NATIONAL STEM CELL RESOURCE

Release Date:  December 23, 1998

RFA:  RR-99-002

P.T.

National Center for Research Resources

Letter of Intent Receipt Date:  February 11,1999
Application Receipt Date:  March 11, 1999

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,
maintenance, preservation and distribution of nonhuman-derived embryonic and
other stem cells from a variety of species, as well as 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" (Full
Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).

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. 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
December 1, 1999.

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 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

Approximately $700,000 (including direct and indirect costs) will be available
for this initiative in Fiscal Year 2000 and for each subsequent year.  It is
anticipated that one award will be made.  Proposed funding levels are subject to
change due to budgetary, administrative and/or scientific considerations, and are
dependent upon the receipt of a sufficient number of applications of high
scientific merit.  The award of grants pursuant to this RFA is contingent upon
the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Embryonic stem cells and other stem cell precursors for differentiated tissues
are critical models for fundamental understanding of 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 transgenic 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 and
developed in such widely used and important model systems as nonhuman primate,
zebrafish and chicken.  As 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 resources are not lost, but are made
available from a centralized source 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 collect, maintain, preserve and distribute
nonhuman embryonic, transgenic and lineage-specific stem cells from a variety of
species.  In addition, the Resource will 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
 
Plans for the National Stem Cell Resource must incorporate features that will
enable the resource to acquire, preserve, maintain, 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,
de-accessioning and general functions of the resource.  

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.

Because the Resource is expected to collect and distribute cells from a variety
of nonhuman 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 for this Resource must also put forward a clear plan for cost
recovery from investigators acquiring materials from the Resource, and clear
plans for how that program income will be used.  Furthermore, the application
should demonstrate institutional support for this resource, including, at a
minimum, a letter from the institutional official with authority for the space
and time of the Principal Investigator.

SPECIAL REQUIREMENTS

A requirement under the P40 mechanism is that research related to improvement of
the Resource 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 are
examples, only, and are not intended to be limiting.

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

The application must include a plan to track users and the general types of
projects the Resource materials are used in on a calendar-year basis.  Users
include both investigators depositing materials and investigators ordering the
materials.  These results must be reported to the Program Director, NCRR, on a
yearly basis to show activity of the Resource with respect to materials deposited
and who has used the materials from the resource.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 11, 1999, 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
6705 Rockledge Drive, Room 6164
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
Email: 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, Email grantsinfo@nih.gov; and from the program
administrator listed under INQUIRIES.

The RFA label available in the PHS 398 application form must 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 line 2 of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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
6705 Rockledge Drive, Room 6164, MSC 7965
Bethesda, MD  20892
Bethesda, MD  20817 (for express/courier service)

Applications must be received by March 11, 1999.  If an application is received
after that date, it will be returned to the applicant without review. 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
responsiveness by the NCRR.  Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.  Applications that
are complete and responsive will be evaluated for scientific and technical merit
by an appropriate peer review group convened 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, NCRR. 

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 the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.  Note that the 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, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

o  Significance.  What will be the impact of this resource on biomedical
research?

o  Approach.  Is the resource designed to effectively provide a service to the
research community?  Will the database support research by providing important
information about the Resource materials to the research community?

o  Innovation.  Are the design of the resource and the method of providing
service innovative?

o  Need.  Is there a demonstrated need for the resource in the biomedical
research community?

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?

The initial review group will also examine the provisions for the protection of
human and animal subjects and the safety of the research environment, as well as
the appropriateness of the budget.

AWARD CRITERIA

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

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas 

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jill L. Carrington, Ph.D.
Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Room 6164
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 480-3819
Email: jillc@ncrr.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Joellen Harper
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD   20892-7965
Telephone: (301) 435-0844
Email:  jh41m@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 PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  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 and contract 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 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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