DEVELOPMENT OF CELL-SELECTIVE TOOLS FOR STUDIES OF THE BLADDER, PROSTATE, AND 
GENITOURINARY TRACT

RELEASE DATE:  August 8, 2002

PA NUMBER: PAR-02-143

EXPIRATION DATE: After February 2, 2005, unless reissued

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (www.niddk.nih.gov)
National Cancer Institute (NCI)
 (www.nci.nih.gov)
National Institute of Child Health and Human Development (NICHD)
 (www.nichd.nih.gov)

APPLICATION RECEIPT DATE:  February 1, 2003, February 1, 2004, February 1, 2005

THIS PAR CONTAINS THE FOLLOWING INFORMATION:

o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PAR  

The bladder, prostate, and other organs of the genitourinary (GU) tract are 
highly heterogeneous, consisting of a large variety of cell types. This 
complexity presents challenges to the study of physiological and cellular 
processes in health and disease. A better understanding of the unique 
characteristics, such as differences in gene and protein expression, and 
function of individual resident cell types will provide an essential 
foundation for investigations directed at preventing and treating disease. 
The present Program Announcement with Referral (PAR) is intended to encourage 
the development of new, cell-selective research tools and methods applicable 
to studies of the bladder, prostate, and other organs of the GU tract. 

Strategies to be supported include 1) discovery of genes selective to 
individual cell types, 2) characterization of cell-selective promoters, 3) 
generation of transgenic mice carrying gene-disruptions under cell-selective 
or temporal control, 4) generation of antibodies to cell-selective proteins, 
5) development of novel imaging techniques to study individual cell-types, 6) 
discovery of biomarkers that indicate health or mass of individual cell-
types, 7) development of cell-selective "drugable" targets and assays for 
such targets in animal models and/or humans, and 8) identification of cell 
specific markers to aid studies of epithelial-stromal interaction in normal 
and malignant tissues.

RESEARCH OBJECTIVES

A. Background

The cellular heterogeneity of the bladder, prostate, and other organs of the 
genitourinary (GU) system creates special challenges for researchers. 
Resident specialized cells have unique roles in maintaining proper organ 
structure and function, and hence they are expected to express a distinct 
compliment of genes, proteins, and cellular features. To describe the roles 
of individual cell types in organ physiology and pathophysiology of disease, 
investigators must successfully isolate and analyze the cell types for their 
unique cellular and functional characteristics. Therefore, the development of 
tools, reagents, and methods to define the cellular complexity and function 
of these organs is critical.

The primary goal of this initiative is to promote the development of research 
tools and innovative methods that may be applied to studies of individual 
cell types of the bladder, prostate, and GU tract. Elucidating the function 
of physiologically relevant, specialized cell types will enhance our 
understanding of the function of these organs under healthy and pathological 
states. This may in turn aid in the future development of therapeutics for 
diseases such as interstitial cystitis, infertility, benign prostatic 
hyperplasia, prostate cancer, and other malignant and non-malignant disorders 
of the GU tract, as well as in the discovery and development of novel targets 
for male contraception.  Achieving the goals outlined in this PAR is deemed a 
high-priority  by both the Bladder Research Progress Review Group  
http://www.niddk.nih.gov/fund/other/bladderprg_web/index.html) and the 
Prostate Research Progress Review Group.

B. Objectives and Scope 

This PAR is intended to encourage the development of new, cell-specific 
research tools and methods that may be applied to studies of the bladder, 
prostate, and other organs of the GU tract. In this PAR, "selective" 
indicates restricted to or prominent in certain cell types. Strategies to be 
supported include the discovery and characterization of cell-selective genes 
and promoters, the generation of transgenic mice, antibodies, and novel 
imaging techniques, the identification of cell-selective biomarkers, and 
efforts to facilitate animal model-to-human comparisons. 

The general goals of these strategies, representative (but not exclusive) 
experimental approaches, and anticipated outcomes are as follows: 

1) Identification of genes that are selectively expressed in individual 
cell types of relevant organs. Examples of experimental approaches 
include recovery of individual cell types through laser capture 
microdissection (LCM) followed by microarray technologies and/or RNA 
subtraction methods. This strategy is anticipated to reveal genes and, 
by extension, gene products contributing to unique functions of 
physiologically important cell types. 

