Full Text RR-93-002

NATIONAL RESOURCE FOR TRANSGENIC ANIMALS

NIH Guide, Volume 22, Number 13, April 2, 1993

RFA:  RR-93-002

P.T. 34

Keywords: 
  Animal Breed. & Facil., Scientific 
  Genetics 


National Center for Research Resources

Application Receipt Date: June 23, 1993

PURPOSE

The National Center for Research Resources (NCRR) invites applications
to establish National Resource(s) for Transgenic Animals, to be awarded
competitively in Fiscal Year 1993.

The primary objectives of this initiative are to:  (1) create a
repository of embryos of transgenic rodents and lagomorphs, and (2)
conduct research to perfect cryopreservation methods for important
animal species.  This award will establish a resource center where
embryos are preserved, maintained (banked), and distributed; where
transgenic animals are produced at request from the maintained embryos;
and where research is conducted on cryopreservation techniques.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges,
laboratories, hospitals, or medical centers.  Applications from foreign
institutions are ineligible for the P40 mechanism.  Applicant
institutions must demonstrate an established research and resource base
in areas related to the Request for Applications (RFA).
Underrepresented minorities, persons with disabilities, and women are
encouraged to apply.

MECHANISM OF SUPPORT

Grants awarded in response to this initiative will be via the NCRR
Animal (Mammalian and Nonmammalian 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. Awards will be administered under Public
Health Service (PHS) grants policy as stated in the PHS Grants Policy
Statement and in this RFA.

The total project period for applications submitted in response to the
RFA may not exceed five years and is renewable.  The earliest expected
award date is September 30, 1993.

Applicants must limit their requests to not more than $350,000 direct
costs for the initial budget period.  Future budget period escalations
may not exceed a four percent increase over the previous budget period.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and will be reviewed according to the customary peer
review procedures.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of
support for this activity are approximately $1,000,000.  It is
anticipated that one or two awards will be made in FY 93 with an
average size of approximately $500,000 total costs.  However, the
specific number of awards will depend upon the scientific merit and
scope of the applications received and the availability of funds.

RESEARCH OBJECTIVE

Background

The laboratory mouse is presently the most widely used, available, and
economical animal model used in biomedical research and, in particular,
transgenic research.  In addition to the many traditional mutant mouse
strains, hundreds of additional strains of mice have been created in
recent years through transgenic technology.  The methods presently
available to preserve, maintain, and produce this proliferating number
of strains include active breeding programs and embryo
cryopreservation.  Breeding is expensive and often duplicative.
Cryopreservation of embryos is less expensive, but is technologically
intensive and heavily dependent on mouse husbandry.  These handicaps
are clearly resulting in the loss of many strains and limiting access
to other users.  The development of refined technology for harvesting
and successfully cryopreserving mouse sperm and reconstitution of
strains through in vitro fertilization or artificial insemination and
relatively simple breeding procedures offer a very promising
alternative to the current situation.

An NCRR-sponsored conference on Development of Transgenic Animal Model
Resources was held in November 1990.  This conference recommended the
development of transgenic technology and cryopreservation of transgenic
embryos and sperm.  Improved preservation of animal genetic resources
through cryopreservation was also recommended in the 1990 Report of the
Committee on Preservation of Laboratory Animal Resources, Institute of
Laboratory Animal Resources, Commission of Life Sciences, National
Research Council.

Objectives

The objective of this RFA is to initiate a long-term, stable,
integrated program for safeguarding national research animal resources
of importance to research projects sponsored by the PHS.  This
initiative will:

1) Provide support to a limited number of centers to serve as
multi-categorical research and service resources for the preservation
and supply of transgenic rodent and lagomorph strains.  These centers
are to be regional in nature, and serve users throughout the United
States.

2) Encourage applied research on the development of improved techniques
for cryopreservation of eggs, sperm, and embryos of numerous rodent and
lagomorph species.

3) Incorporate the resources/equipment for the freezing and maintenance
of embryos, sperm, and eggs of transgenic animals, and provide, on a
full cost recovery basis, live animals from the embryos.  A plan will
be developed that describes the cost recovery procedures to be
implemented.

4) Provide a means for more extensive and long term support to maintain
the embryos of those rodent and lagomorph species and models considered
to be of national importance and that cannot be preserved through
alternate methods.

