NATIONAL STEM CELL RESOURCE
 
Release Date:  December 13, 1999
 
RFA:  RR-00-001
  
National Center for Research Resources
 
Letter of Intent Receipt Date:  January 9,2000
Application Information Meeting:  January 20, 2000
Application Receipt Date:  February 24, 2000
 
PURPOSE
 
The purpose of this Request for Applications (RFA) is to solicit 
applications to establish a National Stem Cell Resource.  The Resource 
will be for deposit, banking, growth and distribution of postnatally-
derived stem cells from a variety of species as well as embryonic stem 
cells from non-human species, and for deposit and distribution of 
related reagents and information in order to make these critical 
research tools available for biomedical research.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," a 
PHS-led national activity for setting priority areas.  This RFA, 
National Stem Cell Resource, is related to several priority areas, 
including cancer, heart disease and stroke, diabetes and chronic 
disability conditions, maternal and infant health, and others.  
Potential applicants may obtain a copy of "Healthy People 2000" at 
http://odphp.osophs.dhhs.gov/pubs/hp2000.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and 
eligible agencies of the Federal government. Foreign institutions are 
not eligible for P40 grants.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as 
Principal Investigators.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) Animal Model 
and Animal and Biological Material Resource Grant (P40) mechanism.  
Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The total 
project period for an application submitted in response to this RFA may 
not exceed 5 years.  The anticipated award date is September, 2000.
 
Because the nature and scope of the research proposed in response
to this RFA may vary, it is anticipated that the size of an award
will vary also.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-
initiated applications and be reviewed according to the customary
peer review procedures.

FUNDS AVAILABLE
 
The NCRR intends to commit approximately $800,000 in FY 2000 to fund 
one new grant in response to this RFA.  An applicant may request a 
project period of up to 5 years.  Although the financial plans of the 
NCRR provide support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of 
applications of outstanding scientific and technical merit. 

RESEARCH OBJECTIVES
 
Background
 
Embryonic stem cells and other stem cell precursors for differentiated 
tissues are critical models for fundamental understanding of normal 
biological and disease processes.  Embryonic stem cell research is 
important to provide the tools for studies of basic mechanisms of 
development and function, in functional genomics, and in production of 
genetically altered animals.  The ability to control differentiation 
and sort differentiated cells from undifferentiated, and possibly 
tumorigenic precursor stem cells, holds great potential for 
therapeutics, particularly involving tissue replacement.  

Many laboratories are now engaged in research using mouse embryonic 
stem cells and lineage-specific precursors derived from embryonic stem 
cells.  In addition, embryonic stem cells are being isolated in such 
widely used and important model systems as the nonhuman primate, 
zebrafish, medaka and chicken.  Furthermore, there have been 
significant advances in the characterization and isolation of stem 
cells derived from postnatal tissues and which have the potential to 
form replacement tissues for the central nervous system, muscle, blood, 
and other organs.  This area of research, with its potential for 
therapeutic use, will require ready accessibility of stem cells to 
understand their developmental potential and the control of that 
potential.  Reagents to characterize these precursor cells and that can 
be used to recognize and sort them from living tissue are becoming 
known and will be invaluable to research, as well as potentially 
valuable in tissue replacement efforts.  

As postnatally-derived and embryonic stem cells are isolated from 
different species, and stem cell precursors for differentiated cell 
types are characterized and isolated, it will be critical that these 
materials are not lost, but are made available from a centralized 
resource for use in studies of biology, disease, and therapies. To 
ensure that invaluable stem cells are available to the research 
community, a National Stem Cell Resource will acquire, bank, grow and 
distribute postnatally-derived stem cells and nonhuman embryonic stem 
cells from a variety of species.  The National Center for Research 
Resources currently supports a repository that receives and distributes 
mouse embryonic stem cells carrying targeted mutations.  The National 
Stem Cell Resource should not duplicate these efforts.  Rather, it 
should provide for sharing of postnatally-derived stem cells from a 
variety of species and enlarge the number of non-human species for 
distribution of embryonic stem cells (with and without targeted 
mutations).  

In order to more fully support stem cell research, and research into 
use of stem cells for replacement of diseased or damaged tissues, it is 
imperative that stem cell-specific reagents are also widely available 
to the research community.  Therefore, the Resource will also be a 
focal point for exchange of reagents directly related to the 
characterization of the stem cells on deposit (specific antibodies or 
nucleic acid probes, for example).
  