2) Identification/modeling of promoter sequences that mediate selective 
expression in individual cell types of relevant organs. Examples of 
experimental approaches include bioinformatics-based promoter-
prediction algorithms and/or exon-mapping applications for genes 
displaying cell-selective expression regulated by transcription rather 
than mRNA stability, etc. It is predicted this strategy will identify 
promoter sequences highly useful for studies requiring cell-selective 
and/or high-level expression of transgenes. It is hoped that 
identification and functional analysis of genes and promoters will 
facilitate the development and design of novel preclinical models of 
human cancer. 

3) Generation of transgenic mice carrying gene disruptions in individual 
cell types by use of appropriate recombinase systems. Experimental 
approaches require identification/selection of relevant gene(s) for 
disruption as well as appropriate promoter(s) to allow cell-specific 
targeting of gene(s) of interest. For example, selective cells may be 
targeted by techniques such as the Cre/loxP recombinase system with or 
without temporal control. Successful generation of mouse strains 
carrying targeted-gene disruptions in individual cell-types should 
provide a significant resource for studies of respective gene-products 
and select cells in relevant organ physiology and development.

4) Generation of antibodies directed to cell-selective proteins. Examples 
of experimental approaches include phage display-single chain antibody 
or conventional hybridoma techniques against cell-selective antigens 
expressed under normal conditions and/or in diseased states. It is 
anticipated that antibodies produced will be an important asset for 
investigations of processes operating in select cells of relevant 
organs. 

5) Development of new and novel imaging techniques capable of analyzing 
individual cell-types. Examples of experimental approaches include: 
modification of existing fluorescence-microscopy techniques, electron-
microscopy (EM) techniques, such as high-voltage EM tomography for 3-
dimensional reconstructions of cellular structures, stacked 
immunohistochemistry (IH) or in situ hybridization (ISH) for 3-
dimensional reconstruction and viewing, and/or application of 
computerized tomography (CT), magnetic resonance imaging (MRI), or 
position emission tomography (PET) with development of appropriate 
contrast agents. Accompanying efforts may include engineering cell-
selective proteins tagged with the green fluorescent protein (GFP), 
fluorescent dyes, and/or analogous moieties. An additional approach may 
be to selectively eliminate individual cell-types in mice, such as 
through novel laser-ablation methodologies, to indirectly assess the 
role of these cells in the physiology and/or development of respective 
organs and tissues. It is expected that advances in imaging, and 
application of other methods described, for select cell-types will 
provide a powerful and important tool to researchers studying relevant 
organs.

6) Identification of cellular biomarkers that may be used to assess health 
and mass of individual-cell types. Examples of experimental approaches 
include: recovery of select cell-types from healthy and/or diseased 
tissues through techniques such as LCM followed by 2-dimensional 
electrophoresis or alternative methods for protein expression 
profiling. Alternatively, proteins or peptides that are preferentially 
secreted, or excreted, into urine may be isolated and profiled. 
Identification of cell-selective biomarkers should facilitate studies 
requiring biochemical isolation/sorting of select cell-types and 
provide additional diagnostic criteria for assessing health and mass of 
individual cell-types present in relevant organs. 

7) Development of cell-selective drugable targets and assays for such 
targets in experimental animal models and/or humans.

8) Identification of novel cell specific markers that will facilitate the 
understanding of epithelial cell-stromal cell interactions in both 
normal and malignant tissues. 

This PAR limits the development of cell-specific tools to human, mice, and 
rat organs. The translation of cell-selective strategies from experimental 
animal models to humans is encouraged. The goal of the NIDDK is the 
development of tools to aid studies of the development/function of the 
bladder, prostate, and other organs of the GU tract in a pre-malignant state. 
The goal of the NCI is the development of such tools for the study of these 
organs in the malignant state. The goal of the NICHD is to study organs of 
the GU tract as they relate to normal or abnormal reproductive function. 