5) Establish a national advisory committee to review, plan, and
prioritize national needs for preservation of important laboratory
animal resources.  This committee will also act as a central point for
the review and evaluation of stocks to be accepted into the repository.
It is suggested that the committee be composed of no fewer than five
members, with the Principal Investigator serving as the chairperson of
the committee.  It is encouraged that a minimum of two members be
appointed from outside the institution receiving the grant.  It is
suggested that the committee meet formally at least twice a year during
the first year, and then at least once a year thereafter.  Conference
calls may be held on an as-needed basis to coordinate and plan the
activities of the center.

6) Establish effective cooperation with other institutions and
organizations with similar interests to minimize costs and avoid
duplication.

7) Establish a modern database for classification of all embryos
maintained by the resource, maintenance of nomenclature for transgenic
embryos being held, and tracking distribution of all embryos or animals
provided to users of the resource.

8) Encourage users who have developed transgenic animals with research
funds provided through the National Institutes of Health (NIH) to store
constructs in these centers.

9) Encourage self-sufficiency of the centers at the end of the project
period.  A detailed plan will be developed that describes how
self-sufficiency will be achieved.

For the purposes of this RFA, users of the centers are defined as those
individuals who have peer-reviewed research projects involving
transgenic animals, with first priority given to those funded by the
NIH, followed by those funded by other agencies of the PHS, followed by
other sources of peer-reviewed research support.

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 09/91),
available at most institutional offices of sponsored research and from
the Office of Grants Inquiries, Division of Research Grants, National
Institute of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD
20892, telephone (301) 710-0267.  For item 2a of the face page of the
application, applicants must enter RFA:  National Resource for
Transgenic Animals, RFA RR-93-002.  The RFA label available in the form
PHS 398 must be affixed to the bottom of the face page.  Failure to use
this label could result in delayed processing of the application to the
extent that it may not reach the review committee in time for review.

Applications must be received by close of business June 23, 1993.  If
an application is received after this date, it will be returned to the
applicant.

Submit a signed, typewritten original and three signed photocopies of
the application to:

Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Dr. Bernadette Tyree
Office of Review
National Center for Research Resources
Westwood Building, Room 10A16
Bethesda, MD  20892

The Division of Research Grants (DRG) 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.  Nor will the DRG 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.

Budgetary Considerations - Allowable Costs

Unless otherwise indicated, allowable costs and policies governing the
research grant programs of the NIH will prevail.  Overlapping support
between the grant and other NIH grants and contracts to the applicant
institution will be administratively reviewed and, if appropriate, will
be adjusted to avoid duplication of funding.

Support may be requested for salaries of professional, technical, and
support personnel who contribute to allowable activities under the
grant.  The salaries derived from the grant will depend on the effort
provided and institutional salary policies.  Stipends for research
fellows/trainees are not allowable.  No overlap of time or effort
between the grant and other separately funded projects is permitted.

Support for secretarial and administrative staff may be provided to the
extent that their activities relate to administrative management of the
grant activities, providing these costs have not been included in the
institution's indirect cost pool.

It is expected that most major equipment necessary to carry out this
work will already be available.  However, requests for major equipment
under this RFA will be considered; this would include, but not be
limited to, equipment for producing and maintaining (freezing)
transgenic embryos, ova, and sperm.  General purpose equipment needs
may be included and justified only after surveying the availability of
such items within the institution.

While costs of animal maintenance (i.e., per diem charges) for research
animals are allowable, it is expected that the costs of production of
live animals from transgenic embryos will be recovered from the users
through a cost recovery system.  Applicants should separately identify
all costs related to the maintenance of research animals and to animal
production.

Costs of domestic travel for grant personnel and advisory committee
members are allowable.  Foreign travel will not be allowed except under
unusual and compelling circumstances, and will require prior approval
by the awarding agency.

Costs for consultant services (consultation fees, per diem, travel) may
be included.  Costs associated with consultation or scientific or
technical assistance, evaluation of planning activities, and
development of new techniques are allowable.

Costs for telephone, facsimile transmissions, photocopying, and
computer time that are directly related to the grant are permitted.

