriate to the experience of 
the principal investigator and other researchers (if any)? Has the 
investigator submitted a statement agreeing to participate and collaborate 
with the other grantees?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o Adequacy of plans to include both genders, minorities and their subgroups, 
and children as appropriate for the scientific goals of the research.  Plans 
for the recruitment and retention of subjects will also be evaluated.
o  The reasonableness of the proposed budget and duration to the proposed 

o  The adequacy of the proposed protection of humans, animals, or the 
environment, to the extent that they may be adversely affected by the project 
proposed in the application.

o Availability of special opportunities for furthering research programs 
through the use of unusual talent resources, populations, or environmental 
conditions in other countries that are not readily available in the United 
States or that augment existing U.S. resources.

o Does the applicant state a willingness to work with  other grantees to 
develop the best possible set of tools for studying prostate and genitourinary 
development?  Is the applicant willing to share protocols and technology with 
the research public? 

Letter of Intent Receipt Date: March 21, 2000
Application Receipt Date: April 21, 2000 
Peer Review Date: June/July 2000 
Council Review: September 20-21, 2000
Earliest Anticipated Start Date: September 29, 2000


Criteria for award decisions include:

o Scientific merit as determined by peer review;

o Availability of funds;

o Programmatic priorities that include ensuring a diverse representation of 
targeted cells of NIDDK and NIEHS interest and willingness to work with other 
institutions to minimize overlap between grantees; and

o Recommendations of NIDDK and NIEHS Advisory Councils.


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:

Robert A. Star, M.D.
Kidney, Urologic and Hematologic Diseases
Room 9A-35
31 Center Drive MSC 2560
Bethesda, MD 20892-2560
Telephone:  (301) 594-7715 
FAX:  (301) 480-3510
E-mail: StarR@extra.niddk.nih.gov

Leroy M. Nyberg, Jr., Ph.D., M.D.
Kidney, Urologic and Hematologic Diseases
NIDDK 45/6AS-13G
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-7717
FAX:  (301) 480-3510
E-mail: NybergL@extra.niddk.nih.gov

Michael E. McClure, Ph.D.
Division of Extramural Research and Training
Organs and Systems Toxicology Branch, NIEHS111 T.W. Alexander Drive
P.O. BOX 12233, Mail Drop EC-23
Research Triangle Park, NC 27709
Telephone: (919) 541-5327
FAX:  (919) 541-5064
E-mail: mm461n@nih.gov

Direct inquiries regarding fiscal matters to:

Trude Hilliard
Division of Extramural Activities 
NIDDK 45/6AN-44B
45 Center Drive MSC 6600
Bethesda, MD 20892-6600
Telephone:  (301) 594-8859 
E-mail: HilliardT@extra.niddk.nih.gov


This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.849 and 93.113.  Awards are 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 NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The NIH 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 NIH mission to protect and advance the physical and mental health of 
the American people.

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