MECHANISM(S) OF SUPPORT 

This PAR will use the National Institutes of Health R01(Research Project)and 
R21 (Exploratory/Development Project) award mechanisms (for a description of 
R01/R21 awards see http://www.niddk.nih.gov/fund/grants_process/revmech.htm).
The R01 award represents an investigator-initiated research grant designed to 
support a discrete, specified research project performed by a principal 
investigator. It is envisioned that R01 grants awarded through this PAR will 
provide up to $300,000 per year in direct costs for a maximum period of five 
years.  Therefore it is suggested that applicants prepare their budgets 
accordingly.  It is also envisioned that these grants will be renewable. The 
R21 award represents an exploratory/developmental research grant for support 
of high-risk pilot and feasibility research designed to develop new ideas 
sufficiently to allow future submission of a full R01 application. R21 grants 
awarded through this PAR will provide up to $100,000 per year in direct costs 
for a maximum of three years and may not be renewed.

This PAR uses just-in-time concepts and both the modular as well as the non-
modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

ELIGIBLE INSTITUTIONS 

You may submit an application(s) if your institution has any of the following 
characteristics: 
 
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

PERSONS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Persons with the skills, knowledge, and resources necessary to carry out the 
proposed research are invited to work with their institutions to develop 
applications for support.  Persons from underrepresented racial and ethnic 
groups as well as persons with disabilities are always encouraged to apply 
for NIH programs.   

SPECIAL REQUIREMENTS 

For the duration of their award, investigators must participate in yearly 
meetings and periodic conference calls organized by the NIH and designed to 
facilitate the exchange of ideas and findings. Investigators receiving awards 
will be required to generate a data-sharing plan. This plan will be reviewed 
for: 1) statements of willingness to share information fully, 2) adequate and 
clear strategies for sharing results, data, tools, and mice with the research 
community and/or websites maintained by the NIH., and 3) non-restrictive 
nature of included Material Transfer Agreements and Mouse Transfer Agreements 
In their applications investigators must acknowledge their willingness to 
fulfill these requirements. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PAR and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research, and financial or grants management issues.

o Direct your questions about scientific and research issues to:

Chris Mullins, Ph.D.
Director of Basic Cell Biology Programs 
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases 
6707 Democracy Blvd., Room 637
Bethesda, MD  20892-5458
Telephone:(301) 594-7717
FAX: (301) 480-3510
Email: cm419z@nih.gov

Robert Star, M.D.
Senior Scientific Advisor
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases 
6707 Democracy Blvd., Room 625
Bethesda, MD  20892-5458
Telephone:(301) 594-7717
FAX: (301) 480-3510
Email: Robert_Star@nih.gov

Tracy L. Rankin, Ph.D.
Program Director, Male Fertility, Infertility and Andrology
Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B01
Bethesda, DM 20892
Telephone: (301) 435-6979
FAX: (301) 496-0962
Email: rankint@mail.nih.gov

Judy Mietz, Ph.D.
Program Director
Division of Cancer Biology
National Cancer Institute
6130 Executive Blvd EPN 5032
Bethesda, MD 20892
Telephone: (301) 496-7028
FAX: (301) 402-1037
Email: mietzj@nih.gov 

o Direct your questions about financial or grants management matters to:

Ms. Teresa Marquette
Senior Grants Management Specialist
Grants Management Branch, DEA
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 728, MSC 5456
Bethesda, MD  20892-5456
(For Express Mail Use Zip Code 20817)
Telephone:  (301) 594-7682
Fax: (301) 480-3504
Email: tf102y@nih.gov

Ms. Crystal Wolfrey
Grants Administration Branch 
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: cw104j@nih.gov

Ms. Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm 8A170
Bethesda, MD  20892
Telephone:  (301) 496-5482
FAX:  (301) 480-4782
Email:  kh47d@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact Grants Info, Telephone: (301) 435-
0714, E-mail: 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:

o 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.
o Surveys, questionnaires, data collection instruments, and clinical 
protocols.  These may be stapled as sets.
o 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

APPLICATION RECEIPT DATES

Applications submitted in response to this announcement must be received by 
the Center for Scientific Review (CSR) on or before February 1 of each year 
for the three year duration of this announcement (2003 through 2005).

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

Applications requesting up to $250,000 per year in direct costs must be 
submitted in a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 
includes step-by-step guidance for preparing modular grants. Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.
 
