NOVEL APPROACHES TO ENHANCE ANIMAL STEM CELL RESEARCH
RELEASE DATE: August 9, 2002
PA NUMBER: PA-02-147 (superseded by PA-04-125)
EXPIRATION DATE: May 31, 2004 unless reissued.
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Heart, Lung and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 PA
The purpose of this program announcement (PA) is to encourage the submission
of applications for research to enhance animal stem cells as model biological
systems. Research to isolate, characterize and identify totipotent and
multipotent stem cells from nonhuman biomedical research animal models, as
well as to generate reagents and techniques to characterize and separate
those stem cells from other cell types is encouraged. Innovative approaches
to the problems of making multipotent stem cells available from a variety of
nonhuman sources, and to creating reagents that will identify those stem
cells across species and allow for separation of multipotent stem cells from
differentiated cell types, will be stressed. Studies involving human
subjects are not allowed under this PA. This PA supersedes PA-01-076 issued
earlier by the NCRR.
RESEARCH OBJECTIVES
Embryonic stem cells and other stem cells are valuable biomedical research
models for the study of biological and disease processes, and for creation of
disease models. In addition, these cells hold promise as model systems for
development of therapeutics and for development of replacement tissues through
understanding of control of cellular differentiation.
Thus far, embryonic stem cells have been isolated from some biomedically
important nonhuman research models. In addition, stem cells with a more
restricted potential have been characterized from post-embryonic tissue types.
However, research is needed to provide for a full array of totipotent and
multipotent stem cells from nonhuman biomedical research animal models, as
well as to provide the research tools to identify, characterize, and purify
those cells.
This initiative will support the isolation and characterization of embryonic
and other multipotent stem cells in a variety of nonhuman animal species.
Examples of research areas appropriate to this announcement include, but are
not limited to:
o Projects to expand the number of nonhuman animal model systems in which
embryonic stem cells are available.
o Projects to identify, isolate, culture and characterize multipotent stem
cell populations derived from nonhuman embryonic stem cells.
o Projects to identify, isolate, culture and characterize multipotent stem
cells from post-fetal tissue types.
o Projects to generate and use panels of markers for stem cell attributes
common across species for use in characterization and isolation of stem cells
in a range of animal species or tissues.
o Projects to create universal methods of culture to maintain the
undifferentiated state of embryonic or other characterized, multipotential
stem cells across nonhuman animal species.
Projects supported by the National Center for Research Resources under this PA
are intended to generate research tools, reagents or multipotential stem cells
of utility to research on a broad range of tissue or cell types and of
interest to more than one categorical or disease-oriented Institute or Center
of the National Institutes of Health. Projects that will focus on research on
tissues or disease processes specific to the mission of an Institute or Center
should be directed to the respective Institute or Center.
The research supported under this PA should clearly expand the usefulness of
nonhuman animal model systems by generating multipotential stem cells
appropriate to those systems and tools that will allow for further research
on those stem cells. The results of R21 projects are expected to include
preliminary data appropriate for applications for further support through the
Research Project grant (R01) or Resource-Related Research Projects grant
(R24) mechanisms. Not all of the NIH Institutes and Centers support R24
applications. Applicants should contact the relevant Program Official before
submitting an R24 application. For further information about the NCRR R24
program please see (http://www.ncrr.nih.gov/compmed/cmguidfl.pdf) or
(http://www.ncrr.nih.gov/compmed/cm_rpg.asp).
MECHANISMS OF SUPPORT
This PA will use the NIH research project (R01) and exploratory/developmental
grant (R21) award mechanisms. As an applicant, you will be solely
responsible for planning, directing, and executing the proposed project.
This PA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
https://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. Support for R21 grants is limited to
two years with a maximum of $100,000 direct costs requested per year.