Other Features of the Resource
 
Advisory Committee: Plans for the National Stem Cell Resource must 
incorporate features that will enable the resource to acquire, bank, 
grow and distribute stem cells and directly related reagents for the 
biomedical research community.  An Advisory Committee must be 
established to advise on policy for acquisition, distribution and 
management of the collection, as well as on general functions of the 
resource and as described below.  The Advisory Committee must be named 
in the application and be composed of individuals with outstanding 
scientific expertise and selected for national representation.  
Biographical sketches and letters from the committee members must be 
provided to demonstrate that the committee comprises the expertise 
necessary to perform these functions.

Stem Cells from Postnatal Tissues: In the case of postnatally-derived 
stem cells, the resource must be prepared to do in vitro expansion and 
appropriate characterization of the cells for distribution.  
Furthermore, the resource must accommodate needs for optimizing methods 
for growth and preservation of these cells from varying tissue and 
species sources.  The Advisory Committee will function to ensure that 
appropriate standards are used to provide the most useful cells to 
investigators.

Non-human Embryonic Stem Cells: Except in the case of mouse, research 
on embryonic stem cells has generally not advanced to the point where 
chimerism and in vivo participation in formation of germline cells can 
be routinely shown for embryonic stem cells from each species.  
Further, such testing on a routine basis would involve prohibitive 
costs. Nevertheless, it is useful and important to make these cells and 
pertinent information for use of the cells available for research.  
This National Stem Cell Resource will not function to routinely perform 
in vivo testing for participation in formation of germline cells for 
embryonic stem cells of all species to be deposited and distributed 
within the initial grant period. Rather, the Resource must incorporate 
a plan to work through the Advisory Committee to determine the level of 
rigor with which deposited cells must be characterized to be of use to 
the research community. It is envisioned that investigators wishing to 
use the services of the Resource to distribute germline-capable, 
totipotent embryonic stem cells, will supply enough cells to meet 
anticipated demand. If the Resource accepts embryonic stem cells 
available in limited quantity and must expand the cells to accommodate 
widespread distribution, there must be a plan to characterize the cells 
according to reasonable Advisory Committee standards and to provide 
full documentation of the degree of characterization to investigators 
receiving the cells.

Information Resources: Because the Resource is expected to collect and 
distribute cells from a variety of animal models, plans to accommodate 
the specific needs for growth, preservation, expansion, and 
distribution of stocks from these various sources will be an important 
part of the project.  The application must demonstrate that mechanisms 
will be in place for exchange of information for optimal growth and 
preservation of the cells from the investigators depositing the cells. 

Plans must include a database component to collect and distribute 
information about the Resource to the research community; this 
information component must be available through the World Wide Web and 
allow researchers to determine what resources are available and how to 
obtain them.  Furthermore, this component should be designed as a 
critical focal point for information exchange for research using the 
cells and reagents in the Resource.

Other:  The application for this Resource must put forward a clear plan 
for charges to investigators acquiring materials from the Resource, and 
clear plans for how program income will be used to enhance the 
Resource.  Inquiries on this aspect of the application are welcomed by 
Program staff.

SPECIAL REQUIREMENTS

Under the P40 mechanism, research related to the improvement of the 
Resource activities must be proposed.  Examples of such research would 
be investigations into optimal methods for cryopreservation of cell 
stocks, or investigations into reagents to characterize and identify 
stem cells of various types.  These examples are not intended to be 
limiting.

The Principal Investigator for the Resource is required to attend the 
annual meeting of resource directors for the Comparative Medicine area, 
NCRR, which is held at one of the Resources.  The application should 
include a budget item for this expense, calculated as a two-day 
meeting.

The application should demonstrate institutional support for this 
resource.

The application must include a plan to document users and all Resource-
related publications resulting from use of the Resource on a yearly 
basis, to be submitted with the annual progress report.  Users include 
both investigators depositing materials and investigators ordering the 
materials.  These results must be reported yearly to the Program 
Director, NCRR, to show activity of the Resource with respect to 
materials deposited and investigators who have used the materials from 
the resource, as well as to demonstrate the impact of the Resource on 
biomedical research.

As research on embryonic stem cells grows, it may be that the level of 
rigor for routinely characterizing these cells in several species may 
approach that of the mouse, including testing for formation of germline 
cells in chimeric animals after initial cell populations are expanded 
in order for the stem cells to be useful for further investigation.  It 
will be incumbent on the Resource to document such needs and 
incorporate a plan to meet any such needs in any competitive renewal, 
including collaborations with laboratories capable of performing the in 
vivo testing methods.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups 
and their subpopulations must be included in all NIH supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification is provided 
that inclusion is inappropriate with respect to the health of the 
subjects or the purpose of the research.  This policy results from the 
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43

All investigators proposing research involving human subjects should 
read the "NIH Guidelines for Inclusion of Women and Minorities as 
Subjects in Clinical Research," which was published in the Federal 
Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for 
Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the 
web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the Inclusion of Children as 
Participants in Research Involving Human Subjects that was published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and is available 
at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