This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
 
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

Use of Human Tissues

If you plan to use human samples or tissues in any of your studies in the 
"Research Plan", then Section e, "Human Subjects", of the Research Plan, must 
address human subjects risk and protection issues as required by the PHS 398 
grant application instructions. If you claim an exemption from human subjects 
regulations, this must be explained and justified in the application as 
required by the instructions in the PHS 398 grant application instructions. 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five (5) signed photocopies in 
one package as well as any appendices 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)

APPLICATION PROCESSING:  The CSR will not accept any application in response 
to this PAR 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 a substantial revision of 
an application already reviewed, but such application must include an 
Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted to this PAR will be assigned to an appropriate 
scientific review group organized and convened by the CSR specifically for 
their review. This review group will act in accordance with the standard NIH 
peer review procedures (http://www.csr.nih.gov/refrev.htm) and will evaluate 
applications for scientific and technical merit.  

As part of the initial merit review, all applications will

o Receive a written critique
o Undergo a selection process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed and assigned a priority score
o Receive a second-level review by the appropriate national advisory council 
or board
 
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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Innovation
o Approach 
o Significance
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) 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 
tools facilitate cell-selective analyses not practical with existing 
reagents/methods? Does the proposal provide breakthrough technology that 
might catalyze research broadly?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
sufficiently developed, well integrated, and appropriate to the aims of 
the project?  Is the proposed approach adequate to: (i) identify, isolate, 
or target individual cell-types of interest from relevant organs,(ii) 
generate or identify tools from select cell-types, and (iii) validate 
cell-selectivity of new tools? Does the applicant acknowledge potential 
problem areas and consider alternative tactics? 

(3) SIGNIFICANCE:  Does the study address an important problem? Are the 
individual cell-types chosen for study of clinical importance? If the aims 
of the application are achieved, how will they advance scientific 
knowledge of relevant tissues and organs?  What will the effect of these 
studies be on the concepts or methods that drive the field(s)? What types 
of investigations will benefit from cell-selective tools 
developed/isolated? What are important uses for tools developed/isolated 
beyond those described in present application?

(4) INVESTIGATOR: Are the principal investigator (PI) and collaborators 
appropriately trained and in general well suited to carry out the work? Is 
the experience level of the PI and other researchers involved adequate to 
accomplish the proposed investigations? Does the PI have a demonstrated 
expertise or special knowledge of area of investigation? Does the PI have 
a good record of productivity in this or a similar area(s) of 
investigation? Are appropriate technical experts and collaborators 
involved in investigation (if applicable)?

(5) ENVIRONMENT:  Does the scientific environment in which the work will 
be done contribute to the overall 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? Are adequate facilities, equipment, and 
technical support available for particularly sophisticated methods such as 
microscopy, tissue-dissection, and imaging techniques and the housing and 
care of animals (if applicable)?

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, your application will also be reviewed 
with respect to the following:

(1) DATA SHARING: Investigators receiving awards will be required to 
generate a data-sharing plan. This plan will be reviewed for statements of 
willingness to share information fully, adequate and clear strategies for 
sharing  results/data, tools, and mice with the research community and/or 
websites maintained by the NIH, and non-restrictive nature of included 
Material Transfer Agreements and Mouse Transfer Agreements.

(2) PROTECTIONS:  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.

(3) INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

(4) BUDGET: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to this PAR will compete for available 
funds with all other recommended applications. The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer 
review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  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 clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete 
copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm  
The amended policy incorporates the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require the following for all NIH-defined Phase III clinical 
trials: a) all applications or proposals and/or protocols must provide a 
description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including subgroups if 
applicable, and b) investigators must report annual accrual and progress in 
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

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.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  
Criteria  for  federal  funding of research on hESCs can be found at
http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic 
Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov). It is the responsibility of the applicant to provide 
the official NIH identifier(s)for the hESC line(s)to be used in the proposed 
research.  Applications that do not provide this information will be returned 
without review.

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.

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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 PA 
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.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.849 (NIDDK), 93.396 (NCI-cancer biology), 
and 93.864 (NICHD-Population Research), and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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.



Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.