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
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA 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/research issues to:
John D. Harding, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Suite 6050, MSC 7965
Bethesda, MD 20892-7965
Telephone: (301) 435-0744
FAX: (301) 480-3819
Email: hardingj@ncrr.nih.gov
Colette Freeman, Ph.D.
Cancer Cell Biology Branch
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, Room 5030
Bethesda, MD 20892-7396
Telephone: (301) 496-7028
FAX: (301) 402-1037
Email: cf33a@nih.gov
Richard S. Fisher, Ph.D.
Division of Extramural Research
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: cornea@nih.gov
John W. Thomas, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10154
Bethesda, MD 20892-7950
Telephone: (301) 435-0050
FAX: (301) 451-5453
Email: thomasj@nhlbi.nih.gov
Christine A. Kelley, Ph.D.
Division of Bioengineering
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Room 957
Bethesda Md 20814-9692
Telephone: (301) 451-4778
FAX: (301) 480-4974
Email: kelleyc@mail.nih.gov
Richard J. Tasca, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room B01-MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6973
FAX: (301) 496-0962
Email: rt34g@nih.gov
David G. Badman, Ph.D.
Hematology Program
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 621, MSC 5458
6707 Democracy Blvd.
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: db70f@nih.gov
Beth-Anne Sieber, Ph.D.
Developmental Neurobiology Program
National Institute of Mental Health
6001 Executive Boulevard, Room 7186, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 402-4720
Email: sieberb@helix.nih.gov
Arlene Y. Chiu, Ph.D.
Repair and Plasticity Program
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2206
6001 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-1447
FAX: (301) 480-1080
Email: chiua@ninds.nih.gov
Jill L. Carrington, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C231
Bethesda, MD 20892-9205
Telephone: (301) 496-6402
FAX: (301) 402-0010
Email: carringtonj@nia.nih.gov
Nancy L. Freeman, Ph.D.
Hearing and Balance/Vestibular Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South-400C
6120 Executive Boulevard, MSC 7180
Rockville, MD 20852
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: Nancy_Freeman@nih.gov
Jonathan D. Pollock, Ph.D.
Genetics and Molecular Neurobiology Research Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4274
Bethesda, MD 20892
Telephone: (301) 435-1309
FAX: (301) 594-6043
Email: jp183r@nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Irene Grissom
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD 20892
Telephone: (301) 435-0844
FAX: (301) 480-3777
Email: grissomi@ncrr.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: WolfreyC@gab.nci.nih.gov
Mr. William W. Darby
Division of Extramural Research
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 496-9997
Email: wwd@nei.nih.gov
Mr. Robert Vinson
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
FAX: (301) 480-3310
Email: vinsonr@nhlbi.nih.gov
Ms. Nancy Curling
Grants Management Office
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd, Room 975
Bethesda, MD 20814-9692
Telephone: (301) 451-4782
FAX: (301) 480-4974
Email: curlingn@mail.nih.gov
Ms. Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17M
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: kathy.hancock@nih.gov
Ms. Aretina Perry-Jones
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 632, MSC 5456
6707 Democracy Blvd.
Bethesda, MD 20892-5456
Telephone: (301) 594-8862
FAX: (301) 480-3504
Email: perrya@extra.niddk.nih.gov
Ms. Carol Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: cr2092@nih.gov
Mr. Jeffrey Domanski
Grants Management Branch, DER
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3290, MSC 9537
6001 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-9231
FAX: (301) 402-0219
Email: jd356w@nih.gov
Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippl@nih.gov
Ms. Sara Stone
Grants Management Office
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: stones@nidcd.nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at https://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
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
https://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
https://grants.nih.gov/grants/funding/modular/modular.htm.
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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five 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)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described at
https://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA 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 for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) 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 Significance
o Approach
o Innovation
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) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
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.
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 a PA 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
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
https://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 Nos. 93.306, 93.396, 93.867, 93.839, 93.287,
93.864, 93.849, 93.242, 93.853, 93.866, 93.173, 93.279 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
https://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.