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PA NUMBER: PA-02-147 (superseded by PA-04-125)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 
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.  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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
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 http://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 
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.

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. 

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 
http://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 
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 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 
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.

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