REVIEW CONSIDERATIONS

Upon receipt, applications will be examined initially by DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation of responsiveness
to the program requirements and criteria stated in this RFA is an NCRR
staff function.

Applications that are considered complete and responsive will be
evaluated in accordance with the criteria stated below by an
appropriate peer review group convened by the Office of Review of NCRR.
It is essential that the written application be in a form that can be
reviewed on its own merit, since no site visit is anticipated.

If the number of applications is large compared to the number of awards
to be made, the NCRR may conduct a preliminary scientific peer review
to eliminate those applications that are clearly not competitive.  The
NCRR will administratively withdraw from competition those applications
judged to be noncompetitive, and will so notify the applicant and the
institutional business official.  Applications judged to be both
competitive and responsive to the RFA will be evaluated further,
according to the review criteria stated below.

Following initial merit review, the applications will receive a
second-level review by the National Advisory Research Resources
Council.

The review of the grant applications will focus on scientific merit.

The evaluation will include the following review criteria:

1.  Overall Program

o  The potential of the center, as proposed, to meet the objectives
stated in this RFA.

o  The scientific merit of the program as a whole, including the
significance of the overall program goals and the development of a
well-defined central focus.

o  The potential of the identified participants to develop research
programs of high merit as evidenced by previous accomplishments.

2. Administration and Planning

o  The scientific and administrative leadership ability and experience
of the grant's Principal Investigator and his/her commitment and
ability to devote adequate time to the effective management of the
center.

o  The composition of the advisory committee, and how the national
needs for preservation of the laboratory animal resources will be
reviewed, planned, and prioritized.

o   Maintenance of internal communication and cooperation among the
investigators involved in the center, and adequacy of plans for such
collaboration.

o  Appropriateness of the budget for the various components of the
grant.

o  Appropriateness of the plan that details full cost recovery for
production of live animals from embryos.

o  Appropriateness of the plan that describes how the resource will
become self-sufficient by the end of the project period.

o  Quality of the plan to develop a database that will classify all
embryos maintained by the resource; maintain nomenclature for
transgenic embryos being held; and track distribution of all embryos or
animals sent to users of the resource.

3. Scientific Expertise of Participants

o  Quality and appropriateness of expertise available at the applicant
institution for research on the development of improved
cryopreservation techniques, maintenance of animals, and development of
the database.

o  Nature and degree of interdisciplinary approach proposed to promote
the collaboration of scientists with expertise in transgenic animal
methodology.

o  Qualifications, experience, and evidence of commitment of the
investigators within the applicant institution, and their willingness
to interrelate with other elements proposed for the center.

4. Institutional Commitment

o  The institutional commitment to the program, including lines of
responsibility for the proposed center and the institution's
contribution to the management capabilities of the center.

o  The degree of institutional contributions for administrative and
planning activities.

o  The research environment and the availability of expertise,
resources, equipment, and space for the freezing and maintenance of
embryos, sperm, and eggs of transgenic animals.

o The availability of expertise and resources required to provide users
with live animals from embryos at their request.

o  The potential for interaction with scientists from other departments
and institutions to minimize costs and avoid duplication.

o  The institutional commitment to any newly-recruited individuals
responsible for conducting essential grant functions and activities.

AWARD CRITERIA

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

o  Quality of the application as determined by peer review
o  Availability of funds
o  Overall program balance and geographic distribution represented by
the applications recommended by peer review

Schedule

Application Receipt Date:  June 23, 1993
Initial Review:            July/August 1993
Second Level Review:       September 1993
Anticipated Award:         September 1993

INQUIRIES

Written and telephone 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:

Dr. Cynthia L. Pond
Laboratory Animal Sciences Program
National Center for Research Resources
Westwood Building, Room 857
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 594-7933

Direct inquiries regarding fiscal matters to:

Ms. Kathy Springmann
Office of Grants and Contracts Management
National Center for Research Resources
Westwood Building, Room 853
Bethesda, MD  20892
Telephone:  (301) 594-7955

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.306, Laboratory Animal Sciences and Primate Research.  Awards
will be made under authorization of the Public Health Service Act,
Title III, Section 301 (Public Law 78.410, as amended; 42 USC 241) and
administered under PHS grant policies and Federal Regulations 42 CFR
Part 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.

.

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