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

LETTER OF INTENT
 
Prospective applicants are asked to submit, by January 9, 2000, a 
letter of intent that includes a descriptive title of the proposed 
project, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, and the number and title of this RFA.  Although a letter 
of intent is not required, is not binding, and does not enter into the 
review of a subsequent application, the information that it contains 
allows NCRR staff to estimate the potential review workload and avoid 
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Jill L. Carrington, Ph.D.
Comparative Medicine
National Center for Research Resources
One Rockledge Centre, Room 6174
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
e-mail: jillc@ncrr.nih.gov
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (Rev. 4/98) is to be used 
in applying for this grant.  These forms are available at most 
institutional offices of sponsored research; from the Division of 
Extramural Outreach and Information Resources, NIH, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714 or 
E-mail grantsinfo@nih.gov; and from the program administrator listed 
under INQUIRIES.
 
The RFA label available in the PHS 398 application form must have the 
RFA number on it and be affixed to the bottom of the face page of the 
application.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review 
committee in time for review.  In addition, the RFA title and number 
must be typed on the label and on line 2a of the face page of the 
application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:
 
Center for Scientific Review (CSR)
National Institutes of Health
Suite 1040
6701 Rockledge Drive MSC 7710
Bethesda, MD   20892-7710

Applicants who wish to use express mail or courier service should 
change the zip code to 20817.

At the time of submission, two additional copies of the application 
must be sent to:
 
Jill L. Carrington, Ph.D.
Comparative Medicine
National Center for Research Resources
One Rockledge Centre, Room 6174
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892 (for express mail please use zip code 20817)
 
Applications must be received by February 24, 2000.  If an application 
is received after that date, it will be returned to the applicant 
without review. The CSR will not accept any application in response to 
this RFA 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 substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by CSR and 
for responsiveness by the NCRR.  Incomplete applications will be 
returned to the applicant without further consideration.  If the 
application is not responsive to the RFA, CSR staff may contact the 
applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next review cycle.

Applications that are complete and responsive will be evaluated for 
scientific and technical merit by an appropriate peer review group 
convened by the NCRR in accordance with NIH peer review procedures.  As 
part of the initial merit review, all applications will receive a 
written critique and may undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the 
top one half of applications under review, will be discussed, assigned 
a priority score, and receive a second level review by the National 
Advisory Research Resources Council. 

Review Criteria
 
o  Significance.  What will be the impact of this resource on 
biomedical research?  Does the application demonstrate the breadth of 
research that will be impacted?
 
o  Approach.  Is the resource designed to effectively provide the 
required service to the research community?  Is the approach sufficient 
to accommodate the varied species and tissue sources of the cells?  
Will the database support research by providing important information 
about the Resource materials to the diverse research community?
 
o  Innovation.  Are the design of the resource and the method of 
providing service innovative?

o  Investigator.  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers?

o   Research Component.  Is the research to be performed of value to 
the resource?  Is the research innovative and significant?

o   Environment.  Does the environment contribute to the probability of 
success of the resource?  Is there evidence of institutional support 
for the resource?
 
In addition to the above criteria, in accordance with NIH policy, all 
applications will be reviewed with respect to the following:

o   The reasonableness of the proposed budget and duration in relation 
to the proposed research.

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

Schedule

Letter of Intent Receipt Date:  January 9, 2000
Application Receipt Date:  February 24, 2000
Peer Review Date:  April, 2000
Council Review:  May, 2000
Earliest Anticipated Start Date:  July 1, 2000
  
AWARD CRITERIA
 
Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities

INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.  
An Applicant Information Meeting to assist applicants unfamiliar with 
the requirements for “Animal Model, and Animal and Biological Materials 
Resource Grant” applications and to clarify any issues or questions 
from potential applicants will be held at 1 P.M. on January 20, 2000 in 
Bethesda, MD.  For additional information regarding the Applicant 
Information Meeting, call (301) 435-0744.  A summary of the 
presentations and issues discussed will be made available on the NCRR 
web site (http://www.ncrr.nih.gov) for those unable to attend.
 
Direct inquiries regarding programmatic issues to:
 
Jill L. Carrington, Ph.D.
Comparative Medicine
National Center for Research Resources
One Rockledge Centre, Room 6174
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
e-mail: jillc@ncrr.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mr. Paul Karadbil 
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD   20892-7965
Telephone: (301) 435-0844
Email:  paulk@ncrr.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance 
No. 93.849.  Awards are made under authorization of the Public Health 
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public 
Law 99-158, 42 USC 241 and 285) and administered under NIH grants 
policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in come 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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