Expired PAR-02-143: DEVELOPMENT OF CELL-SELECTIVE TOOLS FOR STUDIES OF THE BLADDER, PROSTATE, AND GENITOURINARY TRACT

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

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) 710-0267, 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.

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