This Program Announcement expires on October 1, 2004 unless reissued.

PILOT AND FEASIBILITY PROGRAM IN UROLOGY

Release Date:  October 15, 2001

PA NUMBER:  PA-02-013

National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)
National Cancer Institute
 (http://www.nci.nih.gov)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and 
the Division of Cancer Biology of the National Cancer Institute NCI) invite 
exploratory/developmental (R21) grant applications from investigators with 
research interests in urology and that serve the mission of NIH.  The primary 
intent of this initiative is to foster the development of high-risk pilot and 
feasibility research by newly independent or established investigators 
developing a new line of research.  Information thus obtained would allow 
subsequent submission of R01 applications focusing on research problems 
relevant to the study of urologic diseases and their complications.  These 
grants are not intended to support or supplement ongoing funded research of 
an established investigator, or to serve as an alternative mechanism of 
support for projects not receiving funding as competitive continuation 
applications.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas.  This Program Announcement 
(PA), PILOT AND FEASIBILITY PROGRAM IN UROLOGY, is related to one or more of 
the priority areas. Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
and 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.  
Furthermore, this mechanism is for the support of either new investigators  
[defined as independent investigators who have not yet held R01, R29, or 
subprojects of program project (P01) or center grants (P50) or equivalent], 
or established investigators entering a new research field or developing a 
new line of research.

MECHANISM OF SUPPORT

This program will be supported through the exploratory/developmental grant 
(R21) mechanism. These awards are to demonstrate feasibility and to obtain 
preliminary data testing innovative ideas that represent a clear departure 
from ongoing research interests.  Projects will be limited to $100,000 direct 
costs per year and are limited to two years duration.  These grants will not 
be renewable.  Continuation of projects developed under this program will be 
through the regular research grant mechanism (for example, R01).  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The NIH Grants policy 
statement applies to these awards.

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts that have been adopted by the 
NIH.  Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

Areas in which such scientific opportunities exist include, but are not 
limited to:

o  Identification of novel signaling molecules and pathways involved in 
urologic cellular and tissue development, differentiation, transcription, and 
function.

o  Identification and characterization of cells capable of repopulating 
urologic organs (stem cells).

o  Development and characterization of promoters to drive gene expression in 
urologic tissues.

o  Development, characterization and utilization of novel cellular and animal 
models of urologic diseases.

o  Development of novel vectors and delivery systems for use in gene therapy 
of urologic diseases, including both inherited disorders such as hereditary 
oxalosis, and disorders thought to be acquired such as prostatitis, 
interstitial cystitis, and urologic complications of diabetes.

o  Development of new methods for temporal and spatial control of transgene 
expression in urologic tissues.

o  Identification and characterization of biologic markers for the 
development and/or progression of urologic diseases.

o  Development and characterization of full-length genetic libraries from 
understudied urologic tissues, especially the urinary bladder.

o  Use of molecular biologic and proteomic techniques, such as differential 
display RT-PCR or (amplification) to screen for novel urologic tissue-
specific genes, novel disease or regulatory genes, and/or etiologic agents.

o  Development and use of array technology and bioinformatics to characterize 
profiles of gene expression in urologic tissues in disease and health.

o  Use of phage display or other novel approaches to identify cellular 
receptors in urologic tissues.

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 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 
UPDATED “NIH Guidelines For Inclusion of Women and Minorities as Subjects in 
Clinical Research”, published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html

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

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at:  
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 
5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are 
to be used in applying for these grants and will be accepted at the 
standard application deadlines (http://grants.nih.gov/grants/dates.htm) 
as indicated in the application kit.  This version of the PHS 398 is 
available in an interactive, searchable format. Although applicants 
are strongly encouraged to begin using the 5/2001 revision of the PHS 
398 as soon as possible, the NIH will continue to accept applications 
prepared using the 4/1998 revision until January 9, 2002. Beginning 
January 10, 2002, however, the NIH will return applications that are not 
submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

All application instructions outlined in the PHS 398 application kit are to 
be followed, with the following requirements for R21 applications:  

1.  R21 applications will use the “MODULAR GRANT” and “JUST-IN-TIME” 
concepts, with direct costs requested in $25,000 modules, up to the total 
direct costs limit of $100,000 per year. 

2. Although preliminary data are not required for an R21 application, they 
may be included.

3.  Sections a-d of the Research Plan of the R21 application may not exceed 
15 pages, including tables and figures.  

4.  R21 appendix materials should be limited, as is consistent with the 
exploratory nature of the R21 mechanism, and should not be used to circumvent 
the page limit for the research plan.   Copies of appendix material will only 
be provided to the primary reviewers of the application and  will not be 
reproduced for wider distribution.  The following materials may be included 
in the appendix:

Up to five publications, including manuscripts (submitted or accepted for 
publication), abstracts, patents, or other printed materials directly 
relevant to the project.  These may be stapled as sets.
Surveys, questionnaires, data collection instruments, and clinical protocols.  
These may be stapled as sets.

Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within 
the 15 page limit of items a-d of the research plan

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, 
however, to use the 4/1998 revision of the PHS 398 for scheduled application 
receipt dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step instructions for 
Modular Grants available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Additional 
information about Modular Grants is also available on this site.

The program announcement title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked.  Mail the 
signed, original, single-sided application, along with five exact, single-
sided copies and five collated sets of appendix materials 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health 
Service referral guidelines.  Applications that are complete will be 
evaluated for scientific and technical merit by an appropriate peer review 
group convened 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, generally the top half of applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the appropriate national advisory council or board.

Review Criteria

The goals of the supported research are to advance our understanding of 
biological systems, improve the control of disease, improve health care 
services, 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.

(1) Innovation:  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(2) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work? Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?  Is the 
investigator a new investigator or an established investigator developing a 
new line of research?

(3) 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?

(4) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(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 
support?

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

o  The 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 in relation to the 
proposed research.

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

AWARD CRITERIA

Applications will compete for available funds with all other approved 
applications.  The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program priority

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.  Relevant Scientific Program Officers 
may be identified through the DKUHD webpage at 
http://www.niddk.nih.gov/welcome/org/tables/kuh_table.htm or by making direct 
inquiries to:  

Leroy M. Nyberg, M.D., Ph.D.
Urology Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 627
Bethesda, MD  20892-5458
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
E-mail:  ln10f@nih.gov

Direct NCI programmatic inquiries to:

Suresh Mohla, Ph.D.
Chief, Tumor Biology and Metastasis Branch
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard
5038 EPN, Suite 5000
Bethesda, MD  20892
Telephone:  (301) 435-1878
FAX:  (301) 480-0864
Email:  sm82e@nih.gov

Direct inquiries regarding NIDDK fiscal and administrative matters to:

Aretina Perry-Jones
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard
Room 716, MSC 5456
Bethesda, MD  29802-5456
Telephone:  (301) 594-8862
FAX:  (301) 594-9532
Email:  ap19s@nih.gov

Direct inquiries regarding NCI fiscal and administrative matters to:

Crystal Wolfrey
National Cancer Institute GAB
Executive Plaza South, Room 243, MSC 7150
6120 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email:  cw104j@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
Numbers 93.849 and 93.396